AND THEN THERE WERE THREE — The third major insulin manufacturer, Sanofi, said Thursday it will cut the list price of its most widely used insulin by 78 percent starting in January 2024.
If President Joe Biden decides to run for re-election in 2024, he is expected to use insulin price cuts as an example of the positive impact his drug-pricing policies have. We’re also watching to see whether drugmakers of other products decide to announce list price decreases sometime this year.
Keep an eye on drugs whose prices have risen more quickly than inflation, which will owe higher rebates to Medicare and Medicaid next year. The measures could prevent situations like what Turing Pharmaceuticals did to anti-parasitic drug Daraprim in 2015 when it infamously raised the price from $13.50 to $750 per pill.
The decision by Sanofi, Novo Nordisk and Eli Lilly, the three biggest insulin makers, to announce price cuts in the past two weeks comes as they confront increasing political pressure to lower prices, stiffer competition from generic manufacturers and new legislative and regulatory policies going into effect.
Notably, drugmakers who have raised the list prices more rapidly than the pace of inflation are set to be exposed to uncapped rebates in the Medicaid Drug Rebate Program starting in 2024 — meaning manufacturers might be forced to pay rebates greater than what states paid to purchase the drugs.
“These updates have been in development for many months, but due to increased stakeholder interest, we accelerated to announce now,” Novo Nordisk spokesperson Nicole Araujo said Tuesday.
Stacie Dusetzina, a professor at Vanderbilt University School of Medicine, said Novo Nordisk’s decision to follow Eli Lilly’s similar move is not surprising.
“They also face stiff competition for these drugs, meaning they have little to lose by making this change,” Dusetzina said. “As others have noted, this will also allow them to avoid paying substantial additional rebates to Medicaid that would have kicked in in 2024.”
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TODAY ON OUR PULSE CHECK PODCAST, host Alice Miranda Ollstein talks with Ben Leonard about the mistake-ridden electronic health records system at VA medical centers and Sen. Jon Tester‘s (D-Mont.) push to fix them, including renegotiating its contract with Oracle Cerner, the vendor that manages them.
PAXLOVID A STEP CLOSER TO FULL APPROVAL — An outside panel of experts on Thursday voted 16-1 that the FDA should give Pfizer’s Covid-19 antiviral Paxlovid full approval.
The panel concluded that the drug, taken as a five-day oral treatment when Covid symptoms begin, is appropriate for adults with mild-to-moderate infections at high risk of progression to severe disease.
The panel spent considerable time discussing the importance of communicating to health care providers the potential for dangerous drug interactions when the drug, used widely since gaining emergency use authorization in December 2021, is prescribed.
The lone “no” vote was cast by patient representative Terry Gillespie, who said she experienced difficulty accessing the treatment when she had Covid even though she only has one lung and is overweight.
“I’m kind of concerned about the doctors knowing actually when to prescribe it to somebody, say, like me,” Gillespie said.
The FDA often follows its advisory committees’ recommendations but is not obligated to do so. Pfizer said in December the FDA’s target date for deciding the fate of the antiviral is in May.
ADVISERS TO DISCUSS GENE THERAPY — Sarepta Therapeutics said Thursday that the FDA had agreed to convene its external neurological drug advisers to discuss the company’s gene therapy for Duchenne muscular dystrophy, a fatal condition affecting children. Sarepta asked the FDA to grant the therapy, made in partnership with Roche, accelerated approval in November. The FDA has approved three other DMD treatments from Sarepta, but this would be the first one-time treatment approved that could cure patients.
No date is set for the advisory committee meeting yet, but the FDA is slated to make a decision on the therapy by May 29.
CMS LAYS OUT DRUG PRICE NEGOTIATION DETAILS … On Wednesday, the Centers for Medicare and Medicaid Services released initial guidance outlining how Medicare intends to implement its drug price negotiation program in the coming months, David reports.
The details: The agency plans to announce 10 Medicare Part D drugs by Sept. 1 for the first year of the negotiation program; prices will take effect in 2026. The selection process includes a variety of factors, such as annual revenue and sales volume, and research and development costs. The negotiation process will run from October 2023 to August 2024.
… AND NAMES 27 DRUGS SET FOR LOWER COINSURANCE PAYMENTS — The agency also released the names of Medicare Part B drugs that will have lower coinsurance payments thanks to the Inflation Reduction Act. AbbVie’s Humira was among the 26 other drugs whose prices rose faster than inflation in the final months of 2022.
The change means that some older adults may see out-of-pocket drug costs fall by anywhere in the range of $2 to $390 per average dose.
ELDER CARE FIRMS ARE PAID TOO MUCH — Congress’ Medicare Advisory Committee voted unanimously Wednesday to recommend that lawmakers reduce Medicare’s base payment rates for the companies by 7 percent, POLITICO’s Ben Leonard reports.
According to a report to Congress released Wednesday, the Medicare Payment Advisory Commission says the government could cut reimbursements for companies that care for Medicare patients in their homes to save $10 billion over five years without affecting access to care. CMS proposed significant cuts to home health payments last year but didn’t implement them after significant pushback.
GAO WEIGHS IN ON FDA’S ORANGE BOOK — The Government Accountability Office published a report Thursday on stakeholder views of the FDA’s Orange Book, a publication of all approved drugs that includes patent information. Generic drugmakers use the Orange Book to determine when they can ask the FDA to bring their products to market.
Some of the stakeholders interviewed by GAO said the FDA could do a better job vetting patent information from brand-name drug manufacturers to ensure the Orange Book contains all the required information. Others noted the FDA could do a better job at clarifying which device-related patents the Orange Book requires.
ILLUMINA EXPANDING IN D.C. — Illumina, the leading maker of gene-sequencing machines, is bringing on Nick Magallanes to lead its Washington office, POLITICO’s Megan R. Wilson scoops. Magallanes, who is coming from Iovance Biotherapeutics, declined to comment, but a farewell email that landed in Megan’s inbox says he starts on Monday.
As head of government affairs for the Americas, he’ll lead the company’s domestic lobbying operation and its work in Canada and Latin America.
Illumina has “a strategic plan to grow our Washington footprint as we increase our work around the clinical application of genomics,” company spokesperson David McAlpine told Megan, confirming the hire.
The company has been fending off U.S. and international regulators concerned about its acquisition of biotech company Grail. It spent about $6 million on lobbying the federal government last year, nearly double the $3.3 million it spent on advocacy in 2021. The company is also now in a proxy battle with activist investor Carl Icahn.
Edward Kim, the physician-in-chief at City of Hope Orange County, joins the board of the Friends of Cancer Research.
For STAT, Lizzy Lawrence writes that most medical devices have never undergone the gold standard of clinical testing: a head-to-head competition with a placebo.
The FDA on Wednesday published draft guidance for drug manufacturers making long-lasting local anesthetics.
The FDA on Wednesday published final guidance on frequently asked questions for medical foods.
The FDA on Thursday published final guidance on suspect and illegitimate products for drug makers.