Welcome to the Week in Review.
End-Of-Year Spending Bill And Key Drug Price Reforms Still In Flux
In a turbulent week of negotiations, House leadership continues to grapple with internal divisions and external political pressures ahead of tonight’s midnight government funding deadline. The initial continuing resolution (CR) package, released Tuesday, included bipartisan drug pricing measures that would have saved taxpayers billions and lowered drug costs for Americans. But by Thursday night, a pared-down CR – stripped of drug price reforms and many other health care provisions – was brought forward and failed decisively on the House floor. As of 3 P.M. Friday, the most recent bill proposal also excluded the drug price reform bills that the P4ADNow community has been championing for the last 18 months. Those reforms include:
As of this newsletter, negotiations remain in flux, and it’s still unclear when a vote will happen. While the outcome remains uncertain, P4ADNow is keeping an eye on developments and is hopeful that Congress will still deliver long-overdue relief for patients struggling with the high cost of prescription drugs. No matter what happens, we will continue mobilizing our community of patients and allies, and holding lawmakers accountable to ensure these reforms and others like them become a reality as soon as possible. Millions of Americans are counting on it.
Court Watch: US V. Pharma
Patients For Affordable Drugs filed an amicus brief yesterday in the Third Circuit Court of Appeals, defending Medicare’s authority to negotiate lower drug prices in a case filed by Novo Nordisk, one of the Big Three insulin manufacturers that is challenging the program. This case is part of a coordinated, multimillion-dollar legal campaign by Big Pharma and its allies to overturn the historic program and regain its complete control over drug pricing. The amicus brief, P4AD’s second as part of our US v. Pharma campaign, highlights the transformative benefits of the Medicare Negotiation Program and counters Big Pharma’s misinformation surrounding access to and innovation of essential medicines. Further, it exposes the corrupt origins of the “non-interference” clause inserted into the Medicare Modernization Act of 2003 via pharmaceutical industry influence in order to block Medicare from negotiating drug prices. By overturning this loophole the program will lower costs on up to 60 of the most expensive and most used drugs on Medicare, weaken pharma’s monopoly power, and ensure billions in savings for American taxpayers. Patient advocate, Bob Parant, has lived with type 1 diabetes for over 50 years and shared his experience which was included in the amicus brief: that despite having better results using Novolog, Bob had to switch to a less effective medication because of the price Novo Nordisk was demanding. Lower negotiated prices will ensure that patients like Bob, who’ve had to make these difficult decisions, can access their life-sustaining medicine at an affordable price. — (P4AD, Georgetown Litigation Tracker, CBO)
ICYMI
Yesterday, Senators Hickenlooper, Welch, and Collins introduced the “Skinny Labels, Big Savings Act,” a bipartisan reform that would codify skinny labels, a critical pathway for market entry of generic medications, and increase savings for patients and taxpayers. P4ADNow is proud to support this bipartisan reform that reserves a crucial pathway for ensuring patients can continue to access life-saving generic medicines at prices they can afford.
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Pharma’s Excessive Prices Hikes
The new report from the Institute for Clinical and Economic Review (ICER) on price increases of prescription drugs in the U.S. established that five of the top 10 drugs with price hikes above the rate of inflation — Biktarvy, Darzalex, Entresto, Cabometyx, and Xeljanz — lacked significant clinical evidence to justify the price increases. These unjustified hikes drove $815 million in additional costs for patients and taxpayers in 2023, boosting pharmaceutical industry profits while burdening those who depend on these essential medicines. Notably, Entresto is among the first 10 drugs selected for Medicare negotiation, a critical step in addressing price gouging under the Inflation Reduction Act. Earlier this year, P4AD highlighted similar practices with regard to cancer drugs in a mini report, showing how pharma price hikes disproportionately harm Black and Latino patients. While Big Pharma’s price gouging has begun to be reined in by the Inflation Reduction Act, we need to continue to fight for systemic reforms to ensure that all patients can access the medicines they need at prices they can afford. — (ICER, STAT, NBC News, P4AD)
Inhaler Pricing Schemes
