Welcome to the Week in Review.
Pushback: Pharma’s “IRA Watchdog” Analysis Misrepresents Medicare Negotiation
A recent report from DLA Piper argues that Medicare drug price negotiation is failing to deliver meaningful savings to seniors, but the analysis relies on false assumptions and flawed methodology, misrepresenting the truth. DLA Piper houses IRA Watchdog, a group backed by Bristol Myers Squibb, AstraZeneca, Merck, and Eli Lilly — several of which are simultaneously suing to block negotiation. The report narrowly defines “savings” in a manner that does not account for all drug pricing provisions, excluding key reforms such as the out-of-pocket cap and $35 insulin cap, inflation rebates, and Part D redesign. The headline claim that “only 11% of seniors save” relies on a restrictive framing; the same analysis notes that 15% of beneficiaries take a negotiated drug and 73% of those beneficiaries see lower cost sharing. The report also characterizes drugs like Tradjenta entering renegotiation due to generic or biosimilar competition as a negative for patients. Tradjenta’s lower negotiated price may no longer go into effect, but it’s because the drug now has competition — and competition often drives prices even lower than negotiated rates. Furthermore, the analysis incorrectly attributes trends that predate Medicare negotiation, such as premium increases, to the IRA. In short, the analysis minimizes documented savings, overstates access concerns, and is intended to advance the industry’s efforts to weaken negotiation. Lawmakers shouldn’t be fooled by these claims and should understand the financial interests behind them. — [DLA Piper, P4ADNow, Bloomberg Law, FightPharma]
E&C Health Subcommittee Hearing Results In Familiar Finger-Pointing
Representatives from across the drug supply chain, including PhRMA, BIO, Pharmaceutical Care Management Association (PCMA), and other industry groups, testified before the House Energy & Commerce Health Subcommittee this week. Notably absent were any patient voices. As expected, PhRMA blamed PBMs, PBMs blamed drug makers, and the structural drivers of high list prices received less scrutiny than they warranted. Still, several members of the committee pressed on core affordability issues. Lawmakers challenged PhRMA’s repeated claim that high drug prices are necessary for innovation, while others called attention to the secrecy surrounding drugmakers’ MFN pricing deals with President Trump, prompting PhRMA’s COO, Lori Reilly, to tell Congress that “you’ll have to take our word” that the agreements are good for patients. Pharma demands transparency from other actors in the supply chain, but when it comes to the prices they set, they insist we just have to trust them. Members also highlighted patent thickets and exclusivity tactics that extend monopolies well beyond statutory protections, delaying generic competition and driving up costs. While each sector debated its share of the dollar, one fact remains clear: brand-name drug companies play the biggest role in determining what patients will ultimately pay. — [E&C, YouTube, YouTube, YouTube, Washington Post, POLITICO, Roll Call]
TrumpRx: Hype vs. Reality
TrumpRx.gov is officially live, but important questions remain about its scope and impact. For 33 of the 43 drugs currently listed, TrumpRx’s prices match those already available on GoodRx, and reporting from STAT News indicates that at least 18 drugs have lower-cost generics available elsewhere. TrumpRx excludes many of the most widely prescribed and high-cost medications, including blockbuster drugs like Keytruda and Eliquis. Drugs on TrumpRx are also done through voluntary deals, and we have few details on how long their inclusion will last. For a small subset of patients — particularly those on certain GLP-1 or IVF drugs — the discounts could be meaningful, but for most Americans, including many cash-paying patients who can already find lower prices elsewhere, the real-world impact is likely limited, despite being marketed as a life-changing solution for millions. — [P4AD, STAT News, CBS News, Barron’s, Fierce Pharma, Common Dreams]
AbbVie Files Lawsuit against Medicare Negotiation
Just two weeks after Botox and Botox Cosmetic were named as drugs to be included in the third round of Medicare Drug Price Negotiations, manufacturer AbbVie, has filed a lawsuit in the U.S. District Court for the District of Columbia challenging the program. AbbVie argues that, as a plasma-derived product, Botox should be ineligible for negotiation under CMS guidance. The company also claims the program violates the First and Fifth Amendments by compelling speech through the negotiation framework and interfering with private property rights – constitutional arguments that closely mirror those raised in earlier pharmaceutical industry lawsuits challenging the program. While courts have repeatedly rejected similar constitutional claims brought by other manufacturers, AbbVie’s assertion that Botox qualifies as exempt on the basis of being plasma-derived marks a new line of argument in the ongoing litigation against Medicare negotiation. Botox is not simply a cosmetic product – it’s also used to treat a range of serious chronic conditions. Yet AbbVie is suing to protect its billions in profits rather than allow Medicare to secure lower prices for nearly 400,000 people on Medicare who rely on these medicines. — [P4AD, Bloomberg Law, Reuters, Endpoints News, Fierce Pharma, BioSpace, Law360]
ICYMI
