CurrentColorado Rocky Mountain Health PlansPolicy N/A

Vemlidy (tenofovir alafenamide) prior authorization

Defines prior authorization and medical necessity criteria for coverage of Vemlidy (tenofovir alafenamide) for treatment of chronic hepatitis B in eligible patients under UnitedHealthcare Pharmacy Clinical Pharmacy Programs; applies to formularies and plan-specific benefits.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyVemlidy (tenofovir alafenamide) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateAug 1, 2025

Next Review DateN/A

Key ActionSubmit medical records documenting diagnosis of chronic hepatitis B and supporting documentation of intolerance/unsuitability to entecavir and either intolerance to tenofovir disoproxil fumarate or one of the listed renal, bone, fracture, or age criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration on approval

>= 6 yrsminimum age per Vemlidy indication

eGFR <90renal function criterion

BMD ≤ -2.5osteoporosis criterion

P&T through 5/2025

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Coverage Criteria — Vemlidy (tenofovir alafenamide)

Initial Therapy

Covered when ALL of the following are met:

Initial Authorization: Diagnosis of chronic hepatitis B infection

requirement (1)

Alternatives and documentation: Submission of medical records documenting both: (a) history of adverse event or intolerance to entecavir OR patient is not a suitable candidate for entecavir; AND (b) one of: adverse event/intolerance to tenofovir disoproxil fumarate; eGFR < 90 mL/min; osteopenia with progressive bone loss (BMD T-score > -2.5 to ≤ -1); osteoporosis (BMD T-score ≤ -2.5); prior low-trauma/nontraumatic fracture; or patient age < 20 years

Provider must submit supporting records (e.g., medical records, BMD T-scores, serial DEXA, renal function)

Continuation Therapy

Reauthorization criteria — ALL required:

Reauthorization: Documentation of positive clinical response to Vemlidy therapy

clinical response required

Continued unsuitability of alternatives: Patient remains not a suitable candidate for entecavir or tenofovir disoproxil fumarate

must continue to be unsuitable for alternatives

Some benefit plans impose plan-specific exclusions for Vemlidy (tenofovir alafenamide) and brand Viread. When exclusions are in place, plans may require tried/failed (step therapy) criteria before Vemlidy will be considered; verify the member’s specific benefit plan to determine whether the drug is excluded or whether step therapy applies. Note that Nevada‑sitused plans are not subject to the clinical criteria in this policy but may still enforce step therapy or other utilization requirements.

Initial Authorization Criteria

Initial authorization

Initial approval will be granted when all listed conditions are satisfied:

Initial - diagnosis: Diagnosis of chronic hepatitis B infection

requirement (1)

Initial - entecavir consideration: Submission of medical records documenting either: history of adverse event/intolerance to entecavir OR patient is not a suitable candidate for entecavir

provider must submit records

Initial - supportive criteria (one required): One of: submission of medical records documenting adverse event/intolerance to tenofovir disoproxil fumarate; eGFR < 90 mL/min; osteopenia with progressive bone loss (BMD T-score > -2.5 to ≤ -1); osteoporosis (BMD T-score ≤ -2.5); prior low-trauma/nontraumatic fracture; patient age < 20 years

provider must submit specific supporting documentation such as BMD T-scores or renal function

Reauthorization / Continuation Criteria

Reauthorization

Reauthorization will be approved when the following are met:

Reauthorization requirements: Documentation of positive clinical response to Vemlidy therapy

clinical response required

Reauthorization - alternatives: Patient remains not a suitable candidate for entecavir or tenofovir disoproxil fumarate

Authorization issued for 12 months upon approval

Provider Actions and Documentation Requirements

Prior Authorization

Initial authorization criteria

Prior authorization required: Initial approvals granted when ALL of the following are met.

Documentation Required

Provider action: Initial authorization criteria

Initial authorization — Vemlidy will be approved when ALL of the following are documented:

Diagnosis of chronic hepatitis B infection
Submission of medical records documenting ONE of the following for entecavir (Baraclude): history of adverse event or intolerance
Submission of medical records documenting ONE of the following for tenofovir disoproxil fumarate (Viread): history of adverse event or intolerance
Documentation that the patient is not a suitable candidate for entecavir or tenofovir disoproxil fumarate

Clinical Thresholds and Key Clinical Values

inv-04: eGFR threshold — estimated glomerular filtration rate below 90 mL/min

eGFR thresholdEstimated glomerular filtration rate below 90 mL/min

ContextUsed as one of the supportive criteria for initial authorization when tenofovir disoproxil fumarate is not suitable

Documentation requiredMedical records demonstrating measured eGFR supporting value < 90 mL/min

inv-05: BMD T-score osteopenia — greater than -2.5 and less than or equal to -1

BMD T-score (osteopenia)Greater than -2.5 and less than or equal to -1 (T-score > -2.5 to ≤ -1)

Anatomic sitesLumbar spine, hip, or radius

Definitions — Bone Density Terms

inv-12: Osteopenia — BMD T-score greater than -2.5 and less than or equal to -1 on lumbar spine, hip, or radius, with required evidence of progressive bone lo...

DefinitionBMD T-score greater than -2.5 and less than or equal to -1 on lumbar spine, hip, or radius

Additional requirementRequired evidence of progressive bone loss on serial DEXA scans to support initial authorization

DocumentationProvide patient-specific BMD T-scores and serial DEXA evidence when submitting authorization

inv-13: Osteoporosis — BMD T-score ≤ -2.5 on lumbar spine, hip, or radius.

DefinitionBMD T-score less than or equal to -2.5 on lumbar spine, hip, or radius

Policy useCounts as an acceptable supportive criterion for initial authorization of Vemlidy

Step Therapy and Plan-Specific Restrictions

Step	Notes
1	Step therapy or plan-specific exclusions may apply. Vemlidy and brand Viread are typically excluded from coverage for some plans; tried/failed criteria may be required — refer to plan-specific benefit exclusions and step therapy requirements.
2	Plans sitused in Nevada are not subject to clinical criteria; only step therapy may be required for Nevada-sitused plans.

Quantity Limits

inv-17: Vemlidy (tenofovir alafenamide) — Supply limits may be in place

DrugVemlidy (tenofovir alafenamide)

Quantity limits noteSupply limits may be in place

ApplicabilityLimits applied per plan and program; check plan-specific quantity/dispense rules

Background — Drug Information

Vemlidy (tenofovir alafenamide) is an HBV nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B. Coverage decisions are influenced by plan exclusions and utilization rules; Vemlidy and brand Viread are typically excluded from coverage for some plans and tried/failed criteria may be in place. Check the member’s benefit plan for any state mandates, federal requirements, or other programs that could affect coverage. For plans sitused in Nevada, clinical criteria in this policy do not apply although step therapy may still be required. When authorized, approvals are generally issued for 12 months.