In light of World Haemophilia Day, the European Haemophilia Consortium (EHC) took the opportunity to highlight an important set of 12 new consensus recommendations directed at improving haemophilia care and treatment throughout Europe. Over 50 patients, healthcare professionals, regulators and pharmaceutical industry representatives attended the event, organised by the EHC and, hosted by the European Directorate for the Quality of Medicines and Healthcare (EDQM), part of the Council of Europe, in Strasbourg, France.
The recommendations are the result of the latest European symposium ‘Wildbad Kreuth IV’ Initiative on the optimal use of clotting factors and platelets, held in May 2016 and organised by the University of Munich, the Paul-Ehrlich-Institute and the EDQM. During these series of meetings, experts from 36 countries issued consensus recommendations on how to address current challenges in haemophilia treatment and care.
The 12 recommendations cover pressing issues in the haemophilia community and include:
- European haemophilia treatment centres should seek formal certification as either European Haemophilia Treatment Centres or European Haemophilia Comprehensive Care Centres as per the guidelines developed by the European Haemophilia Network (EUHANET) project,
- Countries should develop and adopt national treatment protocols or guidelines for the management of the ageing population with haemophilia,
- Countries should strive to achieve the minimum consumption of 4 international units per capita of coagulation factor VIII and 0.5 international units per capita of coagulation factor IX,
- Treatment for hepatitis C with direct-acting antivirals agents should be provided to all people with haemophilia on a priority basis, and
- People with inhibitors should have access to immune tolerance.
See here the full list of recommendations of the ‘Wildbad Kreuth IV’ Initiative: http://www.ehc.eu/kreuth-iv-consensus-recommendations/
In support of the recommendations, the EHC also unveiled a new project aimed at improving access to treatment for people with bleeding disorders in Europe. The Procurement of Affordable Replacement Therapies – Network of European Relevant Stakeholders (PARTNERS) project seeks to ensure sustainable access to treatment in selected European countries that do not meet the minimum standards of haemophilia care, as outlined by the 2016 consensus recommendations. These countries, where level of factor VIII and IX consumption is below 4IU/capita and .5IU/capita, respectively, provide little or no prophylactic treatment for children and adults with severe haemophilia. By taking part in this project, the selected countries, together with other partners, such as healthcare professionals, patient organisations and product manufacturers, agree to the following:
- To use national-level tender or procurement processes for coagulation factor concentrates,
- To formally include clinicians and EHC NMO representatives on a long-term basis in the tender/procurement system;
- To award contracts to the winning bid(s) of at least a three-year duration; and
- To increase factor purchase without decreasing the national haemophilia budget and to agree in principle to at least double the current national purchased amount of factor replacement therapies over the duration of contracts awarded or until the minimum IU/per capita set by the Kreuth IV consensus recommendations is met.
One of the most important aspects, without which this programme would not be possible, is the involvement of pharmaceutical companies. During the World Haemophilia Day event, three pharmaceutical companies – Kedrion Biopharma, Pfizer and Sobi – signed a Consensus Agreement to confirm their intent to support the development of the PARTNERS programme.
The EHC is an umbrella organisation gathering 45 national patient organisations in the field of rare bleeding disorders including haemophilia, von Willebrand Disease and other rare bleeding disorders. The EHC represents approximately 90.000 patients in Europe who are affected by these life-threatening and congenital disorders. The EHC is both a member of the European Organisation for Rare Diseases (EURORDIS) and the European Patients’ Forum (EPF).
Amongst other activities, the EHC organises three to four ‘Round Table of Stakeholders’ discussions every year, a platform where patient representatives, the medical community, policymakers and the industry come together to discuss current issues for the haemophilia community while bridging the gap between European health policy, the state of medical and scientific research and the state of haemophilia care in Europe.
For a detailed description of the recommendations, please visit: http://www.ehc.eu/kreuth-iv-consensus-recommendations/