Civica Rx Aims to Bring $30 Insulin to Market in 2024


 

Editor’s Note: People who take insulin require consistently affordable and predictable sources of insulin at all times. If you or a loved one are struggling to afford or access insulin, visit GetInsulin.org.

Beyond Type 1 is a proud partner of the Civica Rx Insulin Development Project. Watch our interview with Civica Rx board chair Dan Liljenquist. 


Today, Civica Rx—a non-profit drug manufacturing company founded in 2018—announced its upcoming entrance into the insulin market. Launching in 2024, Civica Rx aims to manufacture and distribute Insulin that is highly similar to and has no clinically meaningful biological differences from an existing FDA-approved biologic insulin.biosimilar rapid-acting and long-acting insulin for no more than $30 per vial and $55 per box of five pens, regardless of insurance status.

They aim to do so by manufacturing generic insulins—glargine (long-acting, generic for Lantus), lispro and aspart (both rapid-actings, generic for Humalog and Novolog)—and making them available through pharmacies and available for reimbursement through insurers. The biosimilar insulins will be manufactured in Civica’s new manufacturing plant being built in Petersburg, Va, using drug substances produced by GeneSys Biologics. The plant is expected to be operational in the first quarter of 2024.

Using a transparent pricing model, Civica Rx will leapfrog current governmental efforts to lower the out-of-pocket costs of existing insulins. This will shorten the current insulin supply chain and bypass the rebates system, which currently adds hundreds of dollars to the out-of-pocket cost of insulin for many who require the drug to survive.

“High quality, modern insulin must be available to people with diabetes, without barriers and at an affordable and predictable price point. Beyond Type 1 supports Civica’s future entry into the marketplace and all efforts to make insulin more accessible to those in need,” said Tracey McCarter, Interim CEO for Beyond Type 1.

As a nonprofit, ​​Civica is launching the Civica Rx Insulin Development Project with a variety of partners including Beyond Type 1, JDRF, The Leona M. and Harry B. Helmsley Charitable Trust, Arnold Ventures, Intermountain Healthcare, Kaiser Permanente, Peterson Center on Healthcare, Providence, Glen E. Tullman Fund, Gary and Mary West Foundation, Transcarent, Trinity Health and Blue Cross Blue Shield Association.

The current state of insulin pricing

In 1921, Drs. Frederick Banting, Charles Best and James Collip sold the American patents for their discovered insulin for just $1 each. Their intention? Ensure that all those who require insulin to survive—all people living with type 1 diabetes, many living with type 2, and many others living with various forms of the disease—be able to access the life-sustaining drug.

Despite their altruistic wishes, in many parts of the world, insulin remains difficult to access or prohibitively expensive. In the United States, insulin list prices are eight times higher than in other wealthy nations. Prices have increased rapidly—a vial of insulin that cost $25 out-of-pocket without insurance in 1997 can cost upwards of $300 in 2022. The average insulin-dependent person needs several vials a month to stay alive.

A deeply opaque supply chain system has added hundreds of dollars to patients’ out-of-pocket costs, driving revenue for the companies involved: manufacturers, pharmacy benefit managers (PBMs), wholesalers, and insurers. Company profits have steadily increased as people who rely on insulin die, go into severe medical debt, ration their insulin, decide not to eat so they don’t require as much insulin, suffer mental health consequences from the resulting stress and more.

Various governmental efforts over the last decade, including the Affordable Care Act, multiple proposed federal bills, and a flurry of state-based insulin copay cap bills have sought to address the insulin pricing issue for select segments of people—mostly those who are covered by traditional forms of health insurance. Those without health insurance or those who are underinsured—like many covered by increasingly prevalent high deductible healthcare plans (HDHPs)—are often left out of governmental policy efforts.

Civica Rx’s launch of the Insulin Development Project is vital for this reason—creating lower-cost insulin for everyone regardless of insurance coverage.

Beyond Type 1’s Advocacy Efforts

We believe everyone impacted by diabetes — type 1, type 2, and beyond — has a right to the best care possible for their unique situation. This means access to the technology, medications, support, and clinical care teams that help each individual manage their chronic condition.

We work to increase access and remove barriers, giving our community the tools needed to succeed. Our advocacy work focuses on equity: making sure people with diabetes have access to care by tackling issues like systemic racism, financial privilege, and discrimination in all its forms. Learn more and get involved with Beyond Type 1’s advocacy efforts.

WRITTEN BY Lala Jackson, POSTED 03/03/22, UPDATED 03/03/22

Lala is an author and communications strategist who has lived with type 1 diabetes since 1997. She worked across med-tech, business incubation, library tech, and wellness before landing in the T1D non-profit space in 2016. A bit of a nomad, she grew up primarily bouncing between Hawaii and Washington state and graduated from the University of Miami. You can usually find her reading, preferably on a beach.