November 15, 2018...2018/11/15 · H.R. 5799: Medicaid Drug Review, Utilization, Good Governance Improvement Act To amend title XIX of the Social Security Act to require as a condition

November 15, 2018

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November 15, 2018

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H.R. 5799: Medicaid Drug Review, Utilization, Good Governance Improvement Act

To amend title XIX of the Social Security Act to require as a condition of full Federal medical assistance percentage receipt under Medicaid that state Medicaid plans have in place certain drug utilization review activities.

Introduced May 15, 2018 with certain amendments 6/12/2018. No further activity noted.

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States Must Establish

Opioid refill limits with automated claims review process

Limits on prescribed daily milligrams of buprenorphine and maximum daily morphine equivalent with automated claims review process

Automated claims review process to identify simultaneous prescribing of opioids and benzodiazepines or antipsychotics

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States Must Have

A program for managing antipsychotic drugs prescribed to children under 18 and children in foster care

An opioid fraud and abuse identification program in place encompassing beneficiaries, prescribers, and pharmacies

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Exemptions from Requirements

Individuals receiving hospice or palliative care or treatment for cancer

Residents of long-term care facilities

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Other Requirements, Reporting and Consequences

Must be in place 10/1/2019

Same requirements for managed care and fee-for-service programs

States must submit a report to HHS on above elements on HHS-identified timeline

For fiscal years after FY 2019, states not in compliance with these requirements for each quarter of the fiscal year will have their FMAPS reduced by 0.025 percentage points for subsequent FY calendar quarters

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Input From Idaho Medicaid Pharmacy Program to NAMD - Positives

Idaho already meets refill and morphine equivalent limits

Can easily program our systems to identify simultaneous prescribing of opioids and benzodiazepine or other drugs

Already working on antipsychotics in kids less than 18 years old

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Input From Idaho Medicaid Pharmacy Program to NAMD – Problems and Challenges Changing drug therapy for chronic established patients with opioids

and benzodiazepines will take time

Prescriber buy-in

Increased work-load on pharmacy prior authorization Medicaid staff

Increased work-load prescribers and pharmacy providers

Time to taper off of drugs

PDMP not available to all Medicaid programs and Medicaid will need access to reporting modules to identify fraud and abuse, not just single beneficiary records

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Input From Idaho Medicaid Pharmacy Program to NAMD - Clarifications Definition of “automated claims review process”

Messaging during claims adjudication vs hard stops (claim denial)

Will annual reporting be part of the current Annual DUR report or a separate report ?

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Additional Input from ADURs

Implement through a quality improvement approach and choose two or three minimum standards at a time to implement over a 2 to 3 year time period

Consider requirements for diagnosis information on the prescription to allow claims to pay for cancer patients without PA requirement

Use the annual DUR report as the vehicle for tracking progress and compliance

Potential for significant problems with existing state laws

Significant claims system programming efforts will be required by some states and streamlined access to enhanced match money and technical assistance for MMIS changes is needed

Encourage rewards (enhanced FMAP) for progression instead of punishment (withholding of FMAP)

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Support for Patients and Communities Act

Long Short Title: Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act

New Opioid Legislation – comprehensive

Title I Medicaid Provisions to Address the Opioid Crisis

Title II Medicare Provisions to Address the Opioid Crisis

Title III FDA and Controlled Substance Provisions

Stopping counterfeit drugs

Stopping Illicit Drug Importation

Empowering pharmacists – circumstances when a pharmacist can decline filling

Opioid quota reform

Preventing drug diversion

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Passed House and Senate and signed by president 10/24/2018

Replacement?

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Section 1004: Medicaid Drug Review and Utilization

Provision: This provision would require State Medicaid programs to:

Have in place a claims review automated process and safety edits (limitations) that indicates

Subsequent opioid fills (i.e. refills) in excess of State identified limitations

Maximum daily morphine equivalent (MME) that exceed state-defined limitations

When an individual is concurrently prescribed opioids and benzodiazepines or antipsychotics

Monitor and Manage antipsychotic prescribing for children

Have in place a process that identifies potential fraud or abuse of controlled substances by enrolled individuals, prescribers and pharmacies

Report to the Secretary annually on the DUR activities being undertaken under this section; and

Have in place managed care contracts that include these provisions effective October 1, 2019.

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Section 1004: Medicaid Drug Review and Utilization Exclusions

Hospice or palliative care

Treatment for cancer

Residents of facilities (e.g. long-term care facility) who dispense drugs through a contract with a single pharmacy

Other individuals the state elects to exempt

Effective Date

October 1, 2019

FY 2020 CMS must annually report to Congress on the DUR Activities State Medicaid programs undertake under this provision

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Discussion

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Follow-up to Previous Reviews

Buprenorphine monotherapy

Buprenorphine patients without psychotherapy

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November 15, 2018

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Buprenorphine Monotherapy

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Buprenorphine Misuse Potential

Because of buprenorphine’s opioid effects, it can be misused, particularly by people who do not have an opioid dependency. Naloxone is added to buprenorphine to decrease the likelihood of diversion and misuse of the combination drug product. When these products are taken as sublingual tablets, buprenorphine’s opioid effects dominate and naloxone blocks opioid withdrawals. If the sublingual tablets are crushed and injected, however, the naloxone effect dominates and can bring on opioid withdrawals.

https://www.samhsa.gov/medication-assisted-treatment/treatment/buprenorphine

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Abuse and Diversion of Generic Buprenorphine Without Naloxone

Although generic buprenorphine monotherapy may be less expensive than combination therapy, it appears to have a higher rate of abuse and diversion. Injecting buprenorphine monotherapy does not cause withdrawal in users dependent on illicit opioids, because there is no naloxone. A study looking at untreated injection users' abuse of buprenorphine alone in comparison to buprenorphine in combination with naloxone found that injection users had a strong preference for the monotherapy version (without naloxone) (Dart, 2011). A large majority of these users indicated that injecting buprenorphine in combination with naloxone caused a "bad" experience (Alho et al., 2006).

