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Cancer Drugs Reimbursed with Limited Evidence on Overall Survival and Quality of Life: Do Follow-Up Studies Confirm Patient Benefits?
University of Gothenburg, Sweden.ORCID iD: 0000-0002-0940-9166
University of Gothenburg, Sweden; Örebro University, Sweden.
Karlstad University, Faculty of Arts and Social Sciences (starting 2013), Karlstad Business School (from 2013).ORCID iD: 0000-0002-7143-8793
Karlstad University, Faculty of Arts and Social Sciences (starting 2013), Center for Societal Risk Research, CSR (from 2020). University of Gothenburg, Sweden.ORCID iD: 0000-0002-1189-9950
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2023 (English)In: Clinical drug investigation, ISSN 1173-2563, E-ISSN 1179-1918, Vol. 43, no 8, p. 621-633Article in journal (Refereed) Published
Abstract [en]

Background and ObjectiveCancer drug costs have increased considerably within healthcare systems, but many drugs lack quality-of-life (QoL) and overall survival (OS) data at the time of reimbursement approval. This study aimed to review the extent of subsequent literature documenting improvements in OS and QoL for cancer drug indications where no such evidence existed at the time of reimbursement approval.MethodsDrug indications with claims of added therapeutical value but a lack of evidence on OS and QoL that were reimbursed between 2010 and 2020 in Sweden were included for review. Searches were conducted in PubMed and ClinicalTrial.gov for randomized controlled trials examining OS and QoL.ResultsOf the 22 included drug indications, seven were found to have at least one trial with conclusive evidence of improvements in OS or QoL after a mean follow-up of 6.6 years. The remaining 15 drug indications either lacked subsequent randomized controlled trial data on OS or QoL (n = 6) or showed no statistically significant improvements (n = 9). Only one drug demonstrated evidence of improvement in both OS and QoL for its indication.ConclusionsA considerable share of reimbursed cancer drug indications continue to lack evidence of improvement in both OS and QoL. With limited healthcare resources and an increasing cancer burden, third-party payers have strong incentives to require additional post-reimbursement data to confirm any improvements in OS and QoL.

Place, publisher, year, edition, pages
Springer, 2023. Vol. 43, no 8, p. 621-633
Keywords [en]
renal-cell carcinoma, european medicines agency, early breast-cancer, clinical benefit, lung-cancer, phase-III, end-points, open-label, everolimus, outcomes
National Category
Cancer and Oncology Health Care Service and Management, Health Policy and Services and Health Economy
Research subject
Economics
Identifiers
URN: urn:nbn:se:kau:diva-96400DOI: 10.1007/s40261-023-01285-4ISI: 001039851200001PubMedID: 37505421Scopus ID: 2-s2.0-85169757424OAI: oai:DiVA.org:kau-96400DiVA, id: diva2:1788854
Funder
The Jan Wallander and Tom Hedelius Foundation, P21-0018University of GothenburgAvailable from: 2023-08-17 Created: 2023-08-17 Last updated: 2023-09-19Bibliographically approved

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Jakobsson, NiklasBonander, Carl

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