ModifiedCentenePolicy CP.PMN.168

Ospemifene (Osphena)

Defines medical necessity, prior authorization requirements, and coverage criteria for ospemifene (Osphena) for treatment of moderate to severe dyspareunia and vaginal dryness due to menopause for Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyOspemifene (Osphena)

Policy CodePolicy CP.PMN.168

Change TypeMaterial revisions and state-mandated step therapy bypass

Effective DateAug 28, 2018

Next Review Date

Key ActionSubmit prior authorization with documentation showing diagnosis, age ≥18, required prior trials (two lubricants/moisturizers and ≥4-week vaginal estrogen) or applicable Illinois HIM bypass, and requested duration not exceeding the revised Commercial limit of 12 months.

SourceLink

POLICY UPDATE CHANGES

Added a step therapy bypass for Illinois HIM requests per IL HB 5395 effective 1/1/2026.

Revised Commercial approval duration from length of benefit to 12 months or duration of request, whichever is less.

Removed 'at up to maximally indicated doses' for vaginal lubricant/moisturizer trial requirement.

60 mg/daymaximum approved dose

12 monthsstandard approval duration

2failed lubricants required

≥4 wksvaginal estrogen trial

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria

inv-01: Initial Therapy — Dyspareunia or Vaginal Dryness — Covered when ALL of the following are met

Covered when ALL of the following are met:

Initial approval criteria: 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 contraindications); 4) Failure of ≥ 4 weeks of one vaginal estrogen (e.g., estradiol vaginal cream, Premarin vaginal cream) unless clinically significant adverse effects or contraindications; 5) Dose does not exceed 60 mg (1 tablet) per day.

For Illinois HIM requests, step therapy requirements do not apply per IL HB 5395 effective 1/1/2026.

inv-02: Continuation Therapy — Covered when ALL of the following are met for continuation

Covered when ALL of the following are met for continuation:

Continued therapy criteria: 1) Member currently receiving medication via Centene benefit or previously met initial approval criteria OR member is currently receiving medication and enrolled in applicable continuity of care; 2) Member is responding positively to therapy (e.g., dyspareunia symptom reduction); 3) If request is for dose increase, new dose does not exceed 60 mg (1 tablet) per day.

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

inv-03: Other Diagnoses/Indications — Requests for other indications

Requests for other indications:

Other uses: 1) If the drug has had a recent label change within the last 6 months that is not reflected in this policy, follow the referenced no coverage or non‑formulary policies for the applicable line of business (see policy references in document). 2) If the requested use is not listed in section III (Diagnoses/Indications not authorized) and criterion 1 does not apply, refer to the off‑label use policy for the relevant line of business (CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, CP.PMN.53 for Medicaid).

See policy cross-references in source (CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16, CP.CPA.09, HIM.PA.154, CP.PMN.53).

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the request includes sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy or the member’s evidence of coverage. Refer to the off‑label policies for the applicable line of business: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), and CP.PMN.53 (Medicaid) when submitting supporting documentation.

For members covered by Medicaid, state Medicaid coverage provisions take precedence when they conflict with the provisions of this clinical policy. Providers should consult the relevant state Medicaid manual for any specific coverage rules that supersede this policy before submitting prior authorization requests.

Use of ospemifene for non‑FDA indications without adequate supporting evidence per the applicable off‑label use policy is considered not authorized. In addition, members with contraindications listed in the policy (for example, undiagnosed abnormal genital bleeding, known or suspected estrogen‑dependent neoplasia, active or history of thromboembolic disease, hypersensitivity, or pregnancy) are not appropriate candidates for therapy and such requests should be denied.

Coding and Dosing

Product availability / NDCNDC

NDC	Tablet: 60 mg

inv-08: Maximum daily dose — 60 mg/day

Maximum daily dose60 mg per day (maximum approved dose)

Standard dosing60 mg orally once daily (1 tablet)

Dose check for renewalsIf request is for dose increase, new dose must not exceed 60 mg/day

inv-09: Vaginal estrogen trial duration — ≥ 4 weeks

Minimum vaginal estrogen trialTrial of ≥ 4 weeks of one vaginal estrogen (unless clinically significant adverse effects or contraindications)

Examples of vaginal estrogen formulationsEstradiol vaginal cream, Premarin vaginal cream, estradiol vaginal tablet, Estring (see Appendix for regimens)

Provider Actions and Authorization Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approval will be granted only when the member meets all policy criteria (diagnosis, prior therapy trials/step therapy, age, dosing limits). Requests that lack documentation demonstrating the member meets approval criteria or that request non‑FDA/unsupported off‑label uses may be denied per applicable off‑label policies (CP.CPA.09 for Commercial, HIM.PA.154 for HIM, CP.PMN.53 for Medicaid).

Applicable off‑label policies: CP.CPA.09 (Commercial), HIM.PA.154 (HIM), CP.PMN.53 (Medicaid)

Prior Authorization

Prior Authorization Duration Limit

Commercial approvals are limited to 12 months or the duration of the request, whichever is less. Requests that exceed this revised commercial approval duration may be denied or will require additional justification and supporting clinical documentation for consideration.

Commercial approval duration = 12 months or duration of request, whichever is less

Background

Ospemifene (Osphena) is a selective estrogen receptor modulator (SERM) approved for the treatment of moderate to severe dyspareunia and vaginal dryness due to menopause. The standard dosing described in the product information is 60 mg orally once daily. Safety considerations include contraindications related to estrogen‑dependent neoplasia and thromboembolic disease; review the policy contraindications and boxed warnings before initiation.

Definitions

inv-19: Ospemifene (Osphena) — SERM indicated for moderate to severe dyspareunia and vaginal dryness; standard dose 60 mg

Drug class and indicationSelective estrogen receptor modulator (SERM) indicated for moderate to severe dyspareunia and vaginal dryness due to menopause

Standard dose60 mg PO once daily

Maximum approved dose60 mg/day

Key safety considerationsContraindications include undiagnosed abnormal genital bleeding, known or suspected estrogen-dependent neoplasia, and thromboembolic disease (see policy Appendix C)

inv-20: Health Plan — Definition of a health plan that has adopted this clinical policy

DefinitionA Health Plan is a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan's affiliates, as applicable