CMS Codifies Medicare Negotiation, Including P4AD-Supported Changes
CMS published the final rule for the Medicare Drug Price Negotiation program, codifying the program and effectively closed a loophole that pharmaceutical manufacturers could exploit to delay negotiation, as we highlighted in our comments. Previous guidance left the door open for manufacturers to launch slightly changed formulations shortly before their drugs become eligible for negotiation — potentially resetting the clock on negotiation eligibility. Now fixed-combination drugs will be grouped together if they’re determined to be new formulations of existing drugs. Additionally, Medicare Part B and Medicare Advantage drug spending will now be included when calculating which drugs qualify for negotiation, giving a more accurate picture of overall spending that doesn’t overlook these costs. This is a critical step for Medicare negotiation, further solidifying the full force of the law as we look towards expansion efforts. — [CMS]
Healthcare & Drug Affordability Drove Midterm Voters
As the dust settles on the midterms, voters made it crystal clear at the ballot box that the high cost of healthcare is a top priority — and any substantive solution must include lowering brand-name prescription drug prices. NBC exit polling and CNN voter polls both found that 85% of voters are concerned about the cost of healthcare, while CNN also found that 61% believe the government’s role in helping Americans get healthcare should be larger. As attention turns to end-of-year legislative vehicles and next year’s agenda, there’s overwhelming popular, bipartisan support for reforms that lower drug prices, including measures that boost competition and crack down on pharma’s abuse of the patent system. Policymakers have an urgent responsibility to act; patients cannot wait. — [NBC News, CNN, Semafor, STAT News, Axios, POLITICO, Pink Sheet]
CVS Health Breaks Up, But the PBM Issues Remains
CVS Health announced Wednesday that it will split into two publicly traded companies by the first half of 2028. Its roughly 9,000 retail pharmacies will become the standalone CVS Pharmacy, while Aetna and the Caremark pharmacy benefit manager (PBM) remain together — unwinding the company’s vertical integration strategy that saw CVS acquire Caremark in 2007 and Aetna in 2018. Vertical integration has been enormously lucrative for CVS, as Rep. Ocasio-Cortez pointed out earlier this year, but it’s far from the only concern with PBMs. Commercial market PBMs continue to negotiate hidden “rebate deals” with drugmakers, forcing patients onto more expensive drugs and pocketing the difference. While Congress has taken a strong first step by delinking PBM compensation from list prices in Medicare Part D earlier this year, real accountability must include fiduciary responsibility and delinking beyond Medicare. It also means addressing drugmakers’ pricing power, and ignoring the finger-pointing that PBMs and drugmakers have used for years to dodge reform. Congress must finish their Section 6(b) study for the FTC, and further examine the impacts of PBM consolidation. — [WSJ, New York Times, POLITICO]
Keytruda Biosimilars Face Difficulties
Last month saw the first publicly announced application for a Keytruda biosimilar accepted by the FDA, as the drug approaches its 2028 patent expiration. With a list price of $12,517.44 for every three week dose, Keytruda is the world’s bestselling cancer drug. Its manufacturer Merck has been responding to its upcoming patent cliff with three biotech acquisitions this year alone, likely in an attempt to build a pipeline of new, patent-protected cancer drugs. Yet even with a dozen other biosimilar candidates in the works, problems persist for Keytruda patients looking for lower costs. Some indications could be excluded from a biosimilar’s approval, if Keytruda has unexpired orphan-drug exclusivity or other protections. And while biosimilars have saved patients and taxpayers billions, PBMs often favor higher-rebate brand-name drugs instead. Congress has an urgent need to pass bills that prioritize competition before the year ends. — [BioPharma Dive]
Round 3 Medicare Negotiation Period Ends Sunday
The third round of Medicare drug price negotiations will end on November 1, with CMS expected to announce lower negotiated prices for the 15 selected drugs in the coming weeks. Four years after the program was established as part of the IRA, the results demonstrate the power of leveraging Medicare’s purchasing power to secure a better deal for patients. A new study found that patients on Medicare Part D are projected to save an average of $685 per year, while Medicare Advantage beneficiaries could save $470 because of just the first round of negotiation. And while Medicare negotiation was a historic step toward reining in the pharmaceutical industry’s pricing power, there is significant room to expand its reach. Polling shows strong public support for going further: 86% of voters support allowing Medicare to negotiate prices for all drugs. With strong support across party lines, policymakers have a responsibility to address the current affordability crisis and an opportunity to build on Medicare negotiations’ success, expanding it to more drugs. — [Vanderbilt Health News, Pharma Lawsuits, Arnold Ventures]
