A Comparison of Reimbursement Recommendations by European HTA Agencies: Is There Opportunity for Further Alignment?

Abstract

Introduction: In Europe and beyond, the rising costs of healthcare and limited healthcare resources have resulted in the implementation of health technology assessment (HTA) to inform health policy and reimbursement decision-making. European legislation has provided a harmonized route for the regulatory process with the European Medicines Agency, but reimbursement decision-making still remains the responsibility of each country. There is a recognized need to move toward a more objective and collaborative reimbursement environment for new medicines in Europe. Therefore, the aim of this study was to objectively assess and compare the national reimbursement recommendations of 9 European jurisdictions following European Medicines Agency (EMA) recommendation for centralized marketing authorization. Methods: Using publicly available data and newly developed classification tools, this study appraised 9 European reimbursement systems by assessing HTA processes and the relationship between the regulatory, HTA and decision-making organizations. Each national HTA agency was classified according to two novel taxonomies. The System taxonomy, focuses on the position of the HTA agency within the national reimbursement system according to the relationship between the regulator, the HTA-performing agency, and the reimbursement decision-making coverage body. The HTA Process taxonomy distinguishes between the individual HTA agency's approach to economic and therapeutic evaluation and the inclusion of an independent appraisal step. The taxonomic groups were subsequently compared with national HTA recommendations. Results: This study identified European national reimbursement recommendations for 102 new active substances (NASs) approved by the EMA from 2008 to 2012. These reimbursement recommendations were compared using a novel classification tool and identified alignment between the organizational structure of reimbursement systems (System taxonomy) and HTA recommendations. However, there was less alignment between the HTA processes and recommendations. Conclusions: In order to move forward to a more harmonized HTA environment within Europe, it is first necessary to understand the variation in HTA practices within Europe. This study has identified alignment between HTA recommendations and the System taxonomy and one of the major implications of this study is that such alignment could support a more collaborative HTA environment in Europe.

Keywords: HTA; archetypes; health technology assessment; new active substances; pharmaceuticals; process taxonomy; reimbursement recommendations; system taxonomy.

Figure 1

EUnetHTA HTA Core model® Domains.

Figure 2

The System taxonomy includes five subsets and is based on the position of three core functions: a national HTA performing agency, if present, in relation to the position of the regulatory authority (REG) and the decision-making coverage body (CB). The five-subset of the System taxonomy: S₁–the regulatory, HTA and coverage body functions are performed by separate agencies. S₂–the regulatory and HTA functions are performed by a single agency and the coverage body functions are independent. S₃–the HTA and coverage body functions are performed by a single agency with the regulatory function performed independently. S₄–the regulatory, HTA and coverage body functions are all performed within a single agency. S₅–no HTA is performed within the national regulatory to reimbursement system.

Figure 3

The HTA process taxonomy includes four subsets and focuses on the key tasks performed by the HTA agency. Each group shows the relative positions of three key tasks, if performed, within the HTA agency: therapeutic value (TV), economic value (EV), and appraisal (AP). The four-subsets of the HTA Process taxonomy: H₁–the therapeutic value assessment, economic evaluation and appraisal are performed within the same agency. H₂–the therapeutic value assessment is conducted within the same agency as Economic evaluation but the appraisal is performed independently, usually by health professionals rather than civil servants. H₃–the therapeutic value is assessed prior to independent appraisal. H₄–the appraisal is conducted using information from an external HTA report or by considering the coverage decisions of reference countries.

Figure 4

Number of HTA reimbursement recommendations for 9 European jurisdictions classified according to recommendation category.

Figure 5

Process maps for Belgium.

Figure 6

Process map for France.

Figure 7

Process map for Germany.

Figure 8

Process map key.