Pharmacy Prior Authorization Criteria

Imlygic (talimogene laherparepvec) - PA, NF

Indications for Prior Authorization

Imlygic (talimogene laherparepvec)

• For diagnosis of Melanoma
  Indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. Limitations of use: IMLYGIC has not been shown to improve overall survival or have an effect on visceral metastases.

Criteria

Imlygic

Prior Authorization, Non Formulary (Initial Authorization)

Length of Approval: 6 Month(s)

• Submission of medical records (e.g., chart notes) confirming diagnosis of recurrent melanoma after initial surgery
AND
• Submission of medical records (e.g., chart notes) confirming disease is both of the following:
• Stage IIIb, IIIc or stage IV
• Not surgically resectable
AND
• Will be used for local treatment of at least one of the following lesion type(s):
• Cutaneous
• Subcutaneous
• Nodal
AND
• Patient is 18 years of age or older
AND
• Patient does not have any of the following:
• Bone metastases
• Active brain metastases
• More than three visceral metastases (except lung or nodal metastases associated with visceral organs)
• Any visceral metastasis greater than 3 cm
• Primary ocular or mucosal melanoma
AND
• Prescribed by one of the following:
• Oncologist
• Dermatologist

Imlygic

Prior Authorization, Non Formulary (Reauthorization)

Length of Approval: 6 Month(s)

• Submission of medical records (e.g., chart notes) confirming presence of treatable lesions
AND
• Prescribed by one of the following:
• Oncologist
• Dermatologist

P & T Revisions

2026-06-17

References

1. Imlygic Prescribing Information. Amgen Inc. Thousand Oaks, CA. November 2024.

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Revision History

• 2026-06-17: New program.

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