Abstract
BackgroundThis study compared the methodological requirements for early health technology appraisal (HTA) by the Federal Joint Committee/Institute for Quality and Efficiency in Health Care (G-BA/IQWiG; Germany) and the National Institute for Health and Care Excellence (NICE; England).MethodsThe following aspects were examined: guidance texts on methodology and information sources for the assessment; clinical study design and methodology; statistical analysis, quality of evidence base, extrapolation of results (modeling), and generalisability of study results; and categorisation of outcome.ResultsThere is some degree of similarity regarding basic methodological elements such as selection of information sources (e.g. preference of randomised controlled studies, RCTs) and quality assessment of the available evidence. Generally, the approach taken by NICE seems to be more open and less restrictive as compared with G-BA/IQWiG. Any kind of potentially relevant evidence is requested, including data from non-RCTs. Surrogate endpoints are also accepted more readily, if they are reasonably likely to predict clinical benefit. Modeling is expected to be performed wherever possible and appropriate, e.g. for study duration, patient population, choice of comparator, and type of outcomes. The resulting uncertainty is quantified through sensitivity analyses before making a recommendation regarding reimbursement. By contrast, G-BA/IQWiG bases its assessment and quantification of the additional benefit largely, if not exclusively, on evidence of the highest level and quality and on measurements of “hard” clinical endpoints. This more conservative approach rather firmly dismisses evidence from non-RCTs and measurements of surrogate endpoints that have not or only partly been validated. Moreover, neither qualitative extrapolation nor quantitative modeling of data is done.ConclusionsMethodological requirements differed mainly in the acceptance of low-level evidence, surrogate endpoints, and data modeling. Some of the discrepancies may be explained, at least in part, by differences in the health care system and procedural aspects (e.g. timing of assessment).Electronic supplementary materialThe online version of this article (doi:10.1186/s13561-014-0012-8) contains supplementary material, which is available to authorized users.
Highlights
This study compared the methodological requirements for early health technology appraisal (HTA) by the Federal Joint Committee/Institute for Quality and Efficiency in Health Care (G-BA/IQWiG; Germany) and the National Institute for Health and Care Excellence (NICE; England)
An overview is primarily given of the methodological requirements currently used for the relative effectiveness assessment by NICE in England and the early benefit assessment by G-BA/IQWiG in German
The German law for reforming the market for pharmaceuticals (AMNOG) introduced an entirely new means of price regulation for recently authorised pharmaceuticals by establishing a new § 35a SGB V on the “Assessment of benefit for pharmaceuticals with new active substances”. This early benefit assessment is mandatory for all new pharmaceuticals or new therapeutic indications authorised in Germany and is based on information provided by the pharmaceutical company
Summary
This study compared the methodological requirements for early health technology appraisal (HTA) by the Federal Joint Committee/Institute for Quality and Efficiency in Health Care (G-BA/IQWiG; Germany) and the National Institute for Health and Care Excellence (NICE; England). In most Western countries, a comparative analysis of clinical efficacy and/or effectiveness is performed to support national decisions regarding reimbursement or pricing of a pharmaceutical drug or other health care technology. The conditions for acceptance of evidence for clinical benefit vary among national HTA agencies since the structure of the health care systems differs greatly from country to country. In England, company profit rather than drug prices are subject to direct regulation, at present. Until end of 2010, drug prices in Germany were not regulated but were indirectly influenced by the reimbursement system (e.g. fixed pricing, agreements on discounts)
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