Pharmacy Prior Authorization Criteria

Scenesse (afamelanotide)

Indications for Prior Authorization

Scenesse (afamelanotide)

• For diagnosis of Erythropoietic protoporphyria - Phototoxic dermatitis
  Indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP).

Criteria

Scenesse

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s) [A]

• Diagnosis of erythropoietic protoporphyria (EPP) confirmed by laboratory or genetic testing [B]
AND
• Patient has history of phototoxic reactions
AND
• Prescribed by or in consultation with one of the following:
• Dermatologist
• Hepatologist

Scenesse

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy (e.g., increased duration of exposure to direct sunlight without pain, decreased number of phototoxic reactions)

P & T Revisions

2024-04-03, 2023-10-26, 2023-04-07, 2022-04-21, 2021-04-07, 2020-04-17

References

1. Scenesse Prescribing Information. Clinuvel, Inc. West Menlo Park, CA. January 2023.
2. Per clinical consult with dermatologist, December 19, 2019.

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End Notes

1. Patients enrolled in clinical trial (Study CUV039, NCT 01605136) were assessed after 180 days and consultant agreed that 6 month approval duration is appropriate to determine if patient is responding to therapy. [1, 2]
2. Per recommendation from consultant to avoid off-label use, diagnosis of erythropoietic protoporphyria (EPP) should be confirmed by laboratory (porphyrin levels in serum and stool) or genetic testing. [2]

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Revision History

• 2024-04-03: 2024 Annual Review. No criteria changes.
• 2023-10-26: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-04-07: Annual Review, no criteria changes.
• 2022-04-21: Annual review: no criteria changes.
• 2021-04-07: 2021 Annual Review, no changes to criteria.
• 2020-04-17: New Program

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