![]() ![]() 18 Insulin is also unique in its market structure: a persistent oligopoly both nationally and globally, in particular with respect to the prices of analog insulins. Unlike many of the new high-priced prescription drugs, insulin is almost 100 years old-discovered in 1921 and first used by a patient in 1922. More work must be done to make insulin affordable and accessible, particularly taking into account the unique aspects of the insulin market. The authorized generics and price decreases by the manufacturers are a good first step, but they do not make insulin affordable to all who need it. 17Įven with these discounts and the increased political attention, insulin continues to be out of reach for many people with diabetes. Since then, Novo Nordisk announced that it would sell an authorized generic of its insulin analog Novolog at half price, 16 and Sanofi announced that it would charge patients with no insurance or who pay cash in the United States only $99 per month for insulin. 15 This insulin product would be identical to Humalog, yet cost half the price of brand name Humalog. In response to public pressure surrounding the high insulin prices, Eli Lilly announced in March 2019 that it would provide, through a subsidiary, an authorized generic of its insulin analog Humalog. Insulin manufacturers have not completely ignored the calls for action. 13 Nevada, taking a different legislative approach, passed a law to mandate transparency in insulin pricing in 2017. For example, Colorado became the first state to legislate a price cap on insulin in 2019, 12 with several other states passing or proposing similar bills. Many states have also taken steps to address access to insulin. 10 In February 2019, Representatives Peter Welch (D-VT) and Francis Rooney (R-FL) submitted a bill to allow importation of affordable insulin from Canada and possibly other countries. 9 In July 2019, Senators Jeanne Shaheen (R-NH), Tom Carper (D-DE), Kevin Cramer (R-ND), and Susan Collins (R-ME) filed proposed legislation aimed at creating a ‘new insulin pricing model’ predominantly by regulating insulin rebates from pharmacy benefit managers. In late 2018, Senator Elizabeth Warren (D-MA) suggested that the federal government starts its own generic manufacturing plant, with insulin put forth as one product of focus. Several members of Congress have made proposals to address insulin pricing specifically. 7 The insulin pricing debate has even gained attention in popular culture: in October 2019, Jonathan Van Ness of Netflix’s Queer Eye discussed insulin pricing challenges with Elizabeth Pfiester, founder of T1International, a non-profit organization focused on access to insulin for all. 6 Several activist groups have held protests outside the United States headquarters of insulin manufacturers, blaming them for the deaths of several people with diabetes. In January 2019, Congress held hearings on insulin prices with top executives from insulin companies 5 and launched a bipartisan probe in February 2019. 4Ĭonsequently, insulin has come to the forefront of the drug pricing debate in the United States. One in four people with diabetes in the United States ration their insulin, which can lead to severe complications and even death. 3 These high prices have devastating consequences for patients. 2 The United States comprises only 15 per cent of the global insulin market, yet it accounts for almost 50 per cent of insulin-related revenue. From 2002 to 2013, the prices of the most popular insulin products tripled, 1 with some costing up to $900 per patient per month. Insulin prices are skyrocketing in the United States. In doing so, this article attempts to explain why there is such limited competition in the insulin market and identifies issues specific to the insulin market for lawmakers to consider in developing proposals to address access to affordable insulin in the United States. Further, this article discusses the potential and limitations of various legislative proposals to address access to insulin. This article examines the barriers to competition in the insulin market, considering the challenges surrounding regulatory approval, interchangeability, trade secrets, and anticompetitive behavior. Unlike many high-priced prescription drugs, insulin has been insulated from competition for years. Despite the fact that insulin was developed almost 100 years ago, the insulin market is dominated by only three companies and there continue to be no biosimilar competitors in the United States. In addition to several challenges common to high-priced prescription drugs, insulin faces several unique legal, regulatory, and practical challenges to increasing access and affordability. Insulin prices in the United States are skyrocketing.
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