SPECIALTY PHARMACY MANAGED CARE 20 ANNUAL MEETING18 · 2018-06-24 · 1 of 3 doses of benralizumab [25 mg (n=6), 100 mg (n=6) or 200 mg (n=6) SC] or placebo (n=6) every 4 weeks for

M e e t i n g H i g h l i g h t s & I n s i g h t s f o r P h a r m a c y S p e c i a l i s t s

Academy of Managed Care PharmacyManaged Care & Specialty Pharmacy Annual Meeting 2018April 23–26, 2018Boston, MA

Boston

AMCP MANAGED CARE &SPECIALTY PHARMACYANNUAL MEETING

2018


2018

FASENRA is proven to reduce annual exacerbation rate and improve lung function in patients with severe eosinophilic asthma. Improvements in lung function were observed as early as Week 4.*1-4

WITH BETTER BREATHING AFTER THE FIRST DOSE*1-4

POWER TO PREVENTEXACERBATIONS

*Statistical significance for FEV1 improvement was established at end of treatment. Week 4 results were descriptive only. FASENRA demonstrated greater improvements in change from baseline in pre-bronchodilator FEV1 compared with placebo at Week 4 (first measured time point after administration of treatment dose) that were maintained through end of treatment.2-4

† The pharmacodynamic response (blood eosinophil depletion) following repeat SC dosing was evaluated in asthma patients in a 12-week phase 2 trial. Patients received 1 of 3 doses of benralizumab [25 mg (n=6), 100 mg (n=6) or 200 mg (n=6) SC] or placebo (n=6) every 4 weeks for a total of 3 doses. Twenty-four hours post dosing, all benralizumab dosage groups demonstrated complete or near complete depletion of blood eosinophil levels, which was maintained throughout the dosing period.1,5

The relationship between the pharmacologic properties and clinical efficacy has not been established.

IMPORTANT SAFETY INFORMATIONCONTRAINDICATIONS Known hypersensitivity to benralizumab or excipients.

WARNINGS AND PRECAUTIONSHypersensitivity Reactions Hypersensitivity reactions (eg, anaphylaxis, angioedema, urticaria, rash) have occurred after administration of FASENRA. These reactions generally occur within hours of administration, but in some instances have a delayed onset (ie, days). Discontinue in the event of a hypersensitivity reaction.Acute Asthma Symptoms or Deteriorating Disease FASENRA should not be used to treat acute asthma symptoms, acute exacerbations, or acute bronchospasm.

IMPORTANT SAFETY INFORMATION (cont’d)Reduction of Corticosteroid Dosage Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with FASENRA. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.Parasitic (Helminth) Infection It is unknown if FASENRA will influence a patient’s response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with FASENRA. If patients become infected while receiving FASENRA and do not respond to anti-helminth treatment, discontinue FASENRA until infection resolves.

Please see additional Important Safety Information on next page and accompanying Brief Summary of full Prescribing Information.

• FASENRA is the first and only biologic that provides near complete depletion of blood eosinophils in 24 hours†1,5

- The mechanism of action of benralizumab in asthma has not been definitively established

° The relationship between the pharmacologic properties and clinical efficacy has not been established

• FASENRA is the first and only biologic for severe asthma with a prefilled syringe and Q8W maintenance dosing schedule1

• The most common adverse reactions (incidence greater than or equal to 5%) include headache and pharyngitis1

FASENRA is indicated as an add-on maintenance treatment of patients 12 years or older with severe eosinophilic asthma.

GET STARTED AT FASENRAFACTS.COM

FASENRA is not indicated for treatment of other eosinophilic conditions or for the relief of acute bronchospasm or status asthmaticus.

US-20804_US-12988 Fasenra AMCP 2018 Conference Highlights.indd 1 6/5/18 9:33 AM

FASENRA is proven to reduce annual exacerbation rate and improve lung function in patients with severe eosinophilic asthma. Improvements in lung function were observed as early as Week 4.*1-4

WITH BETTER BREATHING AFTER THE FIRST DOSE*1-4

POWER TO PREVENTEXACERBATIONS

*Statistical significance for FEV1 improvement was established at end of treatment. Week 4 results were descriptive only. FASENRA demonstrated greater improvements in change from baseline in pre-bronchodilator FEV1 compared with placebo at Week 4 (first measured time point after administration of treatment dose) that were maintained through end of treatment.2-4

† The pharmacodynamic response (blood eosinophil depletion) following repeat SC dosing was evaluated in asthma patients in a 12-week phase 2 trial. Patients received 1 of 3 doses of benralizumab [25 mg (n=6), 100 mg (n=6) or 200 mg (n=6) SC] or placebo (n=6) every 4 weeks for a total of 3 doses. Twenty-four hours post dosing, all benralizumab dosage groups demonstrated complete or near complete depletion of blood eosinophil levels, which was maintained throughout the dosing period.1,5

The relationship between the pharmacologic properties and clinical efficacy has not been established.

IMPORTANT SAFETY INFORMATIONCONTRAINDICATIONS Known hypersensitivity to benralizumab or excipients.

WARNINGS AND PRECAUTIONSHypersensitivity Reactions Hypersensitivity reactions (eg, anaphylaxis, angioedema, urticaria, rash) have occurred after administration of FASENRA. These reactions generally occur within hours of administration, but in some instances have a delayed onset (ie, days). Discontinue in the event of a hypersensitivity reaction.Acute Asthma Symptoms or Deteriorating Disease FASENRA should not be used to treat acute asthma symptoms, acute exacerbations, or acute bronchospasm.

IMPORTANT SAFETY INFORMATION (cont’d)Reduction of Corticosteroid Dosage Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with FASENRA. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.Parasitic (Helminth) Infection It is unknown if FASENRA will influence a patient’s response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with FASENRA. If patients become infected while receiving FASENRA and do not respond to anti-helminth treatment, discontinue FASENRA until infection resolves.

Please see additional Important Safety Information on next page and accompanying Brief Summary of full Prescribing Information.

• FASENRA is the first and only biologic that provides near complete depletion of blood eosinophils in 24 hours†1,5

- The mechanism of action of benralizumab in asthma has not been definitively established

° The relationship between the pharmacologic properties and clinical efficacy has not been established

• FASENRA is the first and only biologic for severe asthma with a prefilled syringe and Q8W maintenance dosing schedule1

• The most common adverse reactions (incidence greater than or equal to 5%) include headache and pharyngitis1

FASENRA is indicated as an add-on maintenance treatment of patients 12 years or older with severe eosinophilic asthma.

GET STARTED AT FASENRAFACTS.COM

FASENRA is not indicated for treatment of other eosinophilic conditions or for the relief of acute bronchospasm or status asthmaticus.


FASENRA™ (benralizumab) injection, for subcutaneous useInitial U.S. Approval: 2017Brief Summary of Prescribing Information. For complete prescribing information consult official package insert. INDICATIONS AND USAGE FASENRA is indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype [see Clinical Studies (14) in the full Prescribing Information].Limitations of use:

• FASENRA is not indicated for treatment of other eosinophilic conditions.• FASENRA is not indicated for the relief of acute bronchospasm or status asthmaticus.

DOSAGE AND ADMINISTRATION Recommended DoseFASENRA is for subcutaneous use only. The recommended dose of FASENRA is 30 mg administered once every 4 weeks for the first 3 doses, and then once every 8 weeks thereafter by subcutaneous injection into the upper arm, thigh, or abdomen. Preparation and AdministrationFASENRA should be administered by a healthcare professional. In line with clinical practice, monitoring of patients after administration of biologic agents is recommended [see Warnings and Precautions (5.1) in the full Prescribing Information].Prior to administration, warm FASENRA by leaving carton at room temperature for about 30 minutes. Administer FASENRA within 24 hours or discard into sharps container.Instructions for Prefilled Syringe with Needle Safety GuardRefer to Figure 1 to identify the prefilled syringe components for use in the administration steps.Figure 1Figure 1

Needle guard activation clips

Syringe body

Label with expiration date

Needle cover

Plunger head

Plunger Finger flange

Viewing window

Needle

Carol Tuck 7/20/2017 11:38 AM

Deleted: Figure 1

Do not touch the needle guard activation clips to prevent premature activation of the needle safety guard.

1 Grasp the syringe body, not the plunger, to remove prefilled syringe from the tray. Check the expiration date on the syringe. Visually inspect FASENRA for particulate matter and discoloration prior to administration. FASENRA is clear to opalescent, colorless to slightly yellow, and may contain a few translucent or white to off-white particles. Do not use FASENRA if the liquid is cloudy, discolored, or if it contains large particles or foreign particulate matter. The syringe may contain a small air bubble; this is normal. Do not expel the air bubble prior to administration.

2

Do not remove needle cover until ready to inject. Hold the syringe body and remove the needle cover by pulling straight off. Do not hold the plunger or plunger head while removing the needle cover or the plunger may move. If the prefilled syringe is damaged or contaminated (for example, dropped without needle cover in place), discard and use a new prefilled syringe.

3Gently pinch the skin and insert the needle at the recommended injection site (i.e., upper arm, thigh, or abdomen).

4Inject all of the medication by pushing in the plunger all the way until the plunger head is completely between the needle guard activation clips. This is necessary to activate the needle guard.

5After injection, maintain pressure on the plunger head and remove the needle from the skin. Release pressure on the plunger head to allow the needle guard to cover the needle. Do not re-cap the prefilled syringe.

6 Discard the used syringe into a sharps container.

CONTRAINDICATIONS FASENRA is contraindicated in patients who have known hypersensitivity to benralizumab or any of its excipients [see Warnings and Precautions (5.1) in the full Prescribing Information]. WARNINGS AND PRECAUTIONSHypersensitivity ReactionsHypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, rash) have occurred following administration of FASENRA. These reactions generally occur within hours of administration, but in some instances have a delayed onset (i.e., days). In the event of a hypersensitivity reaction, FASENRA should be discontinued [see Contraindications (4) in the full Prescribing Information].Acute Asthma Symptoms or Deteriorating DiseaseFASENRA should not be used to treat acute asthma symptoms or acute exacerbations. Do not use FASENRA to treat acute bronchospasm or status asthmaticus. Patients should seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with FASENRA.Reduction of Corticosteroid Dosage Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with FASENRA. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.Parasitic (Helminth) InfectionEosinophils may be involved in the immunological response to some helminth infections. Patients with known helminth infections were excluded from participation in clinical trials. It is unknown if FASENRA will influence a patient’s response against helminth infections.Treat patients with pre-existing helminth infections before initiating therapy with FASENRA. If patients become infected while receiving treatment with FASENRA and do not respond to anti-helminth treatment, discontinue treatment with FASENRA until infection resolves.ADVERSE REACTIONS The following adverse reactions are described in greater detail in other sections:

• Hypersensitivity Reactions [see Warnings and Precautions (5.1) in the full Prescribing Information]

Clinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.Across Trials 1, 2, and 3, 1,808 patients received at least 1 dose of FASENRA [see Clinical Studies (14) in the full Prescribing Information]. The data described below reflect exposure to FASENRA in 1,663 patients, including 1,556 exposed for at least 24 weeks and 1,387 exposed for at least 48 weeks. The safety exposure for FASENRA is derived from two phase 3 placebo-controlled studies (Trials 1 and 2) from 48 weeks duration [FASENRA every 4 weeks (n = 841), FASENRA every 4 weeks for 3 doses, then every 8 weeks (n = 822), and placebo (n = 847)]. While a dosing regimen of FASENRA every 4 weeks was included in clinical trials, FASENRA administered every 4 weeks for 3 doses, then every 8 weeks thereafter is the recommended dose [see Dosage and Administration (2.1) in the full Prescribing Information]. The population studied was 12 to 75 years of age, of which 64% were female and 79% were white. Adverse reactions that occurred at greater than or equal to 3% incidence are shown in Table 1.Table 1. Adverse Reactions with FASENRA with Greater than or Equal to 3%

Incidence in Patients with Asthma (Trials 1 and 2)

Adverse Reactions FASENRA(N= 822)

%

Placebo(N=847)

%Headache 8 6Pyrexia 3 2Pharyngitis* 5 3Hypersensitivity reactions** 3 3

* Pharyngitis was defined by the following terms: ‘Pharyngitis’, ‘Pharyngitis bacterial’, ‘Viral pharyngitis’, ‘Pharyngitis streptococcal’.