In addition to driving down prices, Medicare negotiation is also expanding coverage of included medications. A new analysis from KFF finds that in 2026, all Part D enrollees have coverage of the first 10 negotiated drugs — including all dosages and forms — as required through the IRA. Coverage rates improved for multiple formulations of 9 of the 10 drugs compared to 2025, with especially large gains for insulin products Fiasp and NovoLog and certain doses of the cancer drug Imbruvica. The impact of Medicare negotiation for patients extends far beyond lower negotiated prices. — [KFF]
Patient Advocate Spotlight: Stacy Dyke
Condition: Hemiplegic Migraines, Occipital Neuralgia, Idiopathic Intracranial Hypertension, and Fibromyalgia
Drugs: Nurtec, Spravato, Reyvow, Trudhesa, and Zavzpret (totaling ~$8,500 per month list price)
Background: Patient advocate from Shreveport, Louisiana
In Her Words: “I’m navigating a medical system that often feels designed against me. Each day is a battle against relentless pain, a battle made even harder by the exorbitant cost of treatment. I’ve cycled through countless medication trials, from ineffective generics to brand-name drugs that carry a hefty price tag — commonly ranging from $400 to $6,000 a month each, and forcing me into a continuous struggle to afford my medications. Life often feels like a never-ending game of chess, constantly strategizing to manipulate a broken system and anticipate the next move. This shouldn’t be our reality.”
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TrumpRx Officially Launches
The Trump administration rolled out TrumpRx.gov, a new federal website intended to connect patients with manufacturer discounts on roughly 40 prescription drugs. While the program centralizes manufacturer-run discount and DTC offerings, it does not sell medications directly, and does not change how drug pricing works in the U.S. For most Americans, particularly the ~85% who have insurance, the site is unlikely to significantly lower their costs, as drugs purchased through TrumpRx do not count toward deductibles or out-of-pocket limits. While the program may offer short-term relief to some patients, it’s not a substitute for enforceable, system-wide reforms. TrumpRx was initially slated to release in January, with the delay speculated to be caused by concerns over federal anti-kickback laws. Patients in our community will soon learn if they can reliably access these discounts at the pharmacy counter, where the program will ultimately be tested and where affordability matters most. — [TrumpRx, Senate, Sen. Durbin, Public Citizen, White House, White House, STAT News, BioSpace, MedPage Today]
FTC Settles PBM Insulin Price-Gouging Case with Express Scripts
The FTC announced a settlement with Cigna’s Express Scripts, resolving claims that the pharmacy benefit manager engaged in practices that artificially inflated insulin prices and harmed patients. The settlement included welcome reforms designed to base patient cost-sharing on a drug’s net price, ensure fairer reimbursement for community pharmacies, and delink PBM compensation from list prices — similar to reforms included in the spending package passed earlier in the week, which focused on delinking in Medicare. CVS Caremark, Express Scripts, and OptumRx control roughly 80% of prescriptions filled in the U.S., and the FTC’s 2025 report found that PBMs generated $7.4 billion by inflating the prices of 51 lifesaving drugs between 2017 and 2022. The FTC’s cases against CVS Caremark and OptumRx remain ongoing. Ultimately, patients will judge the impact of this settlement by what they pay at the pharmacy counter. — [FTC, P4ADNow, FTC, Axios, New York Times, Endpoints News, STAT News, Bloomberg, Healthcare Dive, Pink Sheet]
Funding Package Includes Prescription Drug Reforms
P4AD-supported prescription drug pricing reforms were signed into law on Tuesday as part of the government spending package. The package included the so-called Q1/Q2 provision requiring clearer guidance on ingredient differences in generic drug applications to save generic manufacturers time and money in bringing lower-cost alternatives to market. And for the first time ever, Congress passed PBM reforms that would increase transparency and accountability by delinking PBM compensation from drug prices in Medicare Part D, curbing incentives to steer patients toward more expensive prescription drugs and bolstering pricing data reporting requirements. P4AD will continue to push for further reforms that tackle the root causes of high drug prices and rein in Big Pharma. — [Healthcare Finance, P4AD, Washington Post, Fierce Healthcare, BioSpace, Managed Healthcare Executive]
The Growing Success of Medicare Drug-Price Negotiation
In a new article published by the New England Journal of Medicine, Dr. Benjamin Rome and Dr. Aaron Kesselheim find that Medicare drug price negotiation is gaining durability and momentum. The authors note that the program will now have been implemented across two administrations using the same statutory process, strengthening its staying power, with its legality also being repeatedly upheld in court despite industry challenges. They warn that the most imminent threat comes not from the courts, but from pharma-backed carveouts like the ORPHAN Cures Act, which have already blocked negotiation for blockbuster drugs such as Keytruda and Opdivo, and new proposals to delay negotiation for small-molecule drugs, like the EPIC Act. P4AD strongly opposes these bills, and our patient advocates continue to fight relentlessly to halt industry efforts to weaken or roll back this critical program.
