14 April 2011. Follow-up to Previous Reviews Long Acting Beta Agonist Inhalers Lack of Prior Controller Use Long Acting Beta Agonist Inhalers with High

Idaho Medicaid Drug Utilization Review Program

14 April 2011

Follow-up to Previous Reviews

Long Acting Beta Agonist InhalersLack of Prior Controller Use

Long Acting Beta Agonist Inhalers with High Rescue Inhaler Use

Fentanyl Patch Frequency < 72 Hours

2

Long Acting Beta Agonist Inhalers: Lack of Controller UseLetters sent if patient had at least one fill of a

LABA during the 3 month period that ended on 9/30/2010. History was evaluated for long term continuous use of a LABA and lack of a controller medication if applicable.

Results:150 patient profiles were evaluated.Letters were sent to 32 prescribers about 30

patients on 12/16/2010 (21.3% lettering rate.)As of 3/31/2011, 9 responses have been received

(28% response rate.)See packet for copy of the letter .

3

Long Acting Beta Agonist Inhalers: Lack of Controller Use: Response detail as of 3/31/2011:Note that providers may choose more than one selection

per response.Reviewed and do not believe adjustment is needed

3Reviewed and have or will modify the treatment 2 Information clinically useful: plan to monitor 2 I will use this information in the care of future pts

2No longer my patient 1My patient, but I did not prescribe this 2Somewhat useful to my practice 4Not useful to my practice 2 Information appears to be incorrect

1

4

Long Acting Beta Agonist Inhalers with High Rescue Inhaler UsePatients were selected for evaluation if they

had at least one fill of a LABA during the 6 month period and at least 2 fills for a SABA in the period that ended on 10/30/2010.

208 patient profiles were evaluated.Letters were sent to 399 prescribers about

102 patients on 12/28/2010 (192% lettering rate.)

As of 3/31/2011, 119 responses have been received (30% response rate.)

See packet for copy of the letter. 5

SABA overuse in LABA patients: Response detail as of 1/1/2011: Note that providers may choose more than one selection per

response. Reviewed and do not believe adjustment is needed 21 Reviewed and have or will modify the treatment 23 Attempted to modify therapy unsuccessfully 7 Information clinically useful: plan to monitor 25 I will use this information in the care of future pts 8 Not my patient 8 Previously saw this pt, but no longer in my care 14 My patient, but I did not prescribe this 31 Under my care, but have not seen recently 9 Extremely useful to my practice 8 Very useful to my practice 20 Somewhat useful to my practice 11 Not useful to my practice 1o Information appears to be incorrect 2 Will discontinue medication 1 Will change dose 6

6

Fentanyl Topical Patch (Duragesic®): Frequency of AdministrationPatients were selected for evaluation if they

received more than 10 patches in a 30 day period during the 3 month period that ended on 11/30/2010.

291 patient profiles were evaluated.Letters were sent to 60 prescribers about 44

patients on 12/28/2010 (21% lettering rate.)As of 3/31/2011, 29 responses have been

received (48 % response rate.)See packet for copy of the letter.

7

Fentanyl Patch Frequency of Administration: Response detail as of 1/1/2011:Note that providers may choose more than one selection


19Reviewed and have or will modify the treatment

4Attempted to modify therapy unsuccessfully

4 Information clinically useful: plan to monitor

2Previously saw this pt, but no longer in my care

3Very useful to my practice

2Somewhat useful to my practice

2Will change dose

1

8

Low Dose Quetiapine UtilizationQuetiapine (Seroquel® ) is an atypical

antipsychotic with the following indications and recommended doses

9

Indication Recommended Dose Range (PI)

Dose Interval

Schizophrenia, Adults 150-750 mg/day*

BID

Schizophrenia, Adolescents (13-17) 400-800 mg/day

BID-TID

Bipolar Mania, Adults (monotherapy or adjunct with lithium or divalproex)

