California chooses generic drug company Civica to produce low-cost insulin

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Gavin Newsom announced Saturday the Utah-based pick Generic drug manufacturer Civica to produce low-cost insulin for the state of California, an unprecedented move that fulfills the promise of the state government appointment direct competition With branded drug companies dominating the market.

“People should not be forced into debt to obtain life-saving prescriptions,” Newsom said. “California residents will have access to some of the lowest-cost insulin available, helping them save thousands of dollars each year.”

contract with The initial cost is $50 million That Newsom and fellow Democratic lawmakers endorsed last year calls for Civica to manufacture state-branded insulin and make the life-saving drug available to any Californian who needs it, regardless of insurance coverage, by mail and at local pharmacies. But insulin is just the beginning. Newsom said the state would also look into producing the drug naloxone to treat opioid overdoses.

Alan Cockle, senior vice president of public policy at Civica, told KHN that the nonprofit drugmaker is also in talks with Newsom management to potentially produce other generics, but he declined to go into specifics, saying the company is focused on making cheap insulin widely available first.

“We are very excited about this partnership with the state of California,” Cockle said. “We’re not looking to get 100% of the market, but we want 100% of people to have access to fair prices for insulin.”

As insulin costs rise for consumers, Democratic lawmakers and activists have called on the industry to rein in prices. Just weeks after President Joe Biden Big Pharma attacked To raise insulin prices, the three drug makers who control the insulin market – Eli Lilly and Co. And Novo Nordisk and Sanofi – they will Reduce the list pricesome products.

Newsom, who has previously accused the drug industry of gouging Californians with “exorbitant prices,” argued that launching the state’s generic drug label, CalRxIt will add competition and put pressure on the industry. Administration officials declined to say when insulin products will be available in California, but experts say it could be as soon as 2025. Coukell said the state-branded drug would still need approval from the Food and Drug Administration, which could take about 10 months. .

The Pharmaceutical Research and Manufacturers Foundation of America, which lobbies on behalf of brand-name companies, California move swipe. Reed Porter, PhRMA’s senior director of state public affairs, said Newsom “just wants to score political points.”

“If the governor wants to meaningfully influence what patients pay for insulin and other drugs, he needs to broaden his focus to include others in the system that often make patients pay more than they do for drugs,” Porter said, blaming drug companies, known as benefit managers. Pharmacists, who negotiate with manufacturers on behalf of insurance companies to obtain rebates and rebates on medications.

Pharmaceutical Care Management Association, which represents pharmacy benefit managers He argued in turn Pharmaceutical companies are responsible for this high prices.

However, drug pricing experts say pharmacy benefit managers and drugmakers share the blame.

Newsom administration officials say inflated insulin costs force some to pay up to $300 per vial or $500 for a box of injectable pens, and that many Californians with diabetes skip or split their medications. Doing so can lead to blindness, amputations, and life-threatening conditions such as heart disease and kidney failure. approximately 10% of California adults have diabetes.

civic is Three types of development of generic insulin, known as a biosimilar substitute, which will be available in both vials and injectable pens. It is expected to be interchangeable with branded products including Lantus, Humalog, and NovoLog. Cockle said the company will make the drug available for as little as $30 a vial, or $55 for five injectable pens.

Insulin in the state would save many patients $2,000 to $4,000 a year, Newsom said, though critical questions about how California can get the products into consumers’ hands remain unanswered, including how to convince pharmacies, insurance companies and retailers to distribute pharmaceutical.

Last year, Newsom was also insured $50 million in seed money to build an insulin manufacturing facility; Coukell said Civica is exploring building a plant in California.

California’s move, while not tried by the state government, could be dampened by recent industry decisions to lower insulin prices. In March, Lilly, Novo Nordisk, and Sanofi pledged to cut prices, with Lilly offering a Vial at $25 per month; Novo Nordisk Promising big discounts to raise the price of a specific generic bottle to $48; And Sanofi also cut pricesin one vial Tied at $64.

The governor’s office said that manufacturing and distributing insulin would cost the state $30 per vial and would be sold at that price. Doing so, the administration argues, “will prevent the outrageous cost transfer that occurs in traditional drug price games.”

Drug pricing experts said generic production in California could decline further insulin costsand benefit people with high-deductible or no-deductible health insurance plans.

“This is an extraordinary step in the pharmaceutical industry, not just for insulin but potentially for all types of drugs,” said Robin Feldman, a professor at the University of California, San Francisco School of Law. “It’s a very difficult industry to disrupt, but California is ready to do just that.”

This story is produced by KHNthat publish California HealthlineIt is an editorially independent service California Health Care Corporation.




Kaiser Health News

This article has been reprinted from khn.org Courtesy of the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization not affiliated with Kaiser Permanente.

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