Senate Democrats Outline Three-Pillared Drug Pricing Plan
Senate Finance Committee Democrats sent a letter to their colleagues this week outlining their plans for drug pricing reforms. Authored by Ranking Member Wyden (D-OR), Sen. Cortez Masto (D-NV), Sen. Welch (D-VT), and Sen. Gallego (D-AZ), the letter outlined a three-pillar plan emphasizing the importance of Medicare negotiation and advocating for the program’s expansion, counteracting abusive practices and middlemen in the drug supply chain, and bolstering drug innovation by restoring NIH funding and reducing delays in FDA approval processes. With nine in ten Americans calling on Congress to take further action on lowering prescription drug costs, reforming U.S. drug pricing is broadly popular across the aisle. — [Bloomberg, Inside Health Policy]
Patient Advocate Spotlight: Judy Aiken
Condition: Psoriatic arthritis and psoriasis
Drugs: Enbrel ($2,355 / month, down from over $7,000 list price/month before negotiations)
Background: Retired nurse from Portland, Maine
In Her Words: “Seeing Enbrel on the list of drugs to be negotiated first allows me to take a deeper breath, have hope, and honestly live a better life. Enbrel’s high price has been a real burden, a constant anxiety. A better deal on this drug is life-changing for me and thousands of patients and me.”
“This year, my copay for my first refill of Enbrel was $850, much better than the whole $2,100 cap at once.”
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Medicare Negotiation Round Three Drugs Announced
The third round of expensive prescription drugs selected for Medicare negotiation were announced this week, covering medications that account for $27 billion in Medicare spending. The selected drugs treat a variety of chronic conditions — including cancer, diabetes, autoimmune diseases, asthma, and HIV — and several have been subject to recent price hikes by the industry, including Cimzia, which increased by $899 per kit, Entyvio, which increased by $748 per vial, and Xeljanz, which increased by $334 per package, underscoring the urgency of allowing Medicare to negotiate fairer prices. Predictably, PhRMA criticized the plans, but the stakes are clear: nearly 1.8 million people on Medicare rely on these drugs. From patients like Diane, who depends on Xeljanz and is forced to spend nearly her entire disability check in copays, and Dana, whose HIV medication, Biktarvy, costs thousands out of pocket each year, lower negotiated prices offer the promise of real relief. With earlier rounds projected to save patients $2.2 billion annually, round three builds on that momentum, even as the drug industry escalates attacks to block the program in the courts and via Congress. — [P4AD, AP, P4AD]
Impact of ORPHAN Cures Takes Shape
Wednesday’s Medicare negotiation announcement was a win for patients, but it was also notable for what was absent: the world’s best-selling drug Keytruda, a drug with nearly $30 billion worldwide in yearly sales. That omission is due to the passage of the ORPHAN Cures Act via OBBBA in July 2025, an unnecessary nearly $9 billion handout to the pharmaceutical industry that exempts drugs with multiple orphan indications from Medicare price negotiation, despite blockbuster revenues. As a result, prices for medications like Keytruda and Opdivo remain unchecked for years longer, leaving patients exposed to unaffordable prices. Pharma is pushing for even more giveaways like the EPIC Act, which would delay negotiation for small-molecule drugs, roughly 90% of all prescriptions. At a time when 86% of Americans on both sides of the aisle support granting Medicare the authority to negotiate prices for all drugs, efforts to weaken the program stand in clear opposition to both patient needs and public consensus. — [Drug Discovery Trends, The Hill, AV]
Rising Cost of Healthcare Top Worry for Americans
New polling from KFF reveals healthcare costs are now Americans’ top economic concern, eclipsing worries about housing, food, utilities, and gas. Two-thirds of the public (66%) say they are worried about affording health care for themselves or their families, and a majority (55%) report their health care costs have increased over the past year, with one in five saying those costs rose faster than food or utilities. Looking ahead, 56% expect health care to become even less affordable. Against that backdrop, 90% of Americans say that drug prices are too high, and nearly three-quarters blame that on the pharmaceutical industry. The takeaway for lawmakers is clear: reforms that lower drug prices align with voter priorities across party lines.— [KFF, Washington Post, AV]
ICYMI: On Wednesday, CMS Administrator Mehmet Oz met with Republicans on the Senate Finance Committee to discuss drug pricing strategy. The conversation’s focus was on the president’s most-favored-nation pricing strategy, according to insider reporting. — [POLITICO, Washington Post, STAT News]
