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.

中文翻译：

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胰岛素的教训：负担得起的糖尿病和肥胖药物的政策处方

不断上涨的胰岛素价格促使公众对药品制造商、药品福利管理者、健康保险公司以及参与药品生产和分销的药房的行为进行审查。因此，一系列政策被提出或颁布，以提高胰岛素的负担能力并促进更公平的获取。这些政策对其他糖尿病和肥胖症治疗有影响。最近州和联邦层面的立法限制了一些患者的胰岛素自付费用。其他立法直接针对药品制造商，要求对价格上涨超过通货膨胀率的药品进行回扣，这种做法可能会抑制现有药品价格的上涨。此外，政府对药品定价的谈判这一有争议的问题也受到关注，2022 年的《通货膨胀减少法案》允许在没有仿制药或生物仿制药竞争的情况下对某些高支出药物进行有限的谈判，包括一些胰岛素产品和其他糖尿病药物。然而，人们仍然担心这可能会无意中鼓励新药的上市价格上涨。解决竞争壁垒也是一个优先事项，例如加强对反竞争行为（例如“产品跳跃”）的执法力度，并减少对生物仿制药开发和市场准入的监管要求。一种新颖的方法涉及公共生产，加州的 CalRx 计划就是一个例子，该计划旨在以大幅降低的价格提供生物仿制药胰岛素。实现负担得起且公平地获得胰岛素和其他糖尿病和肥胖药物需要采取多方面的方法，包括州和联邦干预、持续的政策评估和完善以及对企业在医疗保健领域影响的严格审查。