[Pharmacoeconomic studies - usability for reimbursement decisions].

BACKGROUND AND OBJECTIVE

In Germany, cost-benefit-assessments are incorporated by law since April 2007. In this study it is examined whether published international pharmacoeconomic studies correspond to the methodological recommendations of the Institute for Quality and Efficiency in Health Care (IQWiG) and international guidelines, and whether they are usable for reimbursement decisions.

METHODS

Pharmacoeconomic studies were identified by a systematic literature review and compared with the requirements of the IQWiG and 15 other international institutions. In hypothetical selection processes it was examined which and how many studies could be considered as basis for reimbursement decisions.

RESULTS

130 out of 1,982 pharmacoeconomic studies were identified as relevant and analyzed. Most frequently, the USA was mentioned as reference country (41 %) prior to UK (15 %), Canada (6 %) as well as Japan and Germany (each 4 %). In 63 % standard therapy was chosen as comparator. In 60 % of studies the payer's perspective was chosen primarily, in 22 % the societal perspective. Two thirds of the studies were modeled in most parts. Only two studies performed a comparison with standard therapy from the perspective of the statutory health insurance and could have been considered for reimbursement decisions of the G-BA. Only one German study examined the real-life effectiveness and compared it to standard therapy.

CONCLUSIONS

The study revealed a congruence between the methods of iqwig and other similar international institutions. However, hitherto existing pharmacoeconomic studies do not follow international and German guidelines in many points. In consequence IQWiG will have to perform the analyses itself and the assessment process will be time-consuming and tedious so that in the short and medium term no relevant cost savings can be expected.