CAPRICORD WP6. PATIENT AND CLINICAL EXPERT INVOLVEMENT IN REIMBURSEMENT PROCESSES (HTA, PRICING NEGOTIATIONS AND DECISION MAKING): A SYSTEMATIC AND GREY LITERATURE REVIEW
Author(s)
Magdalena Rdzanek, PhD1, Ewa Walkiewicz-Zarek, Msc1, Mira Ludwikowska, MPH1, Elzbieta Kuriata, PhD1, Julia Siebielec, MPH1, Joanna Simlat, Msc1, Ewa Walejewska, PhD1, Maciej Dzik, Msc1, Anna Kaczorek-Juszkiewicz, MPH1, Cristiana Elena Spinu, Msc2, Edwin Daniel Harabagiu, Msc2, Monica Negovan, B.pharm2, Felicia Ciulu-Costinescu, Msc3, Anca Zamfirescu, Msc3, Mihaela Popescu, Msc3, Octavian Matei, Msc3.
1Agency for Health Technology Assessment and Tariff System, Warsaw, Poland, 2Ministry of Health, Bucharest, Romania, 3National Agency for Medicines and Medical Devices of Romania (NAMMDR), Bucharest, Romania.
1Agency for Health Technology Assessment and Tariff System, Warsaw, Poland, 2Ministry of Health, Bucharest, Romania, 3National Agency for Medicines and Medical Devices of Romania (NAMMDR), Bucharest, Romania.
OBJECTIVES: The aim of this review was to map practices across EU Member States regarding patients and clinical experts involvement in reimbursement processes, including HTA, price negotiations and decision-making. This was a task realized within Work Package 6 in international, EU-funded project, CAPRICORD.
METHODS: The search in two databases (MEDLINE, EMBASE) was conducted based on a previously prepared search protocol published in the PROSPERO database. Publications from the last 10 years describing the current practice of patients’ or clinical experts’ involvement in processes within EU Member States were included in the systematic literature review (SLR). The Cochrane Handbook for Systematic Reviews of Interventions and The PRISMA 2020 statement were used to develop a template for data extraction. In addition to the SLR, a grey literature search was conducted on the websites of the ministries of health, HTA agencies and payers in individual EU countries.
RESULTS: The SLR identified 2,771 records, of which only 2 publications met inclusion criteria, indicating very limited published evidence. Grey literature review identified approximately 80 websites of public institutions and revealed significant variation across EU countries and more formalized practices regarding the involvement of clinical experts than patients. Most of the identified sources refer to the HTA stage, while reports on stakeholder involvement in price negotiations or decision-making are very limited.
CONCLUSIONS: The findings suggest that although many EU countries involve clinical experts and patients in reimbursement processes, there is no uniform or coherent policy regarding the roles of stakeholders or the methods used to engage them, particularly at stages beyond HTA, which provides a basis for further research on the engagement of patients and healthcare professionals.
METHODS: The search in two databases (MEDLINE, EMBASE) was conducted based on a previously prepared search protocol published in the PROSPERO database. Publications from the last 10 years describing the current practice of patients’ or clinical experts’ involvement in processes within EU Member States were included in the systematic literature review (SLR). The Cochrane Handbook for Systematic Reviews of Interventions and The PRISMA 2020 statement were used to develop a template for data extraction. In addition to the SLR, a grey literature search was conducted on the websites of the ministries of health, HTA agencies and payers in individual EU countries.
RESULTS: The SLR identified 2,771 records, of which only 2 publications met inclusion criteria, indicating very limited published evidence. Grey literature review identified approximately 80 websites of public institutions and revealed significant variation across EU countries and more formalized practices regarding the involvement of clinical experts than patients. Most of the identified sources refer to the HTA stage, while reports on stakeholder involvement in price negotiations or decision-making are very limited.
CONCLUSIONS: The findings suggest that although many EU countries involve clinical experts and patients in reimbursement processes, there is no uniform or coherent policy regarding the roles of stakeholders or the methods used to engage them, particularly at stages beyond HTA, which provides a basis for further research on the engagement of patients and healthcare professionals.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
PCR49
Topic
Health Policy & Regulatory, Organizational Practices, Patient-Centered Research
Topic Subcategory
Patient Engagement
Disease
No Additional Disease & Conditions/Specialized Treatment Areas