Subject: Brisdelle PA with Limit Policy 2926-C 01-2023

Drug

BRISDELLE  (paroxetine mesylate)

Policy:

FDA-APPROVED INDICATIONS
Brisdelle is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.

Limitation of Use:
Brisdelle is not indicated for the treatment of any psychiatric condition. Brisdelle contains a lower dose of paroxetine than that used to treat depression, obsessive compulsive disorder, panic disorder, generalized anxiety disorder, social anxiety disorder, and post-traumatic stress disorder. The safety and efficacy of this lower dose of paroxetine in Brisdelle have not been established for any psychiatric condition. Patients who require paroxetine for treatment of a psychiatric condition should discontinue Brisdelle and initiate a paroxetine-containing medication that is indicated for such use.

COVERAGE CRITERIA
The requested drug will be covered with prior authorization when the following criteria are met:
     •   The requested drug is being prescribed for the treatment of
          moderate to severe vasomotor symptoms (VMS) associated with
          menopause
     AND
     •   The request is NOT for continuation of therapy
     OR
     •   The request is for continuation of therapy
          AND
          º   The patient has achieved or maintained a positive clinical
               response to the requested drug
          AND
          º   The patient has been re-evaluated periodically to determine if
               treatment is still necessary

Quantity Limits apply.
30 capsules / 25 days* or 90 capsules / 75 days*
*The duration of 25 days is used for a 30-day fill period and 75 days is used for a 90-day fill period to allow time for refill processing.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Brisdelle [package insert]. Roswell, GA: Sebela Pharmaceuticals Inc.; September 2021.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online, Hudson, Ohio: UpToDate, Inc.; 2022; Accessed December 6, 2022.
3. Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com. Accessed December 6, 2022.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

July 29, 2023