Economic appraisal differs from clinical assessment, and decision makers benefit from analysis of naturalistic, actual practice data. Despite reviewing the initial trial-based, 'piggy-back' economic analysis, TLV was uncertain of the cost effectiveness in actual practice and deferred a final decision until observational data from the DAPHNE study became available. Second, acceptance of economic modelling and use of temporary reimbursement conditional on additional evidence development provide a mechanism for risk sharing between TLV and manufacturers, which enabled patient access to a drug with proven clinical benefit while necessary evidence to support claims of cost effectiveness could be generated.
Background: The aim of the study was to develop a menopause-specific, preference-based healthrelated quality-of-life (HRQoL) index reflecting both menopausal symptoms and potential sideeffects of Hormone Replacement Therapy (HRT).
Adding highly concentrated n-3 PUFAs to standard treatment in the secondary prevention of MI appears to be cost effective versus standard treatment alone in the five countries studied.
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