An early access pathway of conditional approval for potentially beneficial medicines is available within the European regulatory framework. However, marketing authorization does not necessarily result in recommendations for public funding by health technology assessment (HTA) agencies. As conditional approval goes along with less than complete data on benefits and risks of a treatment option for a high medical need, this raises the question how HTA decision-making is affected by these uncertainties.
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BC Canc, Dept Med Oncol, 600 W 10th Ave, Vancouver, BC V5Z 4E6, Canada
Univ British Columbia, Dept Med, Vancouver, BC, CanadaBC Canc, Dept Med Oncol, 600 W 10th Ave, Vancouver, BC V5Z 4E6, Canada
Ho, Cheryl
Lim, Howard J.
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机构:
BC Canc, Dept Med Oncol, 600 W 10th Ave, Vancouver, BC V5Z 4E6, Canada
Univ British Columbia, Dept Med, Vancouver, BC, CanadaBC Canc, Dept Med Oncol, 600 W 10th Ave, Vancouver, BC V5Z 4E6, Canada
Lim, Howard J.
Regier, Dean A.
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BC Canc, Canc Control Res, Vancouver, BC, Canada
Univ British Columbia, Sch Populat & Publ Hlth, Vancouver, BC, CanadaBC Canc, Dept Med Oncol, 600 W 10th Ave, Vancouver, BC V5Z 4E6, Canada