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Estimation of cost-based prices for injectable medicines in the WHO Essential Medicines List
Open accessAbstract
Objectives: Challenges remain in ensuring universal access to affordable essential medicines. We previously estimated the expected generic prices based on cost of production for medicines in solid oral formulations (ie, capsules or tablets) on the WHO Model List of Essential Medicines (EML). The objectives of this analysis were to estimate cost-based prices for injectable medicines on the EML and to compare these to lowest current prices in England, South Africa, and India. Design: Data on the cost of active pharmaceutical ingredients (APIs) exported from India were extracted from an online database of customs declarations ( www.infodriveindia.com ). A formula was designed to use API price data to estimate a cost-based price, by adding the costs of converting API to a finished pharmaceutical product, including the cost of formulation in vials or ampoules, transportation and an average profit margin. Results: For injectable formulations on the WHO EML, medicines had prices above the estimated cost-based price in 77% of comparisons in England (median ratio 2.54), and 62% in South Africa (median ratio 1.48), while 85% of medicines in India had prices below estimated cost-based price (median ratio 0.30). 19% of injectable medicines in England, 9% in South Africa, and 5% in India had prices more than 10 times the estimated cost-based price. Medicines that appeared in the top 20 by ratio of lowest current price to estimated cost-based price for more than one country included numerous oncology medicines—irinotecan, leuprorelin, ifosfamide, daunorubicin, filgrastim and mesna—as well as valproic acid and ciclosporin. Conclusions: Estimating manufacturing costs can identify cases in which profit margins for medicines may be set significantly higher than average.
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“The minimum price estimates were calculated from export data using an established and published methodology based on costs of API [15,16] extracted from Panjiva, a global shipping records database [17].”
From Estimated minimum prices and lowest available national prices for antiobesity medications: Improving affordability and access to treatment (2023) · cites this paper as [15]
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“The average margin for the Indian pharmaceutical market ranged from 8.8% in 1995 to 15.4% in 2005 [15].”
From Estimated minimum prices and lowest available national prices for antiobesity medications: Improving affordability and access to treatment (2023) · cites this paper as [15]
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Shortages of medicines: a complex global challenge
Gray, A., & Manasse, H. (2012) · Bulletin of the World Health Organization · doi:10.2471/blt.11.101303 · Cited by 136 · cited 1×
“Indeed, some of the therapeutic groups identified in this analysis as having in many cases high differences between market prices and estimated cost-based prices, such as chemotherapy medicines and antibiotics, may also be groups that are vulnerable to shortages.(25) 26 This study, which used broad and conservative as…”
Background
Research works printed but not linked: 13
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- Gotham, 2018, Production costs and potential prices for biosimilars of human insulin and insulin analogues, BMJ Glob Health, 3, 10.1136/bmjgh-2018-000850 · DOI
- Hill, 2015, Analysis of minimum target prices for production of entecavir to treat hepatitis B in high- and low-income countries, J Virus Erad, 1, 103, 10.1016/S2055-6640(20)30484-2 · DOI
- Hill, 2016, Target prices for mass production of tyrosine kinase inhibitors for global cancer treatment, BMJ Open, 6, 10.1136/bmjopen-2015-009586 · DOI
- Hill, 2016, Rapid reductions in prices for generic sofosbuvir and daclatasvir to treat hepatitis C, J Virus Erad, 2, 28, 10.1016/S2055-6640(20)30691-9 · DOI
- Hill, 2017, Estimated generic prices of cancer medicines deemed cost-ineffective in England: a cost estimation analysis, BMJ Open, 7, 10.1136/bmjopen-2016-011965 · DOI
- Gotham D , Fortunak J , Pozniak A , et al . Estimated generic prices for novel treatments for drug-resistant tuberculosis. J Antimicrob Chemother 2017;72. dkw522.doi:10.1093/jac/dkw522 · DOI
- Sedita, 2018, Cost of goods sold and total cost of delivery for oral and parenteral vaccine packaging formats, Vaccine, 36, 1700, 10.1016/j.vaccine.2018.01.011 · DOI
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- 10.1093/heapol/czn046 · DOI
- Iyengar, 2016, Medicine shortages: a commentary on causes and mitigation strategies, BMC Med, 14, 10.1186/s12916-016-0674-7 · DOI
- Hill A , Barber M , Gotham D , et al . Generic treatments for HIV, HBV, HCV, TB could be mass produced for <$90 per patient. In: 9Th IAS conference on HIV science. Paris, 2017. http://programme.ias2017.org/Abstract/Abstract/1978
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Levi, J., Wang, J., Venter, F., & Hill, A. (2023) · Obesity · doi:10.1002/oby.23725 · Cited by 69
“Therefore, we also searched for individual national prices of topiramate and phentermine separately and combined the available data together (from the United States, South Africa, and Kenya), which are also shown in Figure 2B. EMPs for each drug individually were $0.86 for topiramate and $0.53 for phentermine (total o…”
MethodInfluentialSelf-citationDrug utilization studies using WHO prescribing indicators from India: A systematic review
Gujar, A., Gulecha, D. V., & Zalte, D. A. (2021) · Health Policy and Technology · doi:10.1016/j.hlpt.2021.100547 · Cited by 16
Metadata
- Authors
- Gotham, D., Barber, M. J., & Hill, A. M.
- Affiliations
- Independent researcher, Independent, London, UK
- Harvard University (US)
- University of Liverpool (GB)
- Corresponding author
- Gotham, Dzintars
- Venue
- BMJ Open
- Publisher
- BMJ
- Published
- 2019-09
- Volume
- 9
- Issue
- 9
- Pages
- e027780
- ISSN
- 2044-6055 (ISSN-L)
- PMC
- PMC6773329
- OpenAlex
- W2978967276
- Cited by
- 19
- References
- 1
- Citations by year
- 2025: 5 · 2024: 4 · 2023: 1 · 2022: 3 · 2021: 4 · 2020: 1
- FWCI
- 2.50
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by-nc
- Locations
- BMJ Open (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- HighWire Press Open Archive (submittedVersion)
- Funders
- World Health Organization
- Wellcome Trust
- Topics
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Health Systems, Economic Evaluations, Quality of Life
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Healthcare Systems and Reforms
- Keywords
- injectable drugs, cost-based pricing, WHO Model List of Essential Medicines, generic drug prices, active pharmaceutical ingredients, production costs, profit margin, price affordability, oncology drugs, irinotecan, leuprolide, ifosfamide, daunorubicin, filgrastim, mesna, valproic acid, cyclosporine, India, England, South Africa
- MeSH terms
- Costs and Cost Analysis, Drug Industry, England, Humans, India, Injections, South Africa, Drugs, Essential
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