Patient Advocate Spotlight: Marianne
Condition: Diabetes
Drugs: Trulicity ($280 per month)
Background: 66-year-old cosmetologist from Traverse City, Michigan
In Her Words: “I am on Medicare, and its cost is unbelievable with the additional cost of my medication Trulicity. With this medication, I am strapped financially, not knowing or exactly sure of where that money will come from. I am currently paying $280 a month for Trulicity, which is a huge financial burden. One would’ve thought life would be easier in old age! But I was wrong. We need lower-cost prescription drugs now because people like me need them without having to choose to give up food, heat, or electricity, as I do.”
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Government Funding Health Package Advances PBM Reforms & Generic Competition
The House passed a government spending bill on Thursday that includes key drug price reforms that P4AD has consistently pushed for since 2023. The package incorporates the Q1/Q2 provision originally included in the bipartisan Lower Costs, More Transparency Act, which would address a crucial barrier to generic drug approvals by requiring the FDA to provide clearer guidance on ingredient differences in generic drug applications, saving generic manufacturers time and money in bringing lower-cost alternatives to market. A 2023 CBO estimate found that Q1/Q2 would save taxpayers $871 million over a decade. The bill also includes a provision that would delink PBM compensation from drug prices in Medicare Part D, curbing incentives to steer patients toward more expensive prescription drugs. It would also expand reporting requirements to increase transparency for plan sponsors. While these steps represent important steps forward, significant work remains to achieve the systemic reforms still needed to lower drug prices for everyone. The bill now moves to the Senate, which will be back in session on Monday. — [CBO, STAT News, Endpoints News]
Drugmaker Greed and Shameful Threats on Display at JPMorgan Healthcare Conference
Last week’s JPMorgan Healthcare Conference underscored that pharmaceutical executives view President Trump’s most-favored-nation (MFN) pricing push as a threat to be countered. Pfizer CEO Albert Bourla warned that if U.S. prices were lowered to match countries like France, Pfizer would stop selling new medicines there — signaling a willingness to hold entire countries hostage by restricting access to medicines in order to protect higher U.S. prices. Bristol Myers Squibb (BMS)’s executives echoed that approach, pointing to a December U.K. agreement in which the company raised prices after threatening to withhold a new schizophrenia drug, arguing the “deal did not go far enough.” The strategy is familiar: after President Trump’s July letters urging 17 drugmakers to align U.S. prices with those of other high-income countries, Eli Lilly announced plans to raise prices in Europe. What stood out at the JPM conference was how openly and callously executives discussed “the dealmaking calculus” behind these moves — using large portfolios to selectively raise prices or limit supply in lower-priced markets to preserve massive profit margins. Raising prices abroad is pharma attempting to game the system and shift costs elsewhere, and it does nothing to lower costs for U.S. patients. The takeaway was unmistakable: the industry is only focused on maximizing profits with little regard for the lives they harm. — [Financial Times, CNN, Endpoints News]
Supreme Court Eyes Patent Laws & Pharma Lawsuits
On Thursday, the Supreme Court rescheduled AstraZeneca’s petition, choosing to hold its decision until further notice. The company’s petition seeks to block the price reduction of its diabetes drug, Farxiga, and blood cancer drug, Calquence — the latest effort in the industry’s broader legal campaign to undermine or completely stall Medicare drug price negotiation. Separately, the Court agreed last week to review a case involving skinny labels. This long-standing legal protection allows generic manufacturers to compete with name brands without infringing on secondary patents. It’s a practice that’s allowed generic drugs to find a foothold in the market, despite the pharmaceutical industry working hard to manipulate the U.S. patent system and block competition. Research shows that the competition from one generic entering the market can drive a medication’s price down by 39%, with six or more competitors reducing it by as much as 95%. P4AD supports the protection of skinny labelling and the affordable generic alternatives it delivers for patients, and will be closely watching both cases as the Court weighs issues with major implications for drug prices and patient access. — [STAT News, FDA, SCOTUS, The Hill, Endpoints News]
