Swiss insurers to reimburse Clinuvel’s Scenesse

By Dylan Bushell-Embling
Friday, 27 April, 2012


Clinuvel Pharmaceuticals (ASX:CUV) has announced that two Swiss insurers have agreed to provide full reimbursement for its SCENESSE implant as a treatment for rare skin disease EPP.

The insurance companies will fully cover the cost of supply to Scenesse for the approximately 50 EPP patients in Switzerland.

EPP (erythropoietic protoporphyria) is a rare genetic disease causing extreme intolerance of skin to light.

It manifests as a chronic burning and itching sensation on the surface of the skin. Prolonged exposure to the sun can cause edema and blistering, and EPP can be responsible for other complications including bowel and liver disorders.

Clinuvel's Scenesse is an afamelanotide formulation delivered as an injectable subdermal implant that mimics the body’s natural ability to activate the skin pigment melanin.

The drug has shown promise as a treatment for EPP, and Clinuvel plans to commence a final phase III clinical trial of the treatment in the US in May.

Clinuvel filed a marketing authorisation application with the European Medicines Agency (EMA) for Scenesse as an EPP treatment in February.

The Swiss insurers have agreed to provide reinforcement under a new local law, which allows health insurers to recommend reimbursement of medical products for the treatment of severe or life-threatening diseases prior to their formal approval for sale.

Scenesse received an orphan drug designation for EPP from Switzerland’s regulatory authority, Swissmedic, in 2008.

Clinuvel chief scientific officer Dr Hank Agersborg said Swiss EPP sufferers were the first in the world to receive Scenesse as a prophylactic treatment in a phase II trial in the nation in 2006.

Scenesse for EPP sufferers is already reimbursed in Italy through the government health care scheme.

Clinuvel (ASX:CUV) shares were trading 4.79% higher at $1.750 by 3pm on Thursday.

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