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    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsEOHHS DUR interventions Coverage Update | OpenPaye…
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    CurrentExecutive Office of Health and Human ServicesPolicy N/A

    Drug Utilization Review (DUR) Board meeting recommendations — coverage criteria for buprenorphine products, antidepressants, antipsychotics, benzodiazepines, and related interventions

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    Minutes of the Rhode Island DUR Board meeting summarizing safety concerns, utilization reviews, and recommended interventions for medications (notably antidepressants, citalopram/escitalopram, buprenorphine products, Suboxone/Subutex, benzodiazepines, antipsychotics, and lipid agents). Affects Medicaid prescribers, pharmacies, and program administrators.

    Policy Summary
    PayerExecutive Office of Health and Human Services
    PolicyDUR Board meeting recommendations — coverage criteria for buprenorphine products, antidepressants, antipsychotics, benzodiazepines, and related interventions
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateJun 5, 2012
    Key ActionSend DUR intervention letters to prescribers of patients identified on concurrent Suboxone and other opioids; if no response send a second letter from the Medicaid Medical Director and consider prior authorization and dose limits.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    3patients identified on Suboxone plus another opioid
    266patients with concurrent duplicate antipsychotic claims

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    134
    same antipsychotic at different strengths
    52quetiapine plus another antipsychotic
    31patients on two different antipsychotics

    DUR Board Recommendations & Coverage Criteria

    DUR Board intervention and utilization management recommendations

    Board recommendations for medication management and DUR interventions

    Suboxone/Subutex management: Identify patients on Suboxone with concurrent opioids and send DUR intervention letters; if no response and patients continue concurrent opioid therapy, send a second letter from the Medicaid Medical Director (if possible naming the other opioid prescriber). Prescribers of patients taking short-acting opioids >90 days should be sent a DUR intervention letter, with second-letter escalation to single-pharmacy restriction if prescribing does not change. Consider limiting ongoing Subutex use after induction to pregnant women (automated PA criteria could include evidence of prenatal vitamin use for women ≤45). Consider a prospective high-dose edit for Suboxone to limit daily dose to 24 mg and evaluate placing PA restrictions on concurrent Suboxone with other opioids after further utilization review.concurrent therapy detected; short-acting opioids >90 days; Suboxone >24 mg/day

    Three patients identified for immediate letter intervention; Board requested further review at next meeting

    Butrans prior authorization and step therapy: Require prior authorization for Butrans and limit use to patients who have failed two preferred generic long-acting opioids as determined by review of the patient's claims history in the past 60 days.failure of 2 preferred long-acting generics in past 60 days

    Claims review to confirm failures

    Citalopram safety edit and prescriber outreach: Alert prescribers to avoid citalopram doses >40 mg due to risk of QTc prolongation; consider prescriber outreach and potential non-preferred status for safety reasons.>40 mg/day
    Duplicate antipsychotic therapy intervention: Identify prescribers of patients with duplicate antipsychotic therapy (including same drug at different strengths, quetiapine plus another agent, or two different agents) and refer them to the Medicaid Medical Director for follow-up to reduce duplicate therapy.patients meeting duplicate antipsychotic claims criteria

    266 patients met criteria; 134 same drug different strengths; 52 quetiapine plus another; 31 two different agents

    Benzodiazepine combination: Identify prescribers for patients taking clonazepam with another benzodiazepine and refer to the Medicaid Medical Director; Board did not support requiring prior authorization for this combination due to chronic use and tapering difficulty.concurrent clonazepam plus benzodiazepine

    The DUR Board reviewed patients receiving clonazepam combined with another benzodiazepine and judged the combination to be not clinically justified. The Board noted that this concurrent therapy may not trigger current duplicate-therapy alerts because clonazepam is classified as an anticonvulsant, and also recognized legitimate anticonvulsant use in some patients (for example, those with schizophrenia).

    The Board considered whether to require prior authorization for this combination but did not support a PA requirement because many patients have been on both agents chronically and tapering would be difficult or impossible for some. Instead, the Board recommended identifying prescribers of patients on this combination and referring them to the Medicaid Medical Director for follow-up rather than implementing an immediate PA.

    Dose Limits and Coding Notes

    Suboxone daily dose limit considered
    Suboxone daily dose limit consideredProspective high-dose edit to limit Suboxone to 24 mg per day
    Action requestedHID to evaluate Suboxone use by daily dose to identify patients receiving >24 mg/day
    Potential follow-upAfter utilization review, consider prior authorization restrictions for concurrent Suboxone and other opioids
    Citalopram maximum recommended dose
    Maximum recommended doseCitalopram should not be used in doses greater than 40 mg due to QTc prolongation risk
    Prescriber outreachDUR letters were mailed to prescribers to alert them about citalopram dose safety

    Prior Authorization, Step Therapy, and Documentation Requirements

    Prior Authorization

    Prior authorization required for Subutex and Butrans; Subutex limited after induction

    Require prior authorization for Subutex (buprenorphine) and Butrans (transdermal buprenorphine). Limit ongoing use of Subutex after induction to pregnant women; automated PA criteria may require evidence of prenatal vitamin use for women aged 45 and younger. Limit Butrans to patients who have failed two preferred generic long-acting opioids as verified by claims review in the prior 60 days.

