The Week in Review in Prescription Drug Pricing: Xeljanz to be Removed from Negotiations, End of Medicare Drug Premium Subsidies, and more
Xeljanz to be Removed from Negotiations
CMS announced that Xeljanz and Xeljanz XR will be removed from the Medicare Drug Price Negotiation Program in 2029 after determining the drugs will soon face generic competition. While Xeljanz was included in the third round of Medicare negotiations, the lower negotiated prices which will be announced in November 2026 will only be in effect for one year, beginning on January 1 2028. Medicare negotiation is designed to target high-cost, single-source drugs that lack competition. Once meaningful competition enters the market, those drugs are no longer eligible for negotiation — reflecting the program’s role as a strong counterweight to monopoly pricing, not a replacement for competition. While it is too soon to know the impact the new competitor will have on overall prices, increased generic or biosimilar entry has historically driven significant savings for patients, and one generic coming to market lowers prices by an average of 39%. — [FDA]
Trump to End Medicare Drug Premium Subsidies
For years, the pharmaceutical industry claimed that Medicare drug price reforms would drive higher premiums for patients. Now, the Trump administration is ending a program specifically designed to keep those premiums down. A primary driver of high premiums is the high cost of prescription drugs, forcing people with Medicare to effectively subsidize pharma profits. Instead of shifting more costs onto patients, policymakers should focus on lowering the prices drug companies are allowed to charge. — [WSJ, NYT, USA Today, Common Dreams]
New Pharmaceutical Tariffs Take Effect
President Trump’s Section 232 tariffs on patented pharmaceutical products and their ingredients took effect today, imposing rates of up to 100% under a national security justification. While companies with approved onshoring plans or most-favored-nation (MFN) agreements may face lower rates, and generics are currently exempt, those exemptions could change within a year, and generics are also being threatened by new tariffs announced earlier this month. Given that only 10% of active pharmaceutical ingredients (APIs) used in U.S medicines are produced domestically, these tariffs are likely to have widespread impacts across the supply chain. Tariffs do nothing to address the root cause of high drug prices. Instead, they increase the risk of drug shortages and drive higher costs for patients, as manufacturers are unlikely to absorb additional expenses. Any potential benefits from reshoring will likely take years to materialize, while price increases will be felt almost immediately as costs to American patients are already escalating when it comes to healthcare. — [White House]
Patient Advocate Spotlight: Emmabella Rudd
Background: Florida State University student, documentary producer, and insulin accessibility advocate since her diagnosis at 5 years old.
Condition: Type 1 Diabetes
Drug: Insulin ($3,000 per year)
In her words:
“It’s frustrating to see pharmaceutical companies bask in the protection of numerous patents around their insulin products. They’re interested in appearing concerned about drug affordability, but their efforts are always superficial and short-lived. Drug companies need to remember that their actions affect real human lives, and at the end of the day, the people will have the power.”
Welcome to the Week in Review.
House & Senate Markups Advance Drug Pricing Reform
With two markups this week, the House E&C and Senate HELP Committees advanced three bipartisan, P4ADNow-supported drug pricing reforms. The Senate’s INSULIN Act (S. 4189) would establish a $35 monthly out-of-pocket cap for people with private insurance, and crack down on Big Pharma’s abuse of citizen petitions. In the House, the Stop GAMES Act (H.R. 8908) similarly targets citizen petitions, while the Biosimilar Red Tape Elimination Act (H.R. 5526) would streamline FDA requirements on interchangeability — cutting unnecessary regulatory red tape that delays lower-cost biosimilars from coming to market. The Senate version of the Biosimilar Red Tape Elimination Act has also already passed favorably out of committee. Driven in part by sustained advocacy from the P4ADNow community, these bills advancing out of committee keep them in play for potential inclusion in broader legislative packages later this year. If enacted, these reforms would lower out-of-pocket costs for patients, curb pharmaceutical industry tactics that delay competition, and help bring more affordable alternatives to market. — [P4ADNow, P4ADNow, POLITICO, The Hill, POLITICO]
Big Pharma Leads 2026 Health Lobbying
Mid-year lobbying disclosures show the pharmaceutical industry once again dominating Washington, accounting for 42 of the top 100 lobbying spenders. PhRMA alone has spent nearly $20 million so far this year — more than $6 million ahead of the next highest spender — with major drugmakers Eli Lilly, Merck, Pfizer, and Johnson & Johnson also among the top ranks. Even in a relatively unproductive Congress, the pharmaceutical industry’s lobbying remains near record levels, underscoring the scale of its power. With roughly three pharma lobbyists per member of Congress, organizations like P4AD play a critical role as an independent counterweight — elevating patient voices without the influence of industry funding and pushing back against pharma-driven narratives. — [Washington Post, POLITICO]
P4AD Warns Against President Trump’s Generic Tariffs Plan
On Tuesday, President Trump announced his plans to instate a 100% tariff on generic drugs beginning in August 2028, with a planned increase up to 200% in 2029, one year after his term ends. Generics are one of the few areas where Americans pay relatively low prices compared with other countries. Tariffs of this magnitude could have enormous consequences — raising costs, worsening shortages, and putting access to lifesaving medicines at risk. If the administration intends to lower prescription drug prices, it should not pursue policies that threaten to raise them. Imposing massive tariffs on generic medicines risks making lower-cost options millions of Americans rely on more expensive and harder to access. — [P4AD, Truth Social, USA Today, TIME, Reuters, Common Dreams]
Patient Advocate Spotlight: Elaine Kniepfel
Condition: Multiple Sclerosis
Drugs: Copaxone ($100,000/year) and Provigil ($8,000/month)
Background: Retired educator with 47 years of service as a teacher and administrator from Kansas
In Her Words: “Even with Medicare, the $2,000 cap is too much for retired people on fixed incomes. It’s abhorrent that drug companies charge so much to the people who need medicine most.”
