over genomen van ander fora,Unique HAEi Global Access Program launched
Landmark global program opens access to HAE medicine to rare disease sufferers for the first time
Lausanne, Switzerland – 16 May 2015 – Thousands of patients suffering from a rare and potentially fatal genetic disease will have access to medicines for the first time, with the launch of the HAEi Global Access Program (HAEi GAP), a “first-of-its-kind” medication access program.
Driven by HAEi, the International Patient Organization for C1 inhibitor Deficiencies, the new program is the first Global Access Program in hereditary angioedema (HAE), a rare inherited blood disease which leads to attacks of swelling. HAE can be life threatening due to risk of suffocation from swelling attacks in the throat. There is no cure but effective treatments exist to prevent and ease attacks, but these treatments are not licensed or available in all countries worldwide.
“The HAEi Global Access Program brings the opportunity of access to HAE medications in countries where innovative effective therapies are otherwise unavailable,” said Henrik Balle Boysen, Executive Director HAEi. “This is the first program of its kind in HAE, and we believe the first time this type of program has been initiated by a patient organization.”
To realize the program, HAEi has partnered with Clinigen Group plc’s Global Access Programs business/division to manage the distribution and logistics for medications in the HAEi GAP. The first HAE therapy available through the program is the human recombinant C1-inhibitor Ruconest® (conestat alfa) manufactured by Pharming Group N.V. HAEi GAP expects to go live in a matter of weeks.
“HAEi is committed to securing access to HAE medications for patients across the globe”, said Anthony J. Castaldo, President of HAEi. “We are extremely proud to have established HAEi GAP with our current partners and will continue to work with other manufacturers with the hope of expanding the program in the future.”
HAEi GAP follows ethical and regulatory compliant mechanisms and enables patients to gain access to Ruconest through a Named Patient Program (where Ruconest is currently not commercially available). Individuals with a confirmed diagnosis of HAE may be eligible for HAEi GAP. Their doctors can apply to HAEi GAP via Clinigen customer services (customer.services@clinigengroup.com).
“It is a desperate situation for patients in countries without access to licensed HAE therapies. We hear of patients resorting to the black market or international pharmacy websites to try and access medicine”, advised Henrik Balle Boysen. “HAEi GAP offers legitimate access to effective medicine for eligible patients with the security of an established logistics and supply chain to ensure the right medicine reaches the right patient whenever, and wherever they need it”.