Last Review Date: 01/04/2024

Date of Origin: 01/03/2020

Dates Reviewed: 01/2020, 01/2021, 01/2022, 01/2023, 01/2024

1. Length of Authorization

Coverage will be provided for 6 months initially and may be renewed annually thereafter.

2. Dosing Limits

A. Quantity Limit (max daily dose) [NDC Unit]:

• Scenesse 16 mg implant: 1 implant every 2 months

B. Max Units (per dose and over time) [HCPCS Unit]:

• 16 billable units every two months

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND

Erythropoietic Protoporphyria (EPP) † Ф ^1,2

• Patient does not have any malignant or premalignant skin lesions (e.g., melanoma, dysplastic nevus syndrome, Bowen’s disease, basal cell or squamous cell carcinomas, etc.) as evidenced by a baseline full body skin examination for pre-existing skin lesions; AND
• Patient has a definitive diagnosis of erythropoietic protoporphyria as confirmed by elevated free protoporphyrin in peripheral erythrocytes and/or by the identification of biallelic pathogenic variants in ferrochelatase (FECH) on molecular genetic testing; AND
• Used to increase the pain free light exposure in patients with a history of phototoxic reactions; AND
• Patient will continue to maintain sun and light protection measures during treatment to prevent phototoxic reactions  

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ¹

Coverage can be renewed based upon the following criteria:

• Patient continues to meet the indication-specific relevant criteria identified in section III; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe skin darkening, etc.; AND
• Disease response as evidenced by an increase in pain free time during light exposure and/or  a decrease in the number of phototoxic reactions; AND
• Patient is monitored with full body skin examinations (twice yearly) for pre-existing or new skin pigmentary lesions

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS Code:

• J7352 – Afamelanotide implant, 1 mg; 1 billable unit = 1 mg

NDC:

• Scenesse implant, 16 mg, for subcutaneous administration: 73372-0116-xx

7. References

1. Scenesse [package insert]. Burlingame, CA; Clinuvel, Inc., October 2022. Accessed December 2023.
2. Balwani M, Bloomer J, Desnick R; Porphyrias Consortium of the NIH-Sponsored Rare Diseases Clinical Research Network. Erythropoietic Protoporphyria, Autosomal Recessive. 2012 Sep 27 [Updated 2017 Sep 7]. In: Adam MP, Everman DB, Mirzaa GM, et al., editors. GeneReviews® [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2022. Available from: https://www.ncbi.nlm.nih.gov/books/NBK100826/.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A