Additionally, RADARS® found that buprenorphine alone is abused at a much higher rate than the buprenorphine/naloxone combination products and fetches a higher street price (Dart, 2011).

https://www.buppractice.com/node/498921


Side Effects of Buprenorphine

Buprenorphine’s side effects are similar to those of opioids and can include:

Nausea, vomiting, and constipation

Muscle aches and cramps

Cravings

Inability to sleep

Distress and irritability

Fever

https://www.samhsa.gov/medication-assisted-treatment/treatment/buprenorphine

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Suboxone package insert – Table 2

Note: These three are the most common reasons for a request to switch from buprenorphine/naloxone therapy to buprenorphine monotherapy.

DISCUSSION QUESTIONS:

How can you determine that the patient is only having side effects due to one component of a combination drug ?

How can you determine that nausea or vomiting or headaches are not due to drug withdrawal but rather the naloxone component of a combination product ?

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Suboxone 16mg/4mg Subutex 16mg Placebo

Nausea 15.0% 13.6% 11.2%

Vomiting 7.5% 7.8% 4.7%

Headache 36.4% 29.1% 22.4%


129, 28%

327, 72%

443 total patients with at least one paid claim for buprenorphine

and/or buprenorphine/naloxone between 7/1/17 - 9/30/17

buprenorphinemonotherapy

bup/naloxonecombinationtherapy

13 patients had claims for both

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116, 22%

405, 78%

509 patients with at least one paid claim for buprenorphine and/or

buprenorphine/naloxone between 7/1/18 - 9/30/18

buprenorphinemonotherapy

bup/naloxonecombinationtherapy

12 patients had claims for both


A B C D E F G

5 56

7

9

11

21

3

15

17

0

6

15

2

Prescribers who are prescribing buprenorphine monotherapy for at least 5 patients (7/1/17 – 9/30/17)

buprenorphine monotherapy combination therapy patients

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Please refer to DUR Packet for a copy of letters

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Recommendation of the DUR Board for when buprenorphine monotherapy should be approved for payment by Idaho Medicaid

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Questions and Comments ?

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November 15, 2018

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Ongoing Reviews

Idaho Opioid Equivalent Dosing Project Update

Methadone update

Benzodiazepines

Two or more benzodiazepines

High utilization of benzodiazepines

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Idaho Opioid Equivalent Dosing Project Update

DUR Presentation

November 15, 2018

Idaho Opioid Equivalent Dosing Project

Today IDHW’s Pharmacy Unit is managing Opioid utilization in various ways, such as

• Quantity Limits on all drugs

• PA on specific State Drug Classes

• Profile review and educational outreach

MME (Morphine Milligram Equivalence) of 90 is now the recommended goal, a point to understand is that there is not just one MME Calculator:

• CMS MME Calculator (calculator we are going to utilize)

• Other MME Calculators

• Customized MME Calculator

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• Prior Authorization

• First Rx

• First Trax

• First IQ

• Reporting

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Prior Authorization

Goal: require a prior authorization if a patient exceeds the > 90 Morphine Milligram Equivalence (MME) per day combined Short and Long acting narcotic agents*• According to the CDC, clinicians should avoid increasing dosage to ≥ 90 MME or carefully

justify a decision to go above that threshold.

*A report was run to determine those recipients who had an MME of > 90 in the previous 90 days and Prior Authorizations were entered for those recipients for 1 year.

A total of 3,669 members had PA’s entered into the First Rx system.

Criteria to approve override of quantity limit > 90 MME

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First RX

First Rx - capable of supporting standard and custom MME cumulative dosing limits, conversion factors, and drug lists

• Recommend using the CMS standard conversion factor and drug list

‒ Allows for a one time entry and QC

‒ Conversion factor layout (First Rx team) is already defined and approved

‒ Maintenance of the standard drug list

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First Trax – MME display and calculator

1. FirstTrax enhancement to allow IDHW Clinical Pharmacists to view:

• MME of the incoming claim that exceeded the MME Quantity Limit

• MME of each claim that contributed to the incoming claim to exceed the limit

• Total Combined MME of all claims that contributed to the incoming claim to exceed the limit

2. Calculator:

• First Trax has a Calculator functionality installed

‒ Pulls information from relevant opioid claims only

‒ Auto-populates calculator with necessary claims data

‒ Enables the Clinical Pharmacist to change the value of some fields

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First Trax – MME display and calculator, continued

Calculator (continued):

• Calculator functionality

‒ Targeted opioids

‒ Conversion factors

‒ MME limit

Status:

• First Trax development is complete

• Training and rollout for IDHW Staff occurred in July, prior to edit going into place.

The edit went into production on July 19, 2017.

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First IQ - RDUR

FIQ can be used for

• Member identification only, or

• FIQ can used to generate letters for to:

‒ members, prescribers and/or pharmacies

FIQ is highly flexible

• Drug groups for criterion are defined within the application

• Criterion and output can be customized

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Reporting

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OPIOID OVERUTILIZATION

Health Plan Group: Idaho

Line: Medicaid

Date Generated: 10/2/2018

Evaluation Period: 7/1/18 - 9/30/18

Data Sources: PDW

TABLE 1: # of Members Filling Opioids, by Quarters

7/1/2018

9/30/2018

Members on Opioids 10,766

TABLE 2: Opioid Members by MED/Day (mg) > 90 mg MEDDuration of MED > 90 MED 7/1/2018