WASHINGTON, D.C. — Today, the House Energy and Commerce Committee advanced two bipartisan bills supported by P4ADNow that would increase competition and help lower prescription drug costs:
The Biosimilar Red Tape Elimination Act (H.R. 5526), which would codify existing FDA guidance on interchangeability and remove requirements for separate “switching studies” to prove interchangeability — cutting unnecessary regulatory red tape that delays lower-cost biosimilars from coming to market.
The Stop GAMES Act (H.R. 8908), which would curb pharmaceutical companies’ abuse of citizen petitions by allowing the FDA to reject petitions filed solely with the purpose of delaying competition and keeping lower-cost alternatives off the market.
Both bills were added to the Lower Costs, More Transparency Act (H.R. 9393), which the committee unanimously passed during today’s markup. Last month, the Senate version of the Biosimilar Red Tape Elimination Act also advanced through the Senate HELP Committee.
In response, P4ADNow CEO Merith Basey released the following statement:
“Drug companies systematically game the patent system to delay lower-cost alternatives from coming to market, keeping prices high for patients. Today’s bipartisan vote is an important step toward increasing competition in the marketplace. We’re especially encouraged to see the Biosimilar Red Tape Elimination Act advance through committee in both chambers, bringing this bipartisan reform one step closer to becoming law.
We urge Congress to swiftly pass these reforms so patients can benefit from lower-cost competition.”
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Patients For Affordable Drugs Now is the only national, patient advocacy organization focused exclusively on policies to lower drug prices. We empower and mobilize patients and allies, hold accountable those in power, and fight to shape and achieve system-changing policies that make prescription drugs affordable for all people in the United States. P4ADNow is bipartisan and does not accept funding from organizations that profit from the development or distribution of prescription drugs. To learn more, visit: PatientsForAffordableDrugsNOW.org
Welcome to the Week in Review.