** Hypersensitivity Reactions were defined by the following terms: ‘Urticaria’, ‘Urticaria papular’, and ‘Rash’ [see Warnings and Precautions (5.1) in the full Prescribing Information].


STUDY DESIGNSTRIALS 1 AND 2

Trial 1 (48-week) and Trial 2 (56-week) were 2 randomized, double-blind, parallel-group, placebo-controlled, multicenter studies comparing FASENRA 30 mg SC Q4W for the first 3 doses, then Q8W thereafter; benralizumab 30 mg SC Q4W, and placebo SC. A total of 1204 (Trial 1) and 1306 (Trial 2) patients aged 12-75 years old with severe asthma uncontrolled on high-dose ICS (Trial 1) and medium- to high-dose ICS (Trial 2) plus LABA with or without additional controllers were included. Patients had a history of ≥2 exacerbations requiring systemic corticosteroids or temporary increase in usual dosing in the previous year. The primary endpoint was annual exacerbation rate ratio versus placebo in patients with blood eosinophil counts of ≥300 cells/μL on high-dose ICS and LABA. Exacerbations were defined as a worsening of asthma that led to use of systemic corticosteroids for ≥3 days, temporary increase in a stable OCS background dose for ≥3 days, emergency/urgent care visit because of asthma that needed systemic corticosteroids, or inpatient hospital stay of ≥24 hours because of asthma. Key secondary endpoints were pre-bronchodilator FEV1 and total asthma symptom score at Week 48 (Trial 1) and Week 56 (Trial 2) in the same population.2,3

TRIAL 3

A 28-week, randomized, double-blind, parallel-group, placebo-controlled, multicenter OCS reduction study comparing the efficacy and safety of FASENRA (30 mg SC) Q4W for the first 3 doses, then Q8W thereafter; benralizumab (30 mg SC) Q4W, and placebo (SC) Q4W. A total of 220 adult (18-75 years old) patients

with severe asthma on high-dose ICS plus LABA and chronic OCS (7.5 to 40 mg/day), blood eosinophil counts of ≥150 cells/μL, and a history of ≥1 exacerbation in the previous year were included. The primary endpoint was the median percent reduction from baseline in the final daily OCS dose while maintaining asthma control.6

PHASE 2 STUDY

A 12-week, phase 2, randomized, double-blind, placebo-controlled, dose-increase study of benralizumab in adults with mild to moderate asthma. Patients were randomized to receive SC administration of benralizumab 25 mg (n=6), benralizumab 100 mg (n=6), benralizumab 200 mg (n=6), or placebo (n=6) Q4W for a total of 3 doses. One objective was to assess the effect of benralizumab on blood eosinophil counts and protein biomarkers. Median blood eosinophil levels at baseline were 400, 200, 120, and 200 cells/μL in the 25, 100, and 200 mg benralizumab and placebo groups, respectively.5

References: 1. FASENRA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; November 2017. 2. Bleecker ER, FitzGerald JM, Chanez P, et al. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting β2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388:2115-2127. 3. FitzGerald JM, Bleecker ER, Nair P, et al. Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016;388:2128-2141. 4. Data on File, REF-19697, AZPLP. 5. Pham TH, Damera G, Newbold P, Ranade K. Reductions in eosinophil biomarkers by benralizumab in patients with asthma. Respir Med. 2016;111:21-29. 6. Nair P, Wenzel S, Rabe KF, et al. Oral glucocorticoid–sparing effect of benralizumab in severe asthma. N Engl J Med. 2017;376:2448-2458.

ADVERSE REACTIONSThe most common adverse reactions (incidence ≥ 5%) include headache and pharyngitis.

Injection site reactions (eg, pain, erythema, pruritus, papule) occurred at a rate of 2.2% in patients treated with FASENRA compared with 1.9% in patients treated with placebo.

USE IN SPECIFIC POPULATIONSThe data on pregnancy exposure from the clinical trials are insufficient to inform on drug-associated risk. Monoclonal antibodies such as benralizumab are transported across the placenta during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy.

INDICATIONFASENRA is indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.

• FASENRA is not indicated for treatment of other eosinophilic conditions

• FASENRA is not indicated for the relief of acute bronchospasm or status asthmaticus

Please see adjacent Brief Summary of full Prescribing Information on reverse side.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

©2018 AstraZeneca. All rights reserved. US-20804 5/18

FASENRA is a trademark of the AstraZeneca group of companies.

IMPORTANT SAFETY INFORMATION (cont’d)


FASENRA™ (benralizumab) injection, for subcutaneous useInitial U.S. Approval: 2017Brief Summary of Prescribing Information. For complete prescribing information consult official package insert. INDICATIONS AND USAGE FASENRA is indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype [see Clinical Studies (14) in the full Prescribing Information].Limitations of use:

• FASENRA is not indicated for treatment of other eosinophilic conditions.• FASENRA is not indicated for the relief of acute bronchospasm or status asthmaticus.

DOSAGE AND ADMINISTRATION Recommended DoseFASENRA is for subcutaneous use only. The recommended dose of FASENRA is 30 mg administered once every 4 weeks for the first 3 doses, and then once every 8 weeks thereafter by subcutaneous injection into the upper arm, thigh, or abdomen. Preparation and AdministrationFASENRA should be administered by a healthcare professional. In line with clinical practice, monitoring of patients after administration of biologic agents is recommended [see Warnings and Precautions (5.1) in the full Prescribing Information].Prior to administration, warm FASENRA by leaving carton at room temperature for about 30 minutes. Administer FASENRA within 24 hours or discard into sharps container.Instructions for Prefilled Syringe with Needle Safety GuardRefer to Figure 1 to identify the prefilled syringe components for use in the administration steps.Figure 1Figure 1

Needle guard activation clips

Syringe body

Label with expiration date

Needle cover

Plunger head

Plunger Finger flange

Viewing window

Needle

Carol Tuck 7/20/2017 11:38 AM

Deleted: Figure 1

Do not touch the needle guard activation clips to prevent premature activation of the needle safety guard.

1 Grasp the syringe body, not the plunger, to remove prefilled syringe from the tray. Check the expiration date on the syringe. Visually inspect FASENRA for particulate matter and discoloration prior to administration. FASENRA is clear to opalescent, colorless to slightly yellow, and may contain a few translucent or white to off-white particles. Do not use FASENRA if the liquid is cloudy, discolored, or if it contains large particles or foreign particulate matter. The syringe may contain a small air bubble; this is normal. Do not expel the air bubble prior to administration.

2

Do not remove needle cover until ready to inject. Hold the syringe body and remove the needle cover by pulling straight off. Do not hold the plunger or plunger head while removing the needle cover or the plunger may move. If the prefilled syringe is damaged or contaminated (for example, dropped without needle cover in place), discard and use a new prefilled syringe.

3Gently pinch the skin and insert the needle at the recommended injection site (i.e., upper arm, thigh, or abdomen).

4Inject all of the medication by pushing in the plunger all the way until the plunger head is completely between the needle guard activation clips. This is necessary to activate the needle guard.

5After injection, maintain pressure on the plunger head and remove the needle from the skin. Release pressure on the plunger head to allow the needle guard to cover the needle. Do not re-cap the prefilled syringe.

6 Discard the used syringe into a sharps container.

CONTRAINDICATIONS FASENRA is contraindicated in patients who have known hypersensitivity to benralizumab or any of its excipients [see Warnings and Precautions (5.1) in the full Prescribing Information]. WARNINGS AND PRECAUTIONSHypersensitivity ReactionsHypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, rash) have occurred following administration of FASENRA. These reactions generally occur within hours of administration, but in some instances have a delayed onset (i.e., days). In the event of a hypersensitivity reaction, FASENRA should be discontinued [see Contraindications (4) in the full Prescribing Information].Acute Asthma Symptoms or Deteriorating DiseaseFASENRA should not be used to treat acute asthma symptoms or acute exacerbations. Do not use FASENRA to treat acute bronchospasm or status asthmaticus. Patients should seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with FASENRA.Reduction of Corticosteroid Dosage Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with FASENRA. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.Parasitic (Helminth) InfectionEosinophils may be involved in the immunological response to some helminth infections. Patients with known helminth infections were excluded from participation in clinical trials. It is unknown if FASENRA will influence a patient’s response against helminth infections.Treat patients with pre-existing helminth infections before initiating therapy with FASENRA. If patients become infected while receiving treatment with FASENRA and do not respond to anti-helminth treatment, discontinue treatment with FASENRA until infection resolves.ADVERSE REACTIONS The following adverse reactions are described in greater detail in other sections:

• Hypersensitivity Reactions [see Warnings and Precautions (5.1) in the full Prescribing Information]

Clinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.Across Trials 1, 2, and 3, 1,808 patients received at least 1 dose of FASENRA [see Clinical Studies (14) in the full Prescribing Information]. The data described below reflect exposure to FASENRA in 1,663 patients, including 1,556 exposed for at least 24 weeks and 1,387 exposed for at least 48 weeks. The safety exposure for FASENRA is derived from two phase 3 placebo-controlled studies (Trials 1 and 2) from 48 weeks duration [FASENRA every 4 weeks (n = 841), FASENRA every 4 weeks for 3 doses, then every 8 weeks (n = 822), and placebo (n = 847)]. While a dosing regimen of FASENRA every 4 weeks was included in clinical trials, FASENRA administered every 4 weeks for 3 doses, then every 8 weeks thereafter is the recommended dose [see Dosage and Administration (2.1) in the full Prescribing Information]. The population studied was 12 to 75 years of age, of which 64% were female and 79% were white. Adverse reactions that occurred at greater than or equal to 3% incidence are shown in Table 1.Table 1. Adverse Reactions with FASENRA with Greater than or Equal to 3%

Incidence in Patients with Asthma (Trials 1 and 2)

Adverse Reactions FASENRA(N= 822)

%

Placebo(N=847)

%Headache 8 6Pyrexia 3 2Pharyngitis* 5 3Hypersensitivity reactions** 3 3

* Pharyngitis was defined by the following terms: ‘Pharyngitis’, ‘Pharyngitis bacterial’, ‘Viral pharyngitis’, ‘Pharyngitis streptococcal’.

** Hypersensitivity Reactions were defined by the following terms: ‘Urticaria’, ‘Urticaria papular’, and ‘Rash’ [see Warnings and Precautions (5.1) in the full Prescribing Information].


