Tenofovir Alafenamide Fumarate (Vemlidy) Form

Tenofovir alafenamide fumarate (Vemlidy®) is a hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor. FDA Approved Indication(s) Vemlidy is indicated for the treatment of chronic HBV infection in adults and pediatric patients 12 years of age and older with compensated liver disease. 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 Vemlidy is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Hepatitis B Virus Infection (must meet all):

1. Diagnosis of chronic HBV infection;
2. Prescribed by or in consultation with a gastroenterologist, hepatologist, or infectious disease specialist;
   3. Age ≥ 12 years;

3. Failure of tenofovir disoproxil fumarate or entecavir at up to maximally indicated doses, unless clinically significant adverse effects are experienced or both are contraindicated; *Prior authorization may be required for entecavir

   5. Dose does not exceed both of the following (a and b): a. 25 mg per day; b. 1 tablet per day. Approval duration:
      Commercial – 12 months or duration of request, whichever is less Medicaid/HIM – 6 months 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): Page 1 of 5

   CLINICAL POLICY
   Tenofovir Alafenamide Fumarate 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.
      II. Continued Therapy A. Hepatitis B Virus Infection (must meet all):
   3. 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);
4. Member is responding positively to therapy;

5. If request is for a dose increase, new dose does not exceed both of the following (a and b):
   a. 25 mg per day; b. 1 tablet per day. Approval duration:
   Commercial – 12 months or duration of request, whichever is less Medicaid/HIM – 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 Page 2 of 5

   CLINICAL POLICY
   Tenofovir Alafenamide Fumarate 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. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration HBV: hepatitis B virus Appendix B: Therapeutic Alternatives Drug Name Dosing Regimen tenofovir disoproxil fumarate (Viread®) entecavir (Baraclude®) 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. 300 mg PO QD 0.5 to 1 mg PO QD Dose Limit/
   Maximum Dose 300 mg/day 1 mg/day Appendix C: Contraindications/Boxed Warnings • Contraindication(s): none reported • Boxed warning(s): post treatment severe acute exacerbation of hepatitis B Appendix D: General Information • In April of 2017, the FDA removed Vemlidy’s boxed warning regarding lactic acidosis and severe hepatomegaly with steatosis. V. Dosage and Administration Indication HBV infection Dosing Regimen 25 mg PO QD Maximum Dose 25 mg/day VI. Product Availability Tablet: 25 mg VII.