Information on new drugs at market entry: retrospective analysis of health technology assessment reports versus regulatory reports, journal publications, and registry reports.
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ABSTRACT:
SUBMITTER: Kohler M
PROVIDER: S-EPMC4353284 | biostudies-literature | 2015 Feb
REPOSITORIES: biostudies-literature
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Information on new drugs at market entry: retrospective analysis of health technology assessment reports versus regulatory reports, journal publications, and registry reports.
Köhler Michael M Haag Susanne S Biester Katharina K Brockhaus Anne Catharina AC McGauran Natalie N Grouven Ulrich U Kölsch Heike H Seay Ulrike U Hörn Helmut H Moritz Gregor G Staeck Kerstin K Wieseler Beate B
BMJ (Clinical research ed.) 20150226
<h4>Background</h4>When a new drug becomes available, patients and doctors require information on its benefits and harms. In 2011, Germany introduced the early benefit assessment of new drugs through the act on the reform of the market for medicinal products (AMNOG). At market entry, the pharmaceutical company responsible must submit a standardised dossier containing all available evidence of the drug's added benefit over an appropriate comparator treatment. The added benefit is mainly determine ...[more]
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