STUDY DESIGNSTRIALS 1 AND 2

Trial 1 (48-week) and Trial 2 (56-week) were 2 randomized, double-blind, parallel-group, placebo-controlled, multicenter studies comparing FASENRA 30 mg SC Q4W for the first 3 doses, then Q8W thereafter; benralizumab 30 mg SC Q4W, and placebo SC. A total of 1204 (Trial 1) and 1306 (Trial 2) patients aged 12-75 years old with severe asthma uncontrolled on high-dose ICS (Trial 1) and medium- to high-dose ICS (Trial 2) plus LABA with or without additional controllers were included. Patients had a history of ≥2 exacerbations requiring systemic corticosteroids or temporary increase in usual dosing in the previous year. The primary endpoint was annual exacerbation rate ratio versus placebo in patients with blood eosinophil counts of ≥300 cells/μL on high-dose ICS and LABA. Exacerbations were defined as a worsening of asthma that led to use of systemic corticosteroids for ≥3 days, temporary increase in a stable OCS background dose for ≥3 days, emergency/urgent care visit because of asthma that needed systemic corticosteroids, or inpatient hospital stay of ≥24 hours because of asthma. Key secondary endpoints were pre-bronchodilator FEV1 and total asthma symptom score at Week 48 (Trial 1) and Week 56 (Trial 2) in the same population.2,3

TRIAL 3

A 28-week, randomized, double-blind, parallel-group, placebo-controlled, multicenter OCS reduction study comparing the efficacy and safety of FASENRA (30 mg SC) Q4W for the first 3 doses, then Q8W thereafter; benralizumab (30 mg SC) Q4W, and placebo (SC) Q4W. A total of 220 adult (18-75 years old) patients

with severe asthma on high-dose ICS plus LABA and chronic OCS (7.5 to 40 mg/day), blood eosinophil counts of ≥150 cells/μL, and a history of ≥1 exacerbation in the previous year were included. The primary endpoint was the median percent reduction from baseline in the final daily OCS dose while maintaining asthma control.6

PHASE 2 STUDY

A 12-week, phase 2, randomized, double-blind, placebo-controlled, dose-increase study of benralizumab in adults with mild to moderate asthma. Patients were randomized to receive SC administration of benralizumab 25 mg (n=6), benralizumab 100 mg (n=6), benralizumab 200 mg (n=6), or placebo (n=6) Q4W for a total of 3 doses. One objective was to assess the effect of benralizumab on blood eosinophil counts and protein biomarkers. Median blood eosinophil levels at baseline were 400, 200, 120, and 200 cells/μL in the 25, 100, and 200 mg benralizumab and placebo groups, respectively.5

References: 1. FASENRA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; November 2017. 2. Bleecker ER, FitzGerald JM, Chanez P, et al. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting β2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388:2115-2127. 3. FitzGerald JM, Bleecker ER, Nair P, et al. Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016;388:2128-2141. 4. Data on File, REF-19697, AZPLP. 5. Pham TH, Damera G, Newbold P, Ranade K. Reductions in eosinophil biomarkers by benralizumab in patients with asthma. Respir Med. 2016;111:21-29. 6. Nair P, Wenzel S, Rabe KF, et al. Oral glucocorticoid–sparing effect of benralizumab in severe asthma. N Engl J Med. 2017;376:2448-2458.

ADVERSE REACTIONSThe most common adverse reactions (incidence ≥ 5%) include headache and pharyngitis.

Injection site reactions (eg, pain, erythema, pruritus, papule) occurred at a rate of 2.2% in patients treated with FASENRA compared with 1.9% in patients treated with placebo.

USE IN SPECIFIC POPULATIONSThe data on pregnancy exposure from the clinical trials are insufficient to inform on drug-associated risk. Monoclonal antibodies such as benralizumab are transported across the placenta during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy.

INDICATIONFASENRA is indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.

• FASENRA is not indicated for treatment of other eosinophilic conditions

• FASENRA is not indicated for the relief of acute bronchospasm or status asthmaticus

Please see adjacent Brief Summary of full Prescribing Information on reverse side.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

©2018 AstraZeneca. All rights reserved. US-20804 5/18

FASENRA is a trademark of the AstraZeneca group of companies.

IMPORTANT SAFETY INFORMATION (cont’d)


28-Week Trial Adverse reactions from Trial 3 with 28 weeks of treatment with FASENRA (n = 73) or placebo (n = 75) in which the incidence was more common in FASENRA than placebo include headache (8.2% compared to 5.3%, respectively) and pyrexia (2.7% compared to 1.3%, respectively) [see Clinical Studies (14) in the full Prescribing Information]. The frequencies for the remaining adverse reactions with FASENRA were similar to placebo.Injection site reactions In Trials 1 and 2, injection site reactions (e.g., pain, erythema, pruritus, papule) occurred at a rate of 2.2% in patients treated with FASENRA compared with 1.9% in patients treated with placebo.ImmunogenicityAs with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to benralizumab in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.Overall, treatment-emergent anti-drug antibody response developed in 13% of patients treated with FASENRA at the recommended dosing regimen during the 48 to 56 week treatment period. A total of 12% of patients treated with FASENRA developed neutralizing antibodies. Anti-benralizumab antibodies were associated with increased clearance of benralizumab and increased blood eosinophil levels in patients with high anti-drug antibody titers compared to antibody negative patients. No evidence of an association of anti-drug antibodies with efficacy or safety was observed.The data reflect the percentage of patients whose test results were positive for antibodies to benralizumab in specific assays.DRUG INTERACTIONSNo formal drug interaction studies have been conducted.USE IN SPECIFIC POPULATIONS Pregnancy Risk SummaryThe data on pregnancy exposure from the clinical trials are insufficient to inform on drug-associated risk. Monoclonal antibodies such as benralizumab are transported across the placenta during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy. In a prenatal and postnatal development study conducted in cynomolgus monkeys, there was no evidence of fetal harm with IV administration of benralizumab throughout pregnancy at doses that produced exposures up to approximately 310 times the exposure at the maximum recommended human dose (MRHD) of 30 mg SC [see Data].In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.Clinical Considerations Disease-associated maternal and/or embryo/fetal risk:In women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. The level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control.DataAnimal Data In a prenatal and postnatal development study, pregnant cynomolgus monkeys received benralizumab from beginning on GD20 to GD22 (dependent on pregnancy determination), on GD35, once every 14 days thereafter throughout the gestation period and 1-month postpartum (maximum 14 doses) at doses that produced exposures up to approximately 310 times that achieved with the MRHD (on an AUC basis with maternal IV doses up to 30 mg/kg once every 2 weeks). Benralizumab did not elicit adverse effects on fetal or neonatal growth (including immune function) up to 6.5 months after birth. There was no evidence of treatment-related external, visceral, or skeletal malformations. Benralizumab was not teratogenic in cynomolgus monkeys. Benralizumab crossed the placenta in cynomolgus monkeys. Benralizumab concentrations were approximately equal in mothers and infants on postpartum day 7, but were lower in infants at later time points. Eosinophil counts were suppressed in infant monkeys with gradual recovery by 6 months postpartum; however, recovery of eosinophil counts was not observed for one infant monkey during this period.

Lactation Risk Summary There is no information regarding the presence of benralizumab in human or animal milk, and the effects of benralizumab on the breast fed infant and on milk production are not known. However, benralizumab is a humanized monoclonal antibody (IgG1/κ-class), and immunoglobulin G (IgG) is present in human milk in small amounts. If benralizumab is transferred into human milk, the effects of local exposure in the gastrointestinal tract and potential limited systemic exposure in the infant to benralizumab are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for benralizumab and any potential adverse effects on the breast-fed child from benralizumab or from the underlying maternal condition.Pediatric Use There were 108 adolescents aged 12 to 17 with asthma enrolled in the Phase 3 exacerbation trials (Trial 1: n=53, Trial 2: n=55). Of these, 46 received placebo, 40 received FASENRA every 4 weeks for 3 doses, followed by every 8 weeks thereafter, and 22 received FASENRA every 4 weeks. Patients were required to have a history of 2 or more asthma exacerbations requiring oral or systemic corticosteroid treatment in the past 12 months and reduced lung function at baseline (pre-bronchodilator FEV1<90%) despite regular treatment with medium or high dose ICS and LABA with or without OCS or other controller therapy. The pharmacokinetics of benralizumab in adolescents 12 to 17 years of age were consistent with adults based on population pharmacokinetic analysis and the reduction in blood eosinophil counts was similar to that observed in adults following the same FASENRA treatment. The adverse event profile in adolescents was generally similar to the overall population in the Phase 3 studies [see Adverse Reactions (6.1) in the full Prescribing Information]. The safety and efficacy in patients younger than 12 years of age has not been established.Geriatric Use Of the total number of patients in clinical trials of benralizumab, 13% (n= 320) were 65 and over, while 0.4% (n=9) were 75 and over. No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.OVERDOSAGE Doses up to 200 mg were administered subcutaneously in clinical trials to patients with eosinophilic disease without evidence of dose-related toxicities.There is no specific treatment for an overdose with benralizumab. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information).Hypersensitivity ReactionsInform patients that hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, rash) have occurred after administration of FASENRA. These reactions generally occurred within hours of FASENRA administration, but in some instances had a delayed onset (i.e., days). Instruct patients to contact their healthcare professional if they experience symptoms of an allergic reaction [see Warnings and Precautions (5.1) in the full Prescribing Information].Not for Acute Symptoms or Deteriorating Disease Inform patients that FASENRA does not treat acute asthma symptoms or acute exacerbations. Inform patients to seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with FASENRA [see Warnings and Precautions (5.2) in the full Prescribing Information].Reduction of Corticosteroid Dosage Inform patients to not discontinue systemic or inhaled corticosteroids except under the direct supervision of a physician. Inform patients that reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy [see Warnings and Precautions (5.3) in the full Prescribing Information].

