Civica will produce three insulins – glargine, lispro and aspart (biosimilars corresponding to, and interchangeable with, Lantus, Humalog and Novolog, respectively). All will be available both in vials and in cartridges for prefilled pens. Civica insulins are expected to be available in 2024.
What type of insulins will Civica produce and when?
How much will the insulin cost?
Civica plans to set a recommended price to the consumer of no more than $30 per vial and no more than $55 for a box of five pen cartridges, a significant discount to prices charged to uninsured individuals today.1 The single, transparent, price of Civica insulins will be based on the cost of development, production and distribution.
Civica Script’s policy for pharmacies and others who choose to distribute Civica insulins reflects its philosophy that prices to consumers should be fair, reasonable, and transparent, and be no more than the public, recommended price.
1Based on a publicly available current average list price of glargine (Lantus), lispro (Humalog) and aspart (Novolog) on https://www.goodrx.com/ on February 28, 2022.
Why not free insulin for all?
Civica’s goal is to provide insulin at the lowest sustainable cost in the United States that allows us to cover the cost of development, production and distribution.
Where will Civica’s insulins be manufactured?
The insulins will be produced in partnership with GeneSys Biologics at Civica’s state-of-the-art 140,000 square-foot manufacturing plant, being built in Petersburg, Virginia. The facility is expected to be operational in early 2024.
As a result of its partnership with GeneSys Biologics, Civica will have exclusive rights in the U.S. to market and sell these three insulin biosimilars at costs that are substantially lower than what is currently available in the U.S.
How is Civica able to produce insulin at a lower expense?
The entire focus of this effort is on making insulin affordable. That means pricing the product based on the actual cost of development, production and distribution – without the mark-ups and rebates that distort the price today. As a non-profit organization, we’re able to make that happen.
Why is insulin so expensive today?
There has long been an oligopoly on insulin production, with only three manufacturers of insulins, three primary wholesalers, and three PBMs that distribute insulin. Even with biosimilar insulins now entering the market, manufacturers and PBMs are incentivized, as all for-profit companies are, to make money off their products. Even if they lower the price or provide pass-through rebate programs, the cost of insulin remains unattainable for millions of Americans, especially those who are underinsured or uninsured.
Some states have capped insulin prices; can you comment on that?
At Civica, we welcome all efforts to address the current high price of insulin. Some states have capped out-of-pocket insulin costs for insured populations – something that Congress is also considering for Medicare recipients. However, no entity has limited insulin costs for the uninsured, which Civica’s low-cost insulins will.
Civica’s decisive action to bring affordable insulin to market at a drastically reduced cost to people with diabetes will make this a far more affordable product across the board. Even with policies capping insulin out-of-pocket costs, Civica insulin has the potential to produce savings for people with diabetes.
Current legislative proposals, including the Build Back Better plan, suggest capping patient copays for insulin at $35 for a 30-day supply starting in 2023. Wouldn’t that drastically reduce the price of insulin even before you entered the market? Would Civica’s insulin still be needed?
Currently, the proposed Build Back Better legislation and the Affordable Insulin Now Act include a cap of $35 or less per month on the cost of insulin. However, that cap only applies to those with Medicare or those who are privately insured. The cap would not apply to those who are uninsured, who often pay the most out of pocket for their medications.
In addition, Build Back Better sets an even lower out-of-pocket limit on low-cost insulin, meaning there is potential synergy with Civica’s insulin for added savings for those with insurance. Civica’s decisive action to bring affordable insulin to market at a drastically reduced cost to people with diabetes will make this a far more affordable product across the board.
How will Civica guarantee product quality and safety?
Our insulins will be subject to the same rigorous standards as all other insulins on the market. Quality is one of Civica’s core values, reflected by our seasoned management and manufacturing team who bring decades of experience in making injectable drugs.
Civica will independently test and co-test the active substance purchased from GenSys Biologics. Our clinical studies will be done by an independent Contract Research Organization.
Civica will complete the R&D and file for FDA approvals for three biosimilar insulin products. The FDA will then review all the data and make an approval decision.
Where and when will the insulin be available for purchase?
Civica insulins will be available to any hospital, retail or home delivery pharmacy that is willing to sell Civica insulins at no more than the recommended price. Contingent on FDA approval, we anticipate that the first Civica insulins will be available for purchase as soon as early 2024.
How much supply will you be able to produce?
The facility, which will be operational in early 2024, will have more than enough capacity to meet the expected demand and to serve a substantial portion of the total U.S. insulin need. It has additional space available to further increase production if necessary.
Even after Civica’s insulin is on the market, there may be cheaper insulin in other countries – if so, why are other countries able to provide insulin at a lower cost?
Other countries have healthcare systems that are structured differently from the U.S. healthcare system. While we can partner with state governments and can push for healthcare reform at the federal level, there is a limit to the amount of government support available for the manufacturing of drugs and therapies. We have created a model that lowers the cost of insulin for people with diabetes as much as possible while also ensuring a reliable supply of affordable insulin.
Who is funding this effort and how much have they contributed?
Civica is collaborating on this effort with partners that represent nearly every corner of the diabetes ecosystem and are putting their goals into action by coming together to bring accessible, affordable, quality insulin to the people who need most.
These partners, who have made substantial contributions and commitments, include Arnold Ventures, Beyond Type 1, Blue Cross Blue Shield Association and 12 independent BCBS companies (Arkansas Blue Cross and Blue Shield, Blue Cross and Blue Shield of Alabama, Blue Cross and Blue Shield of Hawaii, Blue Cross and Blue Shield of Vermont, Blue Cross of Idaho, Blue Shield of California, CareFirst BlueCross BlueShield, Excellus BlueCross BlueShield, Florida Blue, Highmark Blue Cross Blue Shield, Horizon Blue Cross Blue Shield of New Jersey, Independence Blue Cross), Gary and Mary West Foundation, Glen E. Tullman Fund, Intermountain Healthcare, JDRF, Kaiser Permanente, Peterson Center on Healthcare, Providence, The Leona M. and Harry B. Helmsley Charitable Trust, Transcarent and Trinity Health.
What are Civica and CivicaScript?
Civica is a non-profit, generic pharmaceutical company with a mission to make quality generic medicines accessible and affordable to everyone. Civica was created by hospital systems and philanthropies in 2018 to reduce and prevent chronic drug shortages in hospitals and the unpredictable price spikes that often accompany them.
CivicaScript is the new Civica operating unit dedicated to lowering the cost of select high-cost generic medicines at the pharmacy counter. Using a cost-plus and price transparent model, CivicaScript, with its health plan partners, will further transform the supply chain to lower the cost of prescription medicines to ensure that consumers benefit from these medicines at a fraction of their current cost. CivicaScript is a statutory public benefit company that is bound by the principles of providing sustainable, affordable, essential, generic medications in a manner that promotes the social welfare and health of the community.