Weighing of Evidence by Health Technology Assessment Bodies: Retrospective Study of Reimbursement Recommendations for Conditionally Approved Drugs
| Autor: | Vreman, Rick A, Bouvy, Jacoline C, Bloem, Lourens T, Hövels, Anke M, Mantel-Teeuwisse, Aukje K, Leufkens, Hubert G M, Goettsch, Wim G, Afd Pharmacoepi & Clinical Pharmacology, Sub Pharmacoepidemiology, Pharmacoepidemiology and Clinical Pharmacology |
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| Přispěvatelé: | Afd Pharmacoepi & Clinical Pharmacology, Sub Pharmacoepidemiology, Pharmacoepidemiology and Clinical Pharmacology |
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Pharmacology
medicine.medical_specialty Evidence-Based Medicine Technology Assessment Biomedical business.industry MEDLINE Health technology Retrospective cohort study Controlled studies Marketing authorization 030226 pharmacology & pharmacy Europe 03 medical and health sciences 0302 clinical medicine 030220 oncology & carcinogenesis Family medicine Cohort Insurance Health Reimbursement Medicine Humans Pharmacology (medical) business Drug Approval Reimbursement Retrospective Studies |
| Zdroj: | Clinical Pharmacology and Therapeutics, 105(3), 684. Nature Publishing Group |
| ISSN: | 0009-9236 |
| Popis: | This study assessed whether five Health Technology Assessment (HTA) bodies in Europe were more negative about drugs with a Conditional Marketing Authorization (CMA) that are approved without controlled studies compared to CMA drugs that are approved based on controlled studies. The HTA recommendations were categorized into positive, restricted, and negative. A total of 92 HTA recommendations were available for 27 drugs. Thirty of 62 (48%) and 17 of 30 (57%) of the recommendations were negative for drugs with and without controlled studies, respectively. Overall, only 12 (13%) recommendations were positive. In all jurisdictions, recommendations between drugs with and drugs without controlled data were comparable, which suggests that the presence of controlled data is not decisive in HTA evaluations. The small proportion of unrestricted positive recommendations highlights difficulties with recommending the drugs in this cohort, which may be caused by scientific uncertainty or other factors. Earlier collaboration between stakeholders is advised in order to improve patient access. |
| Databáze: | OpenAIRE |
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