CAPRICORD

CAPRICORD – EU4H-2024-JAIBA-03

Competent Authorities for Pricing and Reimbursement to coordinate Involvement of clinical experts and patients, to manage uncertainty and the challenges associated to ORphan medicinal products

Project number: 101233517

Program – EU4HEALTH, project funded by the European Health and Digital Executive Agency (HaDEA) under grant agreement 101233517 – CAPRICORD-EU4H-2024-JA-IBA-03

Project objective:

The overall objective of the project is to strengthen cooperation between the various entities responsible for the pricing and reimbursement of medicines and healthcare payers operating at different stages of the medicinal product life cycle (Joint Action) in European Union countries.

The specific objectives of the project include:

1. developing a pricing system adapted to uncertainty, including developing an approach to transition from a supply-driven system to a demand/needs-driven system,
2. improving the capacity of national authorities to better involve patients and clinical experts in the reimbursement process for medicinal products at the HTA level,
3. strengthening national capacities to address the challenges of orphan drug financing.

Origin of the project:

Rising drug prices are becoming an increasing challenge for most Member States, as high drug prices threaten the financial stability of healthcare systems. As a result, this limits patients’ access to the medicines they need. Member States, with the support of the Commission, have transformed the group of National Competent Authorities for Pricing and Reimbursement and Public Health Care Payers (NCAPR) from an ad hoc forum into a permanent, voluntary cooperation.

The NCAPR group has developed a joint action plan to address common challenges related to pricing, payments, and public procurement through three main areas of action: (a) efficiency and affordability for the sustainability of healthcare systems; (b) transparency, cost calculation and pricing rules; c) innovative payment methods, public procurement models, new pricing mechanisms, and financial protection.

The objective of this joint action is to develop technical tools and implement measures to support and enable voluntary cooperation between pricing and reimbursement authorities and public healthcare payers; and, as a result, to strengthen national capacities to address common challenges related to pricing, reimbursement, public procurement, and payments for medicines.

Role of the Agency:

The Agency has taken the lead on a work package aimed at improving the involvement of patients and healthcare professionals (hereinafter referred to as Pt./HCP) in the activities of national pricing and reimbursement authorities in EU Member States.

The project includes:

1. analysis of existing practices regarding Pt./HCP involvement in HTA/pricing and reimbursement processes in EU Member States and synthesis of the information collected in a consistent, standardized format;
2. assessment and testing of the impact of these practices on the identified processes using a standardized methodology;
3. Harmonization of practices by developing guidelines for Pt/HCP involvement and creating common templates to support consultations.

Project information:

• Duration: November 1, 2025-October 31, 2028
• Project budget: €2.5 million
• EU contribution: €2 million (80%)
• Role of the Agency for Health Technology Assessment and Tariff System (AOTMiT) – AOTMiT is the leader of the work package – Improve capacities of national competent authorities on pricing and reimbursement to engage public and increase transparency
• Partners:

• • Nemzeti Egészségbiztosítási Alapkezelő (NEAK, Hungary) – Coordinator
  • Javna Agencija Republike Slovenije Za Zdravila in Medicinske Pripomocke (Slovenia)
  • Agency for Health Technology Assessment and Tariff System (Poland)
  • Dolnoslaskie Centrum Onkologii, Pulmonologii I Hematologii (Poland)
  • Ministerio De Sanidad (Spain)
  • Instituto De Salud Carlos III (Spain)
  • Ministerul Sanatatii (Romania)
  • Agentia Nationala A Medicamentului Si A Dispozitivelor Medicale Din Romania (Romania)
  • Ministre De La Sante Et De L’acces Aux Soins (France)
  • Nacionalais Veselibas Dienests (Latvia)
  • Ministry of Health (Cyprus)
  • Health Analysis Organization (Cyprus)
  • Health Insurance and Reinsurance Agency of the Federation of Bosnia and Herzegovina (Bosnia and Herzegovina)
  • Ministry of Health and Active Ageing (Malta)
  • Eurordis – Rare Diseases Europe (France)
  • Agenzia Italiana Del Farmaco (Italy)
  • Federal Ministry of Health (Bosnia and Herzegovina)