9/30/2018

>= 0 Days 2655

< 90 Days 1252

> = 90 Days 1403

Total 2,655

Reporting

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TABLE 3: All Opioid Members by # of Prescribers and Pharmacies

n of

n of pharmacies7/1/2018 % of Total

Opioid Membersprescribers 9/30/2018

≥ 4 ≥ 4 12 0%

≥ 4 3 21 0%

≥ 4 < 3 120 1%

3 ≥ 3 32 0%

3 < 3 359 3%

< 3 ≥ 3 66 1%

< 3 < 3 10156 94%

Totals 10,766 100.00%

TABLE 4: Opioid Members with > 90 mg MED, by # of Prescribers and Pharmacies

n of prescribers n of pharmacies7/1/2018

% of >= 90 consecutive

days > 90 MED Members

% of Total Opioid

Members

9/30/2018

≥ 4 ≥ 4 2 0.14% 0.02%

≥ 4 3 3 0.21% 0.03%

≥ 4 < 3 27 1.92% 0.25%

3 ≥ 3 7 0.50% 0.07%

3 < 3 72 5.13% 0.67%

< 3 ≥ 3 32 2.28% 0.30%

< 3 < 3 1260 89.81% 11.70%

Totals 1,403 100.00% 13.03%

Reporting

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TABLE 5: Top 20 Prescribed Opioids

Label Name Strength GSN Total Drugs

HYDROCODONE-ACETAMIN 5 47430 5,367


TRAMADOL 50 23139 3,385


OXYCODONE-ACETAMINOPHEN 10 48977 1,624

OXYCODONE-ACETAMINOPHEN 5 4222 1,170

HYDROCODONE-ACETAMN 1 53582 912

OXYCODON-ACETAMINOPHEN 8 48976 425

OXYCODONE 10 13467 416

MORPHINE 15 11887 389

MORPHINE 30 4096 269


MORPHINE 15 4091 169


ACETAMINOPHEN-COD 30 4165 126

FENTANYL 25 15880 123

HYDROMORPHONE 4 4112 102

METHADONE 10 4240 98

OXYCONTIN 10 72862 93

MORPHINE 60 4097 77

Totals 21,765

Reporting

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TABLE 6: Top 20 Pharmacies Dispensing Opioids

Pharmacy Name Pharmacy NPI Total

WALGREENS 10603 1811030950 505

WALGREENS 05648 1417962531 497

WALGREENS 04942 1881609907 465

WALGREENS 06863 1962417089 427

DICK'S PHARMACY 1295832574 417

WALGREENS 06380 1144235268 397

WALGREENS 07276 1871508994 396

SHAVER HOLDINGS INC 1083720494 268

ALBERTSONS, LLC 1295781110 248

THRIFTY PAYLESS INC 1164438461 245

WALGREENS 11541 1902087794 240

WALGREENS 11622 1023281656 222

WALGREENS 07949 1598770612 221

WALGREENS 09157 1316952435 213

WALGREENS 05839 1326053448 208

ALBERTSONS LLC 1922054436 202

WAL-MART PHARMACY INC WEST 1891712147 197

WALGREENS 13672 1306086053 191

WALGREENS 15973 1093996399 185

WAL-MART PHARMACY INC WEST 1437176781 181

Totals 5,925

Reporting

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TABLE 7: Top 20 Members with Highest DailyMME

Member ID Cardholder ID Total MME

5,760

3,960

2,160

1,710

1,625

1,440

1,320

1,308

1,276

1,204

1,200

1,170

1,170

1,128

1,080

1,073

1,066

1,035

1,020

1,016

Reporting

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26% decrease in Members on Opioids from 1Q2017 to 3Q2018

28% decrease in Opioid Members on > 90 MED from 1Q2017 to 3Q2018

1451514111

1327812368 12053

1136110766

3699 3669 3390 3170 3034 2787 2655

0

2000

4000

6000

8000

10000

12000

14000

16000

01/01/2017 -03/31/2017

04/01/2017 -06/30/2017

07/01/2017 -09/30/2017

10/01/2017 -12/31/2017

01/01/2018 -03/31/2018

04/01/2018 -06/30/2018

07/01/2018 -09/30/2018


Members on Opioids Opioid Members on > 90 MED


Questions/Comments ???

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November 15, 2018

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Methadone

Growing Public Health Concern

More than 16,500 people in the United States die each year from opioid-related prescription drug overdoses.

Methadone is responsible for nearly 1/3 of these deaths but accounts for only 2% of opioid pain reliever prescription.

Centers for Disease Control and Prevention. “Opioids Drive Continued Increase in Drug Overdose Deaths” (2013). http://www.cdc.gov/media/relases/2013/p0220_drug_overdose_deaths.html.

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Methadone

Historically, methadone was the preferred pain reliever for most state Medicaid programs.

Idaho Medicaid removed Methadone preferred status October 2015.

Prior authorization required.

Informed methadone providers of implementation of methadone prior authorization and requested tapering off of methadone (Jan 2016).

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Methadone

Methadone Prior Authorization Request Forms

Methadone, Initial Request

States initial criteria for review: Failure of all alternative long acting narcotic agents.

Electrocardiogram (QTc interval documentation).

Pain score and functionality documentation.

Other active concurrent opioids (immediate release)

Documentation of failure/intolerance to non-opioid or opioid agents.

Limit to 30 mg/day maximum dose.

Cancer pain treatment is excluded from monitoring criteria.

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Methadone

Methadone, Reauthorization

Emphasizes monitoring and recommends dose tapering: Electrocardiogram (QTc interval annual review).

Doses greater than 30 mg/day will require documentation of medical necessity and clinical reason why dose reduction cannot be employed.

History of failure/intolerance to non-opioid or other opioid agents.

Only prescribers who are familiar with methadone’s titration and risks, or those who are able to consult with a pain specialist or clinical pharmacist, should prescribe or make changes to methadone treatment.

Medicaid is monitoring active patients and providing case management.

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MethadoneAmerican Society of Interventional Pain Physicians (ASIPP) Guidelines

Recommend methadone only for use after failure of other opioid therapy and only by clinicians with specific training in its risks and uses, within FDA recommended doses. (Evidence: Level I; Strength of Recommendation: Strong)

FDA dosing recommendations for Chronic pain

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.

Pain Physician. 2017 Feb;20(2S):S3-S92. Responsible, Safe, and Effective Prescription of Opioids for Chronic Non-Cancer Pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines.

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Methadone

Review of Methadone drug utilization after changing to non-preferred agent.

