Clinuvel To Launch SCENESSE® In USA In April

CLINUVEL PHARMACEUTICALS LTD has announced plans to launch its novel drug SCENESSE® (afamelanotide) ahead of schedule in the USA, with the first patient to be treated as early as 15 April 2020.

The following are excerpts from a press release:

USA DISTRIBUTION SCENESSE® The distribution of SCENESSE® is planned in three phases. During Phase I, three selected hospitals and medical centers will be able to provide treatment to EPP patients. For Phase II, Medicare-Medicaid will need to complete its review of the SCENESSE® dossier and provide an opinion on National and Local Coverage for the treatment, as to be confirmed by the Centers for Medicare & Medicaid Services. The last phase will consist of direct distribution of the drug to a target maximum of 30 centers who will be trained and accredited by CLINUVEL.

INSURANCE COVERAGE SCENESSE® During the first phase of distribution commencing 15 April 2020, patients will be able to receive treatment under Prior Authorization [PA]. PA is a decision by a payor that a healthcare service, treatment plan, prescription drug, or durable medical equipment is medically necessary and is included in a member’s (patient’s) coverage.

CLINUVEL CO-PAYMENT SAVINGS PROGRAM CLINUVEL will establish for American EPP patients a CLINUVEL Co-Payment Savings Program. Individual applications will need to be made, whereby terms & conditions will apply to each patient on a case by case basis. EPP patients with commercial or private health insurance may be eligible, depending on the terms of each insurance policy. Reference is made to the Power Point slide deck released concomitantly today.

The APF has received your many questions regarding this press release. We are working with Clinuvel for responses. Please continue to email your questions to the APF at: kristen@porphyriafoundation.org.

 

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