Pharmacy Prior Authorization Criteria

Vemlidy (tenofovir alafenamide) - ST, NF

Indications for Prior Authorization

Vemlidy (tenofovir alafenamide tablet)

• For diagnosis of Chronic Hepatitis B (HBV)
  Indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults and pediatric patients 6 years of age and older with compensated liver disease.

Criteria

Vemlidy

Step Therapy

Length of Approval: 12 Month(s)

• All of the following:
• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• One of the following:
• Trial and failure, intolerance, or contraindication to generic entecavir
OR
• Both of the following:
• Patient is currently on Viread (tenofovir disoproxil fumarate)
AND
• One of the following:
• Patient has renal impairment
• Patient has a diagnosis of osteoporosis
OR
• For continuation of prior therapy

Vemlidy

Non Formulary

Length of Approval: 12 Month(s)

• All of the following:
• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• One of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, intolerance, or contraindication to generic entecavir
OR
• Paid claims or submission of medical records (e.g., chart notes) confirming both of the following:
• Patient is currently on Viread (tenofovir disoproxil fumarate)
AND
• One of the following:
• Patient has renal impairment
• Patient has a diagnosis of osteoporosis
OR
• Paid claims or submission of medical records (e.g., chart notes) confirming continuation of prior therapy, defined as no more than a 45-day gap in therapy

P & T Revisions

2024-05-01, 2024-02-22, 2023-03-15, 2022-11-30, 2022-03-08

References

1. Vemlidy Prescribing Information. Gilead Sciences, Inc. Foster City, CA. April 2024.

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Revision History

• 2024-05-01: Updated indication to include new approval in 6 years and older and updated references.
• 2024-02-22: 2024 Annual review. No changes.
• 2023-03-15: Annual review - no changes.
• 2022-11-30: Updated indication section per FDA label. Updated references.
• 2022-03-08: New ST program for Vemlidy.

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