Loading...

    Explore
    • Policy Monitoring
    • Live Policy Feed
    • Billing Codes
    • NPI Medicare & Medicaid
    • Healthcare Providers
    • Health Insurance Payers
    • States
    • Service Lines
    • Taxonomy Codes
    Lookup tools
    • Billing Code Lookup
    • CPT Modifier Lookup
    • Provider Taxonomy Code Lookup
    • Healthcare Provider & Facility Lookup
    • Health Insurance Payer Lookup
    • Payer Contact Directory

    Policy & Benchmark Tools

    • Prior Authorization Lookup
    • Coverage Criteria Lookup
    • Timely Filing Lookup
    • Billing Code Reimbursement Rates
    • Payer Comparison Dashboard
    • Facility Comparison Dashboard
    • All tools

    Company

    • About OpenPayer
    • Data Sources
    • Trek Health
    OpenPayerby Trek Health
    LinkedInYouTube

    © 2026 Trek Health. All rights reserved.

    OpenPayer is built and maintained by Trek Health.

    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsMeridian Hepsera (adefovir) Coverage & Prior Auth …
    Ask Trek AI about this page
    CurrentmeridianPolicy MDN.CP.PHAR.142

    Adefovir (Hepsera) coverage criteria

    Customize your policy alerts

    Sign up for meridian Policy MDN.CP.PHAR.142 alerts

    Get alerted when Policy MDN.CP.PHAR.142 changes without checking for updates manually.

    Monitor payer policy activity

    Receive email alerts as soon as relevant payer policies are published or updated.

    Policy governing medical necessity and prior authorization criteria for Hepsera (adefovir) for members (Medicaid line of business), including initial and continuation therapy requirements and dosing limits.

    Policy Summary
    Payermeridian
    PolicyAdefovir (Hepsera) coverage criteria
    Policy CodePolicy MDN.CP.PHAR.142
    Change TypeNo material changes
    Effective DateOct 16, 2023
    Last ReviewOct 16, 2023
    Next Review DateN/A
    Key ActionSubmit prior authorization with documentation showing diagnosis, specialist involvement, age ≥12, and trial/failure of entecavir or tenofovir (unless contraindicated).
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    ≥12minimum age for coverage
    6 moinitial approval duration
    12 mocontinuation approval
    10 mg/daydose limit
    10 mg tab

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    product availability

    Coverage Criteria

    Initial Therapy

    Covered when ALL of the following are met

    Initial Approval - Chronic Hepatitis B: 1) Diagnosis of chronic hepatitis B virus infection; 2) Prescribed by or in consultation with a gastroenterologist, hepatologist, or infectious disease specialist; 3) Age ≥ 12 years; 4) Failure of one of the following, unless contraindicated or clinically significant adverse effects are experienced: entecavir, or tenofovir; 5) Hepsera is not prescribed concurrently with tenofovir; 6) Dose does not exceed 10 mg per day.

    Initial approval duration: 6 months

    Continuation Therapy

    Covered when ALL of the following are met

    Continuation Therapy - Chronic Hepatitis B: 1) Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria, or (b) currently receiving medication and enrolled in a state/product with continuity of care regulations; 2) Member is responding positively to therapy; 3) Hepsera is not prescribed concurrently with tenofovir; 4) If request is for a dose increase, new dose does not exceed 10 mg per day.

    Continuation approval duration: 12 months

    Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the request includes sufficient documentation of efficacy and safety in accordance with the off‑label use policy CP.PMN.53 or other applicable evidence of coverage documents.

    When state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Refer to the applicable state Medicaid manual for specific coverage requirements that may supersede this policy.

    Hepsera (adefovir) must not be prescribed concurrently with tenofovir. The product labeling warns that coadministration can increase serum concentrations of each agent, resulting in additive nephrotoxicity, diminished therapeutic effect, and the potential for multi‑drug resistance. Concurrent use with tenofovir is therefore considered not medically necessary and is excluded from coverage under this policy.

    Initial Therapy

    Initial Therapy — top-level

    Initial Therapy: 1) Diagnosis of chronic hepatitis B virus infection; 2) Prescribed by or in consultation with a gastroenterologist, hepatologist, or infectious disease specialist; 3) Age ≥ 12 years; 4) Failure of one of the following, unless contraindicated or clinically significant adverse effects are experienced: entecavir, or tenofovir; 5) Hepsera is not prescribed concurrently with tenofovir; 6) Dose does not exceed 10 mg per day.

    Initial approval duration: 6 months

    Continuation Therapy

    Continuation Therapy — top-level

    Continuation Therapy: 1) Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria, or (b) currently receiving medication and enrolled in a state/product with continuity of care regulations; 2) Member is responding positively to therapy; 3) Hepsera is not prescribed concurrently with tenofovir; 4) If request is for a dose increase, new dose does not exceed 10 mg per day.

