CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Daliresp (roflumilast) prior authorization coverage criteria

Defines prior authorization coverage criteria for Daliresp (roflumilast) for reducing risk of COPD exacerbations in patients with severe COPD with chronic bronchitis and a history of exacerbations; applies to prescribing providers and pharmacy benefit management under CVS Caremark for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDaliresp (roflumilast) prior authorization coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document that the patient has severe COPD with chronic bronchitis and a history of exacerbations; approval is limited to that indication.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1covered indication specified

250 mcgstarting dose (first 4 weeks)

not a bronchodilatorlimitation of use

Coverage Criteria

Initial prior authorization

Covered when ALL of the following are met:

Required condition: 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

Based on FDA‑approved indication

Daliresp (roflumilast) is not a bronchodilator and is not indicated for relief of acute bronchospasm. Requests for use to treat acute bronchospasm or as a rescue bronchodilator are not consistent with the labeled limitations of use and may be denied.

Dosing and Coding

inv-03: Starting dose — 250 mcg for first 4 weeks

Starting dose250 mcg for the first 4 weeks of treatment (starting dose only, not the therapeutic dose)

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDaliresp (roflumilast) prior authorization coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document that the patient has severe COPD with chronic bronchitis and a history of exacerbations; approval is limited to that indication.

SourceLink

On This Page

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Provider Actions and Authorization Rules

Prior Authorization

Prior Authorization Required

Prior authorization required. Requests will be approved when roflumilast (Daliresp) is prescribed to reduce the risk of COPD exacerbations in a patient with severe COPD associated with chronic bronchitis and a history of exacerbations.

Applies to roflumilast (Daliresp)
Approval contingent on meeting coverage criterion described

Step Therapy

No step therapy requirements specified in this document.

Documentation Required

Required Clinical Documentation

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

Document severity of COPD and history of exacerbations
Document clinical rationale for roflumilast use to reduce exacerbation risk

Denial Risk

Denial Risk for Non-Indicated Use

Requests that do not meet the coverage criterion — i.e., roflumilast not prescribed to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations — are at high risk for denial.

Non-indicated uses (not for reducing COPD exacerbation risk in the specified population) may be denied

OpenPayer

Daliresp (roflumilast) prior authorization coverage criteria

Coverage Criteria

Dosing and Coding

Provider Actions and Authorization Rules

Background

Definitions