400-800 mg/day

BID

Bipolar Mania, Children and Adolescents (10-17) (monotherapy)

400-600 mg/day

BID-TID

Bipolar Depression, Adults 300 mg/day QD at HS

Bipolar I Disorder Maintenance, Adults (adjunct lithium or divalproex)

400-800 mg/day

BID* Clinical studies indicate that the antipsychotic effect occurs in the range of 600-800mg

Seroquel® DosageDosage Strengths Available: 25mg, 50mg, 100mg,

200mg, 300mg, 400mg

Legitimate Use of Lower Strengths Initial dose titration (approximately 5 days)Dose adjustmentsDose individualization not covered by single strength

tablets

Use of ConcernOff label use for insomnia

10

Use of Quetiapine for InsomniaUsed at doses considered sub-therapeutic for

schizophrenia or bipolar disorderUsed for insomnia in patients who do not

have co-morbid psychosisNot FDA-ApprovedNot supported by available clinical evidenceExposure of patients to adverse metabolic

effects including weight gain, hyperglycemia, overt diabetes and adverse lipid profiles

More costly than traditional hypnotics

11

Idaho Medicaid DUR Study April 2008

Reviewed Medicaid Claims 1/2006 thru 12/2007

Identified patients using all AAPs at a low dose without schizophrenia, bipolar disorder or childhood psychosis/developmental disorders

Low dose quetiapine defined as < 300 mg/day

395 patients identified as being on low dose quetiapine without above designated diagnoses (10% of claims)

Educational leaflets distributed12

Current Utilization of Low Dose Quetiapine

Evaluated number of recipients receiving quetiapine 50 mg/day or less for more than 30 days for time period of 4/1/10-3/31/11

130 recipients receiving <25 mg daily525 recipients receiving >25mg & <50mg

dailyTotal cost was $378,99428% of all quetiapine patients were getting

<50mg/day

13

Current Utilization of Low Dose Quetiapine by Gender

14

</=

25m

g da

ily

>25

& <

/= 5

0mg

daily

All Se

roqu

el0

5001000150020002500

FemalesMales

Information based on Idaho Medicaid Claims most recent 12 months (4/1/10-3/31/11)

Current Utilization of Low Dose Quetiapine by Age

15

</=

25m

g

>25

mg

& <

/=50

mg

All Se

roqu

el0%

20%

40%

60%

80%

100%

> 65 years19-65 years10-18 years0-9 years

Proposal for PA Criteria

Quetiapine cumulative daily doses of < 100 mg will be automatically approved only for new starts for a maximum of 15 days. (add all dosage strengths)

All other uses including dose titration in existing patients will require prior authorization review

16

Current Intervention/Outcome Studies

Tramadol with SSRI’s or SNRI’sPotential for Serotonin Syndrome

Thiazolidinedione (TZD) Safety

Proton Pump Inhibitors Long Term Continuous Use

17

Serotonin Syndrome

Potentially life-threatening reaction to an elevation of serotonin in the body. Agents that block the reuptake of serotonin, slow breakdown, or increase release can contribute to development of the syndrome.

Resolves quickly with appropriate treatment, including discontinuation of related medication.

Frequently undiagnosed due to lack of awareness and the wide range of medications that can cause Serotonin Syndrome.

18

Tramadol with SSRI’s or SNRI’s: Potential for Serotonin Syndrome

Patients were selected if they had more than one tramadol fill, at least a 30 day overlap with the SSRI or SNRI, and had both a tramadol and an antidepressant claim within the most recent six weeks of data.