New FDA Move Set To Hinder Big Pharma’s DTC Advertisements
The FDA is expected to strengthen transparency and warning requirements for direct-to-consumer (DTC) prescription drug advertisements as part of the administration’s 2026 regulatory agenda – a move that could make ads increasingly difficult and costly to air – even if it falls short of an outright ban. That shift is significant given how effective DTC advertising is: even small increases in ad spending are associated with major jumps in drug sales. At the same time, lawmakers have advanced proposals like the bipartisan, P4ADNow-endorsed No Handouts for Drug Advertisements Act, which would eliminate tax breaks that subsidize this marketing. Together, these efforts signal growing momentum to rein in a practice – unique to the U.S. and New Zealand – that prioritizes industry profits by encouraging the overprescribing of expensive brand-name products, often while downplaying potential side effects. — [POLITICO, OMB, Axios, TIME, Washington Examiner, Sen. Hawley]
Judge Blocks Colorado PDAB and Enbrel Price Relief
A federal judge has temporarily blocked Colorado’s Prescription Drug Affordability Board (PDAB) from implementing a price cap on Enbrel, halting a first-in-the-nation effort to rein in the cost of high-priced prescription drugs through upper payment limits. The policy would have capped the drug at $600 per week, compared to a monthly list price of over $7,000. The ruling comes as the pharmaceutical industry continues to challenge state-level affordability efforts, with Enbrel manufacturer Amgen praising the decision. For Colorado patients who rely on Enbrel, the pause means continued exposure to high and unaffordable prescription drug costs while the case moves forward. The decision underscores the ongoing legal and political barriers facing efforts to lower drug prices – even as states attempt to take action. — [STAT News, CMS, Colorado Sun, Endpoints News]
HIV Drug Costs Set to Surge for Medicare, EPIC Would Make It Worse
The cost of HIV drugs for Medicare is projected to nearly triple over the next decade, rising from $6.4 billion in 2026 to $17.8 billion by 2035, according to a new study. The analysis finds that the high cost of antiretroviral therapy — not other health conditions — is the primary driver of spending for older Americans living with HIV. These findings reinforce concerns previously raised by P4AD: drugmakers continue to raise prices on HIV treatments while pushing policies that would delay cost-saving reforms. Tools like Medicare drug price negotiation would significantly reduce costs, but many HIV drugs could face delayed eligibility under pharma-backed proposals like the EPIC Act — which would extend the timeline before negotiation could begin. As more people with HIV age into Medicare, the stakes are clear: without protecting and strengthening Medicare negotiation, patients and taxpayers will be left to absorb the rising cost of lifesaving medications. — [JAMA, P4AD]
Bipartisan Push for Broader Insulin Price Caps
Sens. Collins (R-ME) and Shaheen (D-NH) highlighted their bipartisan INSULIN Act this week, which would expand Medicare’s $35 monthly insulin cap to private and employer insurance. While out-of-pocket caps don’t address the root cause of high list prices and instead shift costs away from patients to the government, growing GOP support signals meaningful bipartisan momentum. The proposal was recently folded into a broader drug pricing bill and could see action in an upcoming markup. — [Johns Hopkins, Sen. Shaheen, P4AD]
ICYMI: The FDA approved a new sickle cell disease gene therapy, Casgevy, for children over 2, providing a lifeline for families dealing with this debilitating disease, but it comes with an enormous price tag — Casgevy has a list price of over $2.2 million. Gene therapies are often customized and transformative, but the cost barrier in the United States severely limits patient access, particularly when the same drugs often launch at significantly lower prices in countries like Spain and Brazil.
Patient Advocate Spotlight: Doug Lusty
Condition: Crohn’s disease
Drugs: Stelara ($2,641.09 per injection every eight weeks)
Background: Retired state auditor living in Kaysville, Utah
Read more about Doug in his new Deseret News profile:
“‘Between my wife and I, we were on five of the first 10 medications to get negotiated for Medicare,’ he said. He added that the negotiated prices can still be expensive, but not as expensive as before.”
“Doug retired after 32 years with the state government due to health and meeting his medical needs — not just prescriptions — on a fixed income is challenging.”
“Both of them have at times in recent years skipped medication doses because of the cost. And they’re not alone.”
“Doug Lusty said the bright spot has been that some of the medication costs for them have gone down, thanks in large part to the ability Medicare now has to negotiate the prices on some of the more expensive drugs the program covers.”
Medicare’s GLP-1 Bridge Program Expands Access — But Has Limits
The administration’s GLP-1 “Bridge” program went into effect this week, offering eligible patients on Medicare access to weight loss drugs for $50 per month — marking the first time these treatments are covered for obesity alone. While CMS has not released an official estimate of how many people will qualify, KFF found that roughly 3.8 million beneficiaries would have met the program’s criteria based on 2023 data. For millions of older Americans, this represents a significant step forward, putting highly effective treatments within reach for the first time. At the same time, the program is temporary, does not count toward Medicare’s out-of-pocket cap, and was initially intended to transition into the broader BALANCE model, which remains delayed. GLP-1 drugs continue to cost far more in the U.S. than abroad, highlighting the need for longer-term solutions — but for now, the Bridge program offers meaningful, if limited, relief to some older patients who need it.— [AP, The Hill, USA Today, NBC News, ABC News, Barrons, STAT News]
GLOBE & GUARD Advance, But Questions Remain
CMS has sent the final GLOBE CMMI model rule to the Office of Management and Budget (OMB) for review, the last step before its public release, while its companion model, GUARD, has been under review since June 15th. This move signals that both models are moving from concept to implementation. However, key details remain about how they will function in practice. Reports that drugmakers may be able to avoid participation by entering into voluntary most-favored-nation (MFN) agreements raise uncertainty about whether these models will function as meaningful policy initiatives that will lower costs for patients, or primarily serve as leverage to drive MFN deals. P4ADNow has submitted comments on both of the proposed GLOBE and GUARD models, and we’ll continue to monitor their progression as details emerge. — [OMB, Inside Health Policy]
PBMs and Pharma Continue Pointing Fingers
Pharmacy Benefit Managers are ramping up lobbying spending following the recent passage of bipartisan PBM drug pricing reforms. Drugmakers have spent millions pushing the narrative that middlemen are the primary driver of high drug prices. That messaging push has gained traction, and PBMs are responding with increased advocacy of their own. While PBMs’ opaque and profit-driven practices play a significant role in patients’ access and costs, drug prices are ultimately set by manufacturers. The result is a system where powerful industry players continue to shift blame, while patients face the consequences of high and rising prices. Meaningful reform will require addressing the full system — starting with the pricing power of drugmakers — to deliver lower costs for patients. — [The Hill, P4AD, Congress]
Patient Advocate Spotlight: Josh Swatosh
Condition: Blind, Epilepsy, Cerebral Palsy, Severe Asthma, and Sleep Apnea
Background: 46 year-old patient advocate from Austin, Texas
In His Words: “It’s really been a pain when having to change medications fairly regularly… we should all have more affordable prescription drug prices, as I feel it is not right that drug companies are bringing in massive profits when it does not cost them near what they want you to think it does to manufacture these medications.”
