CurrentCentenePolicy CP PMN.168

Ospemifene (Osphena)

Defines clinical coverage criteria, prior authorization requirements, and approval durations for ospemifene (Osphena) for treatment of moderate to severe dyspareunia and vaginal dryness due to menopause across Centene lines of business.

Policy Summary

PayerCentene

PolicyOspemifene (Osphena)

Policy CodePolicy CP PMN.168

Change TypeNo material changes

Effective DateAug 28, 2018

Next Review Date

Key ActionSubmit clinical documentation (e.g., office notes, lab results) demonstrating the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

60 mg/daymaximum recommended dose

12 monthsapproval duration

2failed lubricant trials required

4 wksvaginal estrogen trial

≥18age requirement

NCapplicable state listed

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Coverage Criteria for Ospemifene (Osphena)

Initial Therapy

Covered when ALL of the following are met:

Initial Approval - Dyspareunia or Vaginal Dryness due to menopause: 1) Diagnosis of dyspareunia or vaginal dryness due to menopause; 2) Age ≥ 18 years; 3) Failure of two vaginal lubricants or vaginal moisturizers unless clinically significant adverse effects or all are contraindicated; 4) Failure of ≥4 weeks of one vaginal estrogen (e.g., estradiol vaginal cream, Premarin vaginal cream) at up to maximally indicated doses unless clinically significant adverse effects or all are contraindicated; 5) Requested dose does not exceed 60 mg (1 tablet) per day.

Provider must submit clinical documentation (e.g., office chart notes, lab results) supporting that the member meets all approval criteria.

Continuation Therapy

Covered for continuation when ANY of the following are met:

Continued Therapy: a) Member is currently receiving medication via the Centene benefit or has previously met initial approval criteria; OR b) Member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; AND member is responding positively to therapy (e.g., reduction in dyspareunia symptoms). If the request is for a dose increase, the new dose must not exceed 60 mg (1 tablet) per day.

Approval duration limits per line of business apply (see authorization guidance).

Coverage for indications not explicitly addressed in this policy (i.e., non‑FDA approved/off‑label uses) is not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), and CP PMN.53 (Medicaid), or unless the member’s evidence of coverage permits the requested use.

Ospemifene is contraindicated and not eligible for coverage when any of the following are present: undiagnosed abnormal genital bleeding; known or suspected estrogen‑dependent neoplasia; active venous thromboembolism (for example, deep vein thrombosis or pulmonary embolism) or a history of thromboembolic disease (including stroke or myocardial infarction); hypersensitivity to Osphena or any of its ingredients (e.g., angioedema, urticaria, rash, pruritus); or known or suspected pregnancy. Boxed warnings include risks of endometrial cancer and cardiovascular disorders (stroke and venous thrombosis).

Coverage determinations under this clinical policy are guidance to assist in medical necessity decisions and the administration of benefits; however, payment is ultimately subject to the member’s individual coverage documents (for example, evidence of coverage, certificate of coverage, policy, or contract). This policy does not guarantee payment and providers must follow the terms, conditions, exclusions, and limitations of the applicable coverage documents and any applicable state or federal requirements.

For Medicaid members, state Medicaid coverage provisions take precedence when they conflict with the coverage provisions in this clinical policy. Providers should consult the applicable state Medicaid manual for any state‑specific coverage requirements or exceptions.

Requests for use of ospemifene for off‑label or non‑FDA indications without adequate supporting documentation will not be authorized unless documentation meets the requirements of the applicable off‑label use policies cited in this policy (CP.CPA.09, HIM.PA.154, CP PMN.53) or the member’s evidence of coverage allows the use.

Provider Requirements and Authorization Details

Prior Authorization

Prior Authorization and Approval Duration

Prior authorization is required. For Medicaid/HIM, approvals are issued for up to 12 months. For Commercial lines of business, approvals are granted for 12 months or for the duration of the request, whichever is less.

Medicaid/HIM: 12 months
Commercial: 12 months or duration of request, whichever is less

Documentation Required

Required Clinical Documentation and Insufficient Documentation

Providers must submit sufficient clinical documentation (e.g., office chart notes, lab results, prior treatment records) to demonstrate the member meets all approval criteria. Requests that lack required documentation will not be authorized.

Examples of required documentation: office notes, laboratory results, medication history showing trials of vaginal lubricants/moisturizers and vaginal estrogen

Background

Ospemifene (Osphena) is a selective estrogen receptor modulator (SERM) approved for treatment of moderate to severe dyspareunia and vaginal dryness due to vulvar and vaginal atrophy from menopause. The usual and FDA‑approved dosing regimen is 60 mg orally once daily. Therapy carries contraindications and boxed warnings related to estrogen‑dependent neoplasia, thromboembolic events, and endometrial cancer risk, and providers should consider these safety issues when evaluating candidates for therapy.

Definitions

Ospemifene (Osphena) — Key facts

Drug classSelective estrogen receptor modulator (SERM)

FDA indicationTreatment of moderate to severe dyspareunia and vaginal dryness due to vulvar and vaginal atrophy from menopause

Usual dose60 mg orally once daily (maximum 60 mg/day)