Manufactured byAstraZeneca ABSödertälje, Sweden SE-15185US License No. 2059

Distributed byAstraZeneca Pharmaceuticals LP,Wilmington, DE 19850

FASENRA is a trademark of the AstraZeneca group of companies.©AstraZeneca 2017

Iss. 11/17 US-12988 11/17

2FASENRATM (benralizumab) injection, for subcutaneous use


April 23–26 • Boston, MA

Table of Contents 06 General Session: Innovation and Change

in the Healthcare System

08 Change on the Horizon for the Management of Oncology

09 Lessons Learned in Value-Based Contracts

10 Challenges, Goals, and Strategies for the Management of Depression

11 Marketplace Trends: Specialty Spending, Generics and Biosimilars, Medication Adherence, and More

12 Clinical Trial Review of Treatment Option for Opioid-Use Disorder

SPECIALTY PHARMACY CONNECT

16 Hemophilia Care: A Future for Gene Therapy?

16 Panel Perspectives on Hemophilia Management

17 Hemophilia Care From the Payer Perspective

POSTERS

07 Patient Treatment Preference for Biologic Asthma Agents

10 Treatment Adherence Improves Paid Pharmacy Claims in Patients with Diabetes, Hypertension

PUBLISHERGene Conselyea

WRITER/EDITORKerri Fitzgerald

EDITORIAL SUPPORTNeal Learner

ART DIRECTORAri Mihos

630 Madison Avenue2nd FloorManalapan, NJ 07726

©2018 American Medical Communications, Inc, Manalapan, NJ 07726. 18057

ASSISTANT ART DIRECTORCharlene DePrizio

PROJECT MANAGERFrancine Pozzolano

SALESMaria SerciaBryan Bonder

5

28-Week Trial Adverse reactions from Trial 3 with 28 weeks of treatment with FASENRA (n = 73) or placebo (n = 75) in which the incidence was more common in FASENRA than placebo include headache (8.2% compared to 5.3%, respectively) and pyrexia (2.7% compared to 1.3%, respectively) [see Clinical Studies (14) in the full Prescribing Information]. The frequencies for the remaining adverse reactions with FASENRA were similar to placebo.Injection site reactions In Trials 1 and 2, injection site reactions (e.g., pain, erythema, pruritus, papule) occurred at a rate of 2.2% in patients treated with FASENRA compared with 1.9% in patients treated with placebo.ImmunogenicityAs with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to benralizumab in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.Overall, treatment-emergent anti-drug antibody response developed in 13% of patients treated with FASENRA at the recommended dosing regimen during the 48 to 56 week treatment period. A total of 12% of patients treated with FASENRA developed neutralizing antibodies. Anti-benralizumab antibodies were associated with increased clearance of benralizumab and increased blood eosinophil levels in patients with high anti-drug antibody titers compared to antibody negative patients. No evidence of an association of anti-drug antibodies with efficacy or safety was observed.The data reflect the percentage of patients whose test results were positive for antibodies to benralizumab in specific assays.DRUG INTERACTIONSNo formal drug interaction studies have been conducted.USE IN SPECIFIC POPULATIONS Pregnancy Risk SummaryThe data on pregnancy exposure from the clinical trials are insufficient to inform on drug-associated risk. Monoclonal antibodies such as benralizumab are transported across the placenta during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy. In a prenatal and postnatal development study conducted in cynomolgus monkeys, there was no evidence of fetal harm with IV administration of benralizumab throughout pregnancy at doses that produced exposures up to approximately 310 times the exposure at the maximum recommended human dose (MRHD) of 30 mg SC [see Data].In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.Clinical Considerations Disease-associated maternal and/or embryo/fetal risk:In women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. The level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control.DataAnimal Data In a prenatal and postnatal development study, pregnant cynomolgus monkeys received benralizumab from beginning on GD20 to GD22 (dependent on pregnancy determination), on GD35, once every 14 days thereafter throughout the gestation period and 1-month postpartum (maximum 14 doses) at doses that produced exposures up to approximately 310 times that achieved with the MRHD (on an AUC basis with maternal IV doses up to 30 mg/kg once every 2 weeks). Benralizumab did not elicit adverse effects on fetal or neonatal growth (including immune function) up to 6.5 months after birth. There was no evidence of treatment-related external, visceral, or skeletal malformations. Benralizumab was not teratogenic in cynomolgus monkeys. Benralizumab crossed the placenta in cynomolgus monkeys. Benralizumab concentrations were approximately equal in mothers and infants on postpartum day 7, but were lower in infants at later time points. Eosinophil counts were suppressed in infant monkeys with gradual recovery by 6 months postpartum; however, recovery of eosinophil counts was not observed for one infant monkey during this period.

Lactation Risk Summary There is no information regarding the presence of benralizumab in human or animal milk, and the effects of benralizumab on the breast fed infant and on milk production are not known. However, benralizumab is a humanized monoclonal antibody (IgG1/κ-class), and immunoglobulin G (IgG) is present in human milk in small amounts. If benralizumab is transferred into human milk, the effects of local exposure in the gastrointestinal tract and potential limited systemic exposure in the infant to benralizumab are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for benralizumab and any potential adverse effects on the breast-fed child from benralizumab or from the underlying maternal condition.Pediatric Use There were 108 adolescents aged 12 to 17 with asthma enrolled in the Phase 3 exacerbation trials (Trial 1: n=53, Trial 2: n=55). Of these, 46 received placebo, 40 received FASENRA every 4 weeks for 3 doses, followed by every 8 weeks thereafter, and 22 received FASENRA every 4 weeks. Patients were required to have a history of 2 or more asthma exacerbations requiring oral or systemic corticosteroid treatment in the past 12 months and reduced lung function at baseline (pre-bronchodilator FEV1<90%) despite regular treatment with medium or high dose ICS and LABA with or without OCS or other controller therapy. The pharmacokinetics of benralizumab in adolescents 12 to 17 years of age were consistent with adults based on population pharmacokinetic analysis and the reduction in blood eosinophil counts was similar to that observed in adults following the same FASENRA treatment. The adverse event profile in adolescents was generally similar to the overall population in the Phase 3 studies [see Adverse Reactions (6.1) in the full Prescribing Information]. The safety and efficacy in patients younger than 12 years of age has not been established.Geriatric Use Of the total number of patients in clinical trials of benralizumab, 13% (n= 320) were 65 and over, while 0.4% (n=9) were 75 and over. No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.OVERDOSAGE Doses up to 200 mg were administered subcutaneously in clinical trials to patients with eosinophilic disease without evidence of dose-related toxicities.There is no specific treatment for an overdose with benralizumab. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information).Hypersensitivity ReactionsInform patients that hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, rash) have occurred after administration of FASENRA. These reactions generally occurred within hours of FASENRA administration, but in some instances had a delayed onset (i.e., days). Instruct patients to contact their healthcare professional if they experience symptoms of an allergic reaction [see Warnings and Precautions (5.1) in the full Prescribing Information].Not for Acute Symptoms or Deteriorating Disease Inform patients that FASENRA does not treat acute asthma symptoms or acute exacerbations. Inform patients to seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with FASENRA [see Warnings and Precautions (5.2) in the full Prescribing Information].Reduction of Corticosteroid Dosage Inform patients to not discontinue systemic or inhaled corticosteroids except under the direct supervision of a physician. Inform patients that reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy [see Warnings and Precautions (5.3) in the full Prescribing Information].

Manufactured byAstraZeneca ABSödertälje, Sweden SE-15185US License No. 2059

Distributed byAstraZeneca Pharmaceuticals LP,Wilmington, DE 19850

FASENRA is a trademark of the AstraZeneca group of companies.©AstraZeneca 2017

Iss. 11/17 US-12988 11/17

2FASENRATM (benralizumab) injection, for subcutaneous use



2018

AMCP 2018

General Session: Innovation and Change in the Healthcare System

AMCP CEO Susan Cantrell, RPh, CAE, began the General Session by discussing the trends in healthcare: “We need to free up space in the healthcare ecosystem

to pay for the new and exciting agents [coming to market],” she said. “We can address the challenging headlines [surrounding drug prices] to make effective medicines available and afford-able.” Dr. Cantrell noted that AMCP is ideally positioned to make these changes happen as a leader in a host of rising initiatives to address drug costs and the move toward value-based models by bringing stakeholders together to discuss and propose solutions.

“AMCP is not only adapting to meet external challenges; we are evolving to meet the needs of our members,” she said, noting that the AMCP organization turns 30 this year, before inviting the eight founding members of the Academy to join her onstage for recognition.

Outgoing AMCP President Diana Brixner, RPh, PhD, then presented the newly elected board members: President-Elect James T. Kenney, RPh, MBA, and Directors Deb Schering Curry, PharmD, Patrick P. Gleason, PharmD, BCPS, and Debra J. Minich, RPh.

Incoming AMCP President Mitzi Wasik, PharmD, challenged members to go beyond simply adjudicating claims and to think about the actual patient behind the decisions made in managed care pharmacy. She also challenged new members and young pharmacists to reach out and find mentors at AMCP. “If you can’t find a mentor at AMCP, you’re not looking hard enough,” she said.

Next, the keynote speaker, John Rossman, former Director of Enterprise Services at Amazon.com, addressed the rapidly changing healthcare system and how technology and innova-tion can be used to create new business models and solutions for some of the biggest challenges in the field. He used some of Amazon’s tactics to provide a model for leading change in the U.S. healthcare system.

One Amazon leadership principle is “customer obsession.” The customer voice needs to be brought into organizations to improve their experience. “Great products and technologies start with a

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customer challenge,” he said, and often, these innovative ideas involve partnerships across entities, platforms, and organizations.

Another leadership principle he touched on was simplicity: “Making things simple is more difficult than creating them,” said Mr. Rossman. Despite all of the technology we have, it is difficult—but most important—to create simple processes and procedures. “What are the errors in the business that are closest to the customer, and how to do you enable change to address the root cause of the issue?” he asked.

He also advised to “constantly” challenge the status quo with a continuous pursuit of improvement when innovating. Determine your organization’s core competencies, and make sure there is a roadmap and process for collecting ideas to drive scale and innovation, he said.

Lastly, he said to think big. Innovation is just stringing together your failures, said Mr. Rossman, “But you have to be able to afford those failures.” At Amazon, when an idea is devised, the company avoids PowerPoint presentations and requires a written narrative with “complete sentences and ideas that someone else can read and understand without you explaining it,” said Mr. Rossman. “This is hard to do.” Three main sections of the narrative include:

• What delighted the customer about the new service or product?

• What are the metrics and/or business case that justifies or measures progress on the product?

• What are the big issues you had to solve to achieve this?

He concluded, “Is Amazon going to be interested in getting into the healthcare industry? The question is not is but when!” he said. He advised that attendees act as if Amazon—or someone else—has already come forward to change the rules of this in-dustry. “What would your response be then?” he asked, saying that stakeholders should get involved now. “The biggest risk you have is not moving to disrupt and innovate yourself before someone else does,” said Mr. Rossman. ●

Presentation: General Session. AMCP Annual Meeting 2018.

7

POSTER

Patient Treatment Preference for Biologic Asthma AgentsThere are limited data on patient preferences for biologic agents for the treatment of asthma. Researchers assessed patient and physician perceptions on biologic agents for the treatment of severe asthma. The results of the study were presented at AMCP Annual Meeting during a poster session titled “Patient and Physician Preferences for Attributes of Biologic Medications for Severe Asthma.”

This cross-sectional mixed-methods study used qualitative interviews and direct rating and preference elicitation questions. The study is ongo-ing, and the researchers plan to enroll up to 50 patients with severe, uncontrolled asthma and 25 board-certified pulmonologists and allergists who have previously prescribed these agents for severe asthma.

Participants provided input on relevant attributes and barriers to these agents in an open-ended, semi-structured telephone interview. They rated the importance of the following:

• Mode of administration

• Dosing frequency

• Number of injections

• Time required for administration

• Time to onset of effect

• Frequency of treatment

• Administration setting

As of the current reporting, nine patient interviews were complete. Time to onset of effect and out-of-pocket cost were most consistently reported by patients as important. The top three attributes of treatment were out-of-pocket cost, onset of effect, and frequency of administration.

Patients consistently preferred biologics that were administered:

• More than one month apart versus less than one month apart

• Every eight weeks versus every two or four weeks

• Subcutaneously versus intravenously

Barriers to care included high out-of-pocket costs and the large time commitment (e.g., ordering the medication, travel to the site, and clinic time for receiving the medication).

“The insights from patients can help inform the decision-making process for biologic treatment for severe asthma,” the researchers concluded. ●

The study was sponsored by AstraZeneca.

Gelhorn H, Ross M, Balantac Z, Cutts K, Buachie R, Fox K, Ambrose C, Stone B. Patient

and Physician Preferences for Attributes of Biologic Medications for Severe Asthma.

Abstract J6. Presented at the AMCP Managed Care & Specialty Pharmacy Annual

Meeting, April 23-26; Boston, MA.

Innovative ideas involve partnerships across entities,

platforms, and organizations.

AMCP 2018

8

Change on the Horizon for the Management of Oncology

O ncology care is undergoing seismic change, driven largely by three factors: value-based care, precision medicine, and digital health. “The ground is shifting

right under our feet,” said Therese Mulvey, MD, the director of quality safety and value at Massachusetts General Hospi-tal, during a presentation at AMCP Annual Meeting 2018 on developments in oncology management.

The overarching issues in oncology right now are the cost of cancer drugs, the uninsured population, heath disparities, and care delivery systems. “We cannot be blind to the cost of cancer drugs anymore,” said Dr. Mulvey.

Precision oncology is a costly area of care. These therapies require next-generation sequencing to match patients to the appropriate agent, and treatments will add to the daily manage-ment workflow, said Dr. Mulvey. “We cannot just send these patients to the emergency room to manage toxicities [associated with these therapies].” Precision oncology involves targeting a smaller and highly selected group of patients. “These therapies require patient engagement,” she said, as these agents have cer-tain toxicities for which patients need to be aware and mindful.

New oncology payment models should focus on deliver-ing patient-centered care. Payment models drive care delivery, and costs influence outcomes and value. Pathways are a tool to influence outcomes, safety, and cost.

