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Assessing the benefit of new pharmaceuticals: Are we talking the same language, can we explain dissagreement, and would it be better to do it together?

Busse R
Health Policy 120(10); DOI: 10.1016/j.healthpol.2016.10.006




As the marketing authorization of process of new pharmaceuticals aims to verify the quality, safety and efficacy of candidate products, it does not necessitate that the pharmaceutical provides a therapeutic benefit that is meaningful to patients in real world conditions - nor does it consider the price of the product or the cost-effectiveness of its usage. The patient-relevant benefit is rather examined during post-marketing evaluations, which have been established in Australia and Canada, and - starting with England in 2000 - in the majority of European countries. As a rule, the focus is on a pharmaceutical's added therapeutic benefit compared to existing alternatives - usually called "comparator". Cost-effectiveness and budget impact are further important aspects, which are, however, not evaluated in all countries at this point. Such post-marketing evaluations usually serve to determine the reimbursement eligibility and/or price of (new) pharmaceuticals in the publicly financed (statutory) health system. Despite the fact that such evaluations at national level are the norm, they vary considerably across countries - both in regard to the organizations and their responsibilities (for the assessment of the therapeutic and economic value, the appraisal of these assessments, and the ultimate decision) as well as the actual process and methodology. 

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