While injectable insulin has existed in some form for a century, the prices of some have tripled over the last 10 years. In part, this has been due to the introduction of branded, performance-enhanced and longer-lasting insulin analogs that offer fewer side effects and other important healthcare benefits to diabetics compared to more basic insulins.
The three major insulin manufacturers, Novo Nordisk, Sanofi, and Eli Lilly, have all offered patient assistance programs to help with the increased costs. But in recent years, changes in healthcare benefit programs (such as the rise of high-deductible healthcare plans), and the large number of patients who remain without insurance, have led an increasing number of people to face affordability challenges for their insulin. Media reports have claimed that as many as a quarter of all insulin-dependent patients have been rationing their insulin because of cost, putting these patients in danger of diabetic ketoacidosis and, in some cases, death.
Insulin has now become a centerpiece of the drug pricing debate in the United States, with criticism and pressure on the issue coming from a variety of sides, including politicians, patients and advocates, the general public, and the media.
Amid the increased criticism, Novo Nordisk, Sanofi, and Eli Lilly each announced in Fall 2019 that they would cut insulin prices. In late January 2020, Novo introduced both a generic insulin option and a $99/ month “with or without insurance” program called “My$99Insulin.” Generic or follow-on insulin is priced between $145 and $279 depending on the brand, an option designed to help lower the costs for patients whose insurance requires that they pay list price through coinsurance or before meeting their deductible. “My$99Insulin,” available to both insured and uninsured patients who register for a redeemable card with NovoCare, provides three vials or two packs of pens (about a normal month’s supply) of any Novo Nordisk insulin for the $99 monthly payment. Novo also announced the institution of a free, one-time option for emergency insulin needs, which provides people who may be at risk of rationing with about a one-month supply of the insulin they have been prescribed. Lilly and Sanofi are reportedly developing similar programs aimed at cutting prices for at least some insulins by half, and capping monthly patient costs for others.
Lawmakers across the United States are also pushing to limit out-of-pocket costs of insulin for their constituents, whether or not they have insurance, to between $25 and $100 per month depending on the state. There has also been bipartisan pressure on the insulin manufacturers and pharmacy benefit managers to end drug rebates, which have reportedly discouraged pharmacies from stocking lower-cost insulins in favor of higher-priced options. Moreover, a recent poll found that a proposal to allow the U.S. government to manufacture insulin was the single most popular element of progressive candidates’ 2020 agendas.
The U.S. FDA is furthermore taking steps aimed at lowering insulin costs by increasing market competition. In late February, the agency passed a final rule aimed at increasing patient access to insulin as well as certain other biological therapeutics. As of March 23, 2020, marketing approvals for biological products including insulin is granted via a product license under The Public Health Service Act, rather than through the previously used approval pathway for new drugs. This change is expected to open the insulin market to new competition as it creates, for the first time, a pathway for the approval of insulin biosimilars and enables interchangeability in insulin prescribing. The agency’s action is expected to increase patient access to insulin products, adding more treatment choices and potentially reducing insulin costs.