CurrentNeighborhood Health Plan of Rhode IslandPolicy 646-A

Daliresp (roflumilast) prior authorization

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

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDaliresp (roflumilast) prior authorization

Policy CodePolicy 646-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit a prior authorization request showing diagnosis of severe COPD with chronic bronchitis and that the drug is prescribed to reduce COPD exacerbations.

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)

1Policy identifier

Coverage Criteria for Daliresp (roflumilast)

Initial prior authorization criteria

Covered when ALL of the following are met

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Indication and patient characteristics: 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

Prior authorization is obtained per plan requirements (prior authorization required)

Approval duration: 12 months if approved

Dosing instruction: Initial dosing of 250 mcg for the first 4 weeks as the labeled starting dose before escalation to therapeutic dose

250 mcg is the recommended starting dose for the first 4 weeks only

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required: The requested drug will be covered with prior authorization when the member meets the coverage criteria for reduction of COPD exacerbations in severe COPD with chronic bronchitis and a history of exacerbations.

Reason for prior auth: reduce risk of COPD exacerbations in severe COPD with chronic bronchitis and prior exacerbations

Documentation Required

Initial Dosing Requirement

Initial dosing must follow the labeled starting regimen: begin at 250 mcg for the first 4 weeks only before escalating to the therapeutic dose.

Start at 250 mcg for weeks 1–4 only; then increase to the therapeutic dose per product labeling.

Documentation Required

Required Documentation

Required documentation must be submitted with the prior authorization request to support medical necessity.

Provider must document diagnosis of severe COPD with chronic bronchitis and history of exacerbations
Clinical rationale for use to reduce risk of COPD exacerbations

Denial Risk

Coverage Indication Required

Coverage indication required — requests may be denied if the drug is not prescribed to reduce risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.

Non-covered uses: not indicated for relief of acute bronchospasm; Daliresp is not a bronchodilator.

Note

Approval Duration

Duration of approval when criteria are met is 12 months.

Approval period: 12 months

Definitions

Daliresp (roflumilast) — key facts

IndicationOral medication to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.

Starting dose250 mcg for the first 4 weeks only (labeled starting dose before escalation to therapeutic dose).

Not a bronchodilatorDaliresp is not a bronchodilator and is not indicated for relief of acute bronchospasm or acute exacerbation relief.

Approval duration (if prior auth met)When prior authorization criteria are met, approval duration is 12 months.

Required documentationPrior authorization request must indicate diagnosis of severe COPD with chronic bronchitis and history of exacerbations and that the drug is prescribed to reduce COPD exacerbations.