Pharma Companies Want to Crush Medicare’s Ability to Negotiate Costs

Of course, the process of getting the challenge before the highest court would take years. But regardless of when or if that comes to pass, legal skirmishes already under way could have wide-ranging implications—including on the stock prices of pharmaceutical companies, the financial well-being of the Medicare program, and potentially for out-of-pocket costs paid by retirees.

Investors are watching closely. The
S&P 500 Pharmaceuticals
index, which fell 8.5% the month Congress passed the law as part of last year’s Inflation Reduction Act, is down 1.9% this year. It’s trailing the broader
S&P 500’s
nearly 19% increase amid worries that negotiations would be a drain on pharmaceutical profits. Those concerns may remain a damper on the sector for years, though wins in the lower courts could boost shares—particularly for Bristol, which would likely take the biggest immediate hit to earnings if the law goes into effect.

In the near-term, the industry’s legal strategy seems poised to delay implementation of the program, staving off negotiations ahead of 2026, the year the new prices would go into effect. “I think at some point between now and the Supreme Court eventually hearing it, the [Centers for Medicare and Medicaid Services] is going to be prevented from moving forward,” says Chris Meekins, a Washington healthcare policy analyst at Raymond James.

The industry puts forward a number of arguments. On the legal side, several of the suits hinge on the Fifth Amendment’s assertion that private property won’t “be taken for public use, without just compensation,” known as the Takings Clause. They argue that the process laid out in the law is not actually a negotiation, but rather unilateral price-setting, and that drug companies that opt out will face unreasonable financial penalties. 

The companies also say that the lost revenue would threaten their ability to develop new medicines. In one legal filing, J&J claimed that the price negotiation program “will deal a fatal blow” to the “innovation ecosystem.”
Novartis
CEO Vas Narasimhan told Barron’s earlier this year that his company had dropped some early-stage cancer drugs from their pipeline because the new law means they are no longer worthwhile for the company.

For Medicare, the ability to begin negotiating the prices of some of the most expensive drugs could be a critical lever to bring down costs, which have climbed in recent years. Medicare Part D, its outpatient prescription drug benefit, spent $120 billion on drugs in 2018, up from $74 billion in 2009, as measured in 2018 dollars, according to the Congressional Budget Office. The negotiation program would save the federal government an estimated $98.5 billion by 2031. (For context, Medicare spent a total of $829 billion in 2021.)

The program could also mean savings for seniors. KFF, an independent health policy group, says the law will “put downward pressure on both Part D premiums and out-of-pocket drug costs,” though the scale of the reductions will depend on the details of the negotiations.

That clarity could arrive soon. On Sept. 1, CMS is set to announce which 10 drugs will have negotiated prices in 2026; companies will then have a month to agree to participate in the negotiation process. Talks will begin in February of 2024, and end in August of 2024.

While Medicare pays for thousands of different drugs, a relative handful of high-price, newer medicines account for much of its spending on pharmaceuticals. In 2021, 10 drugs accounted for 22% of gross spending for its Part D prescription drug benefit, according to a recent KFF analysis. It’s those medicines, like
Pfizer
(PFE) and Bristol’s blood thinner Eliquis, and
Eli Lilly’s
(LLY) diabetes injection Ozempic, that the law is targeting.

The question of whether the pharma industry will succeed in blocking the law will likely be resolved in stages. Its immediate goal is to stop implementation of the program as cases proceed through the legal system. The Chamber of Commerce, in a filing in mid-July, made the first such request, asking a federal judge in Ohio to issue an injunction stopping the steps CMS is already taking to prepare for the first negotiated prices. A decision on that motion is unlikely before the fall.

That shorter-term strategy seems to explain why industry players have filed so many similar cases in jurisdictions around the country. The idea is that the more cases they file, the better chance they have of finding a judge or circuit court panel willing to issue a nationwide injunction.

The industry has, so far, been unlucky in the district court judges to which its cases have been assigned. Four of the judges were appointed by either President Biden or President Clinton, one by President George W. Bush. “They haven’t drawn judges who appear to be particularly ideologically disposed to some of these really aggressive constitutional claims,” says Zachary Baron, an associate director of the Health Policy and the Law Initiative at the O’Neill Institute for National and Global Health Law at Georgetown Law.

Appeals courts might be more welcoming. Decisions by the district court judge in the suit filed by industry lobbying group PhRMA, filed in the Western District of Texas, would be appealed to the Fifth Circuit Court of Appeals, which has found a number of federal programs unconstitutional in recent years. “I think we will end up with a stay on implementation sometime before it ends up at the Supreme Court,” says Raymond James’ Meekins. 

A stay delaying implementation of the law would be particularly good news for Pfizer and Bristol, which would likely face negotiated prices over Eliquis in 2026. Medicare Part D’s gross spending on Eliquis was $12.6 billion in 2021, according to KFF, more than any other drug.

While the drug is expected to begin facing competition from the equivalent of generics in 2028, which would exempt it from negotiation, the initial hit to Bristol in particular would be substantial: Analysts at Cowen wrote last November that negotiations over Eliquis’s price could put at risk 15% of the company’s expected 2026 earnings per share. The analysts estimated that 8% of Pfizer’s 2026 earnings per share would be at risk that year.

The potential path to a Supreme Court challenge would be much longer. 

In the Merck suit, the first case filed, the company and the federal government have agreed to a schedule that would allow the district court to rule on Merck’s motion for summary judgment by early next year. An appeal of that decision to the federal circuit court could take another year, which suggests the case could be eligible for Supreme Court review sometime in 2025.

Although circumstances could certainly change, the business-friendly record of the current court suggests that drug companies have a strong chance of success. Meekins, for his part, puts the odds that at least some portions of the law would be struck down at about 60%.

A pharma victory would certainly be a blow to the savings Medicare and U.S. seniors hope to gain. Baron is also concerned that it could have larger ramifications. In an article in the policy journal Health Affairs, he argued that the claims brought by Bristol and Merck on violations of the Takings Clause could, if successful, open the door for healthcare providers to challenge the negotiated rates that Medicare pays them. “Such a result would have devastating consequences for Medicare’s ability to contain costs and promote other efficiencies,” he writes.

While it’s difficult to look too far into the future with clarity, investors watching the battle unfold can be fairly confident that the industry will win some legal fights in the coming months. That should lift shares in the short term and likely dispel some of the gloom that’s hung over the sector this year.

Write to Josh Nathan-Kazis at [email protected]