Assessing—and Extending—California’s Insulin Manufacturing Initiative

Sherkow, Jacob S.; Adashi, Eli Y.; Cohen, I. Glenn

doi:10.1001/jama.2023.0013

JAMA

2023

DOI: 10.1001/jama.2023.0013

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Assessing—and Extending—California’s Insulin Manufacturing Initiative

Jacob S. Sherkow

Eli Y. Adashi

I. Glenn Cohen³

Abstract: This Viewpoint reviews California’s recently proposed CalRx initiative to manufacture biosimilar insulin, highlights challenges facing the initiative, and suggests ways in which, if successful, the initiative could serve as a model for state-managed development of drugs other than insulin, reduce drug prices, and provide other benefits.

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Cited by 4 publications

References 5 publications

(9 reference statements)

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New Insulins, Biosimilars, and Insulin Therapy

Danne,

Heinemann,

Pieber

2024

Diabetes Technology & Therapeutics

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New Insulins, Biosimilars, and Insulin Therapy

Danne,

Heinemann,

Pieber

2024

Diabetes Technology & Therapeutics

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Lessons From Insulin: Policy Prescriptions for Affordable Diabetes and Obesity Medications

Nagel,

Ramachandran,

Lipska

2024

Diabetes Care

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Escalating insulin prices have prompted public scrutiny of the practices of drug manufacturers, pharmacy benefit managers, health insurers, and pharmacies involved in production and distribution of medications. As a result, a series of policies have been proposed or enacted to improve insulin affordability and foster greater equity in access. These policies have implications for other diabetes and obesity therapeutics. Recent legislation, at both the state and federal level, has capped insulin out-of-pocket payments for some patients. Other legislation has targeted drug manufacturers directly in requiring rebates on drugs with price increases beyond inflation rates, an approach that may restrain price hikes for existing medications. In addition, government negotiation of drug pricing, a contentious issue, has gained traction, with the Inflation Reduction Act of 2022 permitting limited negotiation for certain high expenditure drugs without generic or biosimilar competition, including some insulin products and other diabetes medications. However, concerns persist that this may inadvertently encourage higher launch prices for new medications. Addressing barriers to competition has also been a priority such as through increased enforcement against anticompetitive practices (e.g., “product hopping”) and reduced regulatory requirements for biosimilar development and market entry. A novel approach involves public production, exemplified by California’s CalRx program, which aims to provide biosimilar insulins at significantly reduced prices. Achieving affordable and equitable access to insulin and other diabetes and obesity medications requires a multifaceted approach, involving state and federal intervention, ongoing policy evaluation and refinement, and critical examination of corporate influences in health care.

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et al. 2023

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Assessing—and Extending—California’s Insulin Manufacturing Initiative

Cited by 4 publications

References 5 publications

New Insulins, Biosimilars, and Insulin Therapy

New Insulins, Biosimilars, and Insulin Therapy

Lessons From Insulin: Policy Prescriptions for Affordable Diabetes and Obesity Medications

Moving Naloxone Over the Counter Is Necessary but Not Sufficient

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