She gave an example of the Centers for Medicare & Medic-aid Services’ Oncology Care Model (OCM), which focuses on care coordination and enhanced services to beneficiaries. The program targets high-volume cancers, including breast, prostate, lung, colorectal, lymphoma, leukemia, ovarian, or pancreatic cancers. It involves a two-part payment methodology: A $160 per-beneficiary, per-month care management fee plus perfor-mance-based payments. The care management fee is provided to develop the infrastructure for practice requirements, metric gathering, and quality and performance improvement. OCM involves the following six practice requirements:

• Patient access 24/7 to a clinician who a has real-time ac-cess to the practice’s medical records

• Attestation and use of Office of the National Coordinator for Health Information Technology-certified electronic medical records

• Utilize data for Continuous Quality Improvement

• Provide core functions of patient navigation

• Document care plan in accordance with the Institute of Medicine

• Chemotherapy treatment consistent with nationally recog-nized clinical guidelines

High-quality care involves clinical quality, is patient-centered, and is affordable, and this should extend to both the patient and payer, she said. While overall survival is the “gold standard,” and progression-free and event-free survival are important for drug approval, patients care about quality of life, she said, noting the importance of patient-reported outcome measures.

Dr. Mulvey discussed a study published by Basch in the New England Journal of Medicine in 2017 that found patients who self-reported actually had a median survival that was five months longer compared with those who did not (31.2 vs 26.0 months; P=0.03). “When did we stop listening to patients?” asked Dr. Mulvey. “I think this is the biggest travesty in healthcare.”

In 2015, global costs of oncology therapeutics and sup-portive care medicines increased by 11.5% to $107 billion. Oncology drug prices are rising faster than any other drug space, she said, and patients are baring more of the cost. Dr. Mulvey noted that patients want to talk to their doctors about medication costs. “When I went into oncology, there were no financial counselors,” she said, “but now it’s part of what we do every day. It is important to ask patients what really mat-ters to them.”

She concluded by discussing digital health, which can be used to improve care and interact with patients and popula-tions to provide high-quality care. Specialists have not picked this up in the way primary care providers have, Dr. Mulvey said. “The path forward is complicated and requires new met-rics and care delivery models,” she said.

“The way we practice medicine today will look nothing like the medicine practiced in the future,” Dr. Mulvey concluded. ●

Presentation B1: Key Forces Driving Change in Oncology. AMCP Annual Meeting 2018.

“The way we practice medicine today will look nothing like the

medicine practiced in the future.”—Therese Mulvey, MD

Lessons Learned in Value-Based Contracts

Interest in value-based contracts continues to grow, but most of these arrangements are not publicly

known. A survey of 11 pharmaceutical manufacturers and nine payers found that approximately 29% of payers and 26% of manufacturers have disclosed their value-based agreements, while 71% and 74%, respectively, of agreements that have been implemented are not publicly known.

This secrecy occurs for various rea-sons, including the desire to avoid public scrutiny while these contracts are still in the experimental phase and the competi-tive advantage to keeping them private.

During a presentation at AMCP An-nual Meeting 2018, Robert W. Dubois, MD, PhD, of the National Pharmaceuti-cal Council, Michael S. Sherman, MD, MBA, MS, of Harvard Pilgrim Health Care, and Robert A. Spurr, of Novartis Pharmaceutical Corporation, discussed barriers, the current landscape, and lessons learned in value-based contract implementation.

The survey also found various ne-gotiation breakdowns that led to failed value-based contracts. According to manufacturers, this included challenges with providing data and evidence, imple-mentation costs, and difficulty in iden-tifying appropriate outcomes measures. Payers say these dialogue issues stem from disagreements on financial terms and incentive mechanisms. Both cohorts agreed that Medicaid best pricing and lack of partner buy-in/risk-bearing were also issues.

When asked what can be done to help value-based contract implementa-tion succeed, respondents agreed on a few things:

• The ability to measure outcomes clearly tied to product use

• Target patient populations that can easily be identified in claims

• Make sure the administrative bur-den is reasonable

In the future, value-based agreements are likely to become more sophisticated, more common, and incorporate multiple manufacturers within a contract.

Cost and quality concerns can be addressed by linking payments to outcomes, said Mr. Spurr. The future of these agreements will include a focus on overall clinical outcomes and partnering with customers for better health.

Dr. Sherman gave insights from the payer perspective, noting that value-based agreements that have already been signed are primarily in therapeutic areas where little competition ex-ists and there is a small amount of risk. However, these agreements are most needed in high-cost therapeutic areas where there is significant uncer-tainty about im-pact and budget impact concerns.

He delivered some “lessons learned” from implementing value-based agreements:

• First agree-ments are about proof of concept, and the second wave needs to demonstrate impact

• These require real work to imple-ment and operationalize

• Many contracts require minimum patient numbers, which can cause long delays

• Metrics must be expanded upon—collect more data

• Medicaid best pricing is creating sig-nificant limitations for all stakeholders

• Manufacturers also need to demon-strate that their pricing is rational and tied to value ●

Presentation B5: More than Meets the Eye - Value-Based Contracts are More Prevalent than We Think.

AMCP Annual Meeting 2018.

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AMCP 2018

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Challenges, Goals, and Strategies for the Management of Depression

Major depressive disorder is a complex, chronic and recurrent illness that can affect other medical condi-tions. It is projected that 16.2 million Americans

live with depression, with an estimated economic burden of $210.5 billion, including indirect workplace costs.

Untreated or undertreated depression can increase func-tional impairment, decrease quality of life, create a barrier be-tween patients and providers, induce physical symptoms, and provoke a negative effect on other illnesses. Chronic conditions that can influence mental health include diabetes, cardiovascu-lar diseases, kidney disease, Parkinson’s disease, HIV, chronic obstructive pulmonary disease, and stroke.

Meanwhile, there is a shortage of psychiatrists nationwide, and managed care organizations face many challenges in providing effective care for these patients, according to Jessica L. Ho, PharmD, BCPS, BCPP, a clinical pharmacy specialist at Kaiser Permanente of the Mid-Atlantic States in Virginia, who discussed this condition from a managed care perspective at AMCP Annual Meeting 2018.

Current goals for the management of depression include achieving response and remission, reducing recurrence, optimiz-ing treatment strategies, improving antidepressant adherence, and addressing medical and psychiatric needs. Strategies that

can improve access to care include focusing on screening in pri-mary care, educating primary care providers, developing treat-ment guidelines, referring patients to mental health specialties, using technology such as telepsychiatry, and integrating mental health specialists into the primary care sphere.

Collaborative care is important to managing depression and should include a treatment plan and protocol, practice reorga-nization, systematic attention, and targeted outcomes. Col-laborative care has documented effectiveness and is associated with lower overall healthcare costs than usual care.

A psychiatric pharmacist is another component of optimal depression care. This role can identify and correct medication-related problems, as well as optimize medications, minimize adverse events and drug–drug interactions, provide patient education, and reduce costs.

The benefits of implementing a psychiatric pharmacist include higher rates of antidepressant use, higher medication adherence rates, greater improvement in depression scores, higher patient satisfaction, fewer primary care visits, and overall cost savings. ●

Presentation F6: Holistic Management of Depression – The View from an Integrated Health Care System. AMCP Annual Meeting 2018.

POSTER

Treatment Adherence Improves Paid Pharmacy Claims in Patients with Diabetes, HypertensionAdherence to medications for diabetes, hyperten-sion, and hyperlipidemia are triple-weighted metrics that can significantly impact Centers for Medicare & Medicaid Services’ Medicare Advantage Plan (MAP) Quality Bonus Payments. However, a specific tool that improves medication adherence does not exist.

The Medication Adherence Tracker (MAT) is an innovative initiative to address this issue that holds primary care physicians (PCPs) accountable for interventions that can result in paid pharmacy claims. Researchers used MAT and examined whether this intervention is more likely to result in paid pharmacy claims. The results of the study were presented at AMCP Annual Meeting during a poster session titled “Evaluating the Impact

of Primary Care Physician Intervention on Paid Pharmacy Claims Using a Medication Adherence Tracker in a Medicare Advantage Plan.”

This retrospective analysis used data from MAP beneficiaries in South Texas who were included in the MAT initiative between June and December 2016. The researchers generated a pharmacy report for each PCP biweekly, which identified high-risk, nonad-herent patients based on their estimated year-to-date proportion of days covered rate of <0.8.

Each cycle, a health plan pharmacist prepared the report, and embedded health plan nurses delivered the reports to their assigned PCPs. After approximately three weeks, the PCPs reported the number of interventions to the health plan nurse, who documented them in the MAT spreadsheet.

A total of 3,539 patients were included: 74.7% received the PCP intervention and 25.3% did not.

Patients who received the PCP intervention were 20 times more likely to have a paid pharma-cy claim than those who did not (odds ratio [OR], 20.6; 95% CI, 15.9-26.7). Patients who received the PCP intervention were three times more likely to be adherent to treatment at the end of the year than those who did not (OR, 3.1; 95% CI, 2.6-3.7).

“Our study suggests the MAT is useful for improving rates of paid pharmacy claims and adherence overall,” the researchers concluded. ●

Hong M, Esse T, Vadhariya A, Gallardo E, Serna O, Abughosh

S. Evaluating the Impact of Primary Care Physician

Intervention on Paid Pharmacy Claims Using a Medication

Adherence Tracker in a Medicare Advantage Plan. Abstract

U16. Presented at the AMCP Managed Care & Specialty

Pharmacy Annual Meeting, April 23-26; Boston, MA.

It is projected that 16.2 million Americans live with depression.

Marketplace Trends: Specialty Spending, Generics and Biosimilars, Medication Adherence, and More

Total spending on medicine in the United States was $435 billion in 2017, with a growth of only 1.4%. Specialty growth is outpacing traditional growth (9.4%

vs 4.0%, respectively in 2017) and now comprises 43.3% of the total nondiscounted spend. During a packed session at AMCP Annual Meeting 2018, Douglas Long, BS, MBA, vice president of industry relations at IQVIA, discussed trends in the pharmaceutical marketplace.

First, he gave IQVIA’s definition of specialty, joking, “Ev-eryone wants to be specialty, but here are our six definitions…” This includes agents that are not self-administered; require special handling or unique and narrow distribution; require patient monitoring, counseling, or Risk Evaluation and Mitiga-tion Strategy program; cost in excess of $6,000 per year; are specialist-initiated; and require reimbursement assistance.

Specialty pharmaceuticals are continuing to show value growth in the current calendar year, while traditional value growth is declining (+$16.8 billion vs –$10.7 billion, respec-tively). Autoimmune disease and oncology are driving the value growth in specialty pharmaceuticals, while diabetes, respira-tory agents, and anticoagulants lead traditional absolute value growth.

Oncology therapeutics are leading the late-phase research and development pipeline with 748 agents. In 2017, the major-ity of new launches were for orphan disease indications: 42 products launched in 2017 versus 19 in 2016, which Mr. Long attributed to a lot of novel therapies getting approval ahead of schedule in late 2015. He projected that Alzheimer’s disease and dementia are on the horizon for innovative products, saying, “If you thought hepatitis was a tsunami in the market-place, just wait until these drugs hit.”

Mr. Long then discussed generics, saying that 2017 was a great year for generic approvals, but just 10% of these agents were in a unique therapeutic area, while the other 90% were in crowded markets. But he also noted that 206 generic products that received final approval in 2017 had not launched by Q4. “People are refusing to launch, which shows what the dynam-ics are [in] the marketplace,” said Mr. Long.

Mr. Long then discussed the upcoming opportunity for ge-neric and biosimilar agents, as many key patents will be losing protection. So far, nine biosimilars have received approvals, but just three have launched, and the uptake of these agents is still low. “Infliximab-qbtxis is the most disappointing to me,” he said of the biosimilar agent for the reference drug Remicade,

which is approved for rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. The uptake of this particular biosimilar has been less than 3%, with many payers choosing to remain with rebates for the reference agent. “This is short-sighted,” Mr. Long commented.