New polling from Axios-Ipsos shows that health care costs — particularly prescription drug prices — will be a defining issue in the 2026 midterms, with a majority of voters saying a candidate’s position on affordability will influence their vote. Another survey found that over the past year more than half of voters took steps to attempt to mitigate high health costs, including avoiding doctors’ visits or taking on debt to afford treatment. U.S. health spending hit a record $5.7 trillion in 2025, with one of the biggest factors driving the uptick being demand for high-cost medications, particularly for people on Medicare and private insurance. Average annual growth for prescription drugs was 11.1 percent in 2025 compared to 7.9 percent in 2024. — [Axios, POLITICO, POLITICO]
Insulin Cap Gains GOP Support
Republican support is growing for legislation that would cap insulin costs for privately insured patients. Medicare’s $35 cap on insulin costs is already delivering hundreds of dollars in savings each month for seniors, proving the program’s success and popularity that should be extended to the commercial market. The move reflects mounting pressure to address drug affordability ahead of the midterms. As Senator Josh Hawley (R-MO) stated, “I don’t know why it should divide Republicans… who is in favor of allowing these pharma companies to rip off people with high insulin prices when there is no supply issue or production issue?” While out-of-pocket caps don’t tackle the root cause of high list prices and only shift costs away from patients, their growing bipartisan support signals continued momentum for policies that directly make prescriptions more affordable. — [Congress, POLITICO]
Sickle Cell Cures Advance – But Costs Remain A Barrier
A young man from Louisiana became the first person in the Gulf Coast region to be cured of sickle cell disease after undergoing FDA-approved CRISPR/Cas9 gene editing technology. This breakthrough follows the treatment of a 12 year old boy in Washington, D.C. These advances mark real progress for a debilitating and lifelong condition that disproportionately affects Black and Latino communities. These therapies represent extraordinary scientific progress — but with price tags exceeding $2 million, access remains a significant barrier both for patients and payers. Alternative models like the first of its kind partnership between a Maryland non-profit and the Brazilian government do offer a potential solution, making these promising cures increasingly within reach for patients.— [Guardian, NYT, The Grio, NIH, Biopharma Dive, Fierce Pharma]
ICYMI
Following Germany’s plans to lower drug prices to control rising healthcare costs, the U.S. launched an investigation into what it calls “underpayment for innovative pharmaceutical products,” raising the prospect of new additional tariffs on EU drug imports past the 15% set to begin at the end of July. It’s critical to remember that lowering prices for U.S. patients shouldn’t come at the expense of patients in other countries, and this approach doesn’t even guarantee lower prices at home. — [Bloomberg, POLITICO, STAT News, EU]
Patient Advocate Spotlight: Helen Bell
Condition: Psoriatic Arthritis and Crohn’s disease
Drugs: Methotrexate, Entyvio, and Rinvoq
In Her Words: “My medications have provided me with periods of remission and overall stability. The financial logistics of maintaining this access, however, have become a more stressful burden than my illnesses themselves.
“My Entyvio would have been a massive financial burden on our household, as it falls under Part B as an infusion. I was only able to proceed with this medication because my gastroenterologist’s treatment coordinator navigated a patient assistance program application successfully. Before landing on my current medication combination, six biologic medications failed me. All of these have been expensive enough that I had to avail myself of the manufacturers’ copay assistance programs, at times forcing me to delay new treatments as I coordinated these programs.
