21 September 2016 NHS England has confirmed reimbursement of Elocta® (efmoroctocog alfa) and Alprolix® (efrenonocog alfa) for the treatment of haemophilia A and B respectively. The decision means that Sobi’s recombinant factor VIII and IX Fc-fusion proteins with an extended half-life are now available across the UK.
“We are really pleased to see the UK join the growing list of countries with access to extended half-life factors for people living with haemophilia”, said Liz Carroll, Chief Executive of The Haemophilia Society. “It is important that haemophilia treatment and care continues to move forward and that new developments in treatment are accessible within the NHS as a whole. We will be publishing factsheets for members, explaining these new therapeutic options and stand ready to support members and their families as they consider these new treatments.”
Dr Gary Benson, Haemophilia Centre Director Royal Belfast City Hospital said: “Extended half-life factors could give us a new way to improve care and outcomes for people with haemophilia, using an individualised approach at no extra cost to the NHS. We can significantly reduce the number of intravenous infusions needed, whilst also in many patients aim for increased protection from debilitating bleeding events.”
“Making these new treatments available on the NHS in Scotland is a big step forward in improving the lives of people living with haemophilia,” said Dan Farthing-Sykes, Chief Executive of Haemophilia Scotland. “They offer the prospect of fewer injections and the potential for better protection from painful internal bleeding. We know families all over Scotland are very keen to find out if they could benefit from them. The fact they are now available to Scottish Haemophilia Centres means Scotland’s fantastic specialist teams will be able to work with patients to understand how they can be used most effectively.”
Through the pivotal clinical trials (A-LONG, Kids A-LONG, B-LONG, Kids B-LONG) and extension studies (ASPIRE and B-YOND) 233 patients have been treated with Elocta and 153 with Alprolix in a clinical trial setting. Elocta has been commercially available since June 2014 in the US and other regions (where it is marketed as Eloctate®) and more than 2,700 patients have been treated with it. In addition, more than 1,000 patients have already been treated with Alprolix, which has been available in the US since March 2014.
“This extensive post-approval clinical experience with Elocta and Alprolix complements the clinical data generated by our pivotal clinical studies, and follows the findings of the long term ASPIRE and B-YOND extension studies. We believe that this comprehensive clinical data and real world experience can provide support to clinicians and patients while making their treatment choices,” said Krassimir Mitchev, MD, PhD, vice president and medical therapeutic area head of haemophilia at Sobi.