He then briefly talked about the opioid crisis, noting that the use of medication-assisted treatment is increasing, while regulatory restrictions have resulted in less dispensing of nar-cotics. He mentioned, “There is not as much dialogue on fen-tanyl as there should be.” On the prescription side, fentanyl is responsible for one-third of opioid-related deaths. He described surgery as a “gateway” to opioid use and noted that women 40 to 59 years of age are prescribed opioids more often. Those with mental health disorders are also a vulnerable population that received more than 50% of opioid prescriptions.

“Adherence is the holy grail,” said Mr. Long, moving into a discussion on the topic. He said one benefit of the Affordable Care Act is the focus on Star ratings, which has helped with adherence. “There’s something in adherence for everyone—the patient, hospital, pharmacy,” he said. “If people are adherent, all [stakeholders] will save money.” Medication synchroniza-tion programs are designed by pharmacies to simplify the refill process by enabling patients to pick up all medications in a single visit, which is critical to improving adherence, particu-larly for chronic diseases.

He concluded with six key issues that market access teams are currently facing:

• Tighter, more consolidated payer management

• Higher patient out-of-pocket payments as payers transfer a higher percentage to patients (the average commercial copay increase between 2016 and 2017 was 14%)

• Amplified public pressure and demand for price transparency

• More stringent medical benefit management

• Increase in value-based models

• Evolving provider landscape with growth in the number of integrated delivery networks and accountable care organizations ●

Presentation H1: AMCP Headline Session: 2017-2018 Pharmaceutical Marketplace Trends. AMCP Annual Meeting 2018.

11

AMCP 2018

Clinical Trial Review of Treatment Option for Opioid-Use Disorder

T he opioid crisis has become a public health emergency: 2016 data show that approximately 2 million adults had an opioid use disorder (OUD) and 66% of all

drug overdose deaths involved an opioid. In 2013, total healthcare spending related to OUDs was more than $28 billion, of which $26 billion was paid for by insurance, and over a seven-year period, OUD diagnoses increased by 493% among commercially insured members.

Medication-assisted treatment (MAT) for OUD is support-ed by scientific evidence and is associated with reduced over-dose deaths, treatment retention, decreased heroin use, and reduced relapse. Despite the documented benefits of MAT, utilization management measures and other coverage chal-lenges, such as “fail-first” protocols, can delay MAT.

VIVITROL® (naltrexone for extended-release inject-able suspension) is a once-monthly injectable treatment approved by the U.S. Food and Drug Administration for alcohol dependence and the prevention of relapse to opioid dependence, when used with counseling and following opi-oid detoxification. During a Science & Innovation Theater at AMCP Annual Meeting 2018, Genie L. Bailey, MD, of Brown University, discussed this MAT treatment option, providing various study data on the safety and efficacy of extended-release naltrexone (XR-NTX).

In a six-month, double-blind, placebo-controlled, mul-ticenter trial, 250 patients (21-52 years) who had opioid dependence for nine to 10 years (mean) received XR-NTX 380 mg (n=126) or placebo (n=124) every four weeks over 24 weeks. Participants had recently completed opioid detox of up to 30 days.

Both cohorts also received biweekly psychosocial therapy and a weekly urine test. Patients treated with XR-NTX had higher rates of complete abstinence during weeks five to 24 compared with placebo (36% vs 23%; P=0.0224). The most common adverse events (AEs) observed with XR-NTX were hepatic enzyme abnormalities, injection-site pain, nasopharyngitis, insomnia, and toothache.1

In a 24-week, multicenter, open-label, randomized clini-cal study, researchers included 570 adult patients with OUD (DSM-5 criteria) who had used nonprescribed opioids in the past 30 days. Patients received XR-NTX 380 mg (n=283) or buprenorphine-naloxone (BUP-NX) 8-24 mg/day (n=287). It was more difficult to initiate patients on XR-NTX, and this negatively affected overall relapse; however, once initiated, both treatments were equally safe and effective in preventing relapse. In the intention-to-treat population, the median time to relapse was 8.4 weeks with XR-NTX and 14.4 weeks with BUP-NX (hazard ratio [HR], 1.36; 95% CI, 1.10-1.68; P=0.004). Relapse events occurred in 65% of XR-NTX-group and 57% of BUP-NX-group (odds ratio, 1.44; 95% CI, 1.02-2.01; P=0.036). The per-protocol population included only the participants who successfully began study medication. The median time to relapse was 20.4 weeks in the XR-NTX-treated and 15.2 weeks in the BUP-NX-treated

12

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participants (HR, 0.92, 95% CI, 0.71-1.18; P=0.49). Relapse events occurred in 52% of the XR-NTX-treated versus 56% of the BUP-NX-treated participants. The proportion of reported AEs were similar between treatment groups, with the exception of injection-site reactions among XR-NTX. Five fatal overdoses occurred (2 with XR-NTX and 3 with BUP-NX). Study limitations included study sites varied in detoxification protocols and length of inpatient stay; ease of induction is a well-known limitation of XR-NTX compared to BUP-NX; and a real-world effectiveness study such as this includes more sources of bias than a tightly managed efficacy study, but has potentially higher generalizability.2

A second head-to-head study of these agents showed noninferiority: The 12-week, multicenter, open-label, ran-domized Norwegian study included patients with opioid de-pendence (18-60 years) who were randomized after detoxi-fication to receive BUP-NX 4-24 mg/day (n=79) or XR-NTX 380 mg (n=80).

Patients who received XR-NTX used heroin 3.2 days less and other illicit opioids 2.7 days less than those who received BUP-NX. Treatment retention was 69.3 days with XR-NTX and 63.7 days with BUP-NX, and 70% (n=56) and 62% (n=49), respectively, completed 12 weeks of treat-ment. The study limitation was that it was not blinded. Participants of each treatment group knew which medica-tion they were receiving during trial. For the study to have been blinded, it would have required placebo injections like the XR-NTX kits or placebo tablets for BUP-NX. Patients would be able to determine their respective treatment quite quickly, given their long experience with opioid use. Due to an increase risk of overdose in newly detoxified opioid us-ers, the use of placebo and/or masking of medications was considered unethical.3

A retrospective, claims-based study assessed healthcare resource utilization and costs associated with XR-NTX compared with other opioid dependence therapies. The authors examined data from adult patients treated with XR-NTX (n=1,041), buprenorphine (n=20,566), methadone

(n=745), and nonpharmacologic therapy (n=6,883) be-tween January 1, 2011, and December 31, 2014. XR-NTX was associated with significantly lower total cost increases and healthcare resource utilization. The mean costs from baseline to follow-up were:

• $30,817-$32,372 for XR-NTX

• $13,797-$19,731 for buprenorphine

• $9,220-$13,621 for methadone

• $19,331-$28,839 for nonpharmacologic therapy

Patients treated with XR-NTX had the greatest percentage decrease from baseline in emergency department and inpa-tient utilization and costs, despite having more comorbidi-ties and higher baseline cost. Study limitations included:

• Potential data entry errors in administrative claims

• Claims do not indicate whether the medication was taken as prescribed

• No capture of variables such as disease severity

• Findings may not be generalizable to those without commercial insurance

• Significant differences in baseline characteristics be-tween groups

• Additional unobserved confounding variables4

VIVITROL should be prescribed as part of a comprehensive management program that includes psychosocial support and following detoxification. Serious AEs associated with VIVITROL include severe injection-site reactions, eosino-philic pneumonia, serious allergic reactions, unintended precipitation of opioid withdrawal, accidental opioid over-dose, and depression and suicidality. ●

Please see Brief Summary for VIVITROL on the following pag-es. For more information, visit alkermes.com/products/vivitrol.

References: 1. Krupitsky E et al. Lancet 2011;377(9776):1506-1513. 2. Lee JD et al. Lancet 2018;391(10118):309-318. 3. Tanum L et al. JAMA Psychiatry. 2017;74(12):1197-1205. 4. Shah A et al. J Med Econ. 2018;21(4):406-415.

Alkermes supported this program.

Science & Innovation Theater: Clinical and Economic Considerations for a Medication-Assisted Treatment Option. AMCP Annual Meeting 2018.

13

The opioid crisis has become a public health emergency: 2016 data show that approximately 2 million adults had an opioid use disorder and 66% of all drug overdose deaths involved an opioid.”

VIVITROL® (naltrexone for extended-release injectable suspension)Intramuscular

BRIEF SUMMARY See package insert for full prescribing information (rev. Dec. 2015).

INDICATIONS AND USAGE: VIVITROL is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL. Patients should not be actively drinking at the time of initial VIVITROL administration. In addition, VIVITROL is indicated for the prevention of relapse to opioid dependence, following opioid detoxification. VIVITROL should be part of a comprehensive management program that includes psychosocial support.

CONTRAINDICATIONS: VIVITROL is contraindicated in: patients receiving opioid analgesics, patients with current physiologic opioid dependence, patients in acute opioid withdrawal, any individual who has failed the naloxone challenge test or has a positive urine screen for opioids, and patients who have previously exhibited hypersensitivity to naltrexone, polylactide-co-glycolide (PLG), carboxymethylcellulose, or any other components of the diluent.

WARNINGS AND PRECAUTIONS: Vulnerability to Opioid Overdose: After opioid detoxification, patients are likely to have reduced tolerance to opioids. VIVITROL blocks the effects of exogenous opioids for approximately 28 days after administration. However, as the blockade wanes and eventually dissipates completely, patients who have been treated with VIVITROL may respond to lower doses of opioids than previously used, just as they would have shortly after completing detoxification. This could result in potentially life threatening opioid intoxication (respiratory compromise or arrest, circulatory collapse, etc.) if the patient uses previously tolerated doses of opioids. Cases of opioid overdose with fatal outcomes have been reported in patients who used opioids at the end of a dosing interval, after missing a scheduled dose, or after discontinuing treatment. Patients should be alerted that they may be more sensitive to opioids, even at lower doses, after VIVITROL treatment is discontinued, especially at the end of a dosing interval (i.e., near the end of the month that VIVITROL was administered), or after a dose of VIVITROL is missed. It is important that patients inform family members and the people closest to the patient of this increased sensitivity to opioids and the risk of overdose. There is also the possibility that a patient who is treated with VIVITROL could overcome the opioid blockade effect of VIVITROL. Although VIVITROL is a potent antagonist with a prolonged pharmacological effect, the blockade produced by VIVITROL is surmountable. The plasma concentration of exogenous opioids attained immediately following their acute administration may be sufficient to overcome the competitive receptor blockade. This poses a potential risk to individuals who attempt, on their own, to overcome the blockade by administering large amounts of exogenous opioids. Any attempt by a patient to overcome the antagonism by taking opioids is especially dangerous and may lead to life-threatening opioid intoxication or fatal overdose. Patients should be told of the serious consequences of trying to overcome the opioid blockade. Injection Site Reactions: VIVITROL injections may be followed by pain, tenderness, induration, swelling, erythema, bruising, or pruritus; however, in some cases injection site reactions may be very severe. In the clinical trials, one patient developed an area of induration that continued to enlarge after 4 weeks, with subsequent development of necrotic tissue that required surgical excision. In thepost marketing period, additional cases of injection site reaction with features including induration, cellulitis, hematoma, abscess, sterile abscess, and necrosis, have been reported. Some cases required surgical intervention, including debridement of necrotic tissue. Some cases resulted in significant scarring. The reported cases occurred primarily in female patients. VIVITROL is administered as an intramuscular gluteal injection, and inadvertent subcutaneous injection of VIVITROL may increase the likelihood of severe injection site reactions. The needles provided in the carton are customized needles. VIVITROL must not be injected using any other needle. The needle lengths (either 1 1/2 inches or 2 inches) may not be adequate in every patient because of body habitus. Body habitus should be assessed prior to each injection for each patient to assure that the proper needle is selected and that the needle length is adequate for intramuscular administration. Healthcare professionals should ensure that the VIVITROL injection is given correctly, and should consider alternate treatment for those patients whose body habitus precludes an intramuscular gluteal injection with one of the provided needles. Patients should be informed that any concerning injection site reactions should be brought to the attention of the healthcare professional. Patients exhibiting signs of abscess, cellulitis, necrosis, or extensive swelling should be evaluated by a physician to determine if referral to a surgeon is warranted.

