Cardiometabolic Trends Dominate First Round of Drugs Chosen for Medicare Price Negotiations

The IRA measure is a good first step, but some are looking even further ahead to GLP-1 price drops to increase access.

Cardiometabolic Trends Dominate First Round of Drugs Chosen for Medicare Price Negotiations

With cardiometabolic agents making up the bulk of the first 10 drugs selected for Medicare price negotiations, new data capturing their already-rapid rise in use over a decade—and the rise in spending that comes with it—show that even more action is needed to reduce costs, authors of a new analysis say.

Between 2012 and 2021, the number of prescriptions for all 10 drugs increased by 375%, with  99% increase attributable to the seven cardiometabolic drugs: apixaban (Eliquis; Bristol-Myers Squibb), rivaroxaban (Xarelto; Bayer/Janssen), sacubitril/valsartan (Entresto; Novartis), dapagliflozin (Farxiga; AstraZeneca), sitagliptin (Januvia; Merck), empagliflozin (Jardiance; Boehringer Ingelheim/Eli Lilly), and insulin aspart (Fiasp and NovoLog; Novo Nordisk).

Similarly, total spending for all 10 drugs increased from $3.5 to $27.5 billion per year during the same period (P < 0.001), with more than 80% of the increase attributed to the same seven drugs. As a group, the cardiometabolic agents accounted for nearly 15% of total Medicare Part D expenditures.

“This underscores that given the high prevalence of cardiometabolic disease in the United States, [price negotiation] is a good first step, but we certainly need to do more to reduce both total drug costs as well as out-of-pocket costs for patients,” Kamil F. Faridi, MD (Yale School of Medicine, New Haven, CT), senior author of the analysis published last week in the Journal of the American Heart Association, told TCTMD.

At a time when concerns are being raised about the Trump administration will impact US science and healthcare policy, efforts to enable Medicare to negotiate prices for select drugs as part of the Inflation Reduction Act (IRA), at least for now, remain in place. The first 10 drugs selected for lower pricing are set to take effect for patients with Medicare Part D prescription drug coverage in January 2026.

Just prior to the change in US presidential administrations, the Centers for Medicare & Medicaid Services (CMS) announced the next 15 drugs that had been selected for price negotiations, which includes glucagon-like peptide-1 (GLP-1) receptor agonists. CMS recently proposed changes that would cover those agents for Medicare recipients for the treatment of obesity. The Trump administration will now be involved in those negotiations, with any price changes not taking effect until 2027.

We know for a fact that there are many parts of the Inflation Reduction Act that are at odds with the Republican administration's priorities, but this does not seem to be one of them. Dhruv Kazi

According to information released in August 2024 by CMS, the savings for the first 10 drugs range from 38%-79% off the manufacturers’ 2023 list prices for a 30-day supply. For example, among the nearly 4 million Medicare Part D users taking apixaban, the negotiated price of $231 is less than half of the list price. The most expensive of the 10 drugs is ibrutinib (Imbruvica; AbbVie/Johnson & Johnson), which has an estimated 17,000 Medicare Part D users. The negotiated pricing drops the monthly cost from $14,934 to $9,319.

But reports suggest that the list prices may be overinflated by CMS, with Medicare not paying those exorbitant prices and already receiving significant rebates on at least some of the drugs, calling into question how the deep the discounts ultimately will be.

“Although the actual numbers may be off in the sense that we don't have a full sense of the exact rebate and therefore what Medicare ends up paying for these drugs, the trends over time are important,” said Dhruv Kazi, MD (Beth Israel Deaconess Medical Center, Boston, MA), who commented on the new analysis for TCTMD.

But as both the investigators and Kazi noted, most spending was within 9 years of drug approval. That’s important because the IRA only applies to small molecule drugs that have been on the market more than 7 years and biologics on the market for 11 years. Factoring in about 2 years for selection and price negotiation, that’s at least 9 years that a new drug would continue to increase in price before it would be eligible for negotiation.

For the drugs that are chosen, Kazi said one of the strongest features of the IRA is the expenditure control mechanism built into it in the form of inflationary price checks that limit price increases relative to inflation through penalties to drug makers.

He and Faridi agreed, however, that even while the IRA is limited in scope, its focus on cardiometabolic and cardio-kidney-metabolic medications seems well timed given the climbing prescribing and spending on the drugs.

Cardiometabolic Drug Claims

For the analysis, Faridi and colleagues led by Mohammed Essa, MD (New England Heart and Vascular Institute, Manchester, NH), used publicly available data from 2012 to 2021 to evaluate use and spending for all 10 drugs, which also include etanercept (Embrel; Amgen) and ustekinumab (Stelara; Johnson & Johnson).

Total spending during the study period was $136.3 billion. Of that, 61% was spent on drugs within the first 9 years of market introduction.

Individually, total spending was greatest for apixaban at $8.9 billion in 2021 (32.5%), far outpacing rivaroxaban (13.5%), which racked up $3.7 billion in annual spending. The lowest drug spending was on dapagliflozin at $1 billion. There were less than 400,000 total claims for etanercept, ibrutinib, and ustekinumab across the study period.

By 2015, the investigators found, the seven cardiometabolic drugs constituted 97.2% of annual claims, increasing to 98.3% by 2021.

“We think it’s clear that this class of medications needs particular focus on reductions in total drug costs, out-of-pocket costs, and increased access,” Faridi said.

Kazi said while the hope is that the IRA will aid in all those things, it’s not clear that price negotiation is the most effective way to do that, although in the long run it could help make Medicare Part D more affordable for those who don’t currently have it.

As for what could lie ahead in terms of challenges to the price negotiations, he said fortunately it seems that lowering drug prices are one of the few issues that have bipartisan agreement.

We know for a fact that there are many parts of the Inflation Reduction Act that are at odds with the Republican administration's priorities, but this does not seem to be one of them,” Kazi noted. “This first round of price negotiations feels almost like a trial round compared with the savings that we could get out of the second iteration . . .  and what that would mean for access to GLP-1 receptor agonists for Medicare beneficiaries.”

Sources
Disclosures
  • Essa and Kazi report no relevant conflicts of interest.
  • Faridi reports research funding from the National Institutes of Health/National Heart, Lung, and Blood Institute outside the scope of the current work.

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