Estimated Sustainable Cost-Based Prices for Diabetes Medicines

Author:

Barber Melissa J.123,Gotham Dzintars45,Bygrave Helen5,Cepuch Christa5

Affiliation:

1. Yale Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT), New Haven, Connecticut

2. Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, and Harvard Medical School, Boston, Massachusetts

3. Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, Massachusetts

4. King’s College Hospital, London, United Kingdom

5. Médecins Sans Frontières Access Campaign, Geneva, Switzerland

Abstract

ImportanceThe burden of diabetes is growing worldwide. The costs associated with diabetes put substantial pressure on patients and health budgets, especially in low- and middle-income countries. The prices of diabetes medicines are a key determinant for access, yet little is known about the association between manufacturing costs and current market prices.ObjectivesTo estimate the cost of manufacturing insulins, sodium-glucose cotransporter 2 inhibitors (SGLT2Is), and glucagonlike peptide 1 agonists (GLP1As), derive sustainable cost-based prices (CBPs), and compare these with current market prices.Design, Setting, and ParticipantsIn this economic evaluation, the cost of manufacturing insulins, SGLT2Is, and GLP1As was modeled. Active pharmaceutical ingredient cost per unit (weighted least-squares regression model using data from a commercial database of trade shipments, data from January 1, 2016, to March 31, 2023) was combined with costs of formulation and other operating expenses, plus a profit margin with an allowance for tax, to estimate CBPs. Cost-based prices were compared with current prices in 12 countries, collected in January 2023 from public databases. Countries were selected to provide representation of different income levels and geographic regions based on the availability of public databases.Main Outcomes and MeasuresEstimated CBPs; lowest current market prices (2023 US dollars).ResultsIn this economic evaluation of manufacturing costs, estimated CBPs for treatment with insulin in a reusable pen device could be as low as $96 (human insulin) or $111 (insulin analogues) per year for a basal-bolus regimen, $61 per year using twice-daily injections of mixed human insulin, and $50 (human insulin) or $72 (insulin analogues) per year for a once-daily basal insulin injection (for type 2 diabetes), including the cost of injection devices and needles. Cost-based prices ranged from $1.30 to $3.45 per month for SGLT2Is (except canagliflozin: $25.00-$46.79) and from $0.75 to $72.49 per month for GLP1As. These CBPs were substantially lower than current prices in the 12 countries surveyed.Conclusions and RelevanceHigh prices limit access to newer diabetes medicines in many countries. The findings of this study suggest that robust generic and biosimilar competition could reduce prices to more affordable levels and enable expansion of diabetes treatment globally.

Publisher

American Medical Association (AMA)

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