Precipitation of Opioid Withdrawal: The symptoms of spontaneous opioid withdrawal (which are associated with the discontinuation of opioid in a dependent individual) are uncomfortable, but they are not generally believed to be severe or necessitate hospitalization. However, when withdrawal is precipitated abruptly by the administration of an opioid antagonist to an opioid-dependent patient, the resulting withdrawal syndrome can be severe enough to require hospitalization. Review of postmarketing cases of precipitated opioid withdrawal in association with naltrexone treatment has identified cases with symptoms of withdrawal severe enough to require hospital admission, and in some cases, management in the intensive care unit. To prevent occurrence of precipitated withdrawal in patients dependent on opioids, or exacerbation of a pre-existing subclinical withdrawal syndrome, opioid-dependent patients, including those being treated for alcohol dependence, should be opioid-free (including tramadol) before starting VIVITROL treatment. An opioid-free interval of a minimum of 7–10 days is recommended for patients previously dependent on short-acting opioids. Patients transitioning from buprenorphine or methadone may be vulnerable to precipitation of withdrawal symptoms for as long as two weeks. If a more rapid transition from agonist to antagonist therapy is deemed necessary and appropriate by the healthcare provider, monitor the patient closely in an appropriate medical setting where precipitated withdrawal can be managed. In every case, healthcare providers should always be prepared to manage withdrawal symptomatically with non-opioid medications because there is no completely reliable method for determining whether a patient has had an adequate opioid-free period. A naloxone challenge test may be helpful; however, a few case reports have indicated that patients may experience precipitated withdrawal despite having a negative urine toxicology screen or tolerating a naloxone challenge test (usually in the setting of transitioning from buprenorphine treatment). Patients should be made aware of the risks associated with precipitated withdrawal and encouraged to give an accurate account of last opioid use. Patients treated for alcohol dependence with VIVITROL should also be assessed for underlying opioid dependence and for any recent use of opioids prior to initiation of treatment with VIVITROL. Precipitated opioid withdrawal has been observed in alcohol-dependent patients in circumstances where the prescriber had been unaware of the additional use of opioids or co-dependence on opioids. Hepatotoxicity: Cases of hepatitis and clinically significant liver dysfunction were observed in association with VIVITROL exposure during the clinical development program and in the postmarketing period. Transient, asymptomatic hepatic transaminase elevations were also observed in the clinical trials and postmarketing period. Although patients with clinically significant liver disease were not systematically studied, clinical trials did include patients with asymptomatic viral hepatitis infections. When patients presented with elevated transaminases, there were often other potential causative or contributory etiologies identified, including pre-existing alcoholic liver disease, hepatitis B and/or C infection, and concomitant usage of other potentially hepatotoxic drugs. Although clinically significant liver dysfunction is not typically recognized as a manifestation of opioid withdrawal, opioid withdrawal that is precipitated abruptly may lead to systemic sequelae including acute liver injury. Patients should be warned of the risk of hepatic injury and advised to seek medical attention if they experience symptoms of acute hepatitis. Use of VIVITROL should be discontinued in the event of symptoms and/or signs of acute hepatitis. Depression and Suicidality: Alcohol- and opioid-dependent patients, including those taking VIVITROL, should be monitored for the development of depression or suicidal thinking. Families and caregivers of patients being treated with VIVITROL should be alerted to the need to monitor patients for the emergence of symptoms of depression or suicidality, and to report such symptoms to the patient’s healthcare provider. Alcohol Dependence: In controlled clinical trials of VIVITROL administered to adults with alcohol dependence, adverse events of a suicidal nature (suicidal ideation, suicide attempts, completed suicides) were infrequent overall, but were more common in patients treated with VIVITROL than in patients treated with placebo (1% vs 0). In some cases, the suicidal thoughts or behavior occurred after study discontinuation, but were in the context of an episode of depression that began while the patient was on study drug. Two completed suicides occurred, both involving patients treated with VIVITROL. Depression-related events associated with premature discontinuation of study drug were also more common in patients treated with VIVITROL (~1%) than in placebo-treated patients (0). In the 24-week, placebo-controlled pivotal trial in 624 alcohol-dependent patients, adverse events involving depressed mood were reported by 10% of patients treated with VIVITROL 380 mg, as compared to 5% of patients treated with placebo injections. Opioid Dependence: In an open-label, long-term safety study conducted in the US, adverse events of a suicidal nature (depressed mood, suicidal ideation, suicide attempt) were reported by 5% of opioid-dependent patients treated

with VIVITROL 380 mg (n=101) and 10% of opioid-dependent patients treated with oral naltrexone (n=20). In the 24-week, placebo-controlled pivotal trial that was conducted in Russia in 250 opioid-dependent patients, adverse events involving depressed mood or suicidal thinking were not reported by any patient in either treatment group (VIVITROL 380 mg or placebo).

When Reversal of VIVITROL Blockade Is Required for Pain Management: In an emergency situation in patients receiving VIVITROL, suggestions for pain management include regional analgesia or use of non-opioid analgesics. If opioid therapy is required as part of anesthesia or analgesia, patients should be continuously monitored in an anesthesia care setting by persons not involved in the conduct of the surgical or diagnostic procedure. The opioid therapy must be provided by individuals specifically trained in the use of anesthetic drugs and the management of the respiratory effects of potent opioids, specifically the establishment and maintenance of a patent airway and assisted ventilation. Irrespective of the drug chosen to reverse VIVITROL blockade, the patient should be monitored closely by appropriately trained personnel in a setting equipped and staffed for cardiopulmonary resuscitation. Eosinophilic Pneumonia: In clinical trials with VIVITROL, there was one diagnosed case and one suspected case of eosinophilic pneumonia. Both cases required hospitalization, and resolved after treatment with antibiotics and corticosteroids. Similar cases have been reported in postmarketing use. Should a person receiving VIVITROL develop progressive dyspnea and hypoxemia, the diagnosis of eosinophilic pneumonia should be considered. Patients should be warned of the risk of eosinophilic pneumonia, and advised to seek medical attention should they develop symptoms of pneumonia. Clinicians should consider the possibility of eosinophilic pneumonia in patients who do not respond to antibiotics. Hypersensitivity Reactions Including Anaphylaxis: Cases of urticaria, angioedema, and anaphylaxis have been observed with use of VIVITROL in the clinical trial setting and in postmarketing use. Patients should be warned of the risk of hypersensitivity reactions, including anaphylaxis. In the event of a hypersensitivity reaction, patients should be advised to seek immediate medical attention in a healthcare setting prepared to treat anaphylaxis. The patient should not receive any further treatment with VIVITROL. Intramuscular Injections: As with any intramuscular injection, VIVITROL should be administered with caution to patients with thrombocytopenia or any coagulation disorder (eg, hemophilia and severe hepatic failure). Alcohol Withdrawal: Use of VIVITROL does not eliminate nor diminish alcohol withdrawal symptoms. Interference with Laboratory Tests: VIVITROL may be cross-reactive with certain immunoassay methods for the detection of drugs of abuse (specifically opioids) in urine. For further information, reference to the specific immunoassay instructions is recommended.

ADVERSE REACTIONS: Serious adverse reactions that may be associated with VIVITROL therapy in clinical use include: severe injection site reactions, eosinophilic pneumonia, serious allergic reactions, unintended precipitation of opioid withdrawal, accidental opioid overdose and depression and suicidality. The adverse events seen most frequently in association with VIVITROL therapy for alcohol dependence (ie, those occurring in ≥5% and at least twice as frequently with VIVITROL than placebo) include nausea, vomiting, injection site reactions (including induration, pruritus, nodules and swelling), muscle cramps, dizziness or syncope, somnolence or sedation, anorexia, decreased appetite or other appetite disorders. The adverse events seen most frequently in association with VIVITROL therapy in opioid dependent patients (ie, those occurring in ≥ 2% and at least twice as frequently with VIVITROL than placebo) were hepatic enzyme abnormalities, injection site pain, nasopharyngitis, insomnia, and toothache. Clinical Studies Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In all controlled and uncontrolled trials during the premarketing development of VIVITROL, more than 1100 patients with alcohol and/or opioid dependence have been treated with VIVITROL. Approximately 700 patients have been treated for 6 months or more, and more than 400 for 1 year or longer. Adverse Events Leading to Discontinuation of Treatment: Alcohol Dependence: In controlled trials of 6 months or less in alcohol-dependent patients, 9% of alcohol-dependent patients treated with VIVITROL discontinued treatment due to an adverse event, as compared to 7% of the alcohol-dependent patients treated with placebo. Adverse events in the VIVITROL 380-mg group that led to more dropouts than in the placebo-treated group were injection site reactions (3%), nausea (2%), pregnancy (1%), headache (1%), and suicide-related events (0.3%). In the placebo group, 1% of patients withdrew due to injection site reactions, and 0% of patients withdrew due to the other adverse events. Opioid Dependence: In a controlled trial of 6 months, 2% of opioid-dependent patients treated with VIVITROL discontinued treatment due to an adverse event, as compared to 2% of the opioid-dependent patients treated with placebo.

DRUG INTERACTIONS: Patients taking VIVITROL may not benefit from opioid-containing medicines. Naltrexone antagonizes the effects of opioid-containing medicines, such as cough and cold remedies, antidiarrheal preparations and opioid analgesics.

USE IN SPECIFIC POPULATIONS: Pregnancy: There are no adequate and well-controlled studies of either naltrexone or VIVITROL in pregnant women. VIVITROL should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Pregnancy Category C: Reproduction and developmental studies have not been conducted for VIVITROL. Studies with naltrexone administered via the oral route have been conducted in pregnant rats and rabbits. Teratogenic Effects: Naltrexone has been shown to increase the incidence of early fetal loss when given to rats at doses ≥30 mg/kg/day (11 times the human exposure based on an AUC(0-28d) comparison) and to rabbits at oral doses ≥60 mg/kg/day (2 times the human exposure based on an AUC(0-28d) comparison). There was no evidence of teratogenicity when naltrexone was administered orally to rats and rabbits during the period of major organogenesis at doses up to 200 mg/kg/day (175- and 14-times the human exposure based on an AUC(0-28d) comparison, respectively). Labor and Delivery: The potential effect of VIVITROL on duration of labor and delivery in humans is unknown. Nursing Mothers: Transfer of naltrexone and 6-naltrexol into human milk has been reported with oral naltrexone. Because of the potential for tumorigenicity shown for naltrexone in animal studies, and because of the potential for serious adverse reactions in nursing infants from VIVITROL, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use: The safety and efficacy of VIVITROL have not been established in the pediatric population. The pharmacokinetics of VIVITROL have not been evaluated in a pediatric population. Geriatric Use: In trials of alcohol-dependent subjects, 2.6% (n=26) of subjects were >65 years of age, and one patient was >75 years of age. Clinical studies of VIVITROL did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently from younger subjects. No subjects over age 65 were included in studies of opioid-dependent subjects. The pharmacokinetics of VIVITROL have not been evaluated in the geriatric population. Renal Impairment: Pharmacokinetics of VIVITROL are not altered in subjects with mild renal insufficiency (creatinine clearance of 50-80 mL/min). Dose adjustment is not required in patients with mild renal impairment. VIVITROL pharmacokinetics have not been evaluated in subjects with moderate and severe renal insufficiency. Because naltrexone and its primary metabolite are excreted primarily in the urine, caution is recommended in administering VIVITROL to patients with moderate to severe renal impairment. Hepatic Impairment: The pharmacokinetics of VIVITROL are not altered in subjects with mild to moderate hepatic impairment (Groups A and B of the Child-Pugh classification). Dose adjustment is not required in subjects with mild or moderate hepatic impairment. VIVITROL pharmacokinetics were not evaluated in subjects with severe hepatic impairment.

