Emtricitabine/Tenofovir Alafenamide (Descovy) Form

Emtricitabine/tenofovir alafenamide (Descovy®) is a combination of two nucleoside reverse transcriptase inhibitors (NRTIs). FDA Approved Indication(s) Descovy is indicated:
• • • In combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV)-1 infection in adults and pediatric patients weighing at least 35 kg In combination with other antiretroviral agents other than protease inhibitors that require a CYP3A inhibitor for the treatment of HIV-1 infection in pediatric patients weighing at least 14 kg and less than 35 kg In at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection from sexual acquisition, excluding individuals at risk from receptive vaginal sex. Individuals must have a negative HIV-1 test immediately prior to initiating Descovy for HIV-1 PrEP
Limitation(s) of use: The indication does not include use of Descovy in individuals at risk of HIV-1 from receptive vaginal sex because effectiveness in this population has not been evaluated.
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 Descovy is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. HIV-1 Infection (must meet all):

1. Diagnosis of HIV-1 infection;
2. Descovy is prescribed in combination with other antiretroviral agents for the treatment of HIV-1 infection;
   3. Member weighs ≥ 14 kg;

3. If treatment-naïve and member weighs ≥ 17 kg, member must instead use emtricitabine/tenofovir disoproxil fumarate (generic Truvada®), unless contraindicated, clinically significant adverse effects are experienced, or member has bone/renal co-morbidities or risk factors (see Appendix D); Page 1 of 7

   CLINICAL POLICY Emtricitabine/Tenofovir Alafenamide

   5. Dose does not exceed (a or b): a. Weight 14 kg to < 25 kg: 120/15 mg (1 tablet) per day; b. Weight ≥ 25 kg: 200/25 mg (1 tablet) per day.
      Approval duration: 12 months
      B. Pre-exposure HIV Prophylaxis (must meet all):
   6. Member is HIV-negative and has no signs or symptoms of acute HIV infection;
4. Member is considered at risk for acquiring HIV and meets one of the following (a, b, or c): a. Engaging in sexual activity with a HIV-1 infected partner; b. Engaging in sexual activity and one or more of the following:
   Inconsistent or no condom use;
   i. ii. Diagnosis of sexually transmitted infections;
   iii. Exchange of sex for commodities;
   iv. Incarceration; v. Not in a monogamous partnership;
   vi. Partner of unknown HIV status with any of the preceding risk factors; c. Use of illicit injection drugs;
   3. Member weighs ≥ 35 kg;

5. Member must instead use emtricitabine/tenofovir disoproxil fumarate (generic Truvada), unless contraindicated, clinically significant adverse effects are experienced, or member has bone/renal co-morbidities or risk factors (see Appendix D);

   5. Dose does not exceed 200/25 mg (1 tablet) per day. Approval duration: 12 months
      C. 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.
      Page 2 of 7

   CLINICAL POLICY Emtricitabine/Tenofovir Alafenamide II. Continued Therapy A. All Indications in Section I (must meet all):

   1. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Descovy for a covered indication and has received this medication for at least 30 days;
   2. Member is responding positively to therapy;

6. If request is for a dose increase, new dose does not exceed (a or b): a. Request for the treatment of HIV-1 infection in member weighing 14 kg to < 25 kg: 120/15 mg (1 tablet) per day; b. All other requests: 200/25 mg (1 tablet) per day.
   Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2):

   1. 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
   2. 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 – 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 HIV: human immunodeficiency virus PrEP: pre-exposure prophylaxis
      Page 3 of 7

   CLINICAL POLICY Emtricitabine/Tenofovir Alafenamide Appendix B: Therapeutic Alternatives
   Dosing Regimen Drug Name Truvada (emtricitabine/ tenofovir disoproxil fumarate) HIV-1 Infection: Adults and pediatric patients weighing ≥ 35 kg: 200/300 mg PO QD Pediatric patients weighing between 17 to < 35 kg:
   17 kg to < 22 kg: 100/150 mg PO QD
   22 kg to < 28 kg: 133/200 mg PO QD 28 kg to < 35 kg: 167/250 mg PO QD Dose Limit/ Maximum Dose See regimen PrEP: 200/300 mg PO QD 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): HIV-1 PrEP in individuals with unknown or positive HIV-1 status • Boxed warning (s): post-treatment acute exacerbation of hepatitis b and risk of drug resistance with use of Descovy for HIV-1 PrEP in undiagnosed early HIV-1 infection
   Appendix D: General Information • Tenofovir is available in two forms: tenofovir alafenamide (TAF; found in Descovy) and tenofovir disoproxil fumarate (TDF; found in Truvada). TAF is associated with fewer bone and renal toxicities than TDF, while TDF is associated with lower lipid levels. According to the Department of Health and Human Services guidelines for the use of antiretroviral agents in adults and adolescents with HIV, safety, cost, and accessibility are among the factors to consider when choosing between these drugs. One form is not preferred over the other. • Examples of bone/renal co-morbidities and risk factors include but are not limited to: o Bone disease: osteoporosis, osteopenia, receiving chronic corticosteroids or other therapies known to decrease bone density (e.g., aromatase inhibitors, androgen deprivation therapy, doxorubicin, cyclophosphamide), frail/underweight o Renal disease: chronic kidney disease, estimated creatinine clearance < 60 mL/min, albuminuria, family history of kidney disease, diabetes, receiving nephrotoxic medications
   V. Dosage and Administration
   Indication HIV-1 infection Adults and pediatric patients weighing ≥ 25 kg: Dosing Regimen Maximum Dose See regimen
   200/25 mg PO QD Pediatric patients weighing between 14 kg to < 25 kg: 120/15 mg PO QD
   200/25 mg PO QD 200/25 mg/day PrEP Page 4 of 7

   CLINICAL POLICY Emtricitabine/Tenofovir Alafenamide VI. Product Availability
   Tablets: 200 mg emtricitabine/25 mg tenofovir alafenamide, 120 mg emtricitabine/15 mg tenofovir alafenamide VII.