Les laboratoires contestent les modèles internationaux de fixation des prix des médicaments de Trump

Major biotech and pharmaceutical companies are asking the Trump administration to rescind two proposals seeking to align U.S. drug prices with cheaper ones overseas, warning the sweeping policies harm innovation and exceed the government's authority. The Centers for Medicare & Medicaid Services' plans would test whether alternative methods for calculating rebates under Medicare Part B and Part D, based on international pricing metrics, will reduce drug costs.

The Medicare pilot programs are part of President Trump's effort to get drugmakers to lower prices in the United States to levels charged in other rich countries, a policy generally referred to as most-favored-nation. The Global Benchmark for Efficient Drug Pricing (GLOBE) Model would apply to physician-administered drugs in Medicare's Part B. The Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model would apply to Part D retail drugs. The government estimates that, together, the models would reduce spending by $27 billion over the five years they're in operation.

The pricing demonstrations, which are mandatory for manufacturers to participate in, would help implement President Trump's pricing initiatives. If finalized, the demonstrations could inject a new wave of instability into how manufacturers bring new therapies to the market and price them in the U.S., according to comments the industry submitted in response to the plans.

The models would ultimately require that manufacturers pay an incremental rebate if the Medicare price for a drug exceeds an international benchmark price. That comes in addition to the current inflation rebate they pay under federal law. The models, which would be tested among a random 25% of beneficiaries of the Part B and Part D programs, also don't define a clear population with deficits in care.

Some of the world's largest drugmakers are rejecting the proposals, questioning the agency's legal ground and methodologies. The CMS said it plans to exercise its authority under Section 1115A of the Social Security Act, a law that allows it to test new payment and service delivery models aimed at reducing costs and improving quality of care. But the industry has long questioned whether the proposed systems are allowed under the statute and if the CMS can implement them without congressional authorization.

The plan is "nothing like the sample models included in the statute," industry groups argued. The Pharmaceutical Research and Manufacturers of America, the drug industry's influential lobbying arm, urged the government to withdraw its plans. The Biotechnology Innovation Organization, the chief lobbying group for more than a thousand biotech companies, said to the agency that "imposing pricing policies that introduce additional unpredictability—particularly those tied to foreign price benchmarks—could dampen investment in areas where investments are especially high risk but may yield revolutionary new therapies."

The requests come despite the various deals manufacturers have struck with Trump to slash drug prices. Those agreements, which were voluntary, are primarily focused on Medicaid and direct-to-consumer drug purchasing platforms. Some drugmakers have wondered if they would be exempt from the pricing models if they made a deal with Trump. A CMS spokesperson said in an email that if the proposals are finalized, the agency would outline how the models would interact with existing pricing arrangements.

The demonstrations also stand to influence how manufacturers invest in U.S. innovation if the federal government aligns pricing policies with foreign markets that are rooted in different values, drugmakers said. "These therapies often depend on a small number of approved indications to recoup investment and fund future research," AstraZeneca said. "Mandatory pricing mechanisms that compress revenue without accounting for these realities risk disproportionately harming rare disease drug development."

The development of generic and biosimilar products, which are cheaper alternatives to branded medications, would also be threatened, the Association for Accessible Medicines said. The industries require predictability so that manufacturers can forecast the market they are entering, but the models remove that stability "by imposing pricing benchmarks in randomly selected geographic areas that are not connected to market prices," the group said.

Any policy implementing most-favored-nation would also impair biotech companies' ability to raise the venture capital funding needed to finance research and development, according to Incubate, a coalition of early-stage life sciences investors.

Meanwhile, CMS Administrator Mehmet Oz is urging lawmakers to codify Trump's most-favored-nation policies into law, a move that would bring more legal protections to the plan. At an industry forum, Oz sought to present Trump's most-favored-nation effort as accommodating to manufacturers. "I don't want to hurt innovation," he said. He noted that much of the initiative applies to Medicaid, where "prices are lower anyway, so it's less hurtful; the sector did OK, we believe."

He said the administration is seeking to get Congress to write most-favored-nation agreements into law because once contracts expire, "if it's not done right, a future administration will take more drastic, draconian steps in ways that would hurt this industry."

The industry trade group's CEO told reporters afterward that it unequivocally opposes Congress codifying most-favored-nation pricing, seeing it as "price controls" that will harm innovation. He noted the importance of a "stable, predictable" agency and added that "nothing chills investment like uncertainty."

The industry itself has been divided on the most-favored-nation pricing front, with large companies like AstraZeneca, Pfizer and Eli Lilly agreeing to voluntary deals with the administration, while the trade group remains adamantly opposed to the idea. The CEO said that "there's a big difference between voluntary agreements with individual companies" and "codifying on a broad-basis price controls in legislation."

Congress doesn't appear likely to take action this year, with many Republicans in Congress concerned with the policy and the way it could interfere with the free market.