Welcome to the Week in Review.
Court Watch: US v. PharmaI
Novo Nordisk’s legal battle against the Medicare Negotiation Program has shifted gears, with the company now focusing on challenging elements of the program’s implementation rather than broad constitutional arguments that were rejected by a federal judge in July. Novo Nordisk’s appeal, filed this week in the Third Circuit, claims that the Centers for Medicare & Medicaid (CMS) overstepped its authority by grouping six of the company’s insulin products as a single item for negotiation — Fiasp, Fiasp FlexTouch, Fiasp PenFill, NovoLog, NovoLog FlexPen, and NovoLog PenFill. These products were grouped due to their fundamental similarity, with variations primarily in delivery methods rather than in their formulations. The Third Circuit Court of Appeals will also be hearing combined oral arguments from Bristol Myers Squibb (BMS), AstraZeneca, and Janssen later this month. P4AD filed an amicus brief in the BMS and Janssen case and has signed onto seven other amicus briefs — led by led by Public Citizen and supported by AARP, Protect Our Care, Doctors for America, and Families USA — to defend the historic drug price negotiation program. — (Fierce Pharma, Bloomberg Law, US Court of Appeals)
Bringing CAR-T Closer To Patients
Chimeric antigen receptor T-cell (CAR-T) therapy, a groundbreaking immunotherapy for treatment-resistant cancers, offers the potential for long-lasting remissions without the need for maintenance therapy. However, significant access barriers hinder its potential relief for many patients. New research published in Transplantation and Cellular Therapy found that a patient’s proximity to a treatment center played a significant role in determining whether they received CAR-T therapy. According to their research, patients living 2-4 hours away from the nearest CAR-T treatment center were nearly 40 percent less likely to receive treatment compared with those living within 30 minutes. The current U.S. model often involves patients traveling significant distances to access CAR-T therapy and typically forces patients to wait several weeks to receive their personally modified therapy from remote sites. Contrasting this approach, countries like Spain have adopted a decentralized production model which has led to lower costs in part through bringing treatment closer to patients. As groundbreaking cell and gene therapies enter the U.S. market with price tags in the millions, we must prioritize strategies to make these potentially life-saving innovations accessible and affordable for both individuals and health systems. — (National Library of Medicine, AJMC)
Medicare “Smoothing” OOP Costs
As we approach 2025, the drug pricing provisions in the Inflation Reduction Act (IRA) are set to bring about transformative changes in how older Americans manage the cost of their medication. Two key reforms are taking effect in January: a $2,000 annual cap on out-of-pocket drug expenses and the new Medicare Prescription Payment Plan. In its first year, the spending cap promises significant savings for over 3 million recipients who do not receive the program’s low-income subsidy, addressing a critical financial burden for those with costly medications. Complementing this, the Payment Plan allows patients on Medicare to spread out their cost sharing across monthly installments, helping people who live with a chronic illness manage their out-of-pocket expenses. As implementation of these reforms nears, the growing anticipation among patients underscores the IRA’s promise of more manageable health care experience for millions of Americans. This combination of lower out-of-pocket costs and flexible payment options reflects an understanding of the complex financial challenges faced by millions of Americans who are struggling to afford the drugs they need. — (CMS, AARP)
ICYMI
Novartis recently suffered a legal setback in its effort to block a generic version of heart failure drug Entresto from entering the U.S. market. Undeterred, the pharmaceutical giant is appealing the decision, aiming to protect its lucrative franchise. In 2023, Entresto generated over $6 billion in global sales for Novartis. This case highlights the lengths brand-name drug manufacturers will go to extend their market exclusivity and stop the introduction of affordable generic alternatives that would lower costs and benefit patients.
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