CurrentNeighborhood Health Plan of Rhode IslandPolicy 646-A

DALIRESP (roflumilast) — Prior Authorization

Defines prior authorization requirements for coverage of Daliresp (roflumilast) for members of Neighborhood Health Plan of Rhode Island (implemented via CVS Caremark criteria). Applies to prescriptions seeking coverage for COPD exacerbation risk reduction.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDALIRESP (roflumilast) — Prior Authorization

Policy CodePolicy 646-A

Change TypeNo material change

Effective DateOct 1, 2023

Next Review Date

Key ActionObtain prior authorization and document that the patient has severe COPD with chronic bronchitis and a history of exacerbations; approval is for 12 months if criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsDuration of approval (DOA)

250 mcgstarting dose (first 4 weeks only)

1FDA-approved indication listed

Coverage Criteria

Initial Prior Authorization

Covered when ALL of the following are met:

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Indication: The requested drug is being prescribed to reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations in a patient with severe COPD associated with chronic bronchitis and a history of exacerbations.

Prescriber must document diagnosis and history of exacerbations; see provider documentation requirements.

Approval duration: If criteria are met, approval will be for 12 months.12 months

Duration of approval per policy.

Provider Actions and Authorization Rules

Prior Authorization

Prior Authorization Required

Prior authorization required. If criteria are met the approval duration is 12 months.

Duration of approval: 12 months (Policy 646-A, effective 2023-10-01)

Step Therapy

No step therapy or alternative agent sequencing is specified in this document.

Documentation Required

Required Clinical Documentation

Prescriber must document that the patient has severe COPD associated with chronic bronchitis and a history of exacerbations and that the requested drug is being prescribed to reduce the risk of COPD exacerbations.

Indication must match FDA-approved use: reduction of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations
Policy source: PRIOR AUTHORIZATION CRITERIA — DALIRESP (roflumilast); Coverage criteria

Background

Roflumilast (Daliresp) is 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 therefore must not be used for relief of acute bronchospasm. The recommended starting dose is 250 mcg for the first 4 weeks only; this loading dose is not the therapeutic dose.

Definitions

inv-08: Daliresp (roflumilast) — definition and indication summary

Generic nameRoflumilast

Brand nameDaliresp

Mechanism / drug classOral phosphodiesterase‑4 (PDE‑4) inhibitor

FDA‑approved indicationTo reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.

Not indicated forRelief of acute bronchospasm (not a bronchodilator).

Starting dose guidance250 mcg is the starting dose for the first 4 weeks only (not the therapeutic dose).