Evaluation of Patient Registries Supporting Reimbursement Decisions: The Case of Oxaliplatin for Treatment of Stage III Colon Cancer
| Autor: | Erik Buskens, Chantal W. M. van Gils, Talitha L Feenstra, Leyla Mohseninejad, Carin A. Uyl-de Groot |
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| Přispěvatelé: | Methods in Medicines evaluation & Outcomes research (M2O), Real World Studies in PharmacoEpidemiology, -Genetics, -Economics and -Therapy (PEGET), Value, Affordability and Sustainability (VALUE), Health Economics (HE), Health Technology Assessment (HTA), Erasmus School of Health Policy & Management |
| Jazyk: | angličtina |
| Rok vydání: | 2015 |
| Předmět: |
Research design
Organoplatinum Compounds Cost effectiveness NETHERLANDS Antineoplastic Agents law.invention Value of information RESEARCH DESIGN COST-EFFECTIVENESS patient registry Randomized controlled trial SDG 3 - Good Health and Well-being law medicine Humans Operations management Registries decision theory Survival rate Reimbursement INFORMATION METHODS Neoplasm Staging THEORETIC APPROACH Data collection business.industry Health Policy access with evidence development Public Health Environmental and Occupational Health OPTIMAL SAMPLE-SIZES reimbursement value of information FLUOROURACIL Oxaliplatin Survival Rate Treatment Outcome EXPECTED VALUE Colonic Neoplasms Insurance Health Reimbursement ADJUVANT TREATMENT RANDOMIZED CLINICAL-TRIALS business medicine.drug |
| Zdroj: | Value in Health, 18(1), 84-90. ELSEVIER SCIENCE INC Value in Health, 18, 84-90. Elsevier Ltd. |
| ISSN: | 1098-3015 |
| Popis: | Background: Access with evidence development has been established for expensive intramural drugs in The Netherlands. The procedure involves a 4-year period of conditional reimbursement. During this period, additional evidence has to be gathered usually through a patient registry. Given the costs and time involved in gathering the data, it is important to carefully evaluate the registry. Objectives: This study aimed to develop a model for the regular evaluation of patient registries during an access with evidence development process and find the optimal length of the registry period. Methods: We used data from a recent registry in The Netherlands on oxaliplatin as a treatment option for stage III colon cancer. We added simulated follow-up data to the empirical data available and applied value of information analysis to balance the gains of extending the period and amount of data gathering against the costs of registering patients. Results: We show that given the assumptions on cohort size, follow-up time, and purpose of the registry, the current (partly simulated) registry was not very efficient. Notably, the observation period could have been stopped to make a definite reimbursement decision after a maximum of 2 years rather than the fixed 4-year period. Conclusions: Patient registries may be an efficient way to gather data on new medical treatments, but they need to be carefully designed and evaluated, in particular regarding their follow-up time. For each purpose, data gathering can be tailored to make sure decisions are taken at the moment that sufficient data are available. Copyright (C) 2015, International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. |
| Databáze: | OpenAIRE |
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