179 patient profiles were evaluated.Letters were sent to 174 prescribers about 94 patients

on 2/21/2011.Only prescribers of tramadol, SSRI, or SNRI received

letters.As of 3/31/2011, 39 responses have been received

(22% response rate.)See packet for copy of the letter and Serotonin

Syndrome Informational sheet. 19


20


2 prescribers

3 prescribers

4 prescribers

5 prescribers

6 presribers

7 prescribers

0

5

10

15

20

25

30

10

24

2 1 1 1

21

Tramadol with SSRI’s or SNRI’sCriteria ParagraphTramadol (Ultram®) is a centrally acting synthetic opioid

which also inhibits the reuptake of both serotonin and norepinephrine. Therefore, serotonin syndrome can occur when tramadol is used concomitantly with serotonergic drugs such as Selective Serotonin Reuptake Inhibitors (SSRIs) [examples: citalopram, escitalopram, fluoxetine, paroxetine, and sertraline] and Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs) [examples: venlafaxine, duloxetine and desvenlafaxine]. During a recent review, it was noted that your patient, Recipient Name, is receiving tramadol and a SSRI or SNRI. The specific SSRI or SNRI product is noted in the attached profile. Please review the attached profile and monitor this patient for potential serotonin syndrome and adjust medications if clinically appropriate (e.g. use a different analgesic agent). Please refer to the attached educational leaflet for signs and symptoms of serotonin syndrome as well as a listing of additional drugs that can precipitate serotonin syndrome.

22

Tramadol with SSRI’s or SNRI’s: Response detail as of 3/31/2011:Note that providers may choose more than one selection


15Reviewed and have or will modify the treatment



10Will use this information in care of future patients

8Not my patient, never has been


5Patient under my care, but not seen recently

3

23

Tramadol with SSRI’s or SNRI’s: Response detail as of 3/31/2011 (continued):

Extremely useful to my practice3

Very useful to my practice7

Somewhat useful to my practice5

Not useful to my practice4

Will discontinue medication 2Will change dose

3Other 5

24

Tramadol with SSRI’s or SNRI’s: Comments of Interest*

Profile ID: 0001584482: I was not aware the patient was on tramadol.

Profile ID: 0000022513: Defer long term considerations to patient’s primary provider. I am ER provider for this patient.

* Profile is in member packet for your review25

ThiazolidinedionesTroglitazone – removed from market 1999 due to adverse

hepatic effects

Pioglitazone hydrochloride (Actos ®) – initial approval 1999

Pioglitazone + metformin (Actoplus Met®, Actoplus Met XR®)

Pioglitazone + glimepiride (Duetact ®)

Rosiglitazone maleate (Avandia®) – initial approval 1999

Rosiglitazone + metformin (Avandamet ®) Rosiglitazone + glimepiride (Avandaryl ®)

Plasma glucose is lowered through PPAR gamma receptors

Liver Heart Adipose tissue Skeletal muscle Kidney vascular and gut endothelial cells

26

TZD Adverse EffectsRisk of Heart Failure OR 1.32-2.18

Pio and RosiRisk of Edema OR 2.26-4.62

Pio and RosiFractures in Women OR 2.23

Pio and RosiIncreased all-cause or cardiovascular mortality

RosiglitazoneNo evidence with pioglitazoneSome studies suggest reduced risk of all-cause and CV

mortality with pioglitazone

27

Regulatory Decisions on Rosiglitazone

September 2010 The FDA required GSK to implement a restricted

access program for rosiglitazone and combination products that contain rosiglitazone

Labeling changes REMS implementation Cease global marketing and promotion Independent re-assessment of RECORD study Suspension of TIDE study

European Medicines Agency announced suspension of marketing authorization in Europe

28

Risk Evaluation and Mitigation Strategy (REMS)Restricted Access (added to labeling 2/4/11)

Patients already receiving and benefittingNew patients not controlled with other anti-

diabetic medications and unable to take or do not wish to use pioglitazone

DocumentationPrescribers: attest and document patient

eligibilityPatients: consent form acknowledging review

and understanding of risksREMS to be approved Spring 2011 with

implementation within 6 months29

Thiazolidinediones (TZDs)Safety issues with Avandia® related to increased

risk for Cardiovascular Events.

