Prasterone (Intrarosa) Form

Prasterone (Intrarosa®) is an inactive endogenous steroid and is converted into active androgens and/or estrogens. FDA Approved Indication(s) Intrarosa is indicated for the treatment of moderate to severe dyspareunia, a symptom 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 Intrarosa is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Dyspareunia (must meet all):

1. Diagnosis of dyspareunia due to menopause;
   2. Age ≥ 18 years;
   3. Failure of two vaginal lubricants or vaginal moisturizers, unless clinically significant adverse effects are experienced or all are contraindicated (see Appendix B);
   4. Failure of ≥ 4 week trial of one vaginal estrogen (e.g., estradiol vaginal cream (Estrace®), estradiol vaginal insert (Vagifem®), Premarin® vaginal cream), unless clinically significant adverse effects are experienced or all are contraindicated (see Appendix B);
2. Dose does not exceed one vaginal insert daily.
   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):

3. 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

   CLINICAL POLICY
   Prasterone 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

4. 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):
5. 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);
6. 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 insert daily. 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):
7. 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

8. 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

   CLINICAL POLICY
   Prasterone 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 • Boxed warning(s): none reported Page 3 of 6

   CLINICAL POLICY
   Prasterone V. Dosage and Administration Drug Name Dyspareunia due to menopause Dosing Regimen Administer one vaginal insert once daily at bedtime, using the provided applicator Maximum Dose 1 insert/day VI. Product Availability Vaginal insert: 6.5 mg
   VII.