CurrentAvMedPolicy N/A

Prior authorization for adefovir dipivoxil (Hepsera)

This document governs prior authorization and step-edit requests for adefovir dipivoxil for AvMed members, specifying required clinical, diagnostic, and prescribing documentation for initial and reauthorization of therapy.

Policy Summary

PayerAvMed

PolicyPrior authorization for adefovir dipivoxil (Hepsera)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit completed prior authorization form with required Hepatitis B panel results, ALT, creatinine clearance, chart notes, and prescriber signature to support approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsApproval period

10 mg dailyDosage

30Quantity limit

CrCl ≥50Renal threshold

No tenofovirRestriction

Coverage Criteria

Policy Summary

PayerAvMed

PolicyPrior authorization for adefovir dipivoxil (Hepsera)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit completed prior authorization form with required Hepatitis B panel results, ALT, creatinine clearance, chart notes, and prescriber signature to support approval.

SourceLink

On This Page

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Initial Authorization Criteria

Covered when ALL of the following are met (Initial Authorization):

Prescriber: Prescribed by or in consultation with a specialist in gastroenterology, hepatology, infectious disease, or clinician experienced in Hepatitis B management.

Diagnosis confirmation: Chronic Hepatitis B confirmed by: HBsAg positive for at least 6 months; documented evidence of active viral replication (example: HBeAg+ and HBV DNA >100,000 copies/mL); documented evidence of active liver disease (persistent ALT >2x ULN or moderate to severe hepatitis on biopsy).

Applicable laboratory documentation and Hepatitis B panel results must be submitted.

Serology-specific criteria: Current ALT and HBV DNA meet ONE of: for HBeAg-positive, ALT ≥2x ULN and HBV DNA >20,000 IU/mL; for HBeAg-negative, ALT ≥2x ULN and HBV DNA >2,000 IU/mL.

Lab results must be submitted.

Alternate treatment rationale: If clinical markers are outside the thresholds above, at least one patient variable must support treatment (examples: age >40 years, family history of cirrhosis or hepatocellular carcinoma, previous treatment history, presence of extrahepatic manifestations, or presence of cirrhosis).

Chart notes must confirm patient variables.

Age and drug interaction: Member is 18 years of age or older; adefovir dipivoxil will not be used concurrently with tenofovir or any tenofovir-containing product.

Renal function: Member has estimated creatinine clearance (CrCl) ≥ 50 mL/min for standard dosing; if CrCl < 50 mL/min, dosing must be adjusted per specified schedule (10 mg every 48 hours for CrCl 30–49 mL/min; 10 mg every 72 hours for CrCl 10–29 mL/min).CrCl >= 50 mL/min

Provide most recent estimated CrCl and monitoring during treatment.

Medical necessity vs preferred agents: Provide clinical rationale, pertinent past medical history, and documented previous treatments explaining why adefovir is required instead of clinically preferred treatments (adefovir is nonpreferred per AASLD recommendations).

Previous therapies will be verified via pharmacy claims or chart notes.

Reauthorization Criteria

Reauthorization criteria (all must be met):

Ongoing renal monitoring: Renal function has been monitored during treatment and the most recent estimated creatinine clearance is ≥ 50 mL/min; if CrCl < 50 mL/min, dosing has been adjusted per protocol (10 mg every 48 hours for CrCl 30–49 mL/min; 10 mg every 72 hours for CrCl 10–29 mL/min).CrCl >= 50 mL/min

Most recent CrCl must be provided.

Need for continued therapy: Therapy continuation appropriate due to disease state/phase requiring ongoing treatment (attach recent HBV DNA, ALT, HBeAg, anti-HBe) OR seroconversion occurred but consolidation period not met (attach recent HBV DNA, ALT, HBeAg, anti-HBe).

Attach most recently monitored levels to support continuation.

Concurrent use with tenofovir or tenofovir-containing products is prohibited. Adefovir dipivoxil must not be prescribed or administered at the same time as tenofovir or any product containing tenofovir; requests that indicate concurrent use will not meet coverage criteria and should be denied or clarified prior to approval.

Samples may not be used to initiate therapy for the purposes of meeting step-edit or prior authorization requirements; initiation with sample medication does not satisfy the prior authorization or step-therapy documentation standards. Additionally, because adefovir is a non‑formulary/nonpreferred agent in some plans, medical necessity documentation is required when the drug is non‑formulary to support coverage and override step edits.

Initial Therapy

Initial authorization (12 months) — all criteria must be checked and documentation provided.

Age: Member is 18 years of age or older.>= 18 years

Dose and quantity: Recommended dose 10 mg once daily; quantity limit 30 tablets per 30 days.

Clinical criteria: Meets diagnosis confirmation and HBV DNA/ALT thresholds OR has documented patient variables justifying treatment per SECTION I.

All supporting labs, diagnostics, and chart notes must be submitted.

Renal function: Estimated CrCl ≥ 50 mL/min for standard dosing or documented dosing adjustments for reduced CrCl (10 mg every 48 hours for CrCl 30–49 mL/min; 10 mg every 72 hours for CrCl 10–29 mL/min).CrCl >= 50 mL/min

Provide most recent CrCl.

