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A systematic review of moral reasons on orphan drug reimbursement
JournalArticle (Originalarbeit in einer wissenschaftlichen Zeitschrift)
 
ID 4627615
Author(s) Zimmermann, Bettina M.; Eichinger, Johanna; Baumgartner, Matthias R.
Author(s) at UniBasel Zimmermann, Bettina
Eichinger, Johanna
Year 2021
Title A systematic review of moral reasons on orphan drug reimbursement
Journal Orphanet Journal of Rare Diseases
Volume 16
Number 1
Pages / Article-Number 292
Keywords Allocation of resources; Ethics; Orphan diseases; Orphan drugs; Publicly funded healthcare systems; Rare diseases; Reimbursement; Systematic review of reasons
Mesh terms Budgets; Humans; Morals; Orphan Drug Production; Rare Diseases, drug therapy; Technology Assessment, Biomedical
Abstract The number of market approvals of orphan medicinal products (OMPs) has been increasing steadily in the last 3 decades. While OMPs can offer a unique chance for patients suffering from rare diseases, they are usually very expensive. The growing number of approved OMPs increases their budget impact despite their low prevalence, making it pressing to find solutions to ethical challenges on how to fairly allocate scarce healthcare resources under this context. One potential solution could be to grant OMPs special status when considering them for reimbursement, meaning that they are subject to different, and less stringent criteria than other drugs. This study aims to provide a systematic analysis of moral reasons for and against such a special status for the reimbursement of OMPs in publicly funded healthcare systems from a multidisciplinary perspective.; With a systematic review of reasons, we identified 39 reasons represented in 243 articles (scientific and grey literature) for and against special status for the reimbursement of OMPs, then categorized them into nine topics. Taking a multidisciplinary perspective, we found that most articles came from health policy (n = 103) and health economics (n = 49). More articles took the position for a special status of OMPs (n = 97) than those against it (n = 31) and there was a larger number of reasons identified in favour (29 reasons) than against (10 reasons) this special status.; Results suggest that OMP reimbursement issues should be assessed and analysed from a multidisciplinary perspective. Despite the higher occurrence of reasons and articles in favour of a special status, there is no clear-cut solution for this ethical challenge. The binary perspective of whether or not OMPs should be granted special status oversimplifies the issue: both OMPs and rare diseases are too heterogeneous in their characteristics for such a binary perspective. Thus, the scientific debate should focus less on the question of disease prevalence but rather on how the important variability of different OMPs concerning e.g. target population, cost-effectiveness, level of evidence or mechanism of action could be meaningfully addressed and implemented in Health Technology Assessments.
Publisher BMC
ISSN/ISBN 1750-1172
edoc-URL https://edoc.unibas.ch/85010/
Full Text on edoc Available
Digital Object Identifier DOI 10.1186/s13023-021-01925-y
PubMed ID http://www.ncbi.nlm.nih.gov/pubmed/34193232
ISI-Number WOS:000671281100002
Document type (ISI) Journal Article, Review
 
   

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