Advertisement

Financing and reimbursement of approved advanced therapies in several European countries

  • Carolina Iglesias-Lopez
    Affiliations
    Department of Pharmacology, Therapeutics and Toxicology, Universitat Autònoma de Barcelona, Barcelona, Spain
    Search for articles by this author
  • Antònia Agustí
    Affiliations
    Department of Pharmacology, Therapeutics and Toxicology, Universitat Autònoma de Barcelona, Barcelona, Spain

    Clinical Pharmacology Service, Vall d’Hebron University Hospital, Barcelona, Spain
    Search for articles by this author
  • Antoni Vallano
    Correspondence
    Corresponding author: Antonio Vallano, Medicines Department, Catalan Healthcare Service, Travessera de les Corts 131-159, 08028 Barcelona, Spain. Phone: (34) 403 86 94
    Affiliations
    Department of Pharmacology, Therapeutics and Toxicology, Universitat Autònoma de Barcelona, Barcelona, Spain

    Medicines Department, Catalan Healthcare Service, Barcelona, Spain
    Search for articles by this author
  • Mercè Obach
    Affiliations
    Healthcare Planning Department. Catalan Healthcare Service, Barcelona, Spain
    Search for articles by this author
Open AccessPublished:January 13, 2023DOI:https://doi.org/10.1016/j.jval.2022.12.014
      This paper is only available as a PDF. To read, Please Download here.

      Highlights:

      • What is already known about the topic?
      • Advanced therapy medicinal products (ATMPs) pose a major challenge for reimbursement decisions.
      • What does the paper add to existing knowledge?
      • An updated review on the financing considerations for the approved ATMPs in eight EU countries.
      • Most ATMPs were reimbursed with differences in how the magnitude of added therapeutic benefit is considered among countries.
      • Most ATMPs were associated with high costs, requiring managed entry agreements and taking 9-17 months to HTA recommendation.
      • What insights does the paper provide for informing healthcare-related decision making?
      • Harmonisation of cost-effectiveness analysis and added therapeutic value criteria could lead to an aligned access and EU market attractiveness.

      Abstract

      Objectives

      The uncertainty on cost-benefit of advanced therapy medicinal products (ATMPs) is being a current challenge for their reimbursement in health systems. The aim of this study was to provide a comparative analysis of the national health authorities (NHAs) reimbursement recommendations issued in different European countries. Methods: The NHA reimbursement recommendations for the approved ATMPs were compared among 8 European Countries (EU8: Ireland, England/Wales, Scotland, Netherlands, France, Germany, Spain and Italy). The search was carried out until December 31st, 2021. Results: Nineteen approved ATMPs and 76 appraisal reports were analysed. The majority of the ATMPs were reimbursed, although with uncertainty on added therapeutic value. No relationship between the type of the European Medicines Agency approval and reimbursement was found. Managed entry agreements such as payment by results were necessary to ensure market access. The main issue during the evaluation was to base the cost effectiveness analyses on assumptions due to the limited long-term data. The estimated incremental cost-effectiveness ratio among countries reveals high variability. Overall, the median time to NHA recommendation for the EU8 is in the range of 9-17 months.

      Conclusions

      Transparent, harmonised and systematic assessments across the EU NHAs in terms of cost-effectiveness, added therapeutic value, and grade of innovativeness are needed. This could lead to a more aligned access, increasing the EU market attractiveness, and raising public fairness in terms of patient access and pricing.

      Keywords