Shares in Clinuvel Pharmaceuticals Limited (ASX: CUV) are up more than 9% today, bucking the broader market trend. The ASX 200 healthcare company announced today that it plans to launch its drug Scenesse in the US in April, which has given its share price a boost.
Scenesse was approved by the FDA in October 2019 for the treatment of rare metabolic disorder erythropoietic protoporphyria (EPP). EPP causes a painful burning sensation of the skin after sun exposure. Scenesse works to increase pain free light exposure. The first US EPP patient will be treated with Scenesse on 15 April.
Distribution in the US is planned to occur in 3 phases. In phase 1, 3 selected hospitals and medical centres will be able to provide treatment to EPP patients. For phase 2, Medicare-Medicaid will need to complete its review of the Scenesse dossier and provide an opinion on coverage of the treatment. The last phase will consist of direct distribution of the drug to a target maximum of 30 centres, which will be trained and accredited by Clinuvel.
During the first phase commencing on 15 April 2020, patients will be able to receive treatment under Prior Authorisation. Prior Authorisation is a decision by a payer that a healthcare service or prescription drug is medically necessary and is included in the patient’s coverage.
Clinuvel plans to establish a Co-Payment Savings Program for American EPP patients. Individual applications will need to be made by patients, and terms and conditions will apply to patients 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.
“Contrary to our predictions that the drug would be made available during the 4th quarter of this year, our teams have managed to complete the entire process working closely with the Food and Drug Administration,” Clinuvel’s CEO Dr Philippe Wolgen said in today’s announcement. “It is satisfying to be able to serve our patient population facilitating them a freedom to live without inhibition and handicap,” he added.
With the outbreak of coronavirus, Clinuvel is monitoring the clinical attendance of EPP patients in the European Union. The outlook, however, remains positive, with meetings scheduled with the Food and Drug Administration to discuss the development of a program using Scenesse to treat vitiligo.
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