ModifiedmhnPolicy CP.PMN.268

Tenofovir Alafenamide Fumarate (Vemlidy)

Medical necessity and prior authorization criteria for Vemlidy (tenofovir alafenamide fumarate) for treatment of chronic hepatitis B in applicable lines of business; affects prescribers and prior authorization reviewers for the payer's HIM and Medicaid populations.

Policy Summary

Payermhn

PolicyTenofovir Alafenamide Fumarate (Vemlidy)

Policy CodePolicy CP.PMN.268

Change TypeMaterial clinical and operational revisions

Effective DateDec 1, 2021

Next Review Date

Key ActionSubmit prior authorization with documentation showing age/weight, prior treatment failure or contraindication, and dose within 25 mg/day for approval up to 12 months.

SourceLink

POLICY UPDATE CHANGES

Pediatric indication extended to patients ≥ 6 years and weight ≥ 25 kg.

Step therapy bypass for Illinois HIM per IL HB 5395.

Initial approval duration revised from 6 months to 12 months.

Commercial line of business removed from policy.

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

Removed Commercial line of business.

Revised initial approval duration from 6 months to 12 months.

25 mgMaximum daily dose

12 monthsApproval duration

≥6 yrs; ≥25 kgPediatric eligibility

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HIM, MedicaidLines of business

IL HIMStep therapy bypass

CommercialLOB removed

Coverage Criteria for Vemlidy (tenofovir alafenamide fumarate)

Initial Therapy

Covered when ALL of the following are met:

Hepatitis B Virus Infection (initial): 1. Diagnosis of chronic HBV infection; 2. Prescribed by or in consultation with a gastroenterologist, hepatologist, or infectious disease specialist; 3. Age ≥ 6 years and weight ≥ 25 kg; 4. Failure of tenofovir disoproxil fumarate or entecavir at up to maximally indicated doses, unless clinically significant adverse effects are experienced or both are contraindicated; 5. Dose does not exceed both of the following: (a) 25 mg per day; and (b) 1 tablet per day.

Approval duration: 12 months

Continuation Therapy

Covered when ALL of the following are met:

Hepatitis B Virus Infection (continued): 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. If request is for a dose increase, new dose does not exceed both of the following: (a) 25 mg per day; and (b) 1 tablet per day.

Approval duration: 12 months

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (see HIM.PA.154 for the health insurance marketplace and CP.PMN.53 for Medicaid). Requests for off‑label use should include clinical evidence supporting the indication per those off‑label policies; absence of adequate documentation may result in denial.

When coverage provisions in this clinical policy conflict with state Medicaid rules, state Medicaid coverage provisions take precedence. Refer to the applicable state Medicaid manual for specific coverage requirements and any differing provisions that govern Medicaid members.

Use of this medication for non‑FDA approved (off‑label) indications that are not covered by this policy must follow the payer's off‑label use procedures. Specifically, such requests require submission of sufficient clinical documentation demonstrating efficacy and safety as detailed in HIM.PA.154 (health insurance marketplace) or CP.PMN.53 (Medicaid). If adequate supporting evidence is not provided per those off‑label policies, the request is considered not medically necessary.

Drug Dosing, Pediatric Eligibility, and Codes

inv-06: Maximum daily dose — 25 mg per day (1 tablet per day)

Maximum daily dose25 mg per day (maximum 1 tablet per day).

Dosing regimen referenced25 mg PO once daily for HBV infection.

Approval constraintRequests exceeding 25 mg/day or more than 1 tablet/day do not meet dose criteria.

inv-07: Pediatric eligibility threshold — Age ≥ 6 years and weight ≥ 25 kg

Pediatric eligibility (age and weight)Age ≥ 6 years and weight ≥ 25 kg.

FDA-approved population noteIndicated for pediatric patients 6 years of age and older weighing at least 25 kg with compensated liver disease.

Prior Authorization, Step Therapy, and Documentation Requirements

Prior Authorization

Prior authorization and approval duration

Prior authorization is required for Tenofovir Alafenamide (Vemlidy). Approval may be granted for up to 12 months. Continued therapy requires documentation of positive response and adherence to continuation criteria; requests for dose increases must remain within the policy limits (≤25 mg per day and ≤1 tablet per day).

