Subject: Osphena PA 961-A P01-2025

Drug

OSPHENA  (ospemifene)

Policy:

Indications

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

Authorization may be granted when the requested drug is being prescribed for the treatment of moderate to severe dyspareunia (pain during sexual intercourse) due to menopause.

Moderate to Severe Vaginal Dryness

Authorization may be granted when the requested drug is being prescribed for the treatment of moderate to severe vaginal dryness due to menopause.

Continuation of Therapy

Moderate to Severe Dyspareunia

Authorization may be granted when the requested drug is being prescribed for the treatment of 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 medically necessary.

Moderate to Severe Vaginal Dryness

Authorization may be granted when the requested drug is being prescribed for the treatment of 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 medically 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]. Princeton, NJ: Duchesnay USA, Inc.; February 2024.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2024. https://online.lexi.com. Accessed November 29, 2024.
3. Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 11/29/2024).

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 06, 2025