Calendar quarterly reviews since October 2015

Updated data from 2018 (2nd and 3rd quarters).

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Methadone

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Methadone

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Methadone

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Methadone

In conclusion:

Continued decreased in Methadone claims since incorporation of prior authorization and monitoring criteria implementation.

Total claims for more than 40 mg/day of methadone appears to have plateaued.

High dose methadone utilizers requires a slower tapering plan.

Continue to recommend tapering agent down to acceptable Morphine Daily Equivalents.

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Methadone

Questions/Comments??

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November 15, 2018

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Issue Identified:

More than one benzodiazepine prescribed to a patient at the same time (at least 60 days of overlapping prescriptions).

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Two or more benzodiazepinesSummaryThe pharmacology and pharmacokinetics of benzodiazepines suggest that concomitant use of more than one benzodiazepine at a time may lead to an increased risk of toxicity. When benzodiazepines are included as a treatment option in clinical practice guidelines, other more effective and less toxic agents are recommended prior to benzodiazepine use, and the lowest effective dose for the shortest duration is recommended. Therefore, there exists no clear evidence supporting the use of multiple benzodiazepine agents in combination to produce better clinical outcomes. Safety concerns appear to outweigh potential benefit. Individual patient needs always should be considered and appropriate care may require treatment not supported fully by guidelines; however, the potential for benefit always should be weighed against the potential for toxicity.

https://www.practicalpainmanagement.com/treatments/pharmacological/non-opioids/ask-expert-multiple-benzo-prescriptions

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Sent DUR letters to prescribers of 64 patients prior to the July 2018 DUR meeting.

Responses Received to DUR letters:

Previously reported on the 10 responses received prior to the July 2018 DUR Meeting.

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Continuing both benzos, 7

Discontinuing one benzo, 2

Will discuss tapering with patient, 1

Responses to prescriber letters as of 7/13/18 10 responses received (16% return rate)

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Six additional responses received after the July 2018 DUR meeting.11 – Clonazepam for anxiety and flurazepam for sleep, wants to continue

12 – Diazepam for epilepsy and clorazepate for mental health issues, wants to continue

13 – Unaware that patient was on lorazepam (patient did not disclose), will discontinue clonazepam

14 – Clonazepam for agoraphobia and temazepam for sleep, wants to continue

15 – Clonazepam and lorazepam both for anxiety, will try a different class of medication and try to discontinue one of the benzos

16 – Clonazepam for panic disorder, will discontinue temazepam for sleep

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DUR Letter Responses – Summary

Majority of responses stated that one benzo was being used for one indication and a second benzo was used for a different indication.

Most common indications: anxiety and insomnia.

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Effective in the near future:

Prior authorization will be required on therapeutic duplication for multiple benzos.

For prescribers who responded to the DUR letters, a prior authorization will be proactively entered if they had requested continuation of both benzos.

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Questions and Comments ?

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November 15, 2018

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High Utilization of benzodiazepines

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3130

22

17

2

2827

21

16

2

Clonazepam Alprazolam Lorazepam Diazepam Clorazepate

Patients routinely filling more than 90 tablets monthly.

3/1/18 - 5/31/18 7/1/18 - 9/30/18


Example – lorazepam

Prior to this DUR project, the number of tablets allowed per day was:0.5 mg tablet – 8

1 mg tablet – 5

2 mg tablet – 7

The quantity allowed without prior authorization was changed to 3 tablets daily (90 tablets monthly) on October 1, 2018.

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requests approved, 5, 42%

requests denied, 7, 58%

Between Oct 1-31, 2018, Idaho Medicaid received 12 quantity override prior authorization requests for lorazepam. There were 21 patients who had

received at least one fill of more than 90 tablets between July 1 - September 30, 2018.


Five approvals to continue lorazepam QID dosing – three approvals were for 3 months and two approvals were for one year.

The three month approvals were for patients with anxiety who had been on this dose for at least one year. Prescribers were requested to maximize non-benzodiazepine drug therapy and non-drug therapy for treatment of anxiety.

The two one year approvals were for (a) an autistic patient who had been on QID dosing for many years and (b) a cancer patient on QID dosing for nausea and anxiety.

Seven requests to continue lorazepam QID dosing were denied. These were for patients who were recently initiated or escalated to QID dosing, or who were not filling 120 tablets monthly (e.g. filled 120 tablets every 2-3 months), or who were on QID dosing for anxiety with no other pharmacologic therapy for anxiety.

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Example – diazepam

2 mg tablet – 4 tablets daily, 120 tablets monthly



Quantity changed for 3 tablets/day (90 tablets/30 days) on November 1, 2018.

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29, 3.6%

785, 96.4%

Diazepam utilization between 7/22/18 - 10/22/18

At least one paid claim for more than 90tabets/month

All other patients with paid claims fordiazepam


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5

5

19

Breakdown of patients with at least one paid claim for more than 90 tablets/month of diazepam (n=29)

Dose already reduced (without intervention) to < 90 tablets/month

Benzodiazepine already discontinued (without intervention)

Patients currently filling more than 90 tablets monthly


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1

1

6

11

8mg/day (four 2mg tablets

10mg/day (five 2mg tablets)

20mg/day (four 5mg tablets)

40mg/day (four 10mg tablets)

0 2 4 6 8 10 12

Patients currently filling more than 90 diazepam tablets monthly (n=19)


Patients currently filling more than 90 diazepam tablets monthly (n=19)

For the 8 patients on < 20mg/day, will proactively enter quantity override prior authorizations.

One patient on four 2mg tablets daily

One patient on five 2mg tablets daily

Six patients on four 5mg tablets daily

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1

1

1

2

6

Chronic Pain

Multiple Sclerosis

Anxiety

Cerebral Palsy

Psych patients (bipolar or schizophrenia) Note: psychpatients on 120 tablets/30 days were all from the same

prescriber.

0 2 4 6 8

Patients currently filling more than 90 diazepam 10mg tablets monthly (n=11)


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Pro-actively entered quantity override prior authorizations on the patients with cerebral palsy (n=2) and multiple sclerosis (n=1) who had been on high dose diazepam therapy for years.

