Welcome to the Week in Review.

Court Watch: US v. Pharma

Marking another significant upset for Big Pharma and a critical victory for patients, Novartis faced a setback last week in its lawsuit to stop the implementation of the Medicare Negotiation Program. District Judge Zahid Quraishi rejected Novartis’ claim that the program violated the Takings Clause, compelled speech protections, and the Excessive Fines Clause, underscoring, yet again, the voluntary nature of the program. Novartis’ case was the final of four cases before Judge Quraishi, and he has now ruled in favor of the government and patients in all four. This case also marks the eighth lawsuit to be ruled against the pharmaceutical industry. Next week, oral arguments will be heard as Bristol Myers Squibb, AstraZeneca, and Janssen lay out their appeals before the Third Circuit Court of Appeals. “Behind every one of these legal challenges is a story of a patient rationing their medication or going into debt to afford life-saving drugs,” P4AD’s David Mitchell said in a statement this week. “The court’s decision last week moves us one step closer to a future where no one has to make these impossible choices.” — (Bloomberg Law, Washington Monthly)

First Patient Leaves Hospital After SCD Therapy

Kendric Cromer, a 12-year-old from Washington D.C., made headlines earlier this year when he became the first patient to receive an FDA-approved gene therapy for sickle cell disease (SCD). After nearly five months of treatment, involving intensive chemotherapy and the infusion of new modified blood cells, Kendrick left the hospital this week and is now on the road to living a life without SCD. This groundbreaking treatment offers transformative potential for children, like Kendrick, who suffer from the lifelong, painful blood condition affecting 100,000 people in the United States, most of whom are Black and Latino. However, while the promise of gene therapy is life-changing, the reality is that the newly approved SCD gene therapies, Lyfgenia by Bluebird Bio and Casgevy by Vertex Pharmaceuticals, come with staggering list prices of $3.1 million and $2.2 million per treatment, respectively. These high launch prices raise serious concerns about the financial strain on patients, insurers, hospitals, and our health care system overall. While the potential benefits of gene and cell therapies are profound, the current pricing models create barriers that limit access for many patients. As we celebrate the remarkable advancements in treatment, it is crucial to address the urgent need for a sustainable pricing structure that balances fair profits for manufacturers with accessibility and affordability for patients and the health care system as a whole. — (The New York Times, CDC, CNBC)

Legislators Tout IRA Savings

As we anticipate the drug price reforms in the Inflation Reduction Act taking effect in 2025, patients are already reaping substantial savings this year from the provisions already underway. At an event in New Hampshire, President Biden and Senator Sanders touted a new report by the Office of The Assistant Secretary for Planning and Evaluation (ASPE) that found that because of the Inflation Reduction Act, nearly 1.5 million patients on Medicare saved nearly $1 billion in out-of-pocket costs in just the first half of 2024. The report also revealed that the annual out-of-pocket cap is delivering crucial relief for patients burdened by high cancer drug costs, which comprised nine of ten of the highest-spending medications among those who reached the cap in 2024. In two months, when the out-of-pocket cap for patients on Medicare lowers to $2,000, nearly 19 million people are projected to save roughly $400 per year on prescription drug costs. As the drug price law continues to take effect, patients stand to see substantial savings on their prescription drugs, lower out-of-pocket costs, lower average premiums for patients, and a variety of plans to choose from — ensuring access to a wide range of treatments at more affordable prices. —  (PBS, ASPE, HHS, KFF)

ICYMI

The pharmaceutical industry’s top trade association, The Pharmaceutical Research and Manufacturers of America (PhRMA), closed out last quarter spending $6.9 million in health care lobbying efforts ranking the group as the top spender on health care lobbying among all health trade association groups this year. 

Subscribe to the WEEK IN REVIEW here.