The European Haemophilia Consortium (EHC) joins other leading patient organisations across Europe in releasing a set of ten key recommendations aimed at improving patient involvement in Joint Clinical Assessments (JCAs) under the EU Health Technology Assessment (HTA) Regulation. This collaborative effort highlights the crucial role of patient experiences and insights in shaping effective healthcare assessments and ensuring that the voices of those directly affected by medical innovations are heard and valued.
Developed with input from a wide range of patient groups and based on extensive consultation and practical experience, the recommendations are designed to foster a more inclusive, transparent, and patient-centered approach to JCAs. The following ten points summarise their input and we highly encourage they are considered to ensure meaningful and practical patient involvement:
1. Establish a predictable framework for patient involvement in JCAs;
2. Include input from patients, carers and patient organisations;
3. Include patient experience data in JCAs;
4. Streamline patient involvement throughout the process;
5. Provide plain language summaries of technologies;
6. Broaden the pool of patients and specify selection criteria;
7. Provide support to patients;
8. Make JCA and summary reports available in all EU languages;
9. Provide feedback to patients;
10. Adopt a constructive approach to confidentiality and conflict of interest.
They’re also a call to action for the HTA Coordination Group to integrate these practices into the guidelines they develop to enhance the quality and relevance of JCAs. By doing so, they can ensure that assessments reflect the real-world experiences of patients, ultimately leading to more patient-centered healthcare solutions.
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.
