CurrentCentenePolicy HIM.PA.08

Clinical Policy: Entecavir (Baraclude)

Defines medical necessity criteria, dosing limits, and prior authorization requirements for Baraclude (entecavir) for treatment of chronic hepatitis B for Centene HIM/ICHRA lines of business, affecting prescribers and pharmacy benefits.

Policy Summary

PayerCentene

PolicyEntecavir (Baraclude) prior authorization and coverage criteria

Policy CodePolicy HIM.PA.08

Change TypeStep therapy bypass added (IL)LOB additionwording clarifications

Effective Date06.01.19

Next Review DateN/A

Key ActionSubmit clinical documentation (office notes, labs, or other information) demonstrating that the member meets all approval criteria when requesting prior authorization.

SourceLink

POLICY UPDATE CHANGES

Added step therapy bypass for Illinois HIM per IL HB 5395.

Added ICHRA line of business.

Clarified that HBV is chronic for diagnosis criterion.

≥2Minimum age for FDA-approved indication

1 mg/dayMaximum adult tablet dose

20 mL/dayMaximum oral solution per day

Tablets/SolutionProduct availability

12 months

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Coverage Criteria for Entecavir (Baraclude)

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial HBV criteria: 1. Diagnosis of chronic HBV infection; 2. Prescribed by or in consultation with a gastroenterologist, hepatologist, or infectious disease specialist; 3. Age ≥ 2 years; 4. One of the following: (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; (note: for Illinois HIM requests, the step therapy requirement does not apply as of 1/1/2026 per IL HB 5395); 5. Dose does not exceed either: (a) For oral tablet, both (i) 1 mg per day and (ii) 1 tablet per day; or (b) For oral solution: 20 mL per day (3 bottles per month).

Follow formulary/non-formulary and off-label policies for other indications.

Continued Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Continued HBV criteria: 1. Member meets one of the following: (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 CC.PHARM.03A and CC.PHARM.03B); 2. Member is responding positively to therapy; 3. One of the following: (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; (note: for Illinois HIM requests, the step therapy requirement does not apply as of 1/1/2026 per IL HB 5395); 4. If request is for a dose increase, new dose does not exceed either: (a) For oral tablets, both (i) 1 mg per day and (ii) 1 tablet per day; or (b) For oral solution: 20 mL per day (3 bottles per month).

Continued therapy requires documented positive response.

Other/Off-Label Uses — Other indications (must meet 1 or 2)

Other indications (must meet 1 or 2)

Other uses: 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: (a) HIM.PA.33 for formulary/no coverage criteria for health insurance marketplace/ICHRA; or (b) HIM.PA.103 for non-formulary for health insurance marketplace/ICHRA. 2. If the requested use (diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 does not apply, refer to the off-label use policy HIM.PA.154 for the relevant line of business.

Administrative routing for non-standard or recently changed labeled uses.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation of efficacy and safety in accordance with the off‑label use policy (HIM.PA.154) or the applicable evidence of coverage documents.

Uses that are non‑FDA approved and not supported by adequate clinical evidence are considered not medically necessary. Such off‑label requests must meet the requirements outlined in the off‑label use policy (HIM.PA.154) and be supported by documentation demonstrating efficacy and safety to be considered for authorization.

Product Strengths, Dosing Limits, and Age Limits

Product strengths (NDC-level details not provided)mixed

0.5 mg	Tablet strength
1 mg	Tablet strength
0.05 mg/mL	Oral solution concentration

inv-07: Maximum daily tablet dose — 1 mg/day

Maximum daily tablet dose1 mg per day; limited to 1 tablet per day

ContextApplies to oral tablet requests for adults and pediatric patients as specified in dosing guidance

Related limitIf request is for dose increase, new dose must not exceed 1 mg/day

inv-08: Maximum oral solution per day — 20 mL/day (3 bottles per month)

Maximum oral solution volume per day20 mL per day (equivalent to 3 bottles per month)

Use conditionOral solution requests require documentation supporting inability to swallow tablets

Prior Authorization, Documentation, and Dispensing Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required. Baraclude (entecavir) is medically necessary only when all specified criteria for initial or continued therapy are met.

Prior authorization required for Baraclude (entecavir) requests.

Documentation Required

Required Clinical Documentation

Provider must submit documentation (such as office chart notes, relevant lab results, or other clinical information) supporting that the member has met all approval criteria. Failure to submit supporting documentation may result in denial of the request.

Acceptable documentation: office notes, labs, medication history, specialist consultation notes.

Key Definitions and Typical Dosing

inv-15: Entecavir (Baraclude) — drug class, indication, age labeling

Drug classHepatitis B virus nucleoside analogue reverse transcriptase inhibitor

Brand and genericBaraclude (entecavir)

FDA-indicated populationAdults and children ≥ 2 years with chronic HBV infection and evidence of active viral replication

Common formulationsTablets and oral solution (0.05 mg/mL)

inv-16: Treatment-naïve adult dose — 0.5 mg PO once daily; max 1 mg/day in specified situations

Treatment-naïve adult dose0.5 mg orally once daily for nucleoside inhibitor treatment‑naïve adults/adolescents ≥ 16 years

Clinical Background

Entecavir (Baraclude) is a hepatitis B virus nucleoside analogue reverse transcriptase inhibitor approved for the treatment of chronic hepatitis B infection in adults and in children aged ≥ 2 years with evidence of active viral replication and elevated aminotransferases or histologic disease. Dosing varies by prior nucleoside exposure and by age/weight; for nucleoside inhibitor treatment‑naïve adults and adolescents ≥16 years the usual dose is 0.5 mg orally once daily, with dose adjustments and a maximum of 1 mg per day in certain situations. The product is available as tablets (0.5 mg, 1 mg) and an oral solution (0.05 mg/mL).