Sent letters on the other 8 patients that stated:

Idaho Medicaid will be changing quantity limits on diazepam to three tablets daily. Your patient has been identified as being on four tablets daily. Please submit a quantity override prior authorization request with medical necessity documentation if you wish your patient to remain on four tablets daily (120 tablets monthly).


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Received prior authorization requests on 6 of 8 patients whose prescribers were sent DUR letters concerning their patients on diazepam 10mg QID.

Five of these requests were on psych patients (bipolar or schizophrenia) to continue same QID dosing “to maintain a normal lifestyle.” All of these requests were from the same MD. All of these requests were approved for these patients who have been on the same high dose of diazepam for more than one year.

The sixth request was from a family practice MD who requested to continue diazepam 10mg QID for a patient who was having anxiety secondary to withdrawal from opioids. As the last opioid was filled in January 2018, this request was denied.


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Have not heard back on patient 7 – on diazepam 10mg #120 tablets monthly as well as alprazolam 2mg #90 tablets monthly (same MD). Next fill not due until 11/19/18 for both benzodiazepines. Per electronic profile – heart failure, no psych diagnoses, not on opioids.

Have not heard back on patient 8 – on diazepam 5mg QID along with 84 MME opioids. Chronic pain s/p spinal fusion. Next fill not due until 11/21/18.


Future Plans

Will decrease quantities allowed without prior authorization for alprazolam

Current daily quantities allowed are:

Maximum FDA approved doses – 4mg for anxiety, 6mg for panic disorder

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Regular Tablets ODT Tablets ER Tablets

0.25mg – 4 0.25mg – 4

0.5mg – 5 0.5mg – 5 0.5mg – 1

1mg – 8 1mg – 4 1mg – 1

2mg – 5 2mg -5 2mg – 2

3mg - 2


Future Plans

Will decrease quantities allowed without prior authorization for clonazepam ODT

Current quantities allowed are:

0.125mg ODT – 3 tablets daily, 90 tablets monthly

0.25mg ODT - 3 tablets daily, 90 tablets monthly

0.5mg ODT - 3 tablets daily, 90 tablets monthly

1mg ODT – 3 tablets daily, 90 tablets monthly

2mg ODT - 6 tablets daily, 180 tablets monthly

Additional criteria for ODT tablets: panic disorder, seizure disorder, other documented inability to swallow regular tablets.

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Future Plans

Will decrease quantities allowed without prior authorization for clonazepam

Current quantities allowed are:

0.5 mg – 4 tablets daily, 120 tablets monthly

1 mg - 5 tablets daily, 150 tablets monthly

2 mg - 8 tablets daily, 240 tablets monthly

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Current Interventions/Outcomes Studies

Uloric utilization and new adverse event information

Cystic Fibrosis

Foster Children and behavioral health medications

Oral health issues from mental health medications

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November 15, 2018

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Uloric DURFDA Safety Announcement – November 15, 2017

The U.S. Food and Drug Administration (FDA) is alerting the public that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol. We required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct this safety study when we approved the medicine in 2009. Once we receive the final results from the manufacturer, we will conduct a comprehensive review and will update the public with any new information.

The safety trial was conducted in over 6,000 patients with gout treated with either febuxostat or allopurinol. The primary outcome was a combination of heart-related death, non-deadly heart attack, non-deadly stroke, and a condition of inadequate blood supply to the heart requiring urgent surgery. The preliminary results show that overall, febuxostat did not increase the risk of these combined events compared to allopurinol. However, when the outcomes were evaluated separately, febuxostat showed an increased risk of heart-related deaths and death from all causes.

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Uloric DUR

Between June 1 – Aug 31

08-22-2018 FDA Update

FDA has received the results of the Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Morbidities (CARES) trial and is conducting a comprehensive review. We will also convene an advisory committee meeting of external experts in early 2019 to discuss these trial results and our review. We will update the public after the advisory committee meeting.

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Uloric DUR

June 21, 2018

Public Citizen petitioned the Food and Drug Administration (FDA) to ban the sale of the widely prescribed gout drug febuxostat (sold under the brand name Uloric) because use of the drug increases the risk of death compared with alternative therapies and there exist other effective medications that have been approved by the FDA for treatment of gout that have a lower risk of death.

Public Citizen is a non-profit, liberal / progressive consumer rights advocacy group and think tank based in Washington, D.C.

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Uloric DUR

Idaho Medicaid Utilization of Uloric

Ever since Uloric was approved by the FDA, allopurinol has been the preferred agent and Uloric has been the non-preferred agent. The clinical criteria as listed on the PDL (Preferred Drug List) is:

Uloric will be approved for continuation of gout attacks with serum urate levels > 6mg/dl after at least 3 months of allopurinol at a therapeutic dose or with documented intolerance to allopurinol.

91

Uloric DUR

allopurinol, 298, 97%

Uloric, 9, 3%

Between June 1 - Aug 31, 2018, there were nine patients with paid claims for Uloric

92

Uloric DUR

Male, 5, 56%

Female, 4, 44%

Gender

Yes, 3, 33%

No, 6, 67%

Heart Disease

93

Note: Per electronic profile, one patient s/p bypass surgery, one patient with heart failure, and one patient with cardiovascular disease.

Between June 1 – Aug 31, 2018, there were nine patients with paid claims for allopurinol.

Uloric DUR

3

1 1 1

2

1

≤ 1 YEAR 2 YEARS 4 YEARS 5 YEARS 8 YEARS 9 YEARS

# o

f p

ati

en

ts

Years on Uloric

94

All but one patient were on allopurinol prior to starting Uloric. The ninth patient had CKD Stage 4 and was started on Uloric.

Uloric DUR

Discussion Points

1. Should Idaho Medicaid contact prescribers now or wait until further information is released by the FDA ? If yes, all patients or only patients with heart disease.

