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Does conditional approval for new oncology drugs in Europe lead to differences in health technology assessment decisions?
- Source :
- Clinical Pharmacology and Therapeutics, 98(5), 489. Nature Publishing Group
- Publication Year :
- 2015
- Publisher :
- Wiley, 2015.
-
Abstract
- 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.
- Subjects :
- Pharmacology
Complete data
Technology Assessment, Biomedical
Actuarial science
business.industry
Decision Making
Health technology
Treatment options
Antineoplastic Agents
Marketing authorization
Europe
Taverne
Drug approval
Humans
Medicine
Pharmacology (medical)
CONDITIONAL APPROVAL
Oncology drugs
business
Drug Approval
Public funding
Subjects
Details
- ISSN :
- 00099236
- Volume :
- 98
- Database :
- OpenAIRE
- Journal :
- Clinical Pharmacology & Therapeutics
- Accession number :
- edsair.doi.dedup.....bd62ee5e92330ca9578db4df28f6b913
- Full Text :
- https://doi.org/10.1002/cpt.198