Every person with haemophilia B requiring factor replacement therapy in Ireland will now have access to the latest extended half-life (EHL) therapy after the signing of a new national contract with the Board of St James’ Hospital in Dublin.
This signals the first change in clotting factor concentrate availability for almost 20 years and puts Ireland as the only country in the world to offer all people with haemophilia B the opportunity to move onto a commercially supplied EHL therapy.
The Haemophilia Product Selection and Monitoring Advisory Board (HPSMAB), working on behalf of the National Centre for Haemophilia and Coagulation Disorders (NCHCD) at St James’ Hospital, conducted an open tender competition for supply of recombinant Factor IX therapies.
The supply offer from Sobi (Swedish Orphan Biovitrum) was judged to offer the best value for Irish patients and so has been awarded the contract to supply its recombinant clotting factor therapy Alprolix (rFIXFc) for a minimum of two years.
In recent years, Ireland has emerged as one of the leading countries for the treatment and management of Haemophilia, combining expert medical care co-ordinated across the country by the NCHCD, a very active patient community via the Irish Haemophilia Society and an inclusive approach to efficient purchasing of the necessary therapies via competitive tendering and assessment.
Alprolix, which was approved in the EU in May 2016, uses a naturally occurring pathway to extend the time the therapy remains in the body.
The HPSMAB tender process is run according to EU procurement rules and leads the way in its multi-stakeholder approach, including formal representation of patients within the decision making process. Suppliers are requested to submit product offers into a defined scoring process across clinical and economic elements.
Sobi has been awarded the contract for Alprolix for two years with the opportunity to extend for up to two further years.
Haemophilia B is caused by having substantially reduced or no factor IX activity, which is needed for normal blood clotting. The World Federation of Haemophilia estimates that approximately 28,000 people are currently diagnosed with haemophilia B worldwide.