Drug Affordability Takes Center Stage in House
The House held a series of hearings this week on healthcare and drug affordability. In a Budget Committee hearing, Rep. Doggett (D-TX) pushed back on pharma’s claim that high prices are necessary for innovation, noting that no other industry makes that argument and that much early-stage innovation comes from unprofitable startups. He pointed to stalled biosimilar approvals as a clear area for reform. In Thursday’s Health subcommittee hearing, Rep. Harshbarger (R-TN) and Rep. Trahan (D-MA) warned that vertical integration between PBMs, pharmacies, and insurers has concentrated market power and weakened competition. Rep. Mariannette Miller-Meeks (R-IA) went further, criticizing PBMs for using group purchasing organizations to sidestep oversight and extract additional revenue. The throughline was clear: high drug prices are not a partisan issue, and meaningful relief for patients will require bipartisan action. Real progress will depend on whether Congress translates this concern into action that delivers lower prices for patients. — [House, X, House, X]
Patient Advocate Spotlight: Patricia Sportsman
Condition: Chronic obstructive pulmonary disease (COPD)
Drugs: Trelegy ($563 per month) in addition to Symbicort and Albuterol
Background: Senior from Coos Bay, Oregon
In Her Words: “My Trelegy prescription used to only cost me around $300 for a 90-day supply, totalling about $100 a month, which was financially doable for my situation. That price, however, changed at the beginning of 2025 when I realized my monthly cost would be $563 per month.”
“This is unfathomable. What senior citizen has this type of money? I certainly don’t, and have thus gone without the medication for 2 months. This is why a negotiated price for Trelegy is so crucial and important to me. Drug companies have overpriced their medications for too long, but the Medicare Negotiation Program can prevent this from going any further, lowering costs for patients, like myself, and taxpayers.”
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President Trump Announces Drug Reform Framework
Yesterday, the White House released a new healthcare framework – as Americans face the final days of ACA open enrollment and rising health care costs – that raised more questions than it answered. While the president called on Congress to codify most-favored-nation (MFN) pricing, a notable signal that durable drug price reforms do in fact require statutory authority if they are to have any long-term impact for patients, the framework offers little clarity on how MFN would be implemented, applied, or enforced. Significant questions also remain about the administration’s proposals on PBMs, over-the-counter access, and other drug pricing policies. Many of the ideas outlined would require congressional action to take effect, shifting the focus to lawmakers to determine whether and how these concepts become law. As this debate moves forward, we look forward to working with lawmakers to ensure any legislation delivers lasting savings for patients. — [White House]
New Year, New Price Hikes
Here’s what we know so far about pharma’s January price grab. With some early reporting suggesting that the total number of hikes may reach as many as 900, P4AD has analyzed at least 417 drug price increases, with an average hike of $297.29, or 5.03% per month. Exorbitantly priced cancer drugs like Breyanzi and Abecma experienced the largest hikes up an eyewatering $26,567.52 and $15,849.37, respectively. Notably, 83.7% of the increases exceeded inflation, a higher share than we observed at this point last year. Cancer drugs feature prominently in this round of hikes: the pediatric cancer drug Unituxin was hiked 9.9% per vial, and Trisenox, used to treat acute promyelocytic leukemia, was hiked 9.4% per vial. For patients and families facing life-or-death treatment decisions, these increases aren’t abstract – they reflect an industry that continues to raise prices simply because it can, with little restraint and no regard for patients’ ability to pay. — [NPR]
J.P. Morgan Healthcare Conference Takeaways
