Clinical Policy: Ospemifene (Osphena)

Coverage Summary & Scope

Scope: Defines medical necessity criteria, prior authorization requirements, dosing limits, covered indications, contraindications, and approval durations for ospemifene (Osphena) across Commercial, HIM, and Medicaid lines of business. Subject: Ospemifene (Osphena).

Coverage stance: Covered with criteria for the FDA-approved indication of moderate to severe dyspareunia and vaginal dryness due to menopause when the policy's approval criteria are met (including age and prior therapy requirements).

High-level summary: Ospemifene is a selective estrogen receptor modulator (SERM) indicated for moderate to severe dyspareunia and vaginal dryness due to menopause. Prior therapy expectations include trials of topical vaginal lubricants/moisturizers and a trial of vaginal estrogen. Dosing is limited to a maximum of 60 mg/day (1 tablet).

Approval duration note: Medicaid/HIM – 12 months; Commercial – 12 months or duration of request, whichever is less.

Thresholds

Age≥ 18 years

Maximum daily dose≤ 60 mg/day (1 tablet)

Vaginal estrogen trial duration≥ 4 weeks

IL HIM step therapy bypass date01/01/2026

Initial Therapy Criteria

Initial Approval Criteria - Dyspareunia or Vaginal Dryness

Covered when ALL of the following are met:

ALL of the following

Diagnosis of dyspareunia or vaginal dryness due to menopause
Age ≥ 18 years>= 18 years
Topical therapy failure: Failure of two vaginal lubricants or vaginal moisturizers (see Appendix B for examples), unless clinically significant adverse effects are experienced or all are contraindicated
See Appendix B for examples

Continuation / Renewal Criteria

Continuation/Renewal Criteria - Dyspareunia or Vaginal Dryness

Covered when ALL of the following are met:

ALL of the following

Continuity of care/previous approval: Member currently receiving medication via Centene benefit or previously met initial approval criteria or is receiving medication and enrolled in a state/product with continuity of care regulations
Refer to state specific addendums for continuity of care
Positive response: Member is responding positively to therapy (e.g., dyspareunia symptom reduction)
Example of positive response provided in policy
Dose increase limit: If request is for a dose increase, new dose does not exceed 60 mg (1 tablet) per day

Contraindications, Boxed Warnings & Not Authorized Uses

Contraindications: Osphena is contraindicated in patients with undiagnosed abnormal genital bleeding, known or suspected estrogen-dependent neoplasia, active or history of deep vein thrombosis or pulmonary embolism, active thromboembolic disease (for example, stroke and myocardial infarction), hypersensitivity to Osphena or ingredients, and known or suspected pregnancy.

Boxed warnings: The product carries boxed warnings for endometrial cancer and cardiovascular disorders (stroke and deep vein thrombosis).

Scope of indications: Non-FDA approved indications are not authorized by this policy unless sufficient documentation of efficacy and safety is provided per the applicable off-label use policies referenced in the policy; off-label uses not addressed here are excluded unless they meet those off-label criteria.

Provider Actions & Documentation Requirements

Prior Authorization

Prior authorization required with step therapy

Prior authorization requires documentation that the member failed two vaginal lubricants or moisturizers and failed at least 4 weeks of one vaginal estrogen unless clinically significant adverse effects or contraindications exist.

IL HIM step therapy bypass applies per IL HB 5395 effective 01/01/2026

Documentation Required

Submit supporting documentation

Providers must submit office chart notes, laboratory results, or other clinical information to support that the member has met all approval criteria.

Applicable Codes & Policy References

Relevant policy references (not billing codes)mixed

CP.PMN.168	Clinical Policy Reference Number for Ospemifene
CP.CPA.190	No coverage criteria policy (commercial)
HIM.PA.33	No coverage criteria policy (health insurance marketplace)
CP.PMN.255	No coverage criteria policy (Medicaid)
HIM.PA.103	Non-formulary policy (health insurance marketplace)
CP.PMN.16	Non-formulary policy (Medicaid)
CP.CPA.09	Off-label use policy (commercial)
HIM.PA.154	Off-label use policy (health insurance marketplace)
CP.PMN.53	Off-label use policy (Medicaid)

Clinical Evidence & Guidelines

Evidence sources referenced in this policy include the Osphena Prescribing Information (Shionogi Inc.; February 2025) and guideline citations such as ACOG Practice Bulletin No. 213, NAMS position statement, and the Endocrine Society guideline.

The policy references clinical guidance and trials for topical vaginal lubricants and moisturizers and for vaginal estrogen formulations (examples listed in Appendix B) as expected therapeutic alternatives and step therapy prerequisites prior to approval of Osphena, except where step therapy is bypassed per state-specific provisions.

Appendix and reference sections list specific therapeutic alternatives (e.g., estradiol vaginal cream, Premarin vaginal cream, Vagifem tablets, Estring ring, and named lubricants/moisturizers) and cite the Osphena Prescribing Information and professional society guidelines as supporting sources.

Background & Definitions

Background: Ospemifene (Osphena) is a selective estrogen receptor modulator (SERM) indicated for the treatment of moderate to severe dyspareunia and vaginal dryness due to menopause.

Typical prior therapy expectations before approval include trial of two vaginal lubricants or vaginal moisturizers and a trial of ≥ 4 weeks of one vaginal estrogen (examples and dosing regimens are provided in Appendix B).

Definitions

SERMSelective estrogen receptor modulator

Revision History

01/01/2026policy_addedLatest

Step therapy requirements do not apply for Illinois HIM requests per IL HB 5395; added step therapy bypass for IL HIM (noted in 4Q2025 annual review, P&T approval 11/25/2025).

04/27/2022policy_revised

Commercial approval duration revised to 12 months or duration of request, whichever is less (effective 04/27/2022).

07/31/2024administrative_clarification

Removed 'at up to maximally indicated doses' language for the vaginal lubricant/moisturizer trial requirement because there are no maximum doses for these products (4Q2024 annual review).