Crysvita® (Burosumab-Twza)



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Scenesse® (afamelanotide) For Louisiana Only

|POLICY NUMBER: CSLA2020D0092C |EFFECTIVE DATE: TBD |

|Commercial Policy |

| |

Table of Contents Page

Application 1

COVERAGE RATIONALE 1

APPLICABLE CODES 2

BACKGROUND 2

CLINICAL EVIDENCE 2

U.S. FOOD AND DRUG ADMINISTRATION 3

CENTERS FOR MEDICARE AND MEDICAID SERVICES 4

REFERENCES 4

POLICY HISTORY/REVISION INFORMATION 4

INSTRUCTIONS FOR USE 4

Application

This Medical Benefit Drug Policy only applies to the state of Louisiana

COVERAGE RATIONALE

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

Initial Therapy:

• Submission of medical records (e.g., chart notes, laboratory values, etc.) to support the diagnosis of erythropoietic protoporphyria (EPP) confirming one of the following:

o Both of the following:

- Increased total erythrocyte protoporphyrin (usually 300 to 8000 mcg/dL; normal ................
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