Senators lambast Eli Lilly’s Lispro authorized-generic program

Eli Lilly’s Lispro (insulin) authorized-generic program, which began last spring, is under fire from a report by the staffs of Senators Elizabeth Warren (D-MA) and Richard Blumenthal (D-CT). Reading the report, though, is a version of asking ‘How high is up?’ regarding pharma companies’ efforts to satisfy market demand.

In the ongoing fights over drug pricing in the US, diabetes treatments have emerged as a critical battleground: the disease is widespread (29+ million patients in the US); insulin treatments have seen jacked-up pricing over the past decade (doubling between 2012 and 2016); and the three main providers (Lilly, Sanofi and Novo Nordisk) are all large multinationals. Television news reports have shown patients buying insulin on street corners or traveling to Canada to get the drug; there have also been reports of deaths attributed to a lack of medicine availability.

In response to the criticism, Eli Lilly announced an authorized generic program last March, to provide the same insulin (Humalog) but at a 50% discount ($137.35 for a single 10-ml vial), and branded as Lispro. Lispro is by no means the first authorized generic; the general theory is that payers and their PBMs will continue to specify the branded product, but the authorized generic can serve un- or under-insured patients, who pay cash and/or have high deductibles.

The Warren-Blumenthal team found that, of 386 pharmacies nationally (split between chains and independents, and factoring in the prevalence of diabetes) contacted between July and September, 83% did not have Lispro in stock, and of those, 69% “could not order the drug.” Half of the pharmacies with Lispro in stock offered it as a first option to consumers; and only 15% offered it without prompting.

The report concludes that the Lispro program “rather than expanding access to low-cost insulin, appears instead to be a public relations move intended to ease scrutiny on the rising price of insulin.” Senator Blumenthal’s take: “Our report shows that Eli Lilly has failed to deliver on its promise to put a more-affordable insulin product on the shelves.”

Or not…

A Lilly spokesman told STAT News that “the vast majority” of Humalog users, with insurance coverage or “other assistance” (presumably, Medicare or Medicaid), pay $50 or less per month for the drug. Of course, this means that insurers pay the bulk of the drug’s cost—but that brings in the question of how much behind-the-scenes discounting goes on between list prices and rebated prices. As past patterns have shown, in many situations, payers such as employers are willing to select the higher-priced branded product, expecting to receive the bulk of the rebate back as a way to lower their overall insurance costs. (In effect, sick patients are subsidizing the insurance costs of healthy ones.)

It’s interesting, too, to contemplate what the Warren-Blumenthal team expected Lilly to do, following the Lispro introduction; the assumption is that Lilly could simply will the drug onto pharmacy shelves overnight when it reality, it takes time for distributors to acquire a newly introduced drug, and for pharmacies to add it to their inventories. (The flip side of this is the nearly military-style programs that manufacturers and wholesalers undertake with a new product launch, with “fast fill” programs and prestocking a drug so that it hits pharmacy shelves the day it is permitted to do so.)

Then there’s the consumer-demand part of the issue: even before the Lispro announcement, Lilly had set up a Diabetes Solution Center (daytime phone: 833 808 1234) “to see whether there is a lower-cost alternative available for them,” and that thousands of patients are taking advantage of this. The Warren-Blumenthal team blames Lilly for retail pharmacists not providing up-front information—but those pharmacists are not Lilly employees.

And so… Lilly’s competitors have announced various discount or authorized-generic programs—but all three continue to charge the elevated list prices for their branded products. The Warren-Blumenthal report mentions the alternatives those senators are proposing, including importing product from Canada (where a vial reportedly costs $32); passing legislation to enable the federal government to manufacture product for itself, and mandating price reductions (as is the case in the recently passed House legislation). In all likelihood, the current industry-government standoff will simply continue.