Approval duration: 12 months
Dose limits for all approvals: ≤25 mg per day and ≤1 tablet per day

Documentation Required

Required documentation

Provider must submit clinical documentation supporting that the member meets all approval criteria. Acceptable documentation includes office chart notes, relevant laboratory results, prior treatment history (including trials of tenofovir disoproxil fumarate or entecavir where applicable), and consultation notes when treatment is not prescribed by a specialist.

Clinical Background

Tenofovir alafenamide fumarate (Vemlidy) is a hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B in adults and pediatric patients meeting age and weight criteria. Standard dosing for HBV is 25 mg PO once daily (maximum 25 mg per day; 1 tablet per day). The product labeling includes a boxed warning regarding post‑treatment severe acute exacerbation of hepatitis B, and pediatric approval extends to patients aged ≥ 6 years who weigh ≥ 25 kg.

Key Definitions

inv-17: tenofovir alafenamide fumarate; HBV nucleoside analog reverse transcriptase inhibitor — Vemlidy

Generic nameTenofovir alafenamide fumarate.

Drug classHBV nucleoside analog reverse transcriptase inhibitor.

Brand nameVemlidy®.

inv-18: 'Health Plan' definition

Definition'Health Plan' means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan's affiliates, as applicable.

Context of useTerm used to refer to the payer organization applying this clinical policy and its affiliates.

Policy Summary

Payermhn

PolicyTenofovir Alafenamide Fumarate (Vemlidy)

Policy CodePolicy CP.PMN.268

Change TypeMaterial clinical and operational revisions

Effective DateDec 1, 2021

Next Review Date

Key ActionSubmit prior authorization with documentation showing age/weight, prior treatment failure or contraindication, and dose within 25 mg/day for approval up to 12 months.

SourceLink

On This Page

Pediatric extension to ≥ 6 years and ≥ 25 kg added in policy updates.

Lab results (e.g., HBV viral load, liver function tests)

Medication history demonstrating prior therapies and reasons for discontinuation (adverse effects or contraindications)

Specialist consultation notes when required (gastroenterologist, hepatologist, or infectious disease specialist)

Denial Risk

Documentation and indication risks

Requests that lack adequate documentation (diagnosis, prior therapy, lab data, or required specialist consultation when indicated) may be denied. Ensure the submission clearly states the diagnosis of chronic HBV and documents either step therapy failure or an applicable exception.

Include diagnosis of chronic HBV infection
Document prior failure or intolerance to tenofovir disoproxil fumarate or entecavir unless exceptions apply
If not prescribed by a specialist, include documentation of consultation or justification

Step Therapy

Step therapy requirements

Step therapy requires failure of tenofovir disoproxil fumarate or entecavir at maximally indicated doses before approval of tenofovir alafenamide, unless the member has clinically significant adverse effects or both alternatives are contraindicated.

Step therapy: failure of tenofovir disoproxil fumarate or entecavir required
Exceptions: documented clinically significant adverse effects or contraindications to both agents

Step Therapy

Step therapy bypass for Illinois HIM

Per Illinois HB 5395, step therapy requirements do not apply for Illinois HIM requests as of 01/01/2026. Providers submitting IL HIM requests should indicate the request is for an Illinois HIM member and may bypass step therapy documentation accordingly.

Effective 01/01/2026: IL HIM requests — step therapy bypass per IL HB 5395
Providers must note IL HIM status on the authorization request to ensure bypass is applied

Note

Provider submission guidance and operational risk

Providers should submit all supporting clinical documentation at the time of the prior authorization request to demonstrate medical necessity and adherence to plan-level rules. This includes evidence of prior therapy trials or documented exceptions, lab results, and specialist involvement when required. Failure to follow updated authorization rules (for example, not indicating IL HIM bypass eligibility when applicable) may delay or negatively affect decisioning.

Attach office notes, labs, and medication history to the PA request
Indicate if member is IL HIM to apply step therapy bypass per IL HB 5395
Document positive response for continuation requests and any dose change justification

Health Plan-level administrative policies and procedures govern implementation of this clinical policy.