“The U.S. Food and Drug Administration announced that it will significantly restrict the use of the diabetes drug Avandia® (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia®.”http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm226956.htm

30

Thiazolidinediones (TZD’s)Patients were selected for evaluation if there

was a paid claim for a TZD within the last three months.

83 patient profiles were evaluated.Letters were sent to 65 prescribers about 63

patients on 3/22/2011.As of 3/31/2011, 29 responses have been

received (48% response rate.)See packet for copy of the letter and FDA

Drug Safety Communication Insert.

31

TZD – Concurrent MedicationsOther Concurrent Diabetes Medications

Monotherapy 111 other 292 other 173 other 9

Specific Drugs Used in Combo with Avandia®Metformin 48Sulfonylurea 18Insulin 8 Meglitinide 2Incretin Mimetic 1

32

TZD – Other ObservationsAdherence issues noted in 13 patientsNumber of Prescribers

Single 49Two 13Three 4

Number of PharmaciesSingle 62Two 4

33

TZD’sCriteria ParagraphYour patient, Recipient Name, has received at least one recent prescription

for rosiglitazone. The FDA has notified healthcare professionals and patients that information on the cardiovascular risks (including heart attack) of rosiglitazone has been added to the product labeling and patient Medication Guide. This information was first announced by the FDA on September 23, 2010 as part of new restrictions for prescribing and use of this drug.

In addition to describing the cardiovascular risks, the drug labels for Avandia, Avandamet, and Avandaryl have been revised to state that rosiglitazone and rosiglitazone-containing medicines should only be used:- In patients already being treated with these medicines- In patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare professional, do not wish to use pioglitazone-containing medicines (Actos®, Actoplus Met®, Actoplus Met XR®, or Duetact®).

Please read the attached FDA Drug Safety Communication. A link to the FDA complete safety information is included below.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm226994.htm 34

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm226994.htm

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm226994.htm

TZD’s: Response detail as of 3/31/2011:

Note that providers may choose more than one selection per response.Reviewed and have or will modify the treatment




3Very useful to my practice

2Somewhat useful to my practice

2Will change dose

1

35

TZD’s: Comments of Interest*

Profile ID: 0001642778: I am already complying with the above and am no longer prescribing Avandia®.

Note that prescriber also wrote in next to number 8 that medication was reordered on January 26, 2011

* Profile is in member packet for your review 36

PPI’s: Long Term Use• There are multiple risks associated with long

term Proton Pump Inhibitor (PPI) use.

• Patients were selected for evaluation if they had at least 8 claims for a PPI over the six month period.

• Profiles are under development.

• See packet for copy of the letter and Educational Information Handout*

37

PPI’s: Long Term Use

Risk of Fracture: On May 25, 2010, the FDA revised the prescription label for the proton pump inhibitor (PPI) class of drugs to include new safety information about a possible increased risk of fractures of the hip, wrist, and spine with the use of these medications. There is an associated 25% increase in overall fractures and a 47% increase in spinal fractures in postmenopausal women.

38

PPI’s: Long Term UseHypomagnesemia: The FDA has also issued a

statement warning that PPIs taken for prolonged periods of time (in most cases, longer than one year) may also cause low serum magnesium levels. Low serum magnesium levels can lead to muscle spasm, irregular heartbeat, and convulsions.

Enteric infections: Reduction in acidity may promote bacterial colonization of the gastrointestinal tract which may result in clostridium difficile colitis or bacterial gastroenteritis. 39

PPI’s: Long Term Use

Community-acquired pneumonia: Reduction in acidity may allow ingested pathogens to colonize the stomach with subsequent translocation which increases the incidence of community-acquired pneumonias.

40

PPI’s: The review criteria was for 8 or more fills within a six month period. Considered doses above the FDA approved dose for GERD as high as listed in table.