    • Subutex: allow induction doses; ongoing use limited to pregnant women (documentation required).
    • Butrans: PA required and restricted to patients who have failed two preferred long-acting generic opioids (confirm via 60-day claims history).
    Step Therapy

    Step therapy for Butrans: confirm failure of two preferred long-acting opioids

    Before approving Butrans, require documentation of failure of two preferred generic long-acting opioids determined by a review of the patient's claims history over the prior 60 days.

    Clinical Background and Evidence Summary

    The Board discussed antidepressant efficacy and noted variability across levels of depression severity. In their review they highlighted meta-analytic findings indicating limited benefit for antidepressants in patients with mild-to-moderate depression, and raised specific concerns about use in children and adolescents based on available analyses.

    In addition to efficacy concerns, the Board emphasized safety issues tied to certain agents and dosing: for example, they recommended caution with higher doses of citalopram because of QTc prolongation risk and suggested outreach to prescribers who exceed the 40 mg/day threshold.

    Program Definitions

    Lock-in program definition
    DefinitionProgram to restrict certain patients to a single pharmacy to coordinate prescription services and comprehensive pain management
    Selection criteriaNormally the pharmacy most frequented by the patient is selected; pharmacy staff must agree to coordinate services
    Current statusNo patients are currently restricted due to controlled substance abuse; current lock-ins are for residents of group homes or out-of-state facilities
    Suboxone vs Subutex
    Subutex compositionContains buprenorphine alone
    Suboxone compositionContains buprenorphine plus naloxone (deterrent to injection abuse)

    Induction and Initial Use Criteria for Buprenorphine

    Buprenorphine induction guidance — induction and early use criteria

    Induction and early use

    Subutex induction: Allow initial induction doses of Subutex for opioid dependence induction. After induction, limit ongoing Subutex use to pregnant women; automated prior authorization criteria may require evidence of prenatal vitamin use for women age 45 and younger.

    Continuation Considerations for Suboxone

    Suboxone continuation considerations — concerns about chronic use versus intended short-term use

    Concerns about chronic use vs intended short-term use

    Suboxone chronic use review: Recognize that Suboxone was intended for short-term use but is frequently used chronically; obtain long-term safety data from the manufacturer and evaluate patients' daily dose and concurrent opioid use prior to imposing restrictions. Consider a prospective high-dose edit to limit Suboxone to 24 mg/day and, after utilization evaluation, consider prior authorization to restrict concurrent use of Suboxone with other opioids.

    Step Therapy Requirements

    RequirementOperational detail
    Butrans step therapy requirement
    Approve Butrans only after claims review confirms failure of two preferred generic long‑acting opioids in the prior 60 days.

    Quantity and Dose Limits

    Suboxone — quantity/dose limit
    Quantity/dose limitSuboxone quantity/dose limit considered: 24 mg per day
    RationaleBoard recommended limiting dose because Suboxone is often used chronically although intended for short-term use
    Next stepHID to evaluate patients receiving daily doses greater than 24 mg
    Policy Summary
    PayerExecutive Office of Health and Human Services
    PolicyDUR Board meeting recommendations — coverage criteria for buprenorphine products, antidepressants, antipsychotics, benzodiazepines, and related interventions
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateJun 5, 2012
    Key ActionSend DUR intervention letters to prescribers of patients identified on concurrent Suboxone and other opioids; if no response send a second letter from the Medicaid Medical Director and consider prior authorization and dose limits.
    SourceLink
    On This Page
    DUR Board Recommendations & Coverage CriteriaDose Limits and Coding NotesPrior Authorization, Step Therapy, and Documentation RequirementsClinical Background and Evidence SummaryProgram DefinitionsInduction and Initial Use Criteria for BuprenorphineContinuation Considerations for SuboxoneStep Therapy RequirementsQuantity and Dose Limits
    P&T consideration
    Consider making citalopram non-preferred for safety; escitalopram now available generically
    • Claims history review covering the past 60 days to confirm failures of two preferred long-acting generics.
    Documentation Required

    Suggested documentation checks for prior authorization

    When applying PA criteria that limit Subutex to pregnant women, check for documentation such as concurrent prenatal vitamin use for women aged 45 and younger; also use claims review (past 60 days) to support step therapy decisions for Butrans.

    • Evidence of prenatal vitamin use for women ≤45 when Subutex ongoing use is restricted to pregnant women.
    • Review of patient's claims history in the prior 60 days to confirm failures of preferred long-acting opioids for Butrans step therapy.
    Prior Authorization

    Prior authorization and dose-limit considerations (Suboxone/Subutex/Butrans)

    Consider additional utilization controls: prospective high-dose edit for Suboxone to limit daily dose to 24 mg and possible future PA restrictions on concurrent use of Suboxone with another opioid pending further evaluation of utilization.

    • Prospective high-dose edit considered for Suboxone to limit dose to 24 mg/day.
    • May consider PA to restrict concurrent Suboxone use with another opioid after further utilization review.
    Preferred useSubutex intended only for ongoing use in patients allergic to naloxone or in pregnant females