Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Methodological Requirements for Early Benefit Assessment in Germany (G-BA/ IQWIG) and Single Technology Appraisal in England (NICE) - a Comparison ***

Dr. Viktor Ivandic (Abschlußjahr: 2012)

Summary
This study compares 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 Clinical Excellence (NICE; England), respectively.
There 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. Often more than one relevant comparator is allowed, which offers greater flexibility. Moreover, the view from the manufacturer regarding the choice of comparator is considered early on in the process. Surrogate endpoints are also accepted more readily, if they are reasonably likely to predict clinical benefit. Modelling 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 modelling of data is done, and there is only one appropriate comparator assigned by GBA/IQWiG. The probability and extent of the additional benefit is differentiated using various categories.
Some of the discrepancies in methodological requirements may be explained by differences in the health care system and procedural aspects, e.g. by the combined appraisal of clinical and cost-effectiveness in England. Harmonising the requirements for HTA across countries, at least in part, may help pharmaceutical companies optimise clinical development programmes and improve overall acceptability of evidence to HTA bodies.
Pages: 61, Annexes: pages: 0