GLP-1 drugs dominated the JPMorgan Healthcare Conference, highlighting how central they’ve become to pharma’s growth strategy. Pfizer CEO Albert Bourla said that the company is “all in on obesity,” while Eli Lilly CEO David Ricks pointed to direct-to-consumer (DTC) programs as a key part of the industry’s future. Despite generating tens of billions in revenue while costing a few dollars to manufacture, GLP-1s remain dramatically overpriced in the U.S., with drugs like Ozempic priced up to 16 times higher than in other wealthy countries. While voluntary deals with the White House and DTC programs may offer limited relief for some patients, price cuts will reach a record number of people next January, when several GLP-1s are scheduled to see 71% reductions through Medicare negotiation. Elsewhere at the conference, Regeneron’s chief scientist declined to commit to a price for the company’s new hereditary deafness drug and brushed off their continued refusal to publicly come to the table on most-favored-nation. Along with AbbVie, Regeneron remains one of only two companies from President Trump’s 17 letters last summer that have yet to make a deal, though the company is reportedly currently in talks with the administration. — [CNBC, BioPharma Dive, Morning Brew, STAT News, Bloomberg]
ICYMI: On Monday, the New York Times published an obituary honoring David Mitchell, P4AD’s founder, who passed away two weeks ago today after a 15-year battle with multiple myeloma, a rare blood cancer. The obituary reflects on David’s pivotal role in reshaping the national conversation on drug pricing. You can also read additional coverage and a non-exhaustive list of tributes from friends and allies, highlighting the lasting impact of his leadership and advocacy.
New York Times: David Mitchell, Who Led Fight on Drug Prices, Dies at 75
[STAT News, Detroit News, POLITICO, Real Talk MS Podcast, The Cancer Letter][AARP, Protect Our Care, CxRSP, Families USA, Public Citizen, T1 International, Friends of Cancer Research, Initiative for Medicines, Access & Knowledge, John Arnold]
Patient Advocate Spotlight: Sheldon Armus
Condition: Blood clots
Drugs: Xarelto ($197 as of January 1st, over $500 before)
Background: Former high school science teacher and former pharmaceutical sales representative from Boynton Beach, FLIn His Words: “In 2014, one month into retirement, I underwent a quadruple cardiac bypass operation — a surgery that saved my life. However, the surgery, as well as my diabetes and cardiac conditions, left me taking seven drugs each day. All of these drugs keep me alive, and I’m very thankful for their existence. However, they are also a real financial burden. But last year, I reached my out-of-pocket cap in August, and all my prescriptions were free for the rest of the year. These reforms work!”
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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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White House Announces Deals with Nine Pharmaceuticals Companies
This afternoon, the White House announced it has reached agreements with nine more pharmaceutical giants to lower the prices of certain prescription drugs for patients who purchase them directly, without insurance, through the administration’s new TrumpRx direct-to-consumer (DTC) program, expected to launch in January 2026. Steps to reduce drug prices for patients are welcomed, especially by patients who rely on one of the over-priced essential medicines named in today’s announcement, but voluntary agreements with drug companies — especially when key details remain undisclosed — are no substitute for durable, system-wide reforms. Further, we caution against any approach that encourages drug companies to raise prices for patients in other countries. Pharmaceutical corporations already generate massive profits in every country where they sell their products, and increasing drug prices internationally will do nothing for American patients. — [P4ADNow]
$16 Billion Sent to Cover Medicare Drug Spending
In the largest reconciliation payment since 2006, the federal government sent $16 billion to Medicare drug plans to cover higher-than-expected prescription drug spending. The surge reflects not only the growing use of high-cost cancer and GLP-1 drugs, but also the impact of the $2,000 out-of-pocket cap, which was introduced this year, and which ensures patients on Medicare never pay more than the out-of-pocket limit for their prescription drugs. The cap is a real win for patients — protecting people like Jackie from price spikes and financial hardship — but it doesn’t address the root cause of sky-high costs: the ability of pharmaceutical companies to set and raise prices at will. Drugmakers continue to raise list prices year after year, leaving Medicare and taxpayers to pick up the tab. Drugmakers continue to raise list prices year after year, leaving Medicare and taxpayers to pick up the tab. That’s why Medicare negotiation’s ability to target the underlying problem is so critical. It gives the government leverage to bring down drug list prices directly, establishing structural reforms that don’t merely shift costs around.— [STAT News, P4AD]
New AARP Report Extols Medicare Negotiation
