A consortium of large US hospitals, which four years ago pioneered a system to alleviate chronic drug shortages for inpatients by producing their own, seeks to further disrupt the pharmaceutical system with an attempt to slash insulin costs for diabetics.
The consortium’s non-profit company, Civica Rx, said Thursday that it plans to make and sell generic versions of insulin to no more than $10 dollars per vial and $55 dollars for five injection pen cartridges, a fraction of list prices that currently range from $125 and more than $400 dollars.
The company said it expects to start selling insulin in 2024, once it completes construction of a pharmaceutical plant in 140,000 square feet in Petersb urg, Virginia, as reported by The Washington Post.
You must also be licensed by the Food and Drug Administration.
Although it is at least two years away, the measure could alleviate the high prices of insulin charged by Eli Lilly, Sanofi-Aventis and Novo Nordisk that, according to the defenders, have caused some patients of low-income people ration their insulin or skip doses.
High insulin prices have been denounced for years by advocates, doctors, and members of Congress.
Diabetics they typically use two to three vials of insulin per month, so costs can skyrocket well above $6, dollars a year for people with no insurance, inadequate coverage, or high deductibles.
Trump boasted that he made insulin so cheap it “is like water,” but Americans with diabetes do not agree.
The president Biden, in his State of the Union address on Tuesday, denounced pharmaceutical companies for charging up to 30 times the manufacturing cost of $10 dollars for an insulin vial.
You repeated your request for a price limit of $50 dollars per month for insulin for patients with Medicare, Medicaid and private insurance.
That proposal is bottled up in Congress as part of the Build Back Better initiative of the President, which was approved by the House, but stalled in the Senate.
Furthermore, Biden’s insulin price cap would not apply to people who do not have insurance, who are the patients exposed to higher list prices.
The problem of rising insulin prices has been exacerbated by lack of generic competition. Generics have been slow to arrive for insulin, a discovery from 100 years ago, because it is a biological drug that requires a regulatory framework special “biosimilar” from the Food and Drug Administration that was not fully established until 2020.
“Clearly, there is this pressing need for do something for the benefit of patients,” Civica Rx CEO Martin VanTrieste said in an interview.
“We want to be that biosimilar company that sets a standard, that offers quality insulin to lowest sustainable price.”
Civica Rx is approximately two-thirds of the way to its joint goal $125 millions of dollars in capital from its member hospitals, charitable foundations and Blue Cross Blue Shield insurance plans.
It has entered into a partnership with an Indian company, Genesys, to manufacture an insulin drug for import. ion to the United States.
The Virginia plant will then finish the drugs and fill the vials, with a capacity of up to 100 million vials per year.
“Once production starts, the business will be sustainable without the need for more charitable subsidies,” VanTrieste said.
Congress has repeatedly rejected efforts to reduce drug costs. The Civica Rx plan is among a variety of smaller-scale individual efforts aimed at lowering costs and improving reliability of supplies.
The Trump administration backed Phlow, a private company linked to Civica Rx, with more than $400 million dollars in contracts to produce in the country the materials of origin of medicines, called active pharmaceutical ingredients.
Civica Rx was released in 2018 to combat market failures that have resulted in shortages and price increases of generic injectable drugs, from steroids to pain relievers, commonly used in inpatient wards, emergency rooms and operating rooms.
Expanded last year with a plan to develop some undisclosed outpatient generic drugs that it says have chronically high prices.
Insulin list price rises increased by 250 percent in a period of 10 years.
Since 2020, only a few generics have reached the market, but two of them were “authorized generics” expedited by the brand companies.
Limited availability and prices, with discounts of 50 percent of the brand’s list prices, have attracted criticism.
Under fire because of the high prices, Eli Lilly promised cheaper insulin at 2019. The result has angered some senators
A generic insulin called Semglee, which is a version of Sanofi’s Lantus brand , entered the market in 2020. Its list price of $125 dollars per vial represents a discount of 64 percent of Lantus, at $343 dollars per vial.
Even that discount isn’t enough for people with no insurance and high deductibles, advocates argue. The cost of Semglee is higher for prefilled administration pens that make the injection more convenient: $190 dollars.
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