Estradiol Vaginal Ring (Femring) Form

Estradiol vaginal ring (Femring®) is an estrogen steroid. FDA Approved Indication(s) Femring is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause and moderate to severe 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 Femring is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Dyspareunia (must meet all):

1. Diagnosis of dyspareunia (vulvar and vaginal atrophy) or vasomotor symptoms due to menopause;
   2. Age ≥ 18 years;
   3. Failure of two vaginal lubricants or vaginal moisturizers, unless contraindicated or clinically significant adverse effects are experienced (see Appendix B);
2. Failure of ≥ 4 week trial of one vaginal estrogen (e.g., estradiol vaginal cream (Estrace®), estradiol vaginal insert (Vagifem®), Premarin® vaginal cream), unless contraindicated or clinically significant adverse effects are experienced (see Appendix B);
3. Dose does not exceed one vaginal ring every 3 months.
   Approval duration:
   Medicaid/HIM – 12 months Commercial - Length of Benefit 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: Page 1 of 6

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   Estradiol Vaginal Ring
   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

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 (must meet all):
6. 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);
7. Member is responding positively to therapy (e.g., dyspareunia symptom reduction);
   
   3. If request is for a dose increase, new dose does not exceed one vaginal ring every 3 months. Approval duration:
      Medicaid/HIM – 12 months Commercial - Length of Benefit B. Other diagnoses/indications (must meet 1 or 2):
8. 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

9. 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. Page 2 of 6

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   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 policy – 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 Key FDA: Food and Drug Administration 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 Dosing Regimen 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 insert intravaginally daily for 2 weeks, followed by 1 insert twice weekly Apply intravaginally before sex Dose Limit/
   Maximum Dose Varies Varies 1 insert/day Varies estradiol vaginal cream (Estrace) Premarin (conjugated estrogens) vaginal cream estradiol vaginal insert (Vagifem) 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 Apply intravaginally before sex Varies 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. Appendix C: Contraindications/Boxed Warnings • Contraindication(s): undiagnosed abnormal genital bleeding; known, suspected, or history of breast cancer; known or suspected estrogen-dependent neoplasia; active DVT, PE, or history of these conditions; active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions; known anaphylactic reaction or Page 3 of 6

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   angioedema to Femring; known liver impairment or disease; known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders; known or suspected pregnancy. • Boxed warning(s): endometrial cancer, cardiovascular disorders, breast cancer, and probable dementia V. Dosage and Administration Drug Name Dyspareunia/ vasomotor symptoms due to menopause Dosing Regimen Administer one vaginal ring every 3 months Maximum Dose 1 vaginal ring/3 months VI. Product Availability Vaginal ring: 12.4 mg, 24.8 mg
   VII.