Subject: Osphena PA Policy 961-A 01-2023

Drug

OSPHENA  (ospemifene)

Policy:

FDA-approved Indications          
Osphena is indicated for:
The treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.
The treatment of moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy, due to menopause.

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 any
          of the following: A) Moderate to severe dyspareunia (pain during
          sexual intercourse) due to menopause, B) Moderate to severe
          vaginal dryness due to 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

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Osphena [package insert]. Florham Park, NJ: Shionogi Inc.; January 2019.
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