Patients taking prescription drugs in the first round of Medicare negotiation are projected to see their out-of-pocket costs fall by an average of over 50% once the prices take effect on January 1, 2026, according to brand new analysis from AARP. The report also found that 7 of the 10 negotiated drugs are expected to cost patients under $100 per month in 2026, saving $1.5 billion in total patient out-of-pocket) spending next year alone. — [AARP]
P4AD Announces Retirement of Founder David Mitchell
This week, Patients For Affordable Drugs announced that Founder and President of the Board, David Mitchell, has retired. After his diagnosis with multiple myeloma and facing drug costs exceeding $300,000 a year, David founded 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. Today, the organization has grown into a community of half a million, and David’s relentless commitment to reforming the drug price system — without taking a penny from the industry — made him one of the most trusted and influential voices in the nation on this issue. — [P4AD]
ICYMI
P4AD CEO Merith Basey’s new op-ed in El Tiempo Latino celebrates the lower negotiated prices announced for the second round of Medicare negotiation — and what that means for patients in the Latino community in particular. The Latino community is 18% more likely to report being unable to afford healthcare costs and faces higher rates of illnesses such as diabetes and chronic liver disease, making outreach and education efforts in both English and Spanish critical. — [El Tiempo Latino]
Patient Advocate Spotlight: Jackie Trapp. P4AD Patient Advocate of the Year
Background: Multiple Myeloma, an incurable blood cancer
Drug: Revlimid ($180k / year before the $2k cap) and Xarelto
Background: Former high school teacher from Muskego, WI
From traveling to D.C. to meet with her lawmakers during our bipartisan Hill Day, to sharing her story in media interviews, to participating in a roundtable with HHS Secretary Kennedy and NIH Director Bhattacharya, Jackie has been at the forefront of patient advocacy in 2025. We’re proud to announce Jackie as our Patient Advocate of the Year!
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Welcome to the Week in Review.
New MFN Deals Expected This Month
More most-favored-nation (MFN) drug pricing deals are expected this month, according to CMS Administrator Dr. Oz. Since the administration sent letters to 17 pharmaceutical companies in July demanding adherence to MFN pricing, only five — Pfizer, AstraZeneca, EMD Serono, Eli Lilly, and Novo Nordisk — have announced agreements. The Trump administration has used the threat of pharmaceutical tariffs to bring drugmakers to the table, but those tariffs have repeatedly been delayed. Months after the initial September deadline, the slow pace of new deals highlights the limits of voluntary, company-by-company agreements in securing broad price reductions. Despite the administration’s aggressive posture, most manufacturers have yet to engage — suggesting that without structural reform or enforcement mechanisms, pharma can continue to delay meaningful concessions while appearing cooperative. — [Washington Post, White House, Endpoints News, Truth Social, Reuters]
More Work Needed to Deliver Low-Cost Biosimilars
The FDA’s new draft guidance to accelerate biosimilar approvals is a promising step toward lowering drug costs, but experts say its potential impact is limited without broader reforms. The proposal, supported by P4AD, would remove unnecessary human trials, known as interchangeability studies, when advanced testing already shows that a biosimilar works the same as the brand-name drug and would make it easier for doctors and pharmacists to substitute lower-cost biosimilars, much like generic drugs. Still, barriers remain. Patent thickets, pay-for-delay agreements, and PBM practices continue to block or slow biosimilar entry, even years after approval. Biologics make up more than half of U.S. prescription drug spending, with biosimilars accounting for less than 20% of the market share. Biosimilars have generated $56 billion in savings since 2015, and expanding their use would unlock further savings for patients and for taxpayers. In interviews, experts noted that fixing these problems is critical to ensuring the FDA’s action translates into real affordability for patients. P4AD has been pushing for comprehensive bipartisan reform measures that would help close these loopholes and ensure faster access to affordable medicines for patients. — [Bloomberg Law, P4AD]
Patient Advocate Spotlight: Kevin Baker
Background: 22-year-old college student from Idaho living with Crohn’s disease
Drug: Rinvoq ($6,431)
In the words of his wife Janet:“I’ve lived with Crohn’s disease since I was 11. My current medication, Rinvoq, has a list price of $6,431, and past treatments like Remicade, Humira, and Stelara range from $1,100 to $14,000 per month before insurance. I believe life-saving medicine is a human right.”
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