2. For new prior authorization requests, should Idaho Medicaid screen for current heart disease or ask for any additional monitoring for heart disease?

95

Uloric DUR


96

November 15, 2018

97

Cystic Fibrosis

All Medications, $427,181,404 , 98%

CF Medications, $7,609,740 , 2%

Total amount paid IDHW pharmacy POS claims from 10/1/2016 – 9/30/2018

98

Cystic Fibrosis

Disease State

Cystic fibrosis (CF) is caused by defective or missing cystic fibrosis conductance regulator (CFTR) proteins resulting from mutation in the CFTR gene. Children must inherit two defective CFTR genes – one from each parent – to have CF. There are approximately 2000 known mutations in the CFTR gene. Some of these mutations, which can be determined by a genetic test, lead to CF by creating defective or too few CFTR proteins at the cell surface which results in poor flow of salt and water into or out of the cell in a number of organs, including the lungs. This leads to the buildup of abnormally thick, sticky mucus that can cause chronic lung infections and progressive lung damage.

99

Cystic Fibrosis

100

http://www.google.com/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&ved=2ahUKEwirocnS3dvdAhXJ4IMKHZ0VDGoQjRx6BAgBEAU&url=http://www.visembryo.com/story1131.html&psig=AOvVaw0BNMNPJ8c25iSj48cERPpN&ust=1538156490603326

http://www.google.com/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&ved=2ahUKEwirocnS3dvdAhXJ4IMKHZ0VDGoQjRx6BAgBEAU&url=http://www.visembryo.com/story1131.html&psig=AOvVaw0BNMNPJ8c25iSj48cERPpN&ust=1538156490603326

Cystic Fibrosis

In patients with two copies of the F508del mutation (the most common mutation), the CFTR protein is not processed and trafficked normally within the cell, resulting in little to no CFTR protein at the cell surface.

101

https://www.google.com/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&ved=2ahUKEwirocnS3dvdAhXJ4IMKHZ0VDGoQjRx6BAgBEAU&url=https://www.slideshare.net/SGeorgeAZ/molecular-biology-ppwx&psig=AOvVaw0BNMNPJ8c25iSj48cERPpN&ust=1538156490603326

https://www.google.com/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&ved=2ahUKEwirocnS3dvdAhXJ4IMKHZ0VDGoQjRx6BAgBEAU&url=https://www.slideshare.net/SGeorgeAZ/molecular-biology-ppwx&psig=AOvVaw0BNMNPJ8c25iSj48cERPpN&ust=1538156490603326

Cystic Fibrosis

Kalydeco (ivacaftor)Ivacaftor is designed to enhance the function of the CFTR protein once it reaches the cell surface by potentiating the channel-open probability (or gating) of the CFTR protein.

Orkambi (lumacaftor/ivacaftor)Lumacaftor is designed to increase the amount of mature protein at the cell surface by targeting the processing and trafficking defect of the CFTR protein.

Symdeko (tezacaftor/ivacaftor)Tevacaftor addresses the trafficking and processing defect of the CFTR protein to enable it to reach the cell surface.

102

Cystic Fibrosis

Many other drugs in preclinical and clinical trials

103

https://www.google.com/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&ved=2ahUKEwjGhdiy5NvdAhUB9IMKHU27CQMQjRx6BAgBEAU&url=https://www.dovepress.com/cystic--fibrosis-transmembrane-conductance-regulator-modulators-in-cys-peer-reviewed-fulltext-article-CPAA&psig=AOvVaw2EbyMNA6HVbTN6tjTryCbq&ust=1538158258348491

https://www.google.com/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&ved=2ahUKEwjGhdiy5NvdAhUB9IMKHU27CQMQjRx6BAgBEAU&url=https://www.dovepress.com/cystic--fibrosis-transmembrane-conductance-regulator-modulators-in-cys-peer-reviewed-fulltext-article-CPAA&psig=AOvVaw2EbyMNA6HVbTN6tjTryCbq&ust=1538158258348491

Cystic Fibrosis

Life Expectancy

In 2008, the life expectancy in the US was 37 years (included many patients born the 1970’s and 1980’s who were followed by the CF Foundation).

For patients born with CF in 2016 in the US who are cared for in specialty clinics, life expectancy is 48 years.

Cystic Fibrosis Foundation Patient Registry in the US

30,000 - more than half of the population is age 18 or older

104

Cystic FibrosisKalydeco (ivacaftor)Initial approval for CF – at least one copy of G551D mutation (4% of CF population). It is not effective in patients who are homozygous for the F508del mutation.

January 31, 2012

Approved for 6 years and older for one genetic mutation

February 21, 2014

Approved for 8 additional mutations (total of 9)

Estimated that 150 people in the US have one of these 8 newly approved mutations.

December 29, 2014

Approval for one more mutation (total of 10)

March 18, 2015

Also approved for children 2-5 years

May 17, 2017

Now approved for a total of 33 genetic mutations

Estimated that 900 people in the US have one of these 23 newly approved mutations.

August 1, 2017

Now approved for a total of 38 genetic mutations (five new ones)

August 15, 2018

Approved down to age 12 months105

Cystic FibrosisOrkambi (lumacaftor/ivacaftor)CF – homozygous for F508-del CFTR mutation (most common mutation)

July 2, 2015

Approved for 12 years and older

Sep 28, 2016


Aug 7, 2018


106

Cystic FibrosisSymdeko (tezacaftor/ivacaftor)CF – homozygous for F508del CFTR mutation OR have at least one mutation that is responsive to this combination (27 listed in the current table in the package insert)

Feb 12, 2018

Approved for 12 years and older

107

https://www.google.com/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&ved=2ahUKEwjI7bye49vdAhXkz4MKHfVHDB0QjRx6BAgBEAU&url=https://www.symdeko.com/how-symdeko-works&psig=AOvVaw3U998_PncTMNLyHYZpozMc&ust=1538158001490537

https://www.google.com/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&ved=2ahUKEwjI7bye49vdAhXkz4MKHfVHDB0QjRx6BAgBEAU&url=https://www.symdeko.com/how-symdeko-works&psig=AOvVaw3U998_PncTMNLyHYZpozMc&ust=1538158001490537

Cystic FibrosisPricing for adult patient for one month of therapy based on Wholesale Acquisition Cost (WAC) Package Price as of 11/1/2018.

