CurrentMass General Brigham Health PlanPolicy N/A

Daliresp (roflumilast) prior authorization and coverage

This policy describes prior authorization, quantity limits, continuation, and clinical coverage criteria for roflumilast (Daliresp) for members of Mass General Brigham Health Plan (MassHealth UPPL and Commercial/Exchange). It applies to prescribing providers and pharmacy benefit administrators.

Policy Summary

PayerMass General Brigham Health Plan

PolicyDaliresp (roflumilast) prior authorization and coverage

Policy CodePolicy N/A

Change TypeNo material change

Effective DateAug 1, 2020

Next Review DateN/A

Key ActionSubmit prior authorization showing current Daliresp use or documentation that ALL coverage criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 moInitial approval duration

36 moReauthorization duration

30/tab moQty limit / strength

PA requiredBenefit requirement

Coverage Criteria for Roflumilast (Daliresp)

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inv-01: Initial Therapy

Authorization may be granted when ALL of the following are met

Initial Authorization

Current use clause: Member is currently receiving treatment with Daliresp (excluding when the product is obtained as samples or via manufacturer's patient assistance programs)
This is an alternative to meeting the subsequent ALL criteria
Treatment failure and diagnosis: Patient has had a documented side effect, allergy, or treatment failure with a combination long-acting beta agonist/inhaled corticosteroid OR a long-acting bronchodilator (long-acting beta-agonist or long-acting anticholinergic) and an inhaled corticosteroid used concurrently as separate agents; AND patient has a diagnosis of severe COPD associated with chronic bronchitis and a history of exacerbations.
Both elements required if not currently receiving Daliresp

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inv-02: Continuation of Therapy

Reauthorization may be granted when the following is met

Reauthorization requires physician assessment documenting improvement in overall disease activity within the previous 6 months from time of recertification request.6 months

Reauthorizations will be granted for 36 months per limitations

For continuation under the “currently receiving treatment” pathway, product obtained as samples or through a manufacturer’s patient assistance program is excluded. Authorization via the current-use clause requires documentation that the member is actively receiving commercially dispensed Daliresp; use of non-dispensed samples or medications provided through assistance programs does not qualify as evidence of ongoing treatment for this purpose.

Drug Coding and Quantity Limits

Drug codingNDC

NDC not listed

NDCs not provided in document

Quantity limit — per-strength monthly tablet limits

Daliresp (roflumilast) 250 mcg tablets30 tablets per month

Daliresp (roflumilast) 500 mg tablets30 tablets per month

Initial approval duration12 months (initial approvals will be granted for 12 months)

Reauthorization duration36 months (reauthorizations will be granted for 36 months)

Prescriber and Pharmacy Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for Daliresp (roflumilast). Requests for members currently receiving Daliresp may be authorized when the member is already on therapy (does not include samples or manufacturer patient assistance program supply).

All Plans: Phone 877-519-1908; Fax 855-540-3693
Non-Specialty Medications: Phone 800-711-4555; Fax 844-403-1029

Step Therapy

Step Therapy Status

Step therapy is listed as a program requirement; prior authorization/coverage is contingent on meeting the step therapy criteria (see required documentation and denial triggers).

Documentation Required

Required Documentation

For initiation or continuation requests include clinical documentation of diagnosis, prior medication history, and recent physician assessment. Continuation (reauthorization) requests must document improvement per physician assessment within the previous 6 months.

Diagnosis of severe COPD with chronic bronchitis and history of exacerbations
For initiation: documentation of side effect, allergy, or treatment failure with a combination LABA/inhaled corticosteroid or with a long-acting bronchodilator plus inhaled corticosteroid used concurrently as separate agents
For continuation: physician assessment documenting improvement within the previous 6 months
Exclude medications obtained only as samples or via manufacturer's patient assistance programs from "currently receiving" documentation

Denial Risk

Denial Triggers

Requests may be denied if required documentation is incomplete or criteria are not met. Common denial triggers include lack of documented severe COPD with chronic bronchitis and exacerbation history, absence of prior trial and failure/ intolerance to required controller therapies, or missing recent physician assessment for reauthorization.

No documentation of prior trial/failure or intolerance to required long-acting therapies plus inhaled corticosteroid when applicable
No documentation of severe COPD with chronic bronchitis and history of exacerbations
Reauthorization requests without physician assessment showing improvement within the prior 6 months
Requests relying solely on medication samples or manufacturer patient assistance program supplies to demonstrate current use

Definitions

Roflumilast (Daliresp) — drug definition and indication summary

Drug classPhosphodiesterase-4 (PDE4) inhibitor

Indication summaryIndicated to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations

Mechanism of actionReduces inflammation by inhibiting breakdown of intracellular cyclic AMP

Not for acute bronchospasmNot a bronchodilator and not indicated for relief of acute bronchospasm

Brand and generic namesBrand: Daliresp; Generic: roflumilast

Background

Roflumilast (Daliresp) is a phosphodiesterase-4 (PDE4) inhibitor indicated to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. It is not a bronchodilator and is intended to address the inflammatory component of COPD rather than provide relief for acute bronchospasm.