Here below you can find the documents related to the EHC Round Table of Stakeholders on “Tenders and Procurement of Coagulation Factor Concentrates: A Survey of 38 Countries.’ The event took place on 15 June in Brussels, Belgium.
- Event programme,
- Event outline,
- Round Table Report,
- Speakers’ biographies,
- Presentations from:
- Mr Brian O’Mahony on ‘Results of the EHC survey on tenders and procurement: A European survey of 38 countries‘
- Mr Declan Noone on ‘Product selection and economic aspect‘
- Prof Paul Giangrande on ‘Clinical involvement in the UK tender process‘
- Prof Cédric Hermans on ‘Clinical involvement in alternative processes‘
- Mr Miguel Crato on ‘Patient involvement in the Portuguese Tender Process‘
- Dr Edward Laane on ‘Impact of non-involvement of patient organisations‘
- Mr Jaroslav Kračún on ‘Directive 2014/24/EU on public procurement‘
- Prof Flora Peyvandi on ‘Procurement of longer acting factor concentrates‘
Event Recap:
On 15 June 2015 in Brussels, the European Haemophilia Consortium (EHC) organised its second Round Table of the year on ‘Tenders and Procurement of Coagulation Factor Concentrates: A European Survey of 38 countries.’ The event was an opportunity to present the findings of the 2014 survey conducted by the EHC on how coagulation factor concentrates (CFCs) are purchased in Europe. The survey also sought to identify to what extent patients and healthcare professionals are involved in the procurement of these medicines. During the event stakeholders such as patients and physicians presented their experience of involvement or non-involvement in the tender process in their countries and how this impacted the outcome of the tender. Participants also heard about considerations to take into account in the procurement of new technologies in haemophilia care and on the changes to the European Union (EU) Public Procurement Directive.
The event kicked off with a presentation from Brian O’Mahony, President of the EHC, in which he gave a quick summary of the findings of the survey. Amongst these, he noted that countries holding a tender generally purchase CFCs at a lower price. Additionally prices decrease whenever there is a legal framework and both patients and physicians are involved in the tender process.
Mr Declan Noone, Chair of the EHC Data and Economics Committee, complemented the presentation from Mr O’Mahony with details on the product selection process and economic criteria applied to product purchase. Generally criteria such as cost, quality, efficacy, safety and convenience are applied to the selection process. In addition, other elements such as tax regimens and the set-up of the distribution chain have an impact on the price of the product purchased.
Prof Paul Giangrande, Chair of the EHC Medical Advisory Group (MAG) spoke about his personal experience as a clinician in the organisation of the national CFC tenders in the United Kingdom (UK), one of the first countries to organise a national tender process for haemophilia treatment. He described how the national tender was implemented and the challenges encountered such as identifying patients willing to switch to a new product and allocating the product purchased equitably amongst the different centres.
Prof Cédric Hermans, Vice-President of the European Association for Haemophilia and Allied Disorders (EAHAD) followed with an overview of the situation in Belgium, a country that does not currently have a national tender process. As a physician, he noted that there are many opportunities for improving the current situation in which much of the haemophilia budget (approximately 80 per cent) is spent on CFCs leaving only minimal funding for comprehensive care services. Prof Hermans argued that much of this could be improved by having a central approach to haemophilia care, with a national registry, official treatment centres and a national tender.
Mr Miguel Crato, President of the EHC Portuguese National Member Organisation (NMO) gave an overview of patient involvement in tenders in Portugal. There, patients are officially involved in providing advice in the pre-tender phase, however their advice is non-binding. Mr Crato explained that currently cost is the sole criterion for selecting who is awarded the tender. The Portuguese patient organisation is currently working towards changing that and ensuring that other criteria such as safety, quality and efficacy are also included in the tender process.
Dr Edward Laane from the North Estonia Medical Centre then presented the situation in his country, Estonia. He noted that physicians have only recently become involved in the tender while patients are still not involved. He explained that the country had gone through some corruption scandals, which had considerably impacted patients’ and physicians’ trust in the healthcare system.
Mr Jaroslav Kracun from the European Commission presented the new EU Public Procurement Directive, which has the primary goal of opening the market to as many economic operators as possible, hence creating competition and lowering prices for services and products.
The new EU legislation will have to be transposed into national legislation by April 2016 and offers new methods for procuring services and products such as the pre-commercial procurement and the innovation partnership.
Prof Flora Peyvandi, Member of the EHC MAG, detailed some considerations to be made with regard to the procurement of new technologies in haemophilia treatment that will become available to European patients in the coming years. Prof Peyvandi noted that although the benefits of these treatments were clear (i.e., prolongation of product half-life), it was important for doctors and patients to establish what treatment protocols would be best suited to which patients and in what situations (e.g., bleeds, prophylaxis, surgery).
Dr Paul Rübig, Member of the European Parliament (MEP), concluded the event with a few remarks on the importance for the European Parliament of supporting patients’ access to these new technologies.
The event concluded with a Q&A session.
The main take away message of the Round Table was that the involvement of patients and physicians in the tender process not only brings invaluable benefits in terms of budget impact but can also offer considerable insight to tendering authorities on current patient needs and preferences.
Participants agreed that a centralised approach to procurement with a national haemophilia council, a national registry and a single haemophilia care budget and strategy provides the best outcome in terms of resource use and allocation and access to treatment and comprehensive care. Such a system also helps all parties involved in the provision of haemophilia services to have an accurate idea of the number of patients, the type of treatment administered, potential side effects and the effectiveness of treatment.
Participants also agreed that although longer-acting factor concentrates bring a considerable benefit with longer half-life, there is still much to be discussed on how best to allocate these treatments. Additionally, monitoring of any potential adverse events is critical.
Finally, with the new EU Public Procurement Directive, although tendering authorities will be able to have cost as the sole criterion for running a tender, other economic aspects that can be closely linked to patients’ quality of life can also be taken into account, such as whether the use of a particular product or regimen will cut down on other expenses including hospitalisations and surgery. Nonetheless, all present stressed that quality, safety and efficacy are key elements to be taken into account whenever CFCs are purchased.
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.