Kalydeco – 150mg tablet 1 tablet twice daily #56 = $23,896

Orkambi – 200mg-125mg tablet 2 tablets twice daily #112 = $20,919

Symdeko – 100/150mg-150mg tablet 1 tablet twice daily #56 = $22,400

108

Cystic Fibrosis

Clinical Trials

Primary endpoint – change in FEV1 at week 24 compared to baseline

Secondary endpoints

Number of pulmonary exacerbations from baseline through Week 24

Absolute change in BMI from baseline at Week 24

Change in CFQ-R Respiratory Domain Score from baseline through Week 24

CFQ-R: Cystic Fibrosis Questionnaire-Revised

Measures function in a variety of domains including physical functioning, vitality, health perceptions, respiratory symptoms, treatment burden, role functioning, emotional functioning, and social functioning. Four different versions available – ages 3-6, 6-13 (for both parent and child), and teen/adult for 14 years and older.

109

Cystic Fibrosis

110

Cystic Fibrosis


111

2017 Update

Tami Eide, Pharm.D., BCPS

Idaho Medicaid

112

GAO Study Published December 2011

5 states studied in 2008

Foster Children were prescribed psychotropic drugs at higher rate than nonfoster children

Indicators of potential health risk

Concomitant use of five or more psychotropic drugs

Doses exceeding recommendations

Prescribed under 1 year old

113

Use of Behavioral Health Medications in Foster Children

Percentage of children (0-17 years old) prescribed psychotropic Medications in namedState and year

Foster Children Nonfoster children Ratio of foster to nonfoster children

Florida 2008 22.0% 8.2% 2.7

Massachusetts 2008 39.1% 10.2% 3.8

Michigan 2008 21.0% 7.9% 2.7

Oregon 2008 19.7% 4.8% 4.1

Texas 2008 32.2% 7.1% 4.5

Idaho 2015 19.3% 9.0 % 2.1

Idaho 2016 18.9% 8.1% 2.3

114

Comparison of Idaho Medicaid to Five States in GAO Study

Idaho Medicaid2017 Foster vs. Non-Foster Children Summary

New Criteria used this year: Medications for 2017 defined by MRx – Standard Behavioral Health Drug List. Children defined as 0-19 years old to match age of Foster Children.

Foster Children Non-Foster Children

Total # of Foster ChildrenTotal # of Foster Children Prescribed

BH MedicationsTotal # of Non-Foster Children Total # Prescribed BH Medications

2,755* 481 286,843 20,627

17.5% of all Foster Children had a claim for a BH Medication 7.2% of all Non-Foster Children had a claim for a BH Medication

* Children Provided on list with Medicaid ID Number (additional 32 Children did not have Medicaid ID's and were excluded from this dataset)

Data will be based on Members 0 – 19 years of age

115

Percent of Total Foster and Non-Foster Children Receiving Behavioral Health Medications by Class 2017

10.1%

0.3%

2.3%

10.0%

0.7%

6.9%

4.0%

0.2%0.7%

3.9%

0.1%

1.5%

0.0%

2.0%

4.0%

6.0%

8.0%

10.0%

12.0%

ADHD ANTIANXIETY ANDSEDATIVE HYPNOTIC

ANTICONVULSANTS,MISCELLANEOUS

ANTIDEPRESSANTS ANTIMANIC AGENTS ANTIPSYCHOTIC AGENTS

Foster Non-Foster

116

Total Claims and Cost Comparison Foster and Non-Foster Children

Drug Class Foster Children Claims

Non-Foster Children Claims

Foster Children Cost ($)

Non-Foster Children Cost ($)

ADHD 2,105 92,552 $449,544 $17,994,826

ANTIANXIETY AND SEDATIVE HYPNOTIC

21 2,508 $266 $58,428

ANTICONVULSANTS, MISCELLANEOUS

418 15,970 $21,510 $1,677,252

ANTIDEPRESSANTS 2,203 70,951 $33,108 $1,089,268

ANTIMANIC AGENTS 128 1,620 $1,722 $24,254

ANTIPSYCHOTIC AGENTS

1,568 33,333 $138,556 $3,315,663

Total 6,443 216,934 $644,706 $ 24,159,691

117

Claims* Comparison Foster Children and Non-Foster Children

7.49

2.63

6.53

7.98

6.73

8.258.12

3.70

7.54

6.30 6.18

7.83

0.00

1.00

2.00

3.00

4.00

5.00

6.00

7.00

8.00

9.00




Claims per Foster Child Claims per Non-Foster Child

118

Overall Behavioral Health Drug Claims per Child

2.34

0.76

0 0.5 1 1.5 2 2.5

Per Foster Child

Per Non-Foster Child

119

Cost Comparison Foster Children and Non-Foster Children

$1,599.80

$33.23

$336.10

$119.96$90.64

$729.24

$1,578.77

$86.18

$791.90

$96.70$92.57

$779.24

$0.00

$200.00

$400.00

$600.00

$800.00

$1,000.00

$1,200.00

$1,400.00

$1,600.00

$1,800.00




Cost per Foster Child Cost per Non-Foster Child

120

Overall Behavioral Health Drug Cost per Child

$234

$84

$0 $50 $100 $150 $200 $250

Per Foster Child

Per Non-Foster Child

121

Distribution of ADHD Drugs by Age and Gender

3%

9%

14%

41%

13%

19%

0%2%2%

5%

14%

37%

11%

24%

2%4%

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

0-6 F 0-6 M 7-12 F 7-12 M 13-17 F 13-17 M 18-19 F 18-19 M

Foster % (Total=281) Non-Foster % (Total=11,398)