    Continuation approval duration: 12 months

    Provider Actions & Requirements

    Prior Authorization

    Prior authorization required; approval durations

    Prior authorization is required and must demonstrate the listed initial approval criteria. Initial approvals are granted for 6 months; continued approvals are granted for 12 months.

    Prior Authorization

    Non‑formulary requests — review under HIM.PA.103

    For Health Insurance Marketplace members, non‑formulary drug requests must be reviewed using the non‑formulary policy HIM.PA.103; this applies when the prescribed agent is not on the plan formulary.

    Step Therapy

    Trial/failure of entecavir or tenofovir required

    Policy requires trial and failure of one preferred alternative (entecavir or tenofovir) prior to approval unless the agent is contraindicated or the member is intolerant.

    Step Therapy Requirements

    StepRequirementPreferred alternatives / failure criteria
    1
    Trial and failure of one preferred alternative is required prior to approval (unless contraindicated or intolerant); prior authorization must document failure or intolerance.
    Entecavir or tenofovir (see Appendix B for dosing and alternatives).
    NoteDetails
    Source / origin of criteria
    New criteria were created/adapted from IL.PHAR.142 for PDL alignment; date: 10.16.23.

    Dosing & Coding Information

    Creatinine clearance dosing thresholds — CrCl-based dosing schedule and dialysis dosing
    CrCl ≥ 50 mL/min10 mg PO once daily
    CrCl 30–49 mL/min10 mg PO every 48 hours (Q48H)
    CrCl 10–29 mL/min10 mg PO every 72 hours (Q72H)
    Hemodialysis10 mg every 7 days following dialysis

    Definitions and References

    ALT definition
    DefinitionALT: alanine aminotransferase
    Abbreviation sourceListed in Appendix A: Abbreviation/Acronym Key
    ContextUsed in policy to define elevated aminotransferases as part of FDA‑approved indication
    AST definition
    DefinitionAST: aspartate aminotransferase
    Abbreviation sourceDefined in the policy Appendix as AST
    ContextReferenced with ALT when describing laboratory evidence of active disease

    Background

    Adefovir dipivoxil (Hepsera) is a nucleotide analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B in patients aged ≥ 12 years with evidence of active viral replication and either persistent elevations in aminotransferases or histologically active disease. The FDA‑approved label and referenced prescribing information warn against coadministration with tenofovir because of increased serum concentrations and additive nephrotoxicity, reduced therapeutic effect, and the risk of selecting for resistant viral strains; in patients co‑infected with HIV and hepatitis B, tenofovir alone is generally sufficient for HBV treatment.

    Revision History

    2023-10-16criteria_adoptionLatest

    New coverage criteria were created/adapted from IL.PHAR.142 for PDL alignment (document note indicates creation/adaptation on 10.16.23).

    Policy Summary
    Payermeridian
    PolicyAdefovir (Hepsera) coverage criteria
    Policy CodePolicy MDN.CP.PHAR.142
    Change TypeNo material changes
    Effective DateOct 16, 2023
    Last ReviewOct 16, 2023
    Next Review DateN/A
    Key ActionSubmit prior authorization with documentation showing diagnosis, specialist involvement, age ≥12, and trial/failure of entecavir or tenofovir (unless contraindicated).
    SourceLink
    On This Page
    Coverage CriteriaInitial TherapyContinuation TherapyProvider Actions & RequirementsStep Therapy RequirementsDosing & Coding InformationDefinitions and ReferencesBackgroundRevision History
    • Preferred alternatives listed in Appendix B include entecavir (Baraclude) and tenofovir (Viread).
    Note
    Documentation Required

    Submit supporting clinical documentation

    Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria.

    Documentation Required

    Follow coverage, state/federal, and plan administrative requirements

    Providers must follow applicable coverage documents, state and federal requirements, and Health Plan‑level administrative policies when submitting requests; refer to plan and state manuals for regulatory or contractual requirements.

    Denial Risk

    Potential denial triggers — missing required documentation or criteria

    Requests lacking documentation of chronic hepatitis B diagnosis, specialist involvement, age ≥12 years, prior failure of entecavir or tenofovir (unless contraindicated), documentation avoiding concurrent tenofovir, or requests exceeding 10 mg/day may be denied.

    • Missing evidence of specialist prescription or consultation
    • No documentation of prior trial/failure of entecavir or tenofovir
    • Concurrent use with tenofovir documented
    • Requested dose > 10 mg/day
    Note

    State Medicaid coverage provisions take precedence

    For Medicaid members, state Medicaid coverage provisions take precedence over this clinical policy; if state rules conflict with this policy, state provisions govern.

    Adefovir (Hepsera) prescribing information citation (Gilead, Dec 2018)
    CitationHepsera Prescribing Information. Foster City, CA: Gilead Sciences, Inc.; December 2018. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021449s024lbl.pdf. Accessed August 8, 2022.
    Role in policyPrimary reference for dosing, indications, and safety warnings (e.g., avoid coadministration with tenofovir)
    Document noteCited as reference 1 in the policy's reference list