FDA approved dose and length of therapy for GERDPPI FDA approved GERD dose Length of Therapy

dexlansoprazole (Dexilant®) 30 mg daily 4 weeks

esomeprazole (Nexium®) 20 mg daily 4 weeks: may repeat an additional 4 weeks if not healed

lansoprazole (Prevacid®) 15 mg daily 8 weeks

omeprazole (Prilosec®) 20 mg daily 4-8 weeks

pantoprazole (Protonix®) 40 mg daily 8 weeks: may repeat an additional 8 weeks if not healed

rabeprazole (Aciphex®) 20 mg daily 4-8 weeks

41

*Zegerid® not payable by Idaho Medicaid

PPI’sCriteria Paragraph

During a retrospective drug utilization review, it was noted that your patient, «MemberName», has received 8 or more fills for a PPI over the 6 month review period. The FDA has recently revised the prescription label for the proton pump inhibitor (PPI) class of drugs to include new safety information about a possible increased risk of fractures of the hip, wrist, and spine and may also cause low serum magnesium levels. The FDA recommends that when healthcare professionals prescribe PPI's, they should utilize the lowest dose and shortest duration of therapy to adequately treat the patient's condition.

42

PPI’s: Findings Upon Review:

Over 49 years of age Less than 50 years of age

One PPI 19 22

One PPI with an H2 antagonist 1

Two strengths of one PPI 1 3

Two strengths of one PPI with an H2 antagonist

1

Two PPIs 8 12

Two PPIs with an H2 antagonist 1 2

Three PPIs 2 4

Three PPIs with an H2 antagonist 1

43

PPI’s: Findings Upon Review:Four participants < 50 years of age were

previously denied twice daily therapythree are now receiving two PPIs one is now receiving two PPIs and an H2

antagonist

Three participants over 49 years of age are receiving one PPI at GERD dosing

44

Investigate issues of low dose atypical antipsychotics being used for sleepSpecific Aim 1: Among Medicaid beneficiaries with a mental illness, compare utilization trends of newer sedative hypnotics, alone and in combination with other psychotropics, across three state Medicaid programs from 2003-2008.

Specific Aim 2: Examine the effects of prescription access policies on the utilization of newer sedative hypnotics, pre-to-post policy implementation in each state, and potential substitutions to other psychotropic drugs such as low dose atypical antipsychotics.

Specific Aim 3: Compare the impact of implementing prescription access restriction policies on overall prescription drug expenditures and service utilization expenditures among Medicaid beneficiaries with a mental illness diagnosis, pre- and post-policy implementation.

Specific Aim 4: Compare changes in use of sleep aids (atypical antipsychotics and/or newer sedative hypnotics) attributable to changes in drug policy between people with and without documented mental illness.

NIMH Study Specific AimsSpecific Aim 1: Among Medicaid beneficiaries with a

mental illness, compare utilization trends of newer sedative hypnotics, alone and in combination with other psychotropics, across three state Medicaid programs from 2003-2008.

Specific Aim 2: Examine the effects of prescription access policies on the utilization of newer sedative hypnotics, pre-to-post policy implementation in each state, and potential substitutions to other psychotropic drugs such as low dose atypical antipsychotics.

Specific Aim 3: Compare the impact of implementing prescription access restriction policies on overall prescription drug expenditures and service utilization expenditures among Medicaid beneficiaries with a mental illness diagnosis, pre- and post-policy implementation.

Specific Aim 4: Compare changes in use of sleep aids (atypical antipsychotics and/or newer sedative hypnotics) attributable to changes in drug policy between people with and without documented mental illness.

45

Proposed Studies for Next Quarter:

Analysis of Auto Refill Practice*Atypical Antipsychotics: Impact of P&T RecommendationsColchicine Usage

Place in Therapy for Treatment of GoutHigh Dose Utilization Through Multiple Dosage Strengths

OxycodoneAtypical Antipsychotics

Injectable Antipsychotics

All information based on Idaho Medicaid Pharmacy Data 1st Quarter 2011 (1/1/11-3/31/11) unless otherwise indicated.

