Welcome to the Week in Review.

Remembering David Mitchell: A Distinguished Life In Service to Others

P4AD’s founder, David Mitchell, passed away on Friday, January 2nd, after a 15-year battle with multiple myeloma, a rare blood cancer. Confronted with drug prices exceeding $300,000 a year, David created Patients For Affordable Drugs in 2016 to ensure that patients would have a seat at the table in shaping the nation’s drug pricing policies. Without taking a single penny from the industry, he spent nearly a decade relentlessly committed to reforming the drug price system, making him one of the most trusted and influential voices in the nation on this issue. P4AD’s full statement from Board Chair Chuck Hurley’s is here. — [P4ADNow]

Medicare Negotiations’ Historic Start to 2026

January 1 marked a major milestone for U.S. prescription drug affordability, as lower negotiated prices took effect for the first time in Medicare’s history. Following two decades restricted by the “non-interference” clause that barred Medicare from negotiating prescription drug prices, the Medicare Drug Price Negotiation Program delivered lower prices on 10 of the most expensive and widely used medications. It’s a historic step that’s set to save taxpayers nearly $6 billion in 2026 alone, with the program estimated to prevent more than 656,967 premature deaths over the next decade by improving treatment adherence and access — a powerful indicator of what meaningful reform can deliver. Still, we know that the industry continues attempts to roll back this progress. The Office of the Solicitor General filed a brief last Friday urging the Supreme Court to reject a petition brought by AstraZeneca that challenged the constitutionality of the Medicare Negotiation Program. As a manufacturer with drugs included in both the first and second rounds of negotiation, AstraZeneca’s case reflects a broader industry effort to block implementation through the courts, even as patients begin benefiting from lower prices. — [P4AD, CIDSA, Healthcare Finance]

Initial Price Hikes Data Reaction

While Americans were ringing in the new year, drugmakers were up to business as usual: jacking up prices. Early reporting shows more than 350 hikes on brand-name drugs this month. The median increase of about 4% is meaningfully higher than the 2.7% inflation rate reported by the Bureau of Labor Statistics, continuing a long-running pattern of drug price hikes outpacing broader inflation. And while 4% may not sound like much, for high-priced rare disease drugs or cancer drugs that can mean additional thousands per treatment. Notably, several companies tied to the Trump administration’s recent voluntary pricing agreements — including Boehringer Ingelheim, GSK, Novartis, Pfizer, and Sanofi — appear prominently in this latest round of price hikes, with Pfizer alone raising prices on roughly 80 products. Crucially, those deals (of which details remain largely secret) cover only certain drugs and apply only when purchased through TrumpRx, a cash-only program, leaving list prices untouched and manufacturers free to raise prices across the rest of the market. This is an early snapshot of a pattern that plays out at least twice a year, and P4AD will release further analysis in the coming weeks. — [Reuters, BLS]

CMMI Models GLOBE & GUARD

In late December, the Center for Medicare & Medicaid Innovation (CMMI) announced two new mandatory payment models. The GLOBE model would apply to high-spending Medicare Part B drugs, while GUARD targets certain high-cost Part D drugs, both using international reference pricing to calculate enhanced inflation rebates for single-source products not subject to Medicare negotiation. Unlike the voluntary most-favored-nation (MFN) agreements between drugmakers and the Trump Administration — which apply only to select drugs and purchasing mechanisms — these models would require mandatory manufacturer participation and directly tie penalties to lower prices abroad. GLOBE is slated to begin later this calendar year, with GUARD launching in early 2027. GLOBE and GUARD are projected to reduce Medicare spending by a combined $27 billion over their five and nine-year respective timelines. However, CMS estimates that the GUARD model could also increase patient cost sharing and premiums, with rebates flowing to the government, not patients at the pharmacy counter. Other key questions also remain, including how these models may interfere with future rounds of Medicare negotiation. P4AD will submit comments on both models and will be closely monitoring their development. — [CMS, CMS, Federal Register, Pink Sheet]

ICYMI

TrumpRx, the administration’s proposed direct-to-consumer (DTC) drug platform, has not yet launched. While DTC programs can offer discounts that bypass intermediaries, their impact is limited: purchases are cash only, meaning they can’t be used with insurance and therefore don’t count towards deductibles. TrumpRx may help a narrow slice of consumers, but lasting affordability will require enforceable reforms that directly address drugmakers’ pricing power. We’ll be watching closely as the site launches to better understand how it operates and who ultimately benefits. — [TrumpRx]

Patient Advocate Spotlight: Tim C.

Background: AFIB and COPD
Drug:  Eliquis ($700 to $800 every month) and Trelegy ($800 per month)
Background: Retiree from Chicago, Illinois

In His Words: “For folks that I know who are on fixed incomes like myself, it can make us take a hard look at the month’s budget to try to determine what needs to be either postponed or eliminated for the sake of contingencies that always seem to occur and are never accounted for in advance. These painfully high prescription costs seem to also occur concurrently with newly incurred and often unforeseen doctor and hospital charges which make it all that more difficult to divvy up a month’s fixed income without getting to situations where you start having to play catch up with one bill after another.”

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