Afamelanotide (Scenesse) Form

Afamelanotide (Scenesse®) is a melanocortin 1 receptor (MC1-R) agonist. FDA Approved Indication(s) Scenesse is indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP). Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Scenesse is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Erythropoietic Protoporphyria and X-Linked Protoporphyria (must meet all):

1. Diagnosis of EPP or X-linked protoporphyria (known as XLP or XLEPP);
2. Prescribed by or in consultation with a dermatologist;
3. Age ≥ 18 years;

4. Evidence of EPP/XLP-associated acute non-blistering cutaneous reactions (e.g., pain, stinging, redness, swelling, blanching) following exposure to sun;

   5. EPP/XLP is confirmed by both of the following tests (a and b): a. Elevated total erythrocyte protoporphyrin (e.g., 300 to 5,000 mcg/dL vs. normal at < 80 mcg/dL); b. Erythrocyte fractionation shows ≥ 50% metal-free vs. zinc protoporphyrin (certified laboratories include University of Texas Medical Branch at Galveston - Porphyria Center, and Mayo Medical Laboratories);
   6. Gene sequencing shows an FECH, CLPX, or ALAS2 mutation (genetic testing is available through the Porphyria Center at Mount Sinai Medical Center and Mayo Medical Laboratories);
   7. Sun avoidance and use of sunscreen, protective clothing, and pain medication have proven inadequate in controlling EPP-associated painful skin reactions;
   8. EPP/XLP cutaneous reactions are associated with both of the following (a and b): a. Moderate to severe pain as measured on a pain-intensity Likert scale; b. Negative impact on quality of life (QOL) as measured by a QOL questionnaire (e.g., Dermatology of Life Quality Index [DLQI], EPP-Quality of Life [QoL]);
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   CLINICAL POLICY Afamelanotide

   9. Member does not have any of the following conditions: a. Current Bowen’s disease, basal cell carcinoma, or squamous cell carcinoma; b. Personal history of melanoma or dysplastic nevus syndrome; c. Significant EPP/XLP-associated liver disease;
   10. Dose does not exceed one 16-mg implant every 2 months. Approval duration:
       Medicaid/HIM – 6 months (medical justification is required for requests beyond 3 implants for seasonal coverage) Commercial – 6 months or to the member’s renewal date, whichever is longer (medical justification is required for requests beyond 3 implants a year for seasonal coverage) B. Other diagnoses/indications (must meet 1 or 2):
   11. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
   12. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
       II. Continued Therapy A. Erythropoietic Protoporphyria and X-Linked Protoporphyria (must meet all):
   13. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
   14. Member is responding positively to therapy as evidenced by any of the following (a or b): a. Improvement in acute non-blistering cutaneous reactions (e.g., pain, stinging, redness, swelling, blanching) following exposure to sun;
       b. Improvement on a pain-intensity Likert scale or QOL questionnaire;
   15. Member has received a full skin examination by a dermatologist within the last six months;
   16. If request is for a dose increase, new dose does not exceed one 16 mg implant every 2 months. Page 2 of 6

   CLINICAL POLICY Afamelanotide Approval duration:
   Medicaid/HIM – 6 months (medical justification is required for requests beyond 3 implants a year for seasonal coverage) Commercial – 6 months or to the member’s renewal date, whichever is longer (medical justification is required for requests beyond 3 implants a year for seasonal coverage) B. Other diagnoses/indications (must meet 1 or 2):

   1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
   2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
      III. Diagnoses/Indications for which coverage is NOT authorized:
      A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key DLQI: dermatology of life quality index EPP: erythropoietic protoporphyria FDA: Food and Drug Administration MC1-R: melanocortin 1 receptor Appendix B: Therapeutic Alternatives
      Not applicable QoL: quality of life
      XLP/XLEPP: X-linked protoporphyria/X- linked erythropoietic protoporphyria Appendix C: Contraindications/Boxed Warnings • Contraindication(s): hypersensitivity to the active substance or to any of the excipients • Boxed warning(s): none reported Page 3 of 6

   CLINICAL POLICY Afamelanotide Appendix D: Manufacturer’s Dosing/Administration Information (Prescribing Information) Scenesse should be administered by a health care professional. All healthcare professionals should be proficient in the subcutaneous implantation procedure and have completed the training program provided by Clinuvel prior to administration of the Scenesse implant.
   • A single Scenesse implant is inserted subcutaneously above the anterior supra-iliac crest every 2 months.
   • Use the SFM Implantation Cannula to implant Scenesse. Contact Clinuvel, Inc., for other implantation devices that have been determined by the manufacturer to be suitable for implantation of Scenesse.
   • Maintain sun and light protection measures during treatment with Scenesse to prevent phototoxic reactions related to EPP. V. Dosage and Administration
   Indication EPP Dosing Regimen One 16 mg implant SC every 2 months One implant/2 months Maximum Dose VI. Product Availability
   Implant: 16 mg Not supplied with implantation device; consult manufacturer for list of recommended devices. VII.