SCENESSE® is distributed for the treatment of adult EPP patients in Europe, Switzerland, the USA, and Israel. During the past year, access to Canadian patients was granted under a special access program. The number of EPP patients receiving treatment, total doses of SCENESSE®, and treatment centres facilitating treatment all increased over the year.
In Europe, the number of EPP Expert Centres has increased, with new centres opened in several countries, including Germany, Italy, and Scotland. During the year, the English National Institute for Health and Care and Excellence (NICE) decided not to recommend SCENESSE® for use on the English National Health Service, despite NICE being twice found by its own Appeal Panel to have breached the Equality Act and having acted unfairly in its review of the drug. This decision has resulted in an ongoing asymmetry of access for EPP patients in the UK, with Scottish patients continuing to receive SCENESSE® treatment under a patient access scheme.
April 2023 marked the third anniversary of the commencement of commercial distribution of SCENESSE® for EPP patients in the USA. CLINUVEL has established a network of over 50 Specialty Centers to facilitate patient treatment across 39 states as of 30 June 2023. This advances CLINUVEL’s goal to reduce the time and distance patients need to travel to receive their bi-monthly treatment, with a network of 120 centers planned. Over 100 national and local private insurers are reimbursing SCENESSE®. Following the conclusion of FY2023, in July 2023, the US Department of Veterans Affairs agreed to reimburse SCENESSE®.
Canadian patients were first treated with SCENESSE® under a Special Access Program in May 2023. CLINUVEL can supply up to six doses of SCENESSE® per annum to adult EPP patients through accredited Specialty Centers under insurance coverage.
During FY2023, a number of peer reviewed publications were seen on the use of SCENESSE®. The medical publications reported ongoing clinical benefit under real world conditions – which was greater than that seen in clinical trials. Importantly, during the year we saw the first analyses of the drug showing a possible hepatoprotective effect, further investigations are following.
Uniquely, CLINUVEL maintained a uniform net price for SCENESSE® per jurisdiction, treating payors equally and in full transparency.
CLINUVEL submitted a formal application to the European Medicines Agency (EMA) in September 2022 to expand the approved indication for SCENESSE® (afamelanotide 16mg) to include the treatment of adolescent patients aged 12-17. As part of global pharmacovigilance, CLINUVEL has been closely monitoring the effects of the drug in the adolescent patient population. Based on the data received, the safety profile and clinical benefit of SCENESSE® in these patients has been consistent with that seen in adults. CLINUVEL continues to liaise with the EMA on the submission.