46

Auto Refill PracticesSome pharmacies are instituting Auto Refill

policies which allow them to automatically dispense refills based on days since last fill

IssuesPotential for stockpilingPotential for continued fill of discontinued

medicationsIncrease cost/waste

47

Atypical AntipsychoticsP&T RecommendationsApproved for diagnosis per FDA indications or off-label

indications with supporting evidence-based literature.All patients receiving at least 90 days of therapy for the

past 120 days as of implementation date will be grandfathered. No criteria for diagnosis required.

No PDL requirements for patients with schizophrenia and related psychosis.

Bipolar, major depression adjunctive, autism and other designated acceptable diagnoses will require failure of a preferred agent for designated non-preferred agents.

Age, dose and quantity per labeling information on all drugs.

If the medical diagnosis and required drug history have been submitted as prior claims then the prescription will

auto-approve at point of sale. i.e. No written PA required. 48

Atypical AntipsychoticsP&T Recommendations

Agent Diagnoses/Criteria

Abilify® Schizophrenia and Related Psychoses; Bipolar Disease; Autism; Adjunctive Therapy in Major Depression with continuous antidepressant therapy within the last eight weeks with trials of a minimum of two different antidepressants with a minimum trial of two weeks each.

Abilify® Injectable Schizophrenia and Related Psychoses with Acute Agitation; Bipolar Disease with Acute Agitation

Clozapine Resistant Schizophrenia and Related Psychoses

Fanapt® Schizophrenia and Related Psychoses

Geodon® Schizophrenia and Related Psychoses; Bipolar Disease – Mania and Mixed State

Geodon® Injectable Schizophrenia and Related Psychoses with Acute Agitation

49

Atypical AntipsychoticsP&T Recommendations (continued)

Adherence RatesAgent Diagnoses/Criteria

Invega® Schizophrenia and Related Psychoses

Invega Sustenna® Schizophrenia and Related Psychoses ANDHistory of Oral Invega® or Risperidone within the past 2 years ANDFailure of Risperdal Consta®

Risperidone Schizophrenia and Related Psychoses; Bipolar Disease – Mania and Mixed State; Autism; Disruptive Behavioral Disorders; Obsessive Compulsive Disorder*Brand name will deny for brand/generic rule

Risperdal Consta® Schizophrenia and Related Psychoses

Saphris® Schizophrenia and Related Psychoses; Bipolar Disease – Mania and Mixed State

50



Seroquel® Schizophrenia and Related Psychoses ; Bipolar Disease – Mania and Mixed State; Bipolar Depression; Obsessive Compulsive Disorder

Seroquel XR® Schizophrenia and Related Psychoses ; Bipolar Disease – Mania and Mixed State; Bipolar Depression; Adjunctive Major Depression Continuous - antidepressant therapy within the last eight weeks with trials of a minimum of two different antidepressants with a minimum trial of two weeks each.

Symbyax® Treatment Resistant Depression - Continuous antidepressant therapy within the last eight weeks with trials of a minimum of two different antidepressants with a minimum trial of two weeks each. 51



Zyprexa® Schizophrenia and Related Psychoses, Acute Agitation; Bipolar, Acute Agitation

Zyprexa Injection® Schizophrenia and Related Psychoses; Bipolar Disease, Acute Agitation

Zyprexa Relprevv® Reimbursed as Medical Benefit Only; Schizophrenia and Related Psychoses

52

Atypical AntipsychoticsP&T Recommendations

65%

35%

Patients Receiving Atypical An-tipsychotics

With Approvable DiagnosisWithout Approvable Diagnosis

53

All information based on Idaho Medicaid Pharmacy Data 1st Quarter 2011 (1/1/11-3/31/11).

