Subject: Osphena PA Policy 961-A UDR 01-2024

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

Moderate to Severe Dyspareunia Due to Menopause
Authorization may be granted when the requested drug is being prescribed for moderate to severe dyspareunia (pain during sexual intercourse) due to menopause

Moderate to Severe Vaginal Dryness Due to Menopause
Authorization may be granted when the requested drug is being prescribed for moderate to severe vaginal dryness due to menopause

CONTINUATION OF THERAPY

Moderate to Severe Dyspareunia Due to Menopause
Authorization may be granted when the requested drug is being prescribed for moderate to severe dyspareunia (pain during sexual intercourse) due to menopause when ALL of the following criteria are met:
  •   The patient has achieved or maintained a positive clinical response to the requested drug
  •   The patient has been re-evaluated periodically to determine if treatment is still necessary

Moderate to Severe Vaginal Dryness Due to Menopause
Authorization may be granted when the requested drug is being prescribed for moderate to severe vaginal dryness due to menopause when ALL of the following criteria are met:
  •   The patient has achieved or maintained a positive clinical response to the requested drug
  •   The patient has been re-evaluated periodically to determine if treatment is still necessary

DURATION OF APPROVAL (DOA)

                 •           961-A: DOA: 12 months

 

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. Waltham, MA: UpToDate, Inc.; 2023. https://online.lexi.com. Accessed December 05, 2023.
3. Micromedex (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 12/05/2023).

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.

June 16, 2024