Barriers and facilitators of patient access to medical devices in Europe: A systematic literature review

A. C.C. Beck; V. P. Retèl; P. A. Bhairosing; M. W.M. van den Brekel; W. H. van Harten

doi:10.1016/j.healthpol.2019.10.002

Barriers and facilitators of patient access to medical devices in Europe: A systematic literature review

A. C.C. Beck, V. P. Retèl, P. A. Bhairosing, M. W.M. van den Brekel, W. H. van Harten

Maxillofacial Surgery (AMC)

Research output: Contribution to Journal › Review article › Academic › peer-review

Abstract

A large number of medical devices (MDs) is available in Europe. Procedures for market approval and reimbursement have been adopted over recent years to promote accelerating patient access to innovative MDs. However, there remains uncertainty and non-transparency regarding these procedures. We provide a structured overview of market approval and reimbursement procedures and practices regarding access to MDs in the EU. Market approval procedures were found to be uniformly described. Data on reimbursement procedures and practices was both heterogeneous and incomplete. Time to MD access was mainly determined by reimbursement procedures. The influence of the patient on time to access was not reported. Prescription practices varied among device types. Barriers to and facilitators of early patient access that set the agenda for policy implications were also analyzed. Barriers were caused by unclear European legislation, complex market approval procedures, lack of data collection, inconsistency in evidence requirements between countries, regional reimbursement and provision, and factors influencing physicians’ prescription including the device costs, waiting times and hospital-physician relationships. Facilitators were: available evidence that meets country-specific requirements for reimbursement, diagnosis-related groups, additional payments and research programs. Further research needs to focus on creating a complete overview of reimbursement procedures and practices by extracting further information from sources such as grey literature and interviews with professionals, and defining clear criteria to objectify time to access.

Original language	English
Pages (from-to)	1185-1198
Number of pages	14
Journal	Health Policy
Volume	123
Issue number	12
DOIs	https://doi.org/10.1016/j.healthpol.2019.10.002
Publication status	Published - Dec 2019

Funding

We would like to thank R.J.J.H van Son and J.C. Mewes for translating publications reported in other languages in this study. This work was supported by a non-restricted research grant from ATOS Medical AB contributing to the existing infrastructure for health-related quality of life research of the department of Head and Neck Oncology and Surgery. Various research programs are mentioned for France (see below). The coverage with evidence development (CED) program was described in two articles and has been implemented in France, Germany, the UK and the Netherlands. CED provides conditional reimbursement to innovative devices and simultaneously fosters evidence collection to prove the (cost-)effectiveness of the device [ 31 , 38 ]. CED in France provides reimbursement over at least two years. The CNEDiMTS selects suitable candidates for the program and assesses the application. The Ministry of Health decides which MD will enter the CED program funded by the NHI. Apart from CED, two local research programs are available: the Program for Hospital Clinical Research (PHRC) and the Program for Medical Economic Research (PRME). PHRC and PRME programs are in-hospital programs for which the research departments of hospitals can tender. An independent expert team assesses each application dossier and decides with regard to the PHRC, used for fundamental research, and PRME, used for economic evaluation [ 31 , 34 , 38 ]. The dossier for applying to CED in Germany can be filed by manufacturers, impartial members or patient representatives of the G-BA, the regional and federal associations of SHI physicians and the federal association of SHI funds. The IQWiG is responsible for evaluating that the application conforms to the criteria mentioned in Olberg et al. [ 38 ]: validity, plausibility and applicability. Subsequently, the G-BA makes the final decision on incorporation in the CED. Such a program is funded jointly by the SHI and manufacturer [ 31 , 32 , 38 ]. In the UK, application for CED is assessed by NICE. The CED program is offered in different forms: use of the MD in clinical practice with additional evidence collection (‘Approval With Research’ (AWR)) or only for research purposes (‘Only In Research’ (OIR)). CED is reimbursed by various stakeholders, including the NHS and manufacturers [ 31 , 38 ]. In the Netherlands, the Ministry of Health selects MDs that are eligible for CED. Data on (cost-)effectiveness of the MD is gathered throughout the program. Each clinical study is funded by the Netherlands Organization for Health Research and Development and other payers (e.g. manufacturers) [ 38 , 41 ]. 3.2.3 We would like to thank R.J.J.H van Son and J.C. Mewes for translating publications reported in other languages in this study. This work was supported by a non-restricted research grant from ATOS Medical AB contributing to the existing infrastructure for health-related quality of life research of the department of Head and Neck Oncology and Surgery. Appendix B

Funders	Funder number
Atos Medical AB
J.C.
Netherlands Organization for Health Research and Development
SHI
Ministry of Health
National Health Insurance Administration

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abstract = "A large number of medical devices (MDs) is available in Europe. Procedures for market approval and reimbursement have been adopted over recent years to promote accelerating patient access to innovative MDs. However, there remains uncertainty and non-transparency regarding these procedures. We provide a structured overview of market approval and reimbursement procedures and practices regarding access to MDs in the EU. Market approval procedures were found to be uniformly described. Data on reimbursement procedures and practices was both heterogeneous and incomplete. Time to MD access was mainly determined by reimbursement procedures. The influence of the patient on time to access was not reported. Prescription practices varied among device types. Barriers to and facilitators of early patient access that set the agenda for policy implications were also analyzed. Barriers were caused by unclear European legislation, complex market approval procedures, lack of data collection, inconsistency in evidence requirements between countries, regional reimbursement and provision, and factors influencing physicians{\textquoteright} prescription including the device costs, waiting times and hospital-physician relationships. Facilitators were: available evidence that meets country-specific requirements for reimbursement, diagnosis-related groups, additional payments and research programs. Further research needs to focus on creating a complete overview of reimbursement procedures and practices by extracting further information from sources such as grey literature and interviews with professionals, and defining clear criteria to objectify time to access.",

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Barriers and facilitators of patient access to medical devices in Europe: A systematic literature review

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