Coverage decisions determining the benefit
baskets of health systems have been increasingly relying on evidence
regarding patient benefit and costs. Relevant structures,
methodologies, and processes have especially been established for
pharmaceuticals but approaches differ. The objective of this work was
thus to identify institutions in a broad range of European countries
(n = 36) in charge of determining the value of pharmaceuticals for
pricing and reimbursement purposes and to map their decision-making
process; to examine the different approaches and consider national and
supranational possibilities for best practice.
Institutions were identified through websites of
international networks, ministries, and published literature. Details
on institutional practices were supplemented with information from
institution websites and linked online sources.
The type and extent of information available
varied considerably across countries. Different types of public
regulatory bodies are involved in pharmaceutical coverage decisions,
assuming a range of responsibilities. As a rule, the assessment of
scientific evidence is kept structurally separate from its appraisal.
Recommendations on value are uniformly issued by specific committees
within or commissioned by responsible institutions; these institutions
often also act as decision-makers on reimbursement status and level or
market price. While effectiveness and costs are important criteria in
all countries, the latter are often considered on a case-by-case
basis. In all countries, manufacturer applications, including relevant
evidence, are used as one of the main sources of information for the
Transparency of evidence-based coverage
decisions should be enhanced. International collaboration can
facilitate knowledge exchange, improve efficiency of information
production, and strengthen new or developing systems.