GlaxoSmithKline (GSK) continues to face backlash from patients and legislators over its decision last year to discontinue its popular Flovent asthma inhaler, used widely by children living with asthma, and replace it with a more costly generic version that lacks coverage from many insurers. Senator Elizabeth Warren sent another letter to GSK this week, raising concerns about the decision and highlighting findings from Johns Hopkins University that the discontinuation of Flovent HFA cost Medicaid programs nearly $1 billion in 2024. This move by GSK has left families scrambling to find affordable inhaler alternatives and disproportionately harms Black and Latino children who are diagnosed with asthma at higher rates. This blatant profiteering not only undermines patient access but also exacerbates health disparities, underscoring the urgent need for stronger oversight to hold pharmaceutical companies accountable and legislation to crack down on anti-competitive tactics. — (USA Today, Sierra Sun Times, Managed Healthcare Executive, US News)
Big Pharma’s Patent Abuses Cost Patients & Taxpayers
A new report from Public Citizen found that manufacturers of nine of the 10 drugs selected for negotiation by Medicare engaged in rampant anti-competitive tactics to block generic competition and artificially prolong monopoly periods. The report also highlighted that four of the selected drugs — Stelara, Xarelto, Januvia, and Enbrel — would likely have faced generic competition before negotiated prices went into effect, potentially saving Medicare up to $5.4 billion during that period — almost as much as the $6 billion of expected savings from negotiations in the first year. These inflated prices force patients to make impossible choices, like skipping doses or draining their savings, just to access the medicines they need. To achieve truly fair pricing, the Center for Medicare and Medicaid Services (CMS) must account for these anti-competitive tactics during the negotiation process and ensure the final prices reflect the harm caused by such abuses. — (Public Citizen, CMS)
ICYMI
P4ADNOW was disappointed by the United States Patent and Trademark Office’s (USPTO) decision to withdraw its proposed rule on “terminal disclaimer practice” to address drug manufacturers’ nonstatutory double patenting. This commonsense rule had the potential to curb the use of patent thickets, an abusive tactic used by the pharmaceutical industry to block competition and keep prices high for patients.
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Patient Advocate Of The Year
P4AD proudly began a new tradition: our Patient Advocate of the Year Award. The award honors a patient advocate who has gone above and beyond in the fight for lower drug prices. This year’s recipient was Judy Aiken — a name that should be familiar to Week In Review readers and who was presented with the award yesterday in Washington, DC. Judy is a retired nurse from Maine who has been living with psoriatic arthritis and psoriasis for over four decades. She made headlines earlier this year when she introduced President Biden and Vice President Harris and shared her experience with high drug prices at an event celebrating Medicare’s first 10 new, lower negotiated prices. Judy also testified before the Senate Finance Committee this year to share how the Inflation Reduction Act’s annual $2,000 out-of-pocket cap would rein in the cost of her prescribed medications. Judy’s unwavering commitment to this cause and her willingness to share her personal story continues to help P4AD have a measurable impact. She inspires us all to keep up the fight. — (Portland Press Herald, The New York Times, Fierce Pharma)
EOY Health Care Package Negotiations
As Congress approaches a deadline to pass critical funding bills, negotiations over a health care package are intensifying, with new developments from both parties. Congressional Republicans provided an initial proposal that included provisions that would address the lack of transparency within the pharmacy benefit manager (PBM) industry and delink PBM compensation from list prices. In response, Democrats have put forward a counteroffer that builds on these PBM policies while adding additional drug pricing measures, including S.150, the Affordable Prescription for Patients Act. This bipartisan legislation, which passed the Senate unanimously, targets patent thickets on biologics to accelerate biosimilar competition, lowering costs for patients and potentially generating $1.8 billion in federal savings over 10 years. On Wednesday, P4ADNow, AARP, The ERISA Industry Committee, CSRxP, and The National MS Society sent a letter to House and Senate Leadership urging them to pass S.150 to lower drug costs and generate savings to offset other critical healthcare priorities. Another provision still on the table is Q1/Q2, which P4AD supports, which would expedite the approval process of generic drugs and generate $871 million in government savings over 10 years. These measures align with P4AD’s mission and would help rein in the shady practices of the industry middlemen – while also holding drug manufacturers accountable for their role in setting high list prices. — (STAT, Congressional Budget Office, DC Journal)
ICYMI
The Biden-Harris administration announced that Bluebird Bio and Vertex Pharmaceuticals, two drug makers with FDA-approved gene therapies for sickle cell disease (SCD), have agreed to participate in