InterMune Inc.’s treatment for idiopathic pulmonary fibrosis Esbriet (pirfenidone) has failed to impress Germany’s Institute for Quality and Efficiency in Healthcare (IQWiG) in its first assessment of an orphan drug under the requirements of the pharmaceutical sector restructuring law (AMNOG).
Intermune’s Esbriet Flops In Front Of IQWiG
Germany’s IQWiG remains unconvinced about the added value offered by Intermune’s Esbriet, a decision that adds to industry concerns on assessment methodology
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The policy expectation that the model clinical trial agreements are used without modification is in line requests from industry and the NHS/HSC.
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Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.