Gout TreatmentColchicine’s Place in Therapy

Acute Gout Attacks – NSAIDS and/or corticosteroids can be used for the

management of an acute gout attack. Management of Chronic Gout –

Allopurinol is the drug of choice to lower serum uric acid and does not require prior authorization.

Uloric® will be approved for payment only after (1) continuation of gout attacks after three months of allopurinol therapy at a therapeutic dose, (2) serum urate levels > 6mg/dl after three months of allopurinol therapy at a therapeutic dose, or (3) documented intolerance to allopurinol. To prevent an acute attack as a result of starting allopurinol, low dose NSAID (e.g. naproxen 250mg twice daily) or prophylactic Colcrys® can be used if there are no contra-indications.

Probenecid increases uric acid excretion and does not require prior authorization.

54

Utilization OverviewNumber of Recipients

Number of Claims

Average Cost/Claim

Allopurinol 179 419 $6.56

Colcrys® 18 26 $325.83

Probenecid 3 9 $27.86

Uloric® 9 19 $160.47

Gout TreatmentColchicine’s Place in Therapy

55


High Dose Oxycodone Long ActingSix recipients received more than one strength of LA Oxycodone during Jan, Feb, Mar 2011

1

1

2

2

40mg + 10mg10mg+20mg80mg + 30mg80mg + 40mg

56


High Dose Atypical Antipsychotics377 recipients received multiple doses of the same atypical antipsychotic during Jan, Feb, Mar 2011

1 1 1182365

61

5299

166

Product Distribution by Number of RecipientsMultiple Doses of Same Agent

FANAPTSAPHRISSYMBYAXINVEGACLOZAPINEZYPREXAGEODONABILIFYRISPERIDONESEROQUEL

57


Injectable Atypical AntipsychoticsInvega® Sustenna® and Risperdal® Consta®Indications

Utilization Overview

Agent Indication

Invega® Sustenna® Acute and Maintenance Treatment of Schizophrenia

Risperdal® Consta® Treatment of Schizophrenia

Risperdal® Consta® Mono or Adjunct therapy to Lithium or Valproate in Bipolar I Disorder

Agent Recipients

Invega® Sustenna® 106

Risperdal® Consta® 148

Oral Agents 6936

Patients Receiving Both Oral and Injectable – 1st Quarter 2011

148

*Idaho Medicaid Data 4th Quarter 2010 (10/1/2010-12/31/2010)

58

Injectable Atypical AntipsychoticsInvega® Sustenna® and Risperdal® Consta®Goal 1: Evaluate Adherence Rates

Oral use prior Current adherence For Invega Sustenna – previous adherence on

Risperdal Consta Ensure not receiving oral therapy in addition to

injectable

Goal 2: Program Integrity Ensure doses dispensed by the pharmacy are

actually administered Compare drug profiles, medication administration

records and time period

59

Injectable Atypical AntipsychoticsStudy Responsibilities MMA:

Patient list Pharmacy and Prescriber identification

Program Integrity: Request and obtain the medication administration

records and the progress notes Take action on any identified fraud or billing

irregularities Medicaid Pharmacy Staff

Compile and analyze treatment for each patient Present an analysis of the data to DUR Board and P&T

Committee DUR Board and P&T Committee

Review and interpret results Make Conclusions and Recommendations 60

Injectable Atypical AntipsychoticsInvega® Sustenna® and Risperdal® Consta®Adherence Rates

Agent Adherence Rate

Oral Therapy 66%

Risperdal® Consta® 71%

Invega® Sustenna® 76%

*Idaho Medicaid Data 3rd Quarter 2010 (7/1/2010-9/30/2010)

61

Adherence calculated by evaluating claims for patients receiving multiple claims for the same agent and comparing difference between days’ supply and days between refills.

