Global barriers to accessing off-patent endocrine therapies: a renaissance of the orphan disease?
File(s)
Published version
Author(s)
Type
Journal Article
Abstract
Context
Clinical endocrinology encompasses many diseases requiring long-term drug therapy. Prohibitive pricing of some endocrine drugs classified as essential by the World Health Organization has created suboptimal care of patients with endocrine disorders.
Evidence acquisition
This review is based on evidence obtained from several databases and search engines including PubMed, Google, and Google Scholar; reference searches; manual searching for web pages of international regulatory bodies; and the authors’ experience from different healthcare settings.
Evidence synthesis
After the expiry of a patent, generic versions with the opportunity for increased availability and a price reduction are expected. There are access barriers worldwide for many off-patent endocrine drugs. The high price is the main issue for several medicines including insulin, hydrocortisone, testosterone, and gonadotropins. This is caused by several factors including the market monopoly due to the lack of registered generics or suppliers limiting the benefit of competition and a complex supply chain. Additionally, the lack of some medicines has been concerning due to market factors such as the relatively small number of patients, making it less attractive for the manufacturers. Commissioning of nonprofit manufacturers and state manufacturing as well as strict price control measures could alleviate this situation.
Conclusion
Lack of availability and disproportionate price inflation affecting essential off-patent endocrine therapies is common due to several interrelated factors. Global collaboration among healthcare organizations with the support of policymaking bodies might be needed to mitigate this.
Clinical endocrinology encompasses many diseases requiring long-term drug therapy. Prohibitive pricing of some endocrine drugs classified as essential by the World Health Organization has created suboptimal care of patients with endocrine disorders.
Evidence acquisition
This review is based on evidence obtained from several databases and search engines including PubMed, Google, and Google Scholar; reference searches; manual searching for web pages of international regulatory bodies; and the authors’ experience from different healthcare settings.
Evidence synthesis
After the expiry of a patent, generic versions with the opportunity for increased availability and a price reduction are expected. There are access barriers worldwide for many off-patent endocrine drugs. The high price is the main issue for several medicines including insulin, hydrocortisone, testosterone, and gonadotropins. This is caused by several factors including the market monopoly due to the lack of registered generics or suppliers limiting the benefit of competition and a complex supply chain. Additionally, the lack of some medicines has been concerning due to market factors such as the relatively small number of patients, making it less attractive for the manufacturers. Commissioning of nonprofit manufacturers and state manufacturing as well as strict price control measures could alleviate this situation.
Conclusion
Lack of availability and disproportionate price inflation affecting essential off-patent endocrine therapies is common due to several interrelated factors. Global collaboration among healthcare organizations with the support of policymaking bodies might be needed to mitigate this.
Date Issued
2024-05-01
Date Acceptance
2023-10-01
Citation
Journal of Clinical Endocrinology and Metabolism (JCEM), 2024, 109 (5), pp.e1379-e1388
ISSN
0021-972X
Publisher
Oxford University Press
Start Page
e1379
End Page
e1388
Journal / Book Title
Journal of Clinical Endocrinology and Metabolism (JCEM)
Volume
109
Issue
5
Copyright Statement
© The Author(s) 2023. Published by Oxford University Press on behalf of the Endocrine Society. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
License URL
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/37846800
PII: 7319415
Subjects
access
availability
cost
DISPARITIES
DRUGS
endocrine
Endocrinology & Metabolism
ESSENTIAL MEDICINES
Life Sciences & Biomedicine
medicines
off-patent
Science & Technology
UNITED-STATES
Publication Status
Published
Coverage Spatial
United States
Date Publish Online
2023-10-17