5 Days Out: Healthcare & Prescription Costs Drive Voters
Five days before the midterms, healthcare costs remain a major part of voters’ broad affordability concerns, and polling throughout the year shows these concerns are expected to shape voters’ decisions at the ballot box next week. With one in three Americans struggling to afford their prescriptions, lowering drug prices must be a part of any serious effort to tackle the cost of living. — [STAT News]
Cell & Gene Therapy Model Expands Beyond Sickle Cell Treatments
CMS announced this week that it will broaden the agency’s Cell and Gene Therapy Access Model beyond Genetix Biotherapeutics and Vertex’s sickle cell disease therapies — inviting manufacturers of other cell and gene therapies to apply. The Cell and Gene Therapy Access Model takes aim at that affordability challenge by pooling state Medicaid programs to boost their negotiating leverage, an approach that has already reduced administrative burdens when used for sickle cell therapies. But stronger negotiating leverage only goes so far when manufacturer participation remains voluntary, leaving the model’s ultimate reach and impact dependent on drugmakers’ willingness to participate. Given that the majority of patients with Sickle Cell Disease in the U.S. are enrolled in Medicaid programs, ensuring access through this payer is especially important.— [HHS, Pink Sheet, BioSpace]
ICYMI: Rep. Frank Pallone (D-NJ) is requesting an independent analysis of TrumpRx savings. In a letter this week, the top Democrat on the House Energy and Commerce Committee asked the Government Accountability Office to examine the White House claim that the platform has saved $700 million since its February launch. The administration has yet to substantiate that figure, and with key terms of the MFN agreements behind TrumpRx still undisclosed, there’s currently no way to independently assess how much patients are actually saving. — [Rep. Pallone, STAT News]
Prescription Drug Launch Prices Continue Climbing: New Report
The median annual net launch price of drugs jumped 35% from 2022 to 2025, reaching a “historically high level.” That’s according to a new report from the Institute for Clinical and Economic Review (ICER) this week, which found that the median net launch price for a new drug last year was nearly $257,000. A breakthrough treatment means little to a patient who can’t afford to afford it, and increasingly high launch prices can put new medicines permanently out of reach from day one. Medicare negotiation has begun to rein in the industry’s pricing power for certain expensive drugs that lack competition, but manufacturers still generally face no direct federal or legal constraints on the prices they set when new medicines come to market. With launch prices reaching historically high levels, policymakers must tackle this major driver of unaffordable drug prices. — [ICER, Inside Health Policy, Endpoints News, Axios, BioPharma Dive]
PhRMA’s Last Ditch Effort After Appeals Court Loss
After a unanimous three-judge panel in the Fifth Circuit Court rejected PhRMA’s challenge to Medicare negotiation this summer, the industry group is now asking the full court to rehear the case. The en banc petition is the latest effort to keep alive an industry legal campaign that has repeatedly come up short: courts have rejected challenges to Medicare negotiation at least 25 times, and the Supreme Court declined to hear six industry petitions already this year. Despite that mounting record of losses, PhRMA continues searching for new avenues to invalidate the program and preserve drugmakers’ pricing power. P4AD will continue defending Medicare negotiation against these challenges and fighting to protect the lower prices patients have won. — [PhRMA Petition, P4AD]
Maryland PDAB Pushes to Adopt Medicare Negotiated Prices
Last week, Maryland Governor Wes Moore publicly backed legislation that would allow the state’s Prescription Drug Affordability Board (PDAB) to set upper payment limits based on prices Medicare has already negotiated, rather than starting from scratch for each drug. The proposal would give Maryland a straightforward way to build on the success of Medicare’s negotiation program, extending the reach of federally negotiated prices beyond Medicare. If passed, the bill would apply to the first three rounds of Medicare-negotiated drugs, as well as any drugs negotiated in the future. As affordability boards face legal and political resistance in states like Colorado and Virginia, Maryland’s proposal offers a new path for states to leverage the progress already made at the federal level. — [Maryland Matters, WYPR, WBAL]
ICYMI: P4AD CEO Merith Basey joined NPR Tampa Bay to discuss the upcoming rule change around personal prescription drug importation, and ONNJ to discuss efforts to lower prescription drug prices nationally and in New Jersey. You can watch both segments below.