Prospective DUR ReportHistory Errors:

• DD – drug-to-drug• PG – drug to pregnancy• TD – therapeutic

duplication• ER – early refill• MC – drug-to-disease

Non-History Errors:• PA – drug-to-age• HD – high dose• LD – low dose• SX – drug-to-gender

62

ProDURMessage

ProDURSeverity

MessageCount

MessageAmount

Drug To Drug 1 1,173 $146,999.56

2 12,182 $1,700,261.43

3 51,685 $7,325,789.80

9 1 $23.47

Drug To Gender

1 96 $10,359.56

2 51 $2,176.82

Drug To Known Disease

1 64,326 $7,320,792.62

2 233,655 $32,056,536.99

3 211,605 $31,687,569.10

Drug To Pregnancy

1 108 $2,681.28

2 73 $1,643.76

A 85 $1,236.49

B 105 $14,363.74

C 215 $27,401.45

D 13 $354.95

X 50 $3,617.89

Duplicate Therapy

0 108,695 $18,457,983.74

Min Max 0 37,916 $5,383,620.08

Too Soon Clinical

0 21,418 $3,482,239.41

ALL 743,472 $107,625,652.14

ProDUR Message Report: December 2010 (for comparison)

63

ProDURMessage

ProDURSeverity

MessageCount

MessageAmount

Drug To Drug 1 1,094 $250,625.86

2 11,728 $1,670,211.54

3 49,213 $7,140,413.18

Drug To Gender 1 98 $31,833.78

2 27 $712.45

Drug To Known Disease 1 57,509 $6,975,504.23

2 209,206 $28,797,060.87

3 188,395 $29,958,468.53

Drug To Pregnancy 1 93 $1,567.73

2 85 $2,115.35

A 59 $1,340.40

B 111 $12,052.25

C 219 $16,090.54

D 8 $183.34

X 5 $209.55

Duplicate Therapy 0 96,700 $17,494,927.78

Min Max 0 38,748 $6,081,549.57

Too Soon Clinical 0 18,377 $2,771,725.82

ALL 671,675 $101,206,592.77

ProDUR Message Report: February 2011

64

Top Drugs for Selected ProDUR Type:Duplicate-TherapyHydrocodone/APAP with other Hydrocodone/APAP – 2,516

alerts (14.44% of claims for Hydrocodone/APAP)Methylphenidate with other methylphenidate – 1,917 alerts

(34.72% of claims for methylphenidate)Quetiapine with other quetiapine – 1,915 alerts (51.41% of

claims for quetiapine)Oxycodone/APAP with hydrocodone/APAP – 1,448 alerts

(57.57% of claims for oxycodone/APAP)Venlafaxine with other venlafaxine – 1,438 alerts (73.90%

of claims for venlafaxine)Bupropion with bupropion – 1,409 alerts (45.61% of claims

for bupropion)Hydrocodone/APAP with tramadol – 1,166 alerts (6.69% of

claims for bupropion)65

DUR Spring NewsletterBrainstorm for new topics

66

New Annual DUR Report Electronic SubmissionBackgroundEach State must submit an annual DUR report that

includes Nature and Scope Description

Prospective DUR Program Retrospective DUR Program

Assessment of Education Program Description of DUR Board Activities Assessment of DUR Program

Impact on Quality of Care Cost Savings Generated by Program

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New Annual DUR Report Electronic SubmissionDifferences from Previous Report1. New Sections

Physician Administered Drugs Generic Policy and Utilization Fraud, Waste and Abuse Detection Innovative Practices E-Prescribing

2. Changes ProDUR focus on early refill and therapeutic duplication and

associated override and PA policies Less emphasis on DUR meeting statistics and policies More emphasis on DUR Involvement in programs such as

Disease Management and Medication Therapy Management New format and evaluation process for program evaluation

and cost savings.

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Medicaid Update

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Documents

14 April 2011. Follow-up to Previous Reviews Long Acting Beta Agonist Inhalers Lack of Prior Controller Use Long Acting Beta Agonist Inhalers with High