Scenesse is now available under VA healthcare program in US

Clinuvel to supply implant for sunlight sensitivity in EPP until July 2028

Lindsey Shapiro, PhD avatar

by Lindsey Shapiro, PhD |

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Clinuvel has been awarded a five-year contract with the U.S. Department of Veterans Affairs (VA) to supply Scenesse (afamelanotide) for the treatment of adults with erythropoietic protoporphyria (EPP).

The implantable medication has been listed on the Federal Supply Schedule, a government-wide contract with commercial companies to provide access to products and services at a low price for the government.

This listing means any EPP patient covered under the VA healthcare program can receive Scenesse at all VA facilities until July 2028, with the potential for the contract to be reviewed and renewed after that.

“We extend our heartfelt appreciation to the Veterans for their service and understand the significance of providing them with access to life-altering therapies like Scenesse,” Linda Teng, Clinuvel’s director of North American operations, said in a company press release.

“Following the launch of Scenesse in 2020, our team have worked to facilitate treatment for EPP patients through both private insurance and U.S. government coverage programs, with year-on-year increases in patients seeking and receiving treatment,” Teng added.

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Scenesse may help reduce liver damage in EPP patients

In EPP, genetic mutations in the FECH gene lead to impaired activity of the ferrochelatase enzyme that’s involved in the production of heme, a molecule that helps red blood cells transport oxygen. Consequently, a heme precursor called protoporphyrin IX (PPIX) accumulates toxically in the body.

Because PPIX can be activated by light, this buildup leads to photosensitivity, in which sunlight causes skin reactions such as pain and redness. PPIX buildup in the liver also increases susceptibility to liver damage.

Scenesse under-the-skin implant helps to stimulate production of melanin

Scenesse is an implant that’s inserted under the skin, where it releases its active ingredient, afamelanotide. This compound is a potent antioxidant and helps to stimulate the production of melanin, the brownish pigment that protects skin from damage due to the sun’s ultraviolet rays.

It was first approved in the European Union in 2014 and in the U.S. in 2019 for adults with EPP who have a history of toxic reactions elicited by sunlight. In both regions, patients can receive new implants once every two months.

By reducing painful reactions to sunlight, Scenesse has been found to boost life quality and make participation in activities easier for EPP patients. More recent data also indicate the treatment might help to reduce liver damage.

Common side effects include implant site reactions, nausea, throat pain, cough, fatigue, dizziness, and skin darkening.

Clinuvel now joins about 400 companies authorized to supply pharmaceuticals to the VA under the Schedule. These products help provide care for the approximately nine million people enrolled in the VA healthcare program across the U.S.

For patients not covered by the VA, many private insurance companies will cover Scenesse if it is deemed medically necessary. Clinuvel also has a savings program to help cover out-of-pocket costs not covered by commercial or private insurance, as well as options for patients who don’t have health insurance.