Drug Importation Change Delayed, But Concerns Remain Unchanged
CBP just announced that it is delaying the implementation of its importation rule change by 90 days, until January 20, 2027, just one week before it was set to take effect. For patients concerned about losing access to lower-cost prescriptions from abroad, this delay is a welcome reprieve, but not a permanent solution. Until patients in the U.S. can get access to the prescription drugs they need at prices they can afford, disrupting existing personal-importation practices risks an important safety valve. Groups of lawmakers from both parties, as well as P4AD and other advocacy groups are urging CBP to use the additional time to ensure new international mail requirements do not inadvertently eliminate patients’ ability to secure affordable medications from abroad. — [STAT News, Reuters, POLITICO, NBC News]
Pharma Front Groups Duck Disclosure
New analysis this week found that nearly 40% of FDA advisory committee meetings included a patient or consumer representative with active ties to a Big Pharma-funded advocacy group, rising above 50% for several committees — yet most of those ties were never disclosed at the meetings. That lack of transparency matters: patient representatives are meant to bring an independent patient perspective to FDA deliberations, but industry influence is harder to identify when it comes through organizations presented as independent patient voices. Big Pharma has increasingly relied on these groups to push industry messaging, a practice we’ve documented in three Hidden Hand reports. While the FDA has well-established conflict-of-interest policies for scientific advisory committee members, rules for patient representatives are less stringent, leaving a disclosure gap that can obscure industry financial ties. Patients, policymakers, and FDA officials must be made aware when purportedly independent patient voices speak, because Big Pharma influence may be at work behind the scenes. — [HealthAffairs Scholar, STAT News]
New Legislation Targets Medicare Negotiation
The Biosimilars Access and Affordability Act (H.R. 10628) is a new industry-backed bill that would make it easier for certain biologic drugs to delay Medicare negotiation eligibility based on the projected arrival of biosimilar competition. Current law already allows CMS to delay negotiation for up to two years when biosimilar competition is highly likely, but the bill would create new pathways for manufacturers to qualify for that delay — potentially enabling high-priced biologics to avoid negotiation for longer even when lower-cost biosimilars have yet to reach patients. Medicare should not be forced to delay negotiation based on the promise of future competition that may or may not materialize. This bill is also endorsed by the Alliance for Aging Research (AFAR), an organization whose close ties to pharma and opposition to key drug pricing reforms we’ve documented. P4AD will continue fighting for actually beneficial biosimilar legislation — like Biosimilar Red Tape Elimination Act (H.R. 5526) which would cut unnecessary regulatory red tape that delays lower-cost biosimilars from coming to market — as we stand against any effort to dismantle Medicare negotiation piece by piece. — [National Law Review, P4AD Hidden Hand]
ICYMI: P4AD’s US v Pharma: Fighting to Protect Medicare Negotiation campaign has been named a finalist for the 2026 Anthem Awards! Selected from more than 2,500 submissions for its creative approach to making the fight for lower drug prices accessible to new audiences. Want to help us win? Vote here!
