Welcome to the Week in Review.

SCOTUS Examines Skinny Labels that Drive Low-Cost Generics to Market 

The Supreme Court heard arguments this week in a case that could limit how and when lower-cost generics come to market. The case, Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., focuses on “skinny labeling,” which allows generics to launch for off patent uses of a drug while brand-name manufacturers retain patents on other indications — providing a key pathway for earlier competition that saves patients and taxpayers billions annually. While justices appeared skeptical of their case, a ruling for Amrin could significantly limit that pathway by exposing generic manufacturers to liability based on routine marketing, creating a chilling effect that delays or deters generic entry across multiple drug classes. The stakes for patients are significant, given that a single generic can reduce drug prices by 39%, and multiple competitors can lower prices by as much as 95%. A decision is expected in June. — [SCOTUS, NPR, SCOTUS Blog, FDA, JD Supra, Endpoints News, Reuters] 

Delayed Competition for Pfizer’s Vyndamax Raises Concerns

Pfizer struck agreements this week with three generic drugmakers to delay competition for its blockbuster heart drug Vyndamax until 2031, two years later than previously expected. Vyndamax, which treats a serious and potentially fatal condition, carries a list price of approximately $23,000 per month for 30 capsules. Artificially extending the monopoly on the drug means patients will face high prices for longer without meaningful competition or pricing relief. While the terms remain secret, these types of settlements raise familiar concerns about “pay-for-delay” arrangements where brand-name manufacturers compensate generic competitors for postponing market entry of lower-cost alternatives. Policymakers have increasingly scrutinized these practices, and P4ADNow has endorsed the bipartisan Preserve Access to Affordable Generics and Biosimilars Act to curb them. — [Endpoints News, Congress, Sen. Klobuchar]

Healthcare Costs — and Rx Prices — Remain A Top Voter Concern

New KFF polling shows affordability remains a top concern for Americans, with 64% of adults worried about the cost of health care, on par with concerns about gas and transportation costs amidst the U.S. conflict with Iran. Prescription drug costs remain a key driver, as insured adults overwhelmingly point to lowering out-of-pocket costs as their top priority. The political implications are clear: nearly 9 in 10 voters say healthcare costs will influence their vote in the 2026 midterm. High drug prices are a central political issue, and lawmakers should be feeling the pressure to legislate against pharmaceutical industry greed. — [KFF] 

ICYMI: CMS extended the deadline for applications to the GENEROUS Model for a second time this week, from April 30th to June 11th, stating that they’re looking to give “potentially interested” drug manufacturers additional time to engage. Even if the model is able to eventually achieve broad drugmaker participation, its impact on patient costs is likely limited. — [CMS, Fierce Healthcare]

Patient Advocate Spotlight: Harold Brown

Condition: Type 2 diabetes, high blood pressure, and heart failure

Drugs: Entresto ($700 / month), among other prescriptions 

Background: Retired, worked at the Cleveland Electric Illuminating Company for 27 years

In His Words: “As a patient with Medicare coverage through United Healthcare, I am thankful for having a majority of my health care costs covered. But there were instances in which my Entresto prescriptions were costing me hundreds of dollars a month before getting into a patient assistance program, which I have to apply to each year and see if I am approved. This is just not right. 

If I had to pay out of pocket for my heart medication, I would just have to go without it and trust in God for my life. I mean this. I have already had to decline to purchase prescription medications because I couldn’t afford them, and I wish not to do so again. But the truth of the matter is, as Americans, it shouldn’t have to be this way.”

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