Pharmacy Prior Authorization Criteria

Daliresp (roflumilast)

For diagnosis of Chronic obstructive pulmonary disorder (COPD)
Indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.
Limitations of Use:
Daliresp is not a bronchodilator and is not indicated for the relief of acute bronchospasm.
Daliresp 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose.

Daliresp 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

AND

History of COPD exacerbations which require the use of systemic corticosteroids, antibiotics, or hospital admission [C]

AND

Trial and failure, intolerance, or contraindication to two prior therapies for COPD (e.g., Combivent, Spiriva)

AND

Trial and failure or intolerance to generic roflumilast (Applies to brand Daliresp only)

Daliresp 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose.

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

AND

Trial and failure or intolerance to generic roflumilast (Applies to brand Daliresp only)

2024-09-04, 2023-12-12, 2023-08-22, 2022-12-19, 2022-11-01, 2022-08-31, 2021-09-03, 2021-05-19, 2020-09-01, 2019-09-12, 2019-07-08

Daliresp Prescribing Information. AstraZeneca Pharmaceuticals LP. Wilmington, DE. March 2020.
Micromedex Healthcare Series [database on the Internet]. Greenwood Village (CO): IBM Corporation.; Updated periodically. Available by subscription at: https://www.micromedexsolutions.com/. Accessed August 24, 2021.
FDA Summary Review. Accessed at: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022522Orig1s000SumR.pdf. Accessed August 24, 2021.
Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease (2023 report). Accessed at: file:///C:/Users/hfatani/Downloads/GOLD-2023-ver-1.3-17Feb2023_WMV.pdf. Accessed August 7, 2023.

Patients enrolled in the pivotal trials had a forced expiratory volume in 1 second [FEV1] less than or equal to 50% of predicted and FEV1/forced vital capacity [FVC] less than 0.7). [1-3]
According to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) treatment guidelines, moderate COPD is defined as FEV1 less than 80% but greater than or equal to 50%; severe COPD is defined as FEV1 less than 50% but greater than or equal to 30%; and very severe COPD is defined as FEV1 less than 30%. [4]
In the pivotal studies the rate of moderate exacerbations was defined as requiring intervention with systemic glucocorticosteroids. Severe exacerbations were defined as leading to hospitalization and/or to death. [1]

2024-09-04: Annual review: No criteria changes. Background updates.
2023-12-12: Program update to standard reauthorization language. No changes to clinical intent.
2023-08-22: 2023 UM Annual Review. No criteria changes. Updated references
2022-12-19: Commercial formulary strategy for brand Daliresp to require a trial of its generic.
2022-11-01: Update Guideline
2022-08-31: 2022 Annual Review- updated references
2021-09-03: 2021 Annual Review, no changes to criteria.
2021-05-19: Addition of EHB formulary to guideline, no changes to criteria
2020-09-01: 2020 Annual Review, no changes to criteria.
2019-09-12: 2019 Annual Review
2019-07-08: 1) removed "moderate to very severe" from criterion 1 and wrote out chronic obstructive pulmonary disorder 2) removed criterion 2 that requires chronic bronchitis 3) Combined criterion 3 and 4 so there is only one criterion that reads: "history of COPD exacerbations which required the use of systemic corticosteroids, antibiotics, or hospital admission"; 4) Add examples of COPD drugs in the criterion asking for 2 prior therapies (due to NCQA feedback to PA team) added Combivent and Spiriva