Nonpreferred justification: Provide clinical rationale and documented previous treatments explaining why adefovir must be used instead of clinically preferred treatments (adefovir is nonpreferred per AASLD guidance).

Documentation of prior therapies will be verified via pharmacy claims or chart notes.

Reauthorization / Continuation Criteria

Reauthorization

Reauthorization (12 months) requires demonstration of ongoing need and renal monitoring.

Monitoring & dosing: Renal function monitored with most recent estimated CrCl ≥ 50 mL/min or appropriate dosing adjustments if CrCl < 50 mL/min (10 mg every 48 hours for CrCl 30–49 mL/min; 10 mg every 72 hours for CrCl 10–29 mL/min).CrCl >= 50 mL/min

Provide recent renal monitoring results.

Ongoing treatment justification: Disease phase requires ongoing treatment OR seroconversion consolidation period not met; provide recent HBV DNA, ALT, HBeAg, anti-HBe levels to support continuing therapy.

Attach most recently monitored levels.

Provider Actions & Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for adefovir dipivoxil (Hepsera). Complete and submit the Prior Authorization form including SECTION I (Diagnosis Criteria) and SECTION II (Drug Criteria). Approval may be delayed or denied if required information is incomplete, illegible, or missing.

Form must be signed by the prescribing physician (handwritten signature; preprinted stamps not valid).
Fax completed form to 1-305-671-0200.
Initial authorization: up to 12 months; Reauthorization: up to 12 months.

Step Therapy

Step-Edit / Nonpreferred Drug

Adefovir dipivoxil is a nonpreferred (step-edit) drug for Chronic Hepatitis B. To override the step-edit, submit documentation of medical necessity and verification of previous therapies. Pharmacy claims and submitted chart notes will be used to verify prior therapies.

Provide rationale why adefovir must be used instead of other clinically preferred treatments.
Use of samples to initiate therapy does not meet step-edit/preauthorization criteria.
Medication may be provided by a specialty pharmacy (PropriumRx) and coverage may vary by plan.

Documentation Required

Required Clinical Documentation

Submit all required clinical documentation to support each checked criterion. Required items include recent Hepatitis B panel results, HBV DNA, HBeAg status, ALT levels, biopsy results if applicable, and creatinine clearance (CrCl). For reauthorization, provide most recent monitored HBV DNA, ALT, HBeAg and anti‑HBe status and evidence of renal monitoring during treatment.

Hepatitis B serology: HBsAg documented for ≥6 months.
Evidence of active viral replication (HBeAg+ and HBV DNA >100,000 copies/mL) or HBV DNA thresholds per serostatus.
ALT values showing persistent elevation (≥2× ULN) where applicable; submit lab results.
Liver biopsy showing moderate to severe hepatitis if used to support therapy.
Current creatinine clearance (CrCl) with dosing adjustments noted if <50 mL/min.
Chart notes documenting patient variables (age >40, family history of cirrhosis/HCC, prior treatment history) when clinical markers fall outside specified thresholds.

Documentation Required

Administrative Documentation

Administrative information must be complete and legible. Incomplete or missing administrative items (including prescriber signature) may delay review or result in denial.

Member name and AvMed ID number, date of birth.
Prescriber name, DEA or NPI number, office contact name, phone and fax.
Prescriber signature and date (handwritten signature required).
Drug form/strength, dosing schedule, length of therapy, diagnosis and ICD code, weight, and requested quantity.
If information is incomplete or illegible, the authorization process can be delayed or denied.

Denial Risk

Incomplete/Illegible or Missing Clinical Documentation — Denial Risk

Incomplete or missing clinical documentation (lab results, diagnostics, chart notes) or illegible/incomplete requests (including missing prescriber signature) may delay processing or result in denial of the request. Ensure all checklist items in SECTION I and SECTION II are completed and supporting documentation attached.

All criteria checked must be supported by submitted documentation or request may be denied.
Provide prior treatment history and chart notes when requested.
Failure to submit required labs (HBV DNA, ALT, HBsAg, HBeAg), biopsy results, or CrCl may lead to denial.

Requirement	Documentation needed to override nonpreferred status
Clinical rationale for using adefovir instead of preferred agents (e.g., contraindication, intolerance, prior treatment failure)
Chart notes describing why preferred therapies are not appropriate for this patient
Verification of prior therapies via pharmacy paid claims or submitted chart notes
Relevant laboratory and clinical data supporting need for therapy (HBsAg/HBeAg, HBV DNA, ALT, biopsy results if applicable)
Documentation that treatment was not initiated with a sample (use of samples does not meet step edit/preauthorization criteria)
Specialty pharmacy or plan-specific coverage notes when drug is non‑formulary (medical necessity documentation may be required)

OpenPayer

Prior authorization for adefovir dipivoxil (Hepsera)

Coverage Criteria

Initial Therapy

Reauthorization / Continuation Criteria

Coding and Diagnosis

Provider Actions & Documentation Requirements

Definitions

Quantity Limits

Step Therapy / Nonpreferred Override

Site of Care

Background