Pharmacy Prior Authorization Criteria

Zokinvy (lonafarnib)

Indications for Prior Authorization

Zokinvy (lonafarnib)

• For diagnosis of Hutchinson-Gilford Progeria Syndrome (HGPS)
  Indicated in patients 12 months of age and older with a body surface area (BSA) of 0.39 m^2 and above to reduce the risk of mortality in Hutchinson-Gilford Progeria Syndrome (HGPS).

  Limitations of Use: ZOKINVY is not indicated for other Progeroid Syndromes or processing-proficient Progeroid Laminopathies. Based upon its mechanism of action, ZOKINVY would not be expected to be effective in these populations.

• For diagnosis of Processing-Deficient Progeroid Laminopathies
  Indicated in patients 12 months of age and older with a body surface area (BSA) of 0.39 m^2 and above for the treatment of processing-deficient Progeroid Laminopathies with either heterozygous LMNA mutation with progerin-like protein accumulation or homozygous or compound heterozygous ZMPSTE24 mutations.

  Limitations of Use: ZOKINVY is not indicated for other Progeroid Syndromes or processing-proficient Progeroid Laminopathies. Based upon its mechanism of action, ZOKINVY would not be expected to be effective in these populations.

Criteria

Zokinvy

Prior Authorization

Length of Approval: 12 Month(s)

• One of the following:
• Diagnosis of Hutchinson-Gilford Progeria Syndrome
OR
• For treatment of processing-deficient Progeroid Laminopathies with one of the following:
• Heterozygous LMNA mutation with progerin-like protein accumulation
• Homozygous or compound heterozygous ZMPSTE24 mutations
AND
• Patient is 12 months of age or older
AND
• Patient has a body surface area of 0.39 m^2 and above

P & T Revisions

2024-02-20, 2023-02-17, 2022-01-06, 2021-09-28, 2021-05-26, 2021-05-25, 2021-02-18

References

1. Zokinvy Prescribing Information. Eiger BioPharmaceuticals, Inc. Palo Alto, CA. November 2020.

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Revision History

• 2024-02-20: 2024 annual review: no criteria changes.
• 2023-02-17: Annual review - no criteria changes.
• 2022-01-06: 2022 Annual Review - No changes to clinical criteria
• 2021-09-28: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-26: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-25: Addition of EHB formulary to guideline, no changes to criteria
• 2021-02-18: New program

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