“Having insurance does not guarantee access to affordable care, and lifesaving medications are not guaranteed to be affordable for many. My story is tragically far too common in our broken healthcare system.”
Yesterday, the Senate HELP Committee advanced two bipartisan and P4ADNow-supported bills: The Biosimilar Red Tape Elimination Act (S. 1954), which would reduce unnecessary regulatory hurdles that slow the adoption of lower-cost biosimilars, and The Medication Affordability and Patent Integrity Act (S. 2658), which would strengthen oversight of the patent system and close loopholes that delay competition. P4ADNow has been in support of these bills for years, and we see opportunities for both to pass in a number of potential packages later this year. Additionally, The Ensuring Timely Access to Generics Act of 2025 (S. 3014), which targets sham citizen petitions that block generic entry, was amended to include the INSULIN Act and did not receive a vote. This is another P4ADNow-supported bill, and we anticipate it will be included in a forthcoming July markup. — [IP Watchdog, POLITICO
New Study Reaffirms the Broad Success of OOP Cost Caps
After out-of-pocket expenses were capped for patients on Medicare, their ability to both access and use costly medications increased. That’s according to a new study this week examining changes in prescription fills from 2022 to 2025 — before and after Medicare’s annual out-of-pocket spending caps were introduced. In the researcher’s words, “the policy substantially improved patient access.” After the implementation of the cap, patients had a pronounced increase in fill rates for high-cost drugs, such as treatments for cancer and pulmonary fibrosis. These results mirror what we’ve been hearing from members in our community, and it further reinforces the case for expanding similar caps past Medicare and to the commercial market in conjunction with mechanisms that tackle list price. — [JAMA]
ICYMI
P4AD CEO Merith Basey joined Laura Packard of Care Talk last week to discuss the recent Supreme Court decision to reject six of the largest pharmaceutical industry lawsuits against Medicare negotiation. You can watch the full episode below! — [Care Talk]
Patient Advocate Spotlight: Cheryl Jones
Condition: Thyroid Cancer
Drugs: Armour Thyroid (Over $100 per bottle), and other medications
Background: Patient advocate from Del City, Oklahoma
In Her Words: “For those of us on limited incomes and living off of Social Security benefits, such high costs hurt us badly. We are supposed to be living in our golden years, not dealing with fear and anxiety of where our next meal will come from. It ultimately comes down to the decision of buying prescription drugs or food to eat.
We should all have access to affordable prescription drugs in this country. Instead, the pharmaceutical companies keep raising their drug costs while insurance companies refuse to pay for varying degrees of a medication’s cost.”
WASHINGTON, D.C. — Just now, the Senate HELP Committee advanced two bipartisan bills, all supported by P4ADNow, that will help to increase competition and lower prescription drug prices.
The Biosimilar Red Tape Elimination Act (S. 1954), which would reduce unnecessary regulatory hurdles that slow the adoption of lower-cost biosimilars
The Medication Affordability and Patent Integrity Act (S. 2658), which would strengthen oversight of the patent system and close loopholes that delay competition
In response, P4ADNow CEO Merith Basey released the following statement:
“We applaud the Senate HELP Committee for standing with patients and cracking down on tactics deployed by the pharmaceutical industry that block cheaper biosimilars and generics from coming to market. At a time when nine in ten Americans are demanding Congress do more to lower prescription drug prices, there is both an urgent need and an opportunity to pass these bills as soon as possible. Patients cannot wait.”
P4ADNow has been in support of both these bills for years and our community has pushed hard to get them to this point — including sending nearly 1,500 letters to lawmakers on the Senate HELP Committee in the past four days alone. We see a real path forward for these bills to pass in a number of potential packages later this year.
The Ensuring Timely Access to Generics Act of 2025 (S. 3014), which targets sham citizen petitions that block generic entry, was amended and did not receive a vote today. This is another P4ADNow-supported bill, and we anticipate it will be included in a forthcoming July markup.
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Patients For Affordable Drugs Now is the only national, patient advocacy organization focused exclusively on policies to lower drug prices. We empower and mobilize patients and allies, hold accountable those in power, and fight to shape and achieve system-changing policies that make prescription drugs affordable for all people in the United States. P4ADNow is bipartisan and does not accept funding from organizations that profit from the development or distribution of prescription drugs. To learn more, visit: PatientsForAffordableDrugsNOW.org
