- Eli Lilly will introduce an authorized generic of its top-selling Humalog at a 50% discount to the insulin product's current list price, the diabetes drugmaker said Monday.
- The lower-priced version of Humalog will be identified by the biologic's nonproprietary name, insulin lispro, and will be sold through ImClone Systems, a subsidiary of the Indianapolis-based drugmaker. Lilly said they have already manufactured vials and pens of the copycat insulin and will work to make it available as soon as possible.
- Lilly's move, which shares similarities with recent decisions reached by several other drugmakers, is aimed at addressing the affordability issues experienced by patients exposed to the full list price of Humalog, company CEO David Ricks said in a statement. Insulin manufacturers like Lilly have steadily raised the list prices for their products, although they argue that's due to the increased rebates paid to insurers to gain coverage.
The three major diabetes drugmakers — Lilly, Novo Nordisk and Sanofi — have increasingly felt pressure from both the public and from lawmakers over insulin affordability.
Just last month, leaders of the Senate Finance Committee launched an investigation into insulin pricing practices, adding to a long list of congressional and legal inquiries facing the three companies.
While there are two "follow-on" insulin products mimicking older products like Humalog and Lantus, there are currently no substitutable generics available in the U.S. for the needed drug — due, in part, to a regulatory quirk that has held up development of insulin biosimilars.
Lilly's new insulin lispro will serve as an authorized generic, costing $137.55 per vial and $262.50 for a five-pack of KwikPens. The pharma will continue to market its higher-priced, branded version.
While 50% less, those prices are still too high, according to Patients for Affordable Drugs, an advocacy group.
"After raising the price of Humalog more than 1000 percent in two decades, today's announcement for only a fraction of the insulin community is not enough," the group's executive director, Ben Wakana, said in a statement.
Ricks framed his company's cheaper insulin version as a small fix to a bigger problem.
"For people with diabetes, a lower-priced insulin can serve as a bridge that addresses gaps in the system until a more sustainable model is achieved," Ricks said.
"No one should pay the full Humalog retail price," he added, later referring to the sizable rebates Lilly hands to insurers each year.
For 2017, for example, Lilly disclosed that the average rebate and discounts on its products sold in the U.S. amounted to 51% of list prices. A recent report from rival Sanofi, meanwhile, showed the French drugmaker paid nearly $12 billion in rebates across its U.S. business last year.
Figures from Sanofi's report show the wholesale cost of its flagship insulin Lantus (insulin glargine) more than doubled since 2012, even as the net price fell by 25%.
Increasingly, however, more Americans are facing the full list price of drugs, including insulin. Payers typically use rebates to lower premium costs for healthcare plan members overall, but individuals who are paying through their deductible must cover drug costs in full out-of-pocket. Additionally, co-insurance is usually based off a medicine's list price, rather than the net price after accounting for rebates.
In announcing the decision, Lilly's Ricks indicated his support for a proposal by the Trump administration to recast the role rebates play in Medicare. The plan would eliminate payments to insurers and pharmacy benefit managers, channeling those savings to patients directly at the pharmacy counter.
At a recent Senate hearing, seven of Ricks' pharmaceutical executive peers also said they support the administration's plans.
Pharma companies have increasingly criticized the rebate system, claiming patients don't benefit from the discounts drugmakers give to insurers on their products. Payers, however, argue that rebates are reflective of the negotiations they conduct with drugmakers to lower healthcare costs for their members.
In an effort to sidestep widening gross-to-net price differences, other drugmakers have taken similar actions in recent quarters as Lilly did Monday. Gilead Sciences, for example, recently introduced authorized generic versions of its hepatitis C drugs Harvoni (ledipasvir/sofosbuvir) and Epclusa (sofosbuvir/velpatasvir).