ModifiedCentenePolicy CP.PMN.268

Tenofovir Alafenamide Fumarate (Vemlidy) for chronic hepatitis B

Criteria and coverage policy for Vemlidy for treatment of chronic hepatitis B virus (HBV) infection for Centene-affiliated health plans (HIM, Medicaid). Applies to prescribers and providers requesting prior authorization for members.

Policy Summary

PayerCentene

PolicyTenofovir Alafenamide Fumarate (Vemlidy) for chronic hepatitis B

Policy CodePolicy CP.PMN.268

Change TypeMaterial clinical updates and operational changes

Effective DateDec 1, 2021

Next Review Date

Key ActionSubmit prior authorization with supporting documentation; approvals granted for 12 months when all criteria are met.

SourceLink

POLICY UPDATE CHANGES

Added pediatric extension to ≥ 6 years and weight ≥ 25 kg.

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

Revised initial approval duration from 6 months to 12 months.

Removed Commercial line of business.

References reviewed and updated.

25 mgStandard daily dose

1Maximum tablets/day

12 moApproval duration

≥6 y / ≥25 kg

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Pediatric eligibility

IL HB 5395State law cited

Commercial removedLine of business

Coverage Criteria

A. Hepatitis B Virus Infection (Initial)

Covered when ALL of the following are met:

Initial Therapy Criteria: Member has diagnosis of chronic HBV infection; prescribed by or in consultation with a gastroenterologist, hepatologist, or infectious disease specialist; age ≥ 6 years and weight ≥ 25 kg; failure of tenofovir disoproxil fumarate or entecavir at up to maximally indicated doses unless clinically significant adverse effects are experienced or both are contraindicated; dose does not exceed 25 mg per day and 1 tablet per day; prior authorization may be required for entecavir; for Illinois HIM requests, step therapy requirements do not apply as of 1/1/2026 per IL HB 5395.

A. Hepatitis B Virus Infection (Continuation)

Covered when ALL of the following are met:

Continuation Therapy Criteria: 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; member is responding positively to therapy; if request is for a dose increase, new dose does not exceed 25 mg per day and 1 tablet per day.

B. Other diagnoses/indications

When requested use is not covered by the primary criteria:

Other Indications: If this drug has recently (within the last 6 months) undergone a label change that is not yet reflected in this policy, follow the applicable formulary/no-coverage or non-formulary policies for the relevant line of business (HIM.PA.33 or CP.PMN.255 for formulary; HIM.PA.103 or CP.PMN.16 for non-formulary). If the requested use is not 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 for the relevant line of business (HIM.PA.154 for health insurance marketplace and CP.PMN.53 for Medicaid).

Requests for uses that are non‑FDA approved and are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety consistent with applicable off‑label use policies (see HIM.PA.154 for health insurance marketplace and CP.PMN.53 for Medicaid) or other evidence of coverage documentation.

When this clinical policy conflicts with state Medicaid coverage provisions, the state Medicaid coverage provisions take precedence. Refer to the applicable state Medicaid manual for specific coverage rules that supersede this policy.

Coding and Dosing

Affected codesmixed

affected codes

Placeholder for codes affected by prior authorization and coverage (document references 'affected codes')

Dose limit

Standard daily dose25 mg per day

Maximum tablets per day1 tablet per day

Dose constraint in criteriaDose must not exceed both 25 mg/day and 1 tablet/day (both conditions required)

Pediatric eligibility threshold

Minimum ageAge ≥ 6 years

Minimum weightWeight ≥ 25 kg

Pediatric eligibility as of policy updatePediatric extension added to ≥ 6 years and ≥ 25 kg

Provider Actions and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for requests. When criteria are met, approval is granted for 12 months.

Approval duration: 12 months
Prior authorization may be required for entecavir (see criteria)

Documentation Required

Required Documentation

Provider must submit documentation (such as office chart notes, lab results, medication history, and other clinical information) that supports the member has met ALL approval criteria. Requests for non‑FDA approved (off‑label) indications that are not addressed in this policy will not be authorized unless sufficient documentation is provided per the Health Plan's off‑label use policy.

Examples: office notes, laboratory results, prior medication trials, adverse event documentation, specialist consultation notes

Background

Vemlidy (tenofovir alafenamide fumarate) is a nucleotide/nucleoside analog reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus (HBV) infection. Per this policy, Vemlidy is approved for adults and pediatric patients meeting the policy thresholds (pediatric eligibility: age ≥ 6 years and weight ≥ 25 kg). The standard dosing for HBV is 25 mg orally once daily, with a maximum of 1 tablet per day. The product carries a boxed warning for post‑treatment severe acute exacerbation of hepatitis B following discontinuation.

Definitions and Safety

Vemlidy — Definition

Generic nameTenofovir alafenamide fumarate

Brand nameVemlidy

Drug class/descriptionAn HBV nucleoside analog reverse transcriptase inhibitor

Boxed warning

Boxed warning summaryPost-treatment severe acute exacerbation of hepatitis B

Contraindications reportedNone reported in Appendix C

PlacementListed under Appendix C: Contraindications/Boxed Warnings

Revision History

2025-08-11approval_duration_changeLatest

Initial approval duration for Vemlidy revised from 6 months to 12 months as part of the 4Q 2025 annual review.

2025-06-10line_of_business_change_and_step_therapy_bypass

Commercial line of business removed; step therapy bypass for Illinois HIM members added per IL HB 5395.

2024-04-11pediatric_extension

Policy Summary

PayerCentene

PolicyTenofovir Alafenamide Fumarate (Vemlidy) for chronic hepatitis B

Policy CodePolicy CP.PMN.268

Change TypeMaterial clinical updates and operational changes

Effective DateDec 1, 2021

Next Review Date

Key ActionSubmit prior authorization with supporting documentation; approvals granted for 12 months when all criteria are met.

SourceLink

On This Page

Documentation Required

Provider Responsibilities

Providers are responsible for following applicable Health Plan administrative policies and supplying clinical documentation to support medical necessity. The Health Plan may deny or delay authorization if requested information is incomplete or not provided. Providers should verify state‑specific continuity of care regulations and plan addendums when applicable.

Follow Health Plan administrative policies and procedures
Supply documentation to support medical necessity to avoid delays/denials
Verify state‑specific continuity of care rules (see CC.PHARM.03A / CC.PHARM.03B addendums)

Step Therapy

Illinois HIM Step Therapy Bypass

Step therapy requirements do not apply to Illinois HIM requests as of 1/1/2026 per IL HB 5395; IL HIM requests may bypass the step‑therapy requirement described in the criteria.

Effective 01/01/2026: IL HIM step therapy bypass applies

Health Plan — Definition/identifier

RoleHealth Plan administers benefits and coverage decisions consistent with coverage documents and applicable laws

Not a guaranteePolicy is a guide to medical necessity and does not constitute a contract or guarantee of payment

Medicaid precedence

Precedence statementWhen state Medicaid coverage provisions conflict with this clinical policy, state Medicaid coverage provisions take precedence

Provider actionRefer to the state Medicaid manual for any coverage provisions pertaining to this clinical policy

ScopeApplies specifically to Medicaid members where state rules differ from this policy

Pediatric eligibility extended to include patients ≥ 6 years and weight ≥ 25 kg (pediatric extension added).

2021-12-10approval_duration_standardized

Approval duration for Commercial line revised to 12 months or duration of request, whichever is less (earlier revision reflected in policy history).