Health policy
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Transparency in health care resource allocation decisions is a criterion of a fair process. We used qualitative methods to explore transparency across 11 Canadian drug advisory committees. ⋯ Most committees have some mechanisms to address transparency but none had a fully transparent process. The most important ways to improve transparency include creating formal appeal mechanisms, improving communication, and establishing consistent rules about the use of, and public access to, proprietary evidence.
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Comparative Study
Analysis of endpoints used in marketing authorisations versus value assessments of oncology medicines in Germany.
In Germany, a mandatory early benefit assessment (EBA) by the Federal Joint Committee (G-BA) is required for reimbursement of new marketing-authorised medicines. Additional benefit is based on patient-relevant endpoints in mortality, morbidity and health-related quality of life (HRQoL). We aimed to compare endpoints and related benefit categories used in marketing authorisation to those considered by G-BA in the field of oncology. ⋯ Mortality endpoints are accepted by EMA and G-BA. EMA accepted well established and clinically relevant morbidity endpoints (e.g. progression-free survival and response rate), which were mostly excluded by G-BA from their value decisions. The applicability of methods used for benefit assessments to HRQoL differs from the mortality and morbidity categories, and requires further clarification.