122

Distribution of ANTIANXIETY AND SEDATIVE HYPNOTIC Drugs by Age and Gender

13%

0% 0% 0%

38%

25%

13% 13%

5%4%

8% 8%

27%

18%19%

11%

0%

5%

10%

15%

20%

25%

30%

35%

40%

0-6 F 0-6 M 7-12 F 7-12 M 13-17 F 13-17 M 18-19 F 18-19 M

Foster % (Total=8) Non-Foster % (Total=678)

123

Distribution of ANTICONVULSANTS, MISCELLANEOUS Drugs by Age and Gender

6%

3% 3%

21%

35%

27%

3% 3%3%5%

10%

16%

22%

24%

10% 9%

0%

5%

10%

15%

20%

25%

30%

35%

40%

0-6 F 0-6 M 7-12 F 7-12 M 13-17 F 13-17 M 18-19 F 18-19 M


124

Distribution of ANTIDEPRESSANTS Drugs by Age and Gender

0%1%

14%

19%

38%

22%

3%2%

1% 1%

10%

14%

34%

22%

13%

6%

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

0-6 F 0-6 M 7-12 F 7-12 M 13-17 F 13-17 M 18-19 F 18-19 M


125

Distribution of ANTIMANIC AGENTS Drugs by Age and Gender

0% 0% 0%

11%

53%

32%

5%

0%0% 0%

7%

14%

27% 28%

11%13%

0%

10%

20%

30%

40%

50%

60%

0-6 F 0-6 M 7-12 F 7-12 M 13-17 F 13-17 M 18-19 F 18-19 M

Foster % (Total=19) Non-Foster % (Total=262)

126

Distribution of ANTIPSYCHOTIC AGENTS Drugs by Age and Gender

0%

7%

10%

31%

19%

28%

2%3%

1%

3%

10%

24%

20%

26%

7%8%

0%

5%

10%

15%

20%

25%

30%

35%

0-6 F 0-6 M 7-12 F 7-12 M 13-17 F 13-17 M 18-19 F 18-19 M


127

Prescriber Type by Claims Volume Statewide for Foster Children

Nurse Practitioner, 2507, 39%

Child/Adolescent Psychiatrist/Developmental

Specialist, 831, 13%

Pediatrics, 809, 13%

Physician Assistant, 807, 12%

Psychiatrist, 783, 12%

Family/Internal Medicine, 721, 11%

Other, 11, 0%

128

Regional Prescriber Variation 2017: Prescriber Type by Region

0%

10%

20%

30%

40%

50%

60%

70%

80%

Specialist Generalist Mid-Level

Region 1 Region 2 Region 3 Region 4 Region 5 Region 6 Region 7 Out of State

129

Regional Prescriber Variation 2017: Prescriber Type by Region

0%

10%

20%

30%

40%

50%

60%

70%

80%

Region 1 Region 2 Region 3 Region 4 Region 5 Region 6 Region 7 Out of State

Specialist Generalist Mid-Level

130

Number of Claims/Foster Child

16

14

29

51

121

250

0 50 100 150 200 250 300

> 49

40-49

30-39

20-29

10-19

< 10

Number of Foster Children

Nu

mb

er

of

Cla

ims

131

Foster Children and Behavioral Health Medications


132

November 15, 2018

133

Oral Health Issues from Mental Health Medications

Oral health risk of people with mental health conditions is poorer than the general population.

Compounding factors: Homelessness, poor diet, tobacco smoking, disabilities, dental phobias, and barriers to accessing dental care.

Side effects from psychotropic medications also contribute.

Dry mouth (xerostomia) is a major risk factor for oral health problems. Dental erosion, caries (tooth decay), and periodontal (gum disease).

Studies suggest the use of Atypical antipsychotics have less oral side effects than older alternatives.

Patients with severe mental illness have 2.7 times the likelihood of losing all their teeth, compared to the general population.

Recommend oral health assessments in patients treated with mental health agents.

134


Multiple Medications that cause Xerostomia

(Refer to handout)

Common agents:

Antihistamines

Antidepressants

Antianxiety agents

Antipsychotics

Diuretics

Parkinson’s disease agents

Urinary incontinence agents

135


DUR Board requested review of potential oral health issues in Idaho Medicaid patients treated with agents related to mental health treatment.

Potential prevalence.

Review dental coverage available for mental health population.

136

Oral Health Issues from Mental Health Medications Reviewed all clients/claims (Basic Medicaid Plan) from November 1,

2017 to January 31, 2018.

Selected out:

All clients and claims for the following Therapeutic Class Descriptions: ATARACTICS-TRANQUILIZERS

PSYCHOSTIMULANTS-ANTIDEPRESSANTS

ANTICONVULSANTS (Some agents used for mood disorders)

137


46%26%

138


139


140


MCNA Dental Program Benefits for Idaho Medicaid

Idaho Smiles Dental Medicaid Program

All Medicaid eligible adults (21 and older), regardless if they are on the Pregnant Women's Plan or Basic Plan, have full access to the Medicaid Enhanced Plan dental benefits as of July 1, 2018.

141

142

143


Conclusions: Study group of 12,312 clients reported 5,608 clients (46%) taking one or

more agents in the following therapeutic drug categories.

ATARACTICS-TRANQUILIZERS

PSYCHOSTIMULANTS-ANTIDEPRESSANTS

ANTICONVULSANTS

Oral health issues may be a problem in patients taking medications that cause dry mouth (xerostomia).

Limitations to data collection and documenting of diagnosis.

Multiple factors are involved in oral health issues and mental health disorders.

144

Oral Health Issues from Mental Health Medications Questions/Comments??

145

Study Proposals for Upcoming Quarters:

146

?

Prospective DUR Report

147

History 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

Prospective DUR Report

148

DUR Board Meeting November 15, 2018

149

Next Meeting January 17, 2019

150

Documents

November 15, 2018...2018/11/15 · H.R. 5799: Medicaid Drug Review, Utilization, Good Governance Improvement Act To amend title XIX of the Social Security Act to require as a condition