OVERDOSAGE: There is limited experience with overdose of VIVITROL. Single doses up to 784 mg were administered to 5 healthy subjects. There were no serious or severe adverse events. The most common effects were injection site reactions, nausea, abdominal pain, somnolence, and dizziness. There were no significant increases in hepatic enzymes. In the event of an overdose, appropriate supportive treatment should be initiated.

This brief summary is based on VIVITROL Full Prescribing Information.

Information (rev. December 2015)ALKERMES and VIVITROL are registered trademarks of Alkermes, Inc. Manufactured and marketed by Alkermes, Inc. ©2016 Alkermes, Inc.All rights reserved VIV-004002 Printed in U.S.A.

Specialty Pharmacy ConnectThe Specialty Pharmacy Connect pre-meeting took place Monday, April 23.

16

Hemophilia Care: A Future for Gene Therapy?The first gene therapy trial conducted in 1990 generated big headlines until it was reported in 1999 that a participant in one of the trials died. Much funding and de-velopment of these agents halted, as a result. It wasn’t until 2012 that Europe ap-proved the first gene therapy. That effort also fizzled after only one paying patient was treated and the manufacturer pulled the product in 2017 due to regulatory constraints. Finally, last year, the United States approved its first gene therapy: voretigene neparvovec for the treatment of Leber’s congenital amaurosis.

There is still much to learn, but gene therapy appears to be an important treatment option in the future of hemo-philia management, according to Susan Trieu, PharmD, director of enterprise specialty clinical solutions at MedImpact Healthcare Systems, Inc., in Texas. She discussed the use of gene therapy in hemophilia during the Specialty Connect program, a pre-Annual Meeting event.

Dr. Trieu began with some of the chal-lenges associated with these agents. “The size of the gene makes a big difference,” she said. For example, the development of gene therapy for factor IX (FIX) has been faster than factor VIII (FVIII) because of the smaller size of FIX (1.4 kb vs 4.4 kb, respectively). Gene therapy is not a good fit for every U.S. patient with hemophilia because not all vectors are the same and the immune response will be different; this poses a barrier to proper patient selection for this treatment.

In addition, the duration of clinical response to these therapies remains unknown, and there is a lack of under-standing of long-term issues. “There has been some transparency in [clinical trial] reporting,” said Dr. Trieu, “but there are a lot of variables, and we cannot compare [the findings] head-to-head.”

She then gave an overview of two gene therapies in development:

• BMN270 for adult patients with severe hemophilia A: Phase I/II trials found that patients treated with the high-dose regimen (6×1013 vg/kg) achieved FVIII activity level of ≥5 IU/dL, while those treated at the two lower dose levels did not. The study also reported a decrease in

annualized bleeding ratio (ABR) and use of FVIII products. No patients developed inhibitors to FVIII or thrombosis. However, Dr. Trieu cautioned that more information is needed on vector shedding. Because this is excreted in saliva and other bodily fluids, its impact to people around the patient (i.e., partner, parents, siblings) must be analyzed, she said.

• SPK-9001 for adults with hemophil-ia B (factor IX activity level <2 IU/dL): In the phase I/II trial, a one-time 5×1011 vg/kg dose was adminis-tered to patients with nine different types of FIX genotypes. The study also reported a decrease in ABR and use of FVIII products. No pa-tients developed inhibitors to FVIII.

Dr. Trieu then discussed the pros and cons of these agents. Pros include a hy-pothetical one-time infusion, a potential “cure” with no further treatment neces-sary, high response rates, objective response measures, and a predictable cost. Cons include the high costs, un-known duration of response, inability to currently use in the inhibitor population, limited data on patients with HIV and hepatitis, and unknown consequences of vector integration.

She continued with a discussion of payment models for these costly thera-pies. Proposed options include direct to payer, outcomes-based for short- and long-term agreements, and payment in-stallments. “I’m not sure how installment payments will work in the commercial space,” she said, “but they could work for single-payer Centers for Medicare & Medicaid Services coverage.”

Dr. Trieu predicted that perhaps by 2020 or 2021, the United States may have its first approved gene therapy for hemophilia. She noted that many gene therapies for hemophilia are moving into phase III testing, so payers need to be prepared. ●

Presentation: Gene Therapy for Hemophilia: Hope for a Cure? AMCP Annual Meeting 2018 Specialty Connect.

Panel Perspectives on Hemophilia Management During the Specialty Connect, a panel convened to discuss various perspectives on the current climate of hemophilia care and projections for the future. Steven W. Pipe, MD, of the University of Michigan in Ann Arbor, Gary Tereso, PharmD, a senior clinical pharmacist at Health New England in Massachusetts, Susan Trieu, PharmD, director of enterprise specialty clinical solutions at MedImpact Healthcare Systems, Inc., in Texas, and Michelle Rice, se-nior vice president of external affairs at the National Hemophilia Founda-tion in Indiana, gave the perspective of their respective industry. Ms. Rice has two children with hemophilia, and she spoke as a representative of the patient perspective.

Ms. Rice began by discussing the hemophilia patient community, which is very active and engaged with their care and treatment. “As a patient community, we know what we cost,” she said, noting that many—including herself—want and try to help payers save money, “although there are barriers to that,” she said. She argued for patient “access,” noting that the use of the words “patient choice,” conveys an entitlement. It is important that payers create metrics and tools for costs, which can include inventory and assay management, methods for adherence, and data sharing. “This is something we all need to work on together,” she said.

The discussion turned to patient care, and Ms. Rice said she advises patients to know what is prescribed and track what they receive each month. “If you always see an over-age [in the dose], call your specialty pharmacy provider and ask, ‘Can we get this closer to the dosage,’” she said. “Be the steward of your own healthcare.”

On the topic of received dosage, Dr. Pipe reminded, “We are talking about biologic agents where there is variability.” He said while there is not a need for 20 different factor VIII (FVIII) products, “I don’t think one

[preferred agent] per product category is enough,” he said. As long as access to treatment is not impeded, the preferred agents and formulary tiers are not as big an issue as it is made out to be, he said, noting a need for a pathway to the right product.

Turning to gene therapy, Dr. Pipe said that an important part of the gene therapy clinical trial data that are being published is the product pool from differ-ent serotypes. “We want to choose gene therapies appropriately because patients in these clinical trials will not [currently be eligible for] retesting of other gene therapies,” he said.

“It’s an exciting time for the hemophilia community,” with regard to new treat-ment options, said Ms. Rice, although she

noted that the hemophilia community will not just jump into the “new, shiny” therapy. “Don’t assume that everyone who’s eligible for gene therapy will go for it,” she advised. She noted that patients will likely have concerns that switching to a new treatment will lead to the devel-opment of an inhibitor—which is some-thing that “hangs over the [hemophilia] patient’s head,” she said. “[The develop-ment of] inhibitors are the greatest fear” in this patient population, she said.

With that, Dr. Pipe noted that the vast majority of inhibitors occur within the first 10 exposures to FVIII, and these patients tend to present themselves fairly quickly. He said refractory inhibitors is an area where innovative treatment options are needed. He said emicizumab was an

agent that helped this patient population significantly. “I believe gene therapy will have something to offer for patients with inhibitors,” he said, “but not in the first wave.”

Dr. Trieu pointed to some important factors of hemophilia care, including assay management, auto-refills on treat-ments, and patient education. With gene therapy, she said, “We are potentially not going to [see] inhibitors, and patients may not need to be logged for every bleed and target joint. These are things payers [should] think about.” ●

Presentation: Perspectives in Hemophilia Management. AMCP Annual Meeting 2018 Specialty Connect.

17

Hemophilia Care From the Payer PerspectiveHemophilia is a costly and complex disease, and while there has been “incred-ible growth” in treatment options—48 products are currently on the market—the increased product choice is not driving down costs, said Sam Leo, PharmD, director of specialty clinical programs at Magellan Rx Management in New York.

Dr. Leo and Gary Tereso, PharmD, a senior clinical pharmacist at Health New England in Massachusetts, discussed roles of various stakeholders in hemophilia care, as well as spending considerations from a payer perspective at the Specialty Connect event.

The average cost of care for a patient with hemophilia is $300,000 per-member, per-year, with factor replacement products representing up to 94% of total costs for patients with severe disease. The rar-ity and genetic nature of he-mophilia, as well as the wide range in cost per patient, can lead to substantial variation in the number of patients and total hemophilia-related costs for health plans.

More and more agents in

the pipeline are highly com-plex, including more extend-ed half-life agents and nonre-placement therapies, as well as gene therapy. There are a lot of unanswered questions with these products, includ-ing “How will we afford this?” asked Dr. Leo. It is essential for plans to understand their populations to evaluate how hemophilia is being managed, he added.

Management challenges, meanwhile, include fragmen-tation of care and lack of uniformity, limited transpar-ency, robust and complex product selection, lack of individualized treatment, po-tential stockpiling and product waste, pharmacy and medical benefit utilization, and navi-gating the need for reinsur-ance programs for high-cost members.

Among stakeholders, payers have little insight into clinical data outside of factor product cost, and providers may have limited insight into product utilization, dispensing amounts, and total healthcare resource utilization. “We need to promote proactive commu-nication between stakehold-ers to optimize patient care,”

Dr. Leo said.Pharmacokinetic (PK)-guid-

ed dosing and assay manage-ment may result in a better patient-tailored approach, he noted. PK-guided dosing can provide better and more accurate targeting of factor levels, better ability to adapt dosing to lifestyle, and a po-tential reduction in cost and units utilized without com-promising efficacy. However, doing this is time-intensive for both patients and provid-ers, and many facilities do not have the capability to conduct PK testing. Medical and Scientific Advisory Council guidelines recommend dis-pensing of factor products to be within plus or minus 10% of prescribed assays, and many specialty pharmacies will “guarantee” assay manage-ment within narrower ranges, but it is difficult for payers to measure and monitor.

Dr. Tesaro then discussed management strategies. First, utilization management ensures specific standards of care, improves transpar-ency and data collection (e.g., bleed history, reason for treatment, product utilized), and improves care coordina-

tion. Pharmacy management should include standardized assay and inventory manage-ment, bleed history tracking, no auto-refills, standards of care for patient engagement and clinical contacts, and adherence monitoring and counseling. Product prefer-encing can also be used, but he noted that this concept is not intended for patients already on a certain therapy, but for those with “new starts.” Data collection and analy-sis is also very important to determine benchmarks and measure relevant outcomes.

Dr. Tesaro’s organization rolled out a hemophilia pro-gram in July 2017 that added a prior authorization to the medical benefit. This in-cluded PK testing for high-risk patients, and dispensing phar-macies were required to man-age assays to a standardized range and to report monthly drug inventory and bleed his-tory. After six months, 50% of patients in the population had an average reduction in dose either through assay manage-ment or PK testing. ●

Presentation: Managing Patients with Hemophilia: A Payer’s Perspective.

AMCP Annual Meeting 2018 Specialty Connect.

Documents

SPECIALTY PHARMACY MANAGED CARE 20 ANNUAL MEETING18 · 2018-06-24 · 1 of 3 doses of benralizumab [25 mg (n=6), 100 mg (n=6) or 200 mg (n=6) SC] or placebo (n=6) every 4 weeks for