File:Cost-Based Estimated Price Algorithm for Insulins and Injectable and Glucagonlike Peptide 1 Agonists (GLP1As).png

English: "API indicates active pharmaceutical ingredient."

"The cost of manufacture for medicines in a range of different therapeutic areas has been estimated.12-14 The methods of these earlier studies served as a starting point for our approach. The cost of the active pharmaceutical ingredient (API) is the first input to which we add the costs of formulation and secondary packaging, logistical costs, profits, and an allowance for tax. A range of CBPs was produced using a competitive formula that assumes large-scale production and a conservative formula that assumes smaller production volumes and/or higher operating or profit margins (Figure 1 and Figure 2). Average API market prices were estimated by statistical analysis of international API shipment data (January 1, 2016, to March 31, 2023) available from a trade database (weighted least-squares regression model) (eMethods in Supplement 1), supplemented with direct solicitation from manufacturers and inference of costs based on product similarity if data could not be identified using the aforementioned means. Costs of specialized injection devices were derived from interviews with industry experts. Further details on API analysis and cost modeling are described in the eMethods and eTables 1-5 in Supplement 1."

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"Results In 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 Relevance High 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."

This study was featured in 2024 in science.