BARACLUDE, Entecavir Form

Entecavir (Baraclude®) is a hepatitis B virus nucleoside analogue reverse transcriptase inhibitors.
FDA Approved Indication(s) Baraclude is indicated for the treatment of chronic hepatitis B virus infection in adults and children at least 2 years of age with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active 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 Baraclude is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Hepatitis B Infection (must meet all):

1. Diagnosis of hepatitis B virus infection;
   2. Prescribed by or in consultation with a gastroenterologist, hepatologist, or infectious disease specialist;
2. Age ≥ 2 years;
   
   4. Evidence of active viral replication;
   5. Member meets one of the following (a or b): a. Evidence of persistent elevations in serum aminotransferases (ALT or AST); b. Histologically active disease;
   6. Member must meet either (a or b): a. For Baraclude tablet requests, member must use generic entecavir tablets, unless contraindicated or clinically significant adverse effects are experienced;
      b. For Baraclude oral solution requests: Documentation supports inability to swallow tablets;

3. Dose does not exceed either of the following (a or b): a. For oral tablet, both (i and ii): i. 1 mg per day; ii. 1 tablet per day; b. For oral solution: 20 mL per day (3 bottles per month). Approval duration: 12 months
   Page 1 of 6

   CLINICAL POLICY Entecavir 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: HIM.PA.33 for health insurance marketplace; 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: HIM.PA.103 for health insurance marketplace; 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: HIM.PA.154 for health insurance marketplace. II. Continued Therapy A. Hepatitis B Infection (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;
   2. Member is responding positively to therapy;
   3. Member must meet either (a or b): a. For Baraclude tablet requests, member must use generic entecavir tablets, unless contraindicated or clinically significant adverse effects are experienced;
      b. For Baraclude oral solution requests: Documentation supports inability to swallow tablets;;
7. If request is for a dose increase, new dose does not exceed either one of the following (a or b): a. For oral tablets, both (i and ii): i. 1 mg per day; ii. 1 tablet per day; b. For oral solution: 20 mL per day (3 bottles per month). Approval duration: 12 months
   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: HIM.PA.33 for health insurance marketplace; or Page 2 of 6

   CLINICAL POLICY Entecavir b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: HIM.PA.103 for health insurance marketplace; 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: HIM.PA.154 for health insurance marketplace. 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 – HIM.PA.154 for health insurance marketplace or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key AST: aspartate aminotransferase ALT: alanine aminotransferase FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives
   Not applicable Appendix C: Contraindications/Boxed Warnings • Contraindication(s): none reported • Boxed warning(s):
   o Severe acute exacerbation of hepatitis B o Potential for development of resistance to HIV nucleoside reverse transcriptase inhibitors o Lactic acidosis and hepatomegaly V. Dosage and Administration
   Indication Hepatitis B infection Dosing Regimen Adults and adolescents ≥ 16 years
   Nucleoside inhibitor treatment-naïve: 0.5 mg PO QD Maximum Dose 1 mg/day or 20 mL/day History of hepatitis B viremia while receiving lamivudine, known lamivudine/telbivudine resistance substitutions rtM204I/V, or decompensated liver disease: 1 mg PO QD Pediatric patients ≥ 2 years to < 16 years Weight-based dose PO QD:
   Body weight (kg) 10 – 11

   11 – 14 Treatment- Naïve
   3 mL 4 mL Lamivudine- Experienced 6 mL 8 mL Page 3 of 6

   CLINICAL POLICY Entecavir Indication Dosing Regimen

   14 – 17 17 – 20 20 – 23 23 – 26 26 – 30 30 5 mL 6 mL 7 mL 8 mL
   9 mL 10 mL 10 mL 12 mL 14 mL 16 mL 18 mL 20 mL Maximum Dose VI. Product Availability
   • Tablets: 0.5 mg, 1 mg • Oral solution: 0.05 mg/mL VII.