Allan Coukell, Civica’s senior vice president of public policy, discusses how the generic manufacturer is disrupting the market for insulins.
The nonprofit company Civica aims to do things differently, selling lower cost generic drugs that don’t include a high mark up for profit. But it also wants to function differently in the market, Senior Vice President of Public Policy, Allan Coukell said.
Civica, a nonprofit company, partners with both manufacturing organizations and health systems to develop and offer generic medications. Recently, Civica announced it will sell insulins for no more than $30 per vial and no more than $55 for a box of five pen cartridges.
Civica will co-develop and manufacture the insulins, complete the clinical trials, and file the necessary applications for FDA approval. The company will produce three insulins — glargine, lispro, and aspart (biologics that could be interchangeable with Lantus, Humalog, and Novolog respectively).
Civica, along with CivicaScript and The Civica Foundation, is collaborating on this effort with Blue Cross Blue Shield Association and 12 independent BCBS companies, as well as other insurers and foundations. Civica has entered into co-development and commercial agreement with GeneSys Biologics for the three insulins.
The insulins will be manufactured at Civica’s manufacturing plant, being built in Petersburg, Va. The facility is expected to be operational in early 2024, and Civica anticipates that the first insulin (glargine) will be available as soon as early 2024.
“We're going to be very transparent about our selling price and what patients should pay,” Coukell said recently in an interview with Formulary Watch. "We're not going to have a high price and a subsequent discount or rebate that's only available to some purchasers. We're going to have one price for all, and we will say to patients, you should never pay more than x dollars for Civica insulin.”
Since 2019, the overall retail price of insulins has declined by about 5%, according to GoodRx. Most of this decline is a result of recent approvals of generics and biosimilars. Retail prices for generic insulin lispro and insulin aspartare are about half what the branded products sell for. The same is true some mixed insulins, such as insulin lispro 75/25 and insulin aspart 70/30, compared with Humalog 75/25 and Novolog 70/30, respectively. Traditional insulins such as Novolin and Humulin are about half of the cost of the newer products.
For the three products Civica plans to manufacture — glargine, lispro, and aspart — GoodRx shows them to be priced at well over $100 for a vial. A Humalog 10 mL, for example, sells for $335.62 per vial, and Humalog 3 mL sells for $122.81 per vial. Novolog 10 mL sells for $353.64 per vial. Lantus 10 mL sells for $343.00 per vial.
Manufacturers are charging what the market will bear, Coukell said “The retail distribution system for drugs is a system that incentivizes very high list prices; it is also not transparent about negotiated prices.
“Part of what we see with insulin is extremely high list prices, and that primarily affects people who don't have insurance or who have to pay a coinsurance based on those list prices, even if health plans and others are actually paying a much lower price,” Coukell said. “A lot of what you're looking at is a profit margin with those products.”
He points out that manufacturing costs are lower than what most companies are charging for insulin, and branded companies have repaid initial costs for developing and building manufacturing plants.
In addition to building its own manufacturing facility, Civica works with several contract manufacturers, including Patheon/Thermo Fisher. The company also sources its drug ingredients from mostly U.S. and European suppliers. For injectable medications, 88% of the company’s medicines are manufactured in the United States, Canada, and Europe. It will also include manufacturing location on the product’s label in an effort for more transparency.
Launched in 2018, Civica introduced its first drugs in the last quarter of 2019. These include: the antibiotics vancomycin, which is used to treat colitis and intestinal infections caused by Clostridium difficile, and daptomycin, which is used to treat skin and skin structure infections caused by Staphylococcus aureus. (See table below for a list of Civica’s medications.)
The Civica model allows member hospital systems to purchase drugs in predetermined volumes at stable prices. The long-term purchase commitment allows manufacturers to commit production capacity and provides a reliable supply to hospitals.
Within the market for insulins specifically, Coukell said the introduction of Civica’s insulins will bring competition and lower prices to the market. “Our mission is to fix problems because the market is not fixing things on its own. We hope that if Civica insulin is out there for no more than $30 a vial that other manufacturers will have to respond to that. It will become difficult or impossible for anybody to try to charge patients hundreds of dollars for an identical product.”
Beyond insulin, Civica has identified other areas ripe for generic competition and has several products in development. But Coukell would not say specifically what they are. “They go across therapeutic areas, and they are all off-patent.”