Economic evaluations in European reimbursement submission guidelines: current status and comparisons

Abstract

This study aimed to review European national health-economic (HE) guidelines and to identify recent developments in guideline recommendations by comparing the findings with those of a review published in 2001. Guidelines were identified by searching websites of the Internal Society for Pharmacoeconomics and Outcomes Research (ISPOR) and government health insurance agencies, and by a literature review. National guidelines showed broad consistency in ranking clinical data sources and choice of comparators for HE analysis, but varied in recommended costs to be included, methods related to cost calculation and discounting. Many European countries have developed or revised national HE guidelines. The recommendations in these guidelines differ in some key aspects, limiting transferability of outcomes of HE evaluations.

Keywords::

• health economics
• health technology assessment
• pharmacoeconomic guidelines
• reimbursement
• societal perspective

Financial & competing interests disclosure

A Bracco is an employee of Amgen and holds stock. No funding was received for this research. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Medical writing and editorial support were provided by W Mark Roberts, Montreal, Canada.

Key issues

• • The objective of this review was to identify Health Economics (HE) guidelines in Europe.

• • The second objective was to review the guidelines and compare the recommendations with those of an earlier publication back in 2001.

• • HE guidelines were retrieved from 23 European countries. Of those, 10 were newly developed and 12 were updated since 2001.

• • Most guidelines were formalized and contained requirements for reimbursement submissions.

• • Some consistency on the recommendations for clinical data and HE analysis were observed.

• • Most of the guidelines recommended cost–utility, cost–effectiveness or cost–minimization analyses while discouraging cost–benefit analysis.

• • However, the recommendations in the guidelines differ in some key aspects like the perspective of the economic analysis (healthcare perspective vs societal) and the methods related to cost calculation and discounting, and the costs to be included.

• • The inconsistency in some key areas of the guidelines will limit the transferability of outcomes of HE evaluations.