CurrentUnitedHealthcarePolicy CS2026D0092L

Scenesse (Afamelanotide)

Defines medical benefit drug coverage criteria, initial and continuation authorization requirements, applicable HCPCS and diagnosis codes, administration and provider training requirements for Scenesse (afamelanotide) in adult patients with EPP. Excludes certain states from this policy's applicability.

Policy Summary

PayerUnitedHealthcare

PolicyScenesse (Afamelanotide)

Policy CodePolicy CS2026D0092L

Change TypeApplication updates; state applicability changes

Effective DateApr 1, 2026

Next Review Date

Key ActionSubmit medical records (chart notes, laboratory values, genetic testing) supporting EPP diagnosis and meeting diagnostic criteria; initial authorization limited to no more than 12 months.

POLICY UPDATE CHANGES

Application section updated to exclude certain states (Kansas, North Carolina, Ohio listed as not applicable).

Removed content/language pertaining to the states of Indiana and Louisiana.

1HCPCS code listed

1ICD-10 diagnosis referenced

18+Age requirement

12 monthsMax authorization duration

Coverage Summary & Rationale

Erythropoietic protoporphyria (EPP) is an inherited cutaneous porphyria causing painful, non‑blistering photosensitivity due to accumulation of protoporphyrin IX. Scenesse (afamelanotide) is indicated to increase pain‑free light exposure in adults with EPP. This policy defines medical‑benefit drug coverage criteria for Scenesse in adult patients with EPP and specifies initial and continuation authorization requirements, applicable HCPCS/diagnosis codes, administration and provider training requirements. The policy does not apply to the states listed in the Application section; refer to state‑specific policy where noted.

Coverage Rationale / Initial Therapy

Scenesse (afamelanotide) is proven and medically necessary for the treatment of erythropoietic protoporphyria (EPP) when all the following criteria are met:

ALL of the following

Diagnostic confirmation (ONE of)
- Laboratory criteria (BOTH of)
  - Increased total erythrocyte protoporphyrin (usually 300 to 8,000 mcg/dL; normal < 80 mcg/dL)
  - Increased percentage of erythrocyte metal-free protoporphyrin rather than zinc protoporphyrin (generally greater than 85% of total porphyrins)
- Molecular/genetic testing confirming ONE of
  - Ferrochelatase (FECH) gene mutation
  - Delta-aminolevulinate synthase-2 (ALAS2) gain-of-function gene mutation
Patient is 18 years of age or older
Patient has a history of phototoxic reactions due to EPP
Prescribed by, or in consultation with, a hematologist, or a specialist with expertise in the diagnosis and management of EPP
Scenesse is to be administered by a healthcare professional proficient in the subcutaneous implantation procedure
The administering healthcare professional has completed requisite procedural training provided by product manufacturer
Scenesse dosing is in accordance with the U.S. Food and Drug Administration (FDA) approved labeling
Initial authorization will be for no more than 12 months
authorization duration limit

Continuation Therapy (Reauthorization)

Continuation of Therapy (Reauthorization)

Reauthorization is approved when ALL of the following are met:

ALL of the following

Patient has previously received Scenesse for the treatment of EPP
Patient has experienced a positive clinical response while on Scenesse
Prescribed by, or in consultation with, a hematologist, or a specialist with expertise in the diagnosis and management of EPP
Scenesse is to be administered by a healthcare professional proficient in the subcutaneous implantation procedure
The administering healthcare professional has completed requisite procedural training provided by product manufacturer
Scenesse dosing is in accordance with the U.S. Food and Drug Administration (FDA) approved labeling
Reauthorization will be for no more than 12 months
reauthorization duration limit

Prior Authorization, Documentation & Billing Requirements

Prior Authorization

Prior Authorization Required

Initial prior authorization is required. Submit medical records (chart notes, laboratory values, genetic testing) supporting an EPP diagnosis and meeting the diagnostic criteria; initial authorization is limited to no more than 12 months.

Affected code: J7352
Initial authorization limit: 12 months

Prior Authorization

Reauthorization documentation

For continuation of therapy, document prior receipt of Scenesse and a positive clinical response while on therapy; reauthorization will be for no more than 12 months and prescriptions should be by or in consultation with a hematologist or EPP specialist.

Affected code: J7352

Documentation Required

Provider specialty and training requirement

Prescriber must be a hematologist or a specialist with expertise in EPP; the administering healthcare professional must be proficient in the subcutaneous implantation procedure and have completed requisite procedural training provided by the product manufacturer.

Billing Rule

Dosing per FDA label

Scenesse dosing must follow the U.S. Food and Drug Administration (FDA) approved labeling to meet coverage criteria.

Affected code: J7352

Clinical Trial Evidence

6.0 vs 0.75EU randomized trial median pain-free hours (270 days): Afamelanotide 6.0 hours vs vehicle 0.75 hours

64.1 vs 40.5U.S. randomized trial median pain-free hours (180 days): Afamelanotide 64.1 hours vs vehicle 40.5 hours

Key randomized trial results: In the European (270‑day) trial the median total pain‑free hours in direct sunlight (10 a.m.–3 p.m.) was 6.0 hours with afamelanotide versus 0.75 hours with vehicle. In the U.S. (180‑day) trial the median total pain‑free hours in direct sunlight (10 a.m.–6 p.m.) was 64.1 hours with afamelanotide versus 40.5 hours with vehicle. These values are trial medians and the comparator was vehicle/placebo.

Background & Definitions

EPP is a genetic disorder in which impaired ferrochelatase activity leads to accumulation of protoporphyrin IX, producing severe burning phototoxic pain most often on the face and hands; approximately 1 in 140,000 people in the U.S. are affected. Available treatment options are limited — avoidance of strong sunlight and protective measures are essential, systemic β‑carotene has been used though robust efficacy data are lacking, and other interventions (PUVA, UVB, oral cysteine, cholestyramine) have unproven clinical benefit. Scenesse provides a targeted treatment option for adults with EPP when coverage criteria are met.

Term	Definition
EPP	Erythropoietic protoporphyria, an inherited cutaneous porphyria characterized by painful, non-blistering photosensitivity due to protoporphyrin IX accumulation.

Clinical Thresholds & Limits

Thresholds

Total erythrocyte protoporphyrinusually 300 to 8,000 mcg/dL; normal < 80 mcg/dL

Percentage metal-free protoporphyringenerally greater than 85% of total porphyrins

Patient age>= 18 years

Initial authorization durationno more than 12 months

Authorization duration limits: initial authorization is for no more than 12 months, and reauthorization (continuation) is also limited to no more than 12 months.