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[Pharmacoeconomic studies - usability for reimbursement decisions].

E S Dietrich1, T Nakashima, S Ahrens

  • 1WINEG, Wissenschaftliches Institut der TK für Nutzen und Effizienz im Gesundheitswesen, Hamburg, Deutschland. pharmacoeconomics@web.de

Deutsche Medizinische Wochenschrift (1946)
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Summary

Most pharmacoeconomic studies do not meet international guidelines for health technology assessment. This necessitates in-house analysis by the Institute for Quality and Efficiency in Health Care (IQWiG), leading to time-consuming evaluations.

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Area of Science:

  • Health Economics
  • Pharmacoeconomics
  • Health Technology Assessment

Background:

  • Germany legally mandates cost-benefit assessments for pharmaceuticals since April 2007.
  • Evaluating the alignment of published pharmacoeconomic studies with established guidelines is crucial for reimbursement decisions.

Purpose of the Study:

  • To assess whether international pharmacoeconomic studies adhere to the methodological recommendations of the Institute for Quality and Efficiency in Health Care (IQWiG) and global guidelines.
  • To determine the usability of existing pharmacoeconomic studies for German reimbursement decisions.

Main Methods:

  • A systematic literature review identified relevant pharmacoeconomic studies.
  • Studies were compared against the requirements of IQWiG and 15 other international health technology assessment institutions.
  • Hypothetical selection processes evaluated study suitability for reimbursement decisions.

Main Results:

  • 130 of 1,982 studies were analyzed, with the USA (41%) being the most frequent reference country.
  • Standard therapy was the comparator in 63% of studies, and the payer's perspective was primary in 60%.
  • Only two studies met the criteria for German reimbursement decisions (G-BA), and only one German study assessed real-life effectiveness.

Conclusions:

  • A methodological congruence exists between IQWiG and other international institutions.
  • Existing pharmacoeconomic studies frequently deviate from international and German guidelines.
  • IQWiG's need for in-house analysis will prolong assessments, limiting short-to-medium term cost savings.