OSPHENA, Ospemifene Form

Ospemifene (Osphena®) is a selective estrogen receptor modulator (SERM). FDA Approved Indication(s) Osphena is indicated for the treatment of moderate to severe dyspareunia and vaginal dryness, symptoms of vulvar and vaginal atrophy, due to menopause. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Osphena is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Dyspareunia or Vaginal Dryness (must meet all):

1. Diagnosis of dyspareunia or vaginal dryness due to menopause;
   2. Age ≥ 18 years;
   3. Failure of two vaginal lubricants or vaginal moisturizers at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated;
2. 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 are experienced or all are contraindicated;
3. 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 B. Other diagnoses/indications (must meet 1 or 2):

4. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or Page 1 of 6

   CLINICAL POLICY
   Ospemifene
   b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

5. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above 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, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Dyspareunia or Vaginal Dryness (must meet all):
   
   1. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
   2. Member is responding positively to therapy;
   3. If request is for a 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 B. Other diagnoses/indications (must meet 1 or 2):
6. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

7. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above 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, and CP.PMN.53 for Medicaid.
   III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – Page 2 of 6

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   CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration SERM: selective estrogen receptor modulator Appendix B: Therapeutic Alternatives This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization. Drug Name Dosing Regimen Dose Limit/ Maximum Dose Varies estradiol vaginal cream (Estrace) Initial: 2 to 4 gm vaginally QD for 1 to 2 weeks, gradually reduce to 50% of initial dose for 1 to 2 weeks Maintenance: 1 gm 1 to 3 times a week 0.5 gm intravaginally twice per week continuously 1 tablet intravaginally QD for 2 weeks, followed by 1 tablet twice weekly 2 mg intravaginally for 90 days Varies 1 tablet/day Apply intravaginally before sex 2 mg every 90 days Varies Premarin (conjugated estrogens) vaginal cream estradiol vaginal tablet (Vagifem) Estring (estradiol vaginal ring) Vaginal lubricants:
   Water-based
   Astroglide, FemGlide, Just Like Me, K-Y Jelly, Pre-Seed, Slippery Stuff, Summer’s Eve Silicone-based ID Millennium, Pink, Pjur, Pure Pleasure Vaginal moisturizers: Fresh Start, K-Y Silk-E, Moist Again, Replens, K-Y Liquibeads Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Apply intravaginally before sex Varies Appendix C: Contraindications/Boxed Warnings • Contraindication(s): undiagnosed abnormal genital bleeding; known or suspected estrogen-dependent neoplasia; active deep vein thrombosis, pulmonary embolism, or a history of these conditions; active thromboembolic disease (for example, stroke and myocardial infarction) or a history of these conditions; hypersensitivity (for example, Page 3 of 6

   CLINICAL POLICY
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   angioedema, urticaria, rash, pruritis) to Osphena or any ingredients; known or suspected pregnancy • Box warning(s): endometrial cancer and cardiovascular disorders (stroke and deep vein thrombosis).
   V. Dosage and Administration
   Indication Moderate to severe dyspareunia or vaginal dryness due to menopause VI. Product Availability
   Tablet: 60 mg Dosing Regimen Maximum Dose 60 mg PO QD 60 mg/day VII.