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How Lilly’s cuts will affect other efforts to lower insulin prices; pharma rebukes U.K.over clawback

STAT+ Pharmalot

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is a decidedly low-key affair. We look forward to promenading with the official mascot, binge-watching in front of the telly, and holding our weekly listening party (the rotation includes this, this and this). And what about you? Spring is edging closer, so this may be an opportunity to get a head start on cleaning out your castle. You could slow down and catch up on your reading, plan an overdue getaway, or simply chart the rest of your life. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

Now that Eli Lilly slashed the price for some of its insulin products, the moves raised questions about what will happen to other efforts to provide low-cost insulin, Kaiser Health News explains. Civica, a nonprofit, plans to begin selling biosimilar insulin for roughly $30 per vial by 2024 — $5 more than the new price of Lilly’s generic insulin. And the Mark Cuban Cost Plus Drug Co. plans to sell low-cost insulin. But drug=pricing experts predict Lilly’s moves will not undercut those efforts. And these other initiatives to bring lower-cost insulin to market, in turn, would put pressure on Lilly to keep its prices down.

A Biden administration proposal to broaden access to over-the-counter medications is drawing interest from manufacturers of products as varied as birth control, erectile dysfunction, and cholesterol medication. But while some companies are already altering plans to fit the requirements, the idea is also raising concerns among consumer advocates over cost and safety issues, Roll Call tells us. The proposed rule would allow drugmakers to sell certain products over the counter with an extra step, or an “additional condition for nonprescription use,” to help mitigate safety concerns. That could include a brief phone, online, or in-store survey to weed out those at risk for side effects.

A decision by the U.K. government to raise the revenue clawback rate in its Statutory Scheme for controlling the costs to the National Health Service for purchasing branded medicines has prompted a swift rebuke from the pharmaceutical industry, Pharmaphorum writes. Raising the rate to 24.4% to 27.5% on April 1 will make it less likely that industry will invest in the U.K., undermining the government’s drive to make the U.K. a life sciences superpower, warned the Association of the British Pharmaceutical Industry. The Statutory Scheme was established alongside a voluntary scheme for branded-medicines pricing and access as a way of capping annual drug spending by the NHS at 2%.

In response, Viatris warned that it will stop selling some essential medicines in the U.K. that are already in short supply unless the government makes changes to its voluntary medicines pricing agreement, Reuters notes. The clawback rate rose during the pandemic and is worsening business environment in the U.K. already strained by soaring costs associated with the war in Ukraine amid other inflationary pressures, a Viatris executive said. Viatris estimates it will pay the government $71.6 million under the program this year and has determined that it must prioritize other markets where it can make a profit.

The U.S. invested at least $31.9 billion in public funds directly into the development, production, and purchase of Covid-19 vaccines based on mRNA technology through channels ranging from the National Institutes of Health to the U.S. Department of Defense, Health Policy Watch writes, citing a study in BMJ. That vast pool of U.S. public funding was indispensable to the development of mRNA vaccines that have netted Moderna and Pfizer over $100 billion in sales revenues since their launch, an amount 20 times greater than the budget of the World Health Organization for 2020-21.

The number of generic drugs approved by the U.S. Food and Drug Administration rebounded in 2022 after a drop in 2021, according to Regulatory Focus. Last year, the agency approved or tentatively approved 917 abbreviated new drug applications compared with 776 in 2021, 948 in 2020, and 1,014 in 2019. The number of ANDAs approved last year include 106 so-called first generics, which refer to drugs that previously had not had generic competition. In a report, the FDA Office of Generic Drugs highlighted the first generic approval of a generic version of the Restasis eye treatment.

Attorneys general from 22 states wrote to the U.S. Centers for Disease Control and Prevention and the National Center for Health Statistics urging the federal government to adopt a new diagnostic code for HIV prevention medicines, or PrEP. The goal is to ensure that patients are not improperly charged copays for preventive services. They noted that, under the Affordable Care Act, preventive services, such as PrEP, should be covered at no cost to the patient. However, several states have received complaints from patients who have been charged copays for covered PrEP-related services, which would violate the law.

Reporter: Ed Silverman, Pharmalot Columnist, Senior Writer


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