AstraZeneca Advances Legal Challenge, While New Report Shows How They Kept Blockbuster Drug Prices High for Years
On Monday, AstraZeneca revived one of its multiple lawsuits against Medicare negotiation, this time asking the Fourth Circuit to reverse a Maryland district court dismissal earlier this year. The legal challenge comes as new analysis from AARP’s Public Policy Institute examines AstraZeneca’s layered efforts to delay generic competition, offering a striking look at how drugmakers work to preserve pricing power throughout a drug’s lifecycle. To delay competition on its blockbuster inhaler Symbicort — which has generated more than $55 billion in lifetime global sales — the company accumulated more than 90 patents around the drug and shifted marketing to the newer, more expensive Breztri Aerosphere as Symbicort faced loss of exclusivity — a strategy known as product hopping. Taken together, the developments illustrate the multi-pronged strategy used by drugmakers to fight any constraints on their pricing power: using patent and product strategies to delay competition, while challenging Medicare’s new authority to negotiate prices in court. — [AstraZeneca, Law360, AARP]
PhRMA Files Lawsuit Against the Already Gutted GLOBE Model
PhRMA filed a lawsuit this week challenging the Trump administration’s GLOBE model, asking a D.C. federal court to declare the program unconstitutional. The challenge comes after the administration already substantially weakened GLOBE by allowing drugmakers with voluntary MFN agreements to receive waivers from the mandatory model, alongside additional drug category exemptions. GLOBE is now projected to save only 4% of what CMS originally projected, yet even still, PhRMA is seeking to invalidate what remains. That should be a warning for CMS as it develops GUARD, the corresponding model for Medicare Part D; exempting drugmakers from mandatory pricing policies in exchange for voluntary agreements does not guarantee industry acceptance of the underlying reforms. CMS should not repeat the same mistake by allowing voluntary agreements to hollow out another mandatory model. — [POLITICO, STAT News, Endpoints News, Medical Daily, Pharma Commerce]
Health Care Costs Remain at the Center of Americans’ Affordability Concerns
New KFF polling this week finds that health care costs remain one of voters’ top affordability concerns, exceeding worries about housing, food, utilities, and on par with concerns over gas and transportation costs. Eighty-two percent of voters polled say healthcare costs are extremely or very important for candidates to discuss, while 60% are worried about their ability to afford healthcare for themselves and their families — including insurance, office visits, and prescription drugs. Additionally, a new POLITICO poll also found that 34% of voters say health care costs are the main reason driving their vote this midterm, only second to 45% who listed broader concerns about “affordability and the economy.” These findings continue a pattern KFF has been tracking: policymakers looking to address Americans’ cost-of-living concerns must not overlook lowering prescription drug prices as an important piece of any broader affordability agenda. — [KFF, POLITICO]
ICYMI: Last week, tariffs on imported patented drugs and their ingredients expanded beyond the 17 large drugmakers who received letters from the Trump administration in July. But the policy’s impact will vary significantly: all 17 of those large drugmakers have since secured a 0% tariff through January 2029 under MFN pricing and U.S. manufacturing agreements, while other manufacturers could face rates as high as 100% depending on their products, manufacturing plans, and country of origin. — [Managed Healthcare Executive]
Administration Guts Mandatory GLOBE Drug Pricing Model with Pharma Carveouts
The finalized GLOBE model is now projected to save just $440 million — a staggering 96% decrease from CMS’s original projection of $11.9 billion. Central to the dramatic reduction is the administration’s decision to allow drugmakers participating in voluntary deals, including the GENEROUS model, to receive waivers from mandatory participation, a fact that we warned would drastically limit patient savings and impact. The administration moved forward with the carveout anyway, and today only a few drugmakers are included in GLOBE, down from an initial 19. A mandatory model only works if drugmakers are actually required to participate. The administration should reverse course on these pharma-friendly carveouts and ensure GLOBE delivers the savings it was designed to achieve for patients and taxpayers — and as CMS finalizes GUARD, its corresponding model for Medicare Part D, it should not repeat the same mistake. — [P4AD, STAT News, Bloomberg Law, Fierce Healthcare]
56 Members of Congress Side with Big Pharma to Weaken Medicare Negotiation
56 members of Congress signed a letter urging CMS to withdraw a proposed policy designed to close a loophole in the Medicare negotiation program. This is the tried-and-tested industry playbook: if they can’t defeat negotiation in the courtroom, they’ll try to chip away at it piece by piece on Capitol Hill. Under current policy, a drugmaker can combine an existing drug with an additional ingredient that is not biologically active against the disease and have the resulting fixed-dose combination treated as a separate drug when CMS determines eligibility for negotiation — potentially resetting the negotiation clock and giving the new product a later eligibility date. CMS has identified this technicality as a program integrity risk, warning that manufacturers could use minor changes to existing drugs to avoid selection for negotiation which would keep prices high for patients for longer. Its proposed policy for the 2029 negotiation cycle would address the loophole by putting certain fixed-dose combinations together with the original drug when determining negotiation eligibility. We strongly support CMS’s proposal and submitted comments in August urging the agency to stand firm against Big Pharma’s efforts to weaken negotiation. — [Fox News, P4AD]
Patients Respond — CBP Importation Change Threatens Low-Cost Medications
Lawmakers on both sides of the aisle are pushing back on an upcoming Customs and Border Protection (CBP) rule taking effect October 22 that would create a significant new hurdle for Americans who buy lower-cost medications from pharmacies outside the U.S. In an informal survey of just over 100 patients in our community, 52 respondents said they receive medication shipped from a pharmacy abroad — and among those patients, 94% are concerned the new requirements could affect their access to medication and 79% said their medication costs more in the U.S. Several even told us that losing self-importation would mean going without their medication altogether. No patient should have to look outside the U.S. to afford the medicine they need, but disrupting a pathway patients currently rely on without addressing the high U.S. prices that drove them there leaves some patients without an affordable way to access their medication. — [STAT News]
Former House Majority Leader Eric Cantor to Lead PhRMA
Eric Cantor, Former Republican House Majority Leader from 2011 to 2014, was named the next president and CEO of PhRMA, the pharmaceutical industry’s lobbying group. Cantor takes the helm as drugmakers face mounting pressure in Washington over high drug prices and policies aimed at lowering them, including Medicare negotiation. This is the second time PhRMA has chosen a former Republican House member as its leader, after Congressman Billy Tauzin ran the group from 2005 to 2010. As chair of the Energy and Commerce Committee, Tauzin played a leading role in securing the pharma-backed non-interference clause that stopped Medicare from negotiating drug prices for two decades. — [P4AD, STAT News, Endpoints News, Axios, POLITICO, The Hill, Pink Sheet]
ICYMI: New research in JAMA finds no evidence that the Inflation Reduction Act accelerated the trend of pharmaceutical companies setting and raising launch prices. Drug companies were launching drugs at increasingly unaffordable prices long before Medicare negotiation — and contrary to industry fearmongering, the IRA did not make the problem worse. However, median launch prices climbed from roughly $39,000 between 2008 and 2013 to $254,000 between 2020 and 2025. Now policymakers need to tackle the part of the pricing system the IRA largely left untouched: what drug companies can charge at launch. — [JAMA, Managed Healthcare Executive]
FOIA’d MFN Agreements Reveal New Details — But Key Terms Remain Secret
Newly released, heavily redacted Pfizer and Eli Lilly MFN agreements reveal concerning drug exclusions and terms while leaving key details about pricing and implementation unknown. That’s according to Public Citizen, which obtained the heavily redacted agreements through FOIA litigation. Eli Lilly’s deal, for example, excludes Mounjaro and Zepbound from certain MFN pricing requirements — undercutting one of the administration’s biggest selling points for the deals. According to Public Citizen, the exclusion could reduce potential first-year GENEROUS savings by up to $300 million. The documents also confirm that Pfizer’s agreement takes precedence over GENEROUS where the two agreements conflict, raising additional questions about the program’s potential long-term savings. Ultimately, these disclosures reinforce a central concern with these voluntary agreements: we still don’t know which drugs are covered, what prices manufacturers have agreed to, or how much savings they will actually deliver for patients and taxpayers. — [Public Citizen, Washington Post, PharmaPhorum, NBC Polling, STAT News]
Pharma Says the Quiet Part Out Loud on Innovation
At a specialty pharmacy conference this week, BRG executives spoke candidly about the financial calculations behind investment in new treatments, asking “why would you want to invest in this space to get your 10 to 20 adopted cell and gene therapies a year if you could invest in AI or a data center, where you have a more certain return?” It reveals what the pharmaceutical industry intends to protect when it warns that policies to lower drug prices could threaten innovation. In parallel, AbbVie EVP Perry Siatis claimed this week that Germany’s pricing and reimbursement policies “veer drastically” from incentivizing innovation. It’s rich that AbbVie is lecturing Germany on “fair contribution” while their blockbuster drug Humira is a textbook patent-thicketing case, preventing biosimilars from reaching the market in the U.S. for years longer than they did in Germany. Increasing competition is one of the primary ways to incentivize true innovation. — [Endpoints News, AJMC]
Upcoming CBP Drug Importation Change Could Harm Patients
A new Customs and Border Protection rule change taking effect October 22nd will require prescription drugs mailed from abroad to go through a formal customs entry process. In practice, this change will likely make the personal importation of lower-cost medicines from other countries very difficult and potentially impossible. An estimated 2.3 million Americans have purchased prescription drugs outside the U.S., and members of P4AD’s patient community could be directly affected. Maureen has purchased her brand-name seizure medications from Canada for years, while Darlene’s blood pressure drug costs five times more in the U.S. than in Canada. Even P4AD’s founder David Mitchell relied on Canadian pharmacies to purchase Eliquis when his Part D plan wouldn’t cover the drug — or allow him to pay out-of-pocket for it. At the time, he was able to purchase it for just a third of the US price. Patients shouldn’t have to look outside the U.S. to afford the medicines they need, but for those who already do, disrupting this pathway without addressing the high prices that drove them there could put their access to treatment at risk. — [Wall Street Journal]
ICYMI: Public Interest Patent Law Institute (PPLI) sent a letter to the House Judiciary Subcommittee this week highlighting how drugmakers use terminal disclaimers to accumulate multiple closely related patents on the same invention, creating costly legal hurdles for generic competitors. As PPLI put it, “a company holding dozens of them can turn one dispute into a war of attrition.” The bipartisan ETHIC Act would limit drugmakers to asserting one patent from a terminally disclaimed group against a generic or biosimilar competitor, reducing a barrier to lower-cost competition. — [PPLI]
POTUS Announcement — The State of GENEROUS and MFN
President Trump announced from the Oval Office that all 50 states have agreed to participate in the GENEROUS (GENErating cost Reductions fOr U.S. Medicaid) voluntary CMS model. But the announcement leaves significant questions unanswered. The administration has not disclosed which drugs are included, the prices Medicaid programs will pay, or the underlying deal terms needed to independently evaluate its savings projections, although the White House is claiming $64.3 billion in federal and state savings over the next decade. Medicaid already receives substantial statutory and supplemental rebates, and states can stick with previous agreements if they offer a better deal. Ultimately, the model’s success will depend not on how many states sign up, but on whether it delivers lower drug prices and improved access for patients on Medicaid — [White House, Semafor]
HHS Adviser Chris Klomp Faces Questions Over MFN Deals
Chris Klomp, the CMS Medicare Director who has played a key role in negotiating the administration’s MFN agreements with drugmakers, faced questions from two Senate committees this week as part of his Deputy HHS Secretary confirmation, with much of the scrutiny focused on the deals’ lack of transparency. Senator Wyden pressed Klomp over HHS Secretary Kennedy’s April commitment to provide Congress with the agreements, which have yet to be released, while Senator Warren pointed to drugmakers’ own statements that the deals are not expected to materially affect their financial outlook, and questioned what companies received in return. Klomp maintained that transparency is a core principle of the agreements, but their terms remain largely confidential, making it difficult to independently assess their impact. What has emerged publicly, including reports that some deals are structured to expire after three years and exclude key products, only adds to those concerns. The stakes of that opacity were underscored by a new study released the same week, which found that confidential exemption deals with an estimated 26 drugmakers could wipe out close to 80% of the Medicare savings projected under the administration’s GLOBE and GUARD models. A well-designed MFN policy has the potential to lower prices for patients, but voluntary time-limited agreements whose terms remain secret make it difficult to know whether these deals will deliver meaningful, lasting savings. — [P4AD, The Lancet]
ICYMI: The Congressional Black Caucus Foundation’s 55th Annual Legislative Conference took place this week, and P4AD was there representing patients with our “Guess The Price” booth. With a heavy pharmaceutical industry presence at the conference including drugmakers like Merck and Vertex, we made sure patients’ perspective was represented, challenging attendees to guess the sky-high price of drugs like Entresto and Casgevy — a sickle cell treatment. How many can you get right?
