Novartis is the latest pharmaceutical company to challenge the White House’s Medicare drug pricing negotiation program, joining six others in legal action. Their lawsuit followed the Department of Health and Human Services (HHS) revealing ten drugs included in the program. HHS anticipates further legal challenges. The Biden administration’s initiative aims to save $25 billion annually by 2031 through drug price negotiations. HHS faces additional lawsuits from the U.S. Chamber of Commerce, PhRMA, and others. Family caregiver support is another key issue discussed at the upcoming HLTH event in Las Vegas.
Novartis, the latest pharmaceutical company to challenge the White House’s Medicare drug pricing negotiation initiative, filed its lawsuit just three days after the Department of Health and Human Services (HHS) unveiled the initial ten medications included in the program, with Novartis’ heart failure drug Entresto among them. Experts anticipate that HHS may encounter additional legal challenges from the manufacturers of these ten drugs.
Last Friday, Novartis joined the ranks of seven drug manufacturers contesting the White House’s Medicare drug pricing negotiation program. Their lawsuit followed HHS’s announcement of the first ten drugs covered under Medicare Part D, selected for price negotiation purposes, with Novartis’ heart failure medication, Entresto, among the chosen medications.
Legal experts warn that HHS could face more lawsuits from the manufacturers of the ten drugs named last week.
The Biden administration’s drug pricing reform plan aims to achieve annual savings of $25 billion by 2031 through negotiating the prices of high-cost medicines covered by Medicare. The ten drugs recently disclosed by HHS accounted for a total of $50.5 billion in gross covered prescription drug costs under Part D, representing 20% of the total Part D drug expenses between June 1, 2022, and May 31, 2023. In 2022, Medicare beneficiaries spent $3.4 billion out of pocket on these drugs.
Novartis now joins Astellas, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Johnson & Johnson, and Merck in opposing the Medicare drug pricing negotiation program. Except for Astellas, all these pharmaceutical companies have at least one drug on HHS’s list from last week.
Although Amgen, Eli Lilly, Novo Nordisk, and Pfizer also have drugs on the list, they have not yet filed lawsuits against HHS over the negotiation plan. Nevertheless, legal experts suggest that lawsuits from these companies may be forthcoming.
HHS is simultaneously facing lawsuits from the U.S. Chamber of Commerce, the Pharmaceutical Research and Manufacturers of America (PhRMA), and a joint complaint filed by the National Infusion Center Association and the Global Colon Cancer Association, all regarding the price negotiation plan’s legality.
Support for Family Caregivers is a crucial topic, especially considering the time-consuming and stressful nature of caregiving, particularly when caregivers must juggle their responsibilities alongside work, raising children, and other family commitments. This issue will be one of many discussed at the upcoming HLTH event in Las Vegas from October 8-11.
Like the previously filed complaints, Novartis’ lawsuit asserts that the White House’s plan is unconstitutional. Novartis stated in a press release, “The drug price-setting provisions in the [Inflation Reduction Act] represent an unconstitutional taking of pharmaceutical manufacturers’ private property and would impose excessive and crippling fines on any pharmaceutical company that refuses either to participate in the supposedly voluntary ‘negotiations’ or to accept CMS’ purported ‘maximum fair price’ for a particular drug at the end. The provisions also force the company to endorse views with which it profoundly disagrees, in clear violation of Novartis’ rights under the First Amendment.”
Healthcare law expert Robin Feldman previously noted that plaintiffs challenging the drug price negotiation plan face a formidable task in convincing the courts of its constitutional violation. However, these lawsuits are likely intended to reach the Supreme Court, potentially delaying the government’s ability to implement price negotiations. Moreover, companies with drugs on the list may enhance their lawsuits by providing more specific details about the plan’s potential financial repercussions, bolstering their legal case.
