-
Participants during the event -
Speakers outlining the importance of the Wild Bad Kreuth initiative recommendations -
Companies signing an agreement to join the PARTNERS project -
Group photo
EHC World Haemophilia Day celebrations: Presenting the recommendations from the fourth Wildbad Kreuth initiative on optimal treatment of haemophilia in Europe.
On 19 April 2017, the European Haemophilia Consortium (EHC) held an event at the European Directorate for the Quality of Medicines and Healthcare (EDQM), a directorate part of the Council of Europe, in Strasbourg, France to mark World Haemophilia Day. This is an international observance traditionally held on 17 April to raise awareness about issues in the haemophilia and rare bleeding disorders community.
This year the EHC decided to commemorate the day with an event presenting the recommendations on haemophilia care developed during the last Wildbad Kreuth consensus intiative held in May 2016. This is an initiative organised by the University of Munich, the Rudolf Marx Foundation and the EDQM, which brings together experts from across Europe including regulators, scientists, clinicians, representatives from patient organisations and representatives from the pharmaceutical industry to discuss best practices for the treatment of haemophilia and other rare bleeding disorderes. These recommendations are significant for the haemophilia community as the set developed for the third Wildbad Kreuth initiative was endorsed as a resolution (a non-binding legal instrument) by the health ministers of countries taking part in the European pharmacopoeia convention. It is hoped that the newest set of recommendations will also be endorsed by European health ministers to promote equal standards of haemophilia care across Europe.
Topics covered by the last set of recommendations include, amongst others, best practices for the treatment of people with inhibitors, access to hepatitis C treatment, minimum levels of coagulation factor consumption and the certification of haemophilia treatment centres. During the event, a range of speakers representing patients and clinicians gave compelling presentations on the need for rapid endorsement and implementation of these recommendations. In fact, although, Europe may often be seen as an homogeneous region, there are still many disparities in terms of access to- and standards of haemophilia treatment and care, which are detrimental to patients.
The event was also the opportunity for the EHC to introduce its newest project ‘Procurement of Affordable Replacement Therapies – Network of European Relevant Stakeholders (PARTNERS).’ This 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 4 international units (IU)/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. In the long-term the PARTNERS project also aims to promote best practices for the treatment of haemophilia care.
Additional pictures of the event can be found on the EHC Facebook page.
Relevant documents:
- Agenda
- Speakers’ biographies
- List of participants
- Wildbad Kreuth IV initiative recommendations
- Event’s press release
Presentations from the event:
- Wildbad-Kreuth Initiatives I-IV, by Prof Wolfgang Schramm
- Status of the Wildbad Kreuth recommendations, by Dr Marie-Emmanuelle Behr-Gross
- Formal designation of haemophilia treatment centres: EUHANET and beyong, by Mr Brian O’Mahony
- Importance of minimum factor concentrate levels, by Prof Margit Serban and Mr Daniel Andrei
- Ageing and haemophilia: A personal experience and more, by Mr Cees Smit
- New support modality: UNDP Ukraine Experience, by Dr Zafar Yuldashev
- Genotyping and carriers, by Ms Naja Skouw-Rasmussen
- Inhibitors, EIN and inhibitor treatment guidelines, by Prof Cedric Hermans
- European Inhibitor Network by Mr Mirko Jokic
- Outcome data by Dr Radoslaw Kaczmarek
Jim is aged 66 and has Haemophilia A with a high titer inhibitor which he developed at age 14.
Maria Elisa Mancuso (MD, PhD) is a Haematologist and works as a Senior Haematology Consultant at the Center for Thrombosis and Haemorrhagic Diseases of IRCCS Humanitas Research Hospital in Rozzano, Milan, Italy. She is Adjunct Clinical Professor at Humanitas University. She obtained a post-degree in Clinical and Experimental Haematology and a PhD in Clinical Methodology. She is involved in clinical research and has published several original articles in peer-reviewed journals a The Lancet, Blood, Journal of Thrombosis and Haemostasis, Haematologica, Thrombosis and Haemostasis, British Journal of Haematology and Haemophilia. She is reviewer for several peer-reviewed journals and member of the Editorial Board of JTH. She is a member of several scientific societies (ISTH, WFH, ASH, EAHAD, SISET, AICE) and was a medical member of the Inhibitor Working Group of the European Hemophilia Consortium. She is co-chair of the ADVANCE Study Group. She has acted also as co-chair of the Scientific and Standardization Subcommittee of ISTH on FVIII, FIX and rare bleeding disorders. She has been involved as principal and co-investigator in several clinical trials, and she takes care of both children and adults with hemophilia and other congenital bleeding disorders with a specific scientific interest in novel therapies, prophylaxis, inhibitors, and chronic hepatitis C.
As a patient with factor II deficiency, the diagnostic and treatment of rare bleeding disorders is a matter dear to my heart. My motivation to participate in the work of the ERIN committee is to improve both diagnostic and treatment for patients with rare bleeding disorders across Europe.
Economist and financial expert by profession, executive coach and trainer by passion and haemophilia advocate by every drop of my blood through my son (who has severe haemophilia A with inhibitors). Bringing a good decade of practical experience from the corporate insurance world, laser focus, growth mindset and resilience from my own experience, offering you anything I can just do, in hope that together we can make life more fulfilled for those impacted by bleeding disorders.
Amy Owen-Wyard is a Registered Mental Health Nurse. With experience working with children, young people, their families and adults with severe and enduring mental health conditions. Amy was also involved in a service improvement to provide a holistic care approach for those in general hospitals to support both their mental and physical health, whilst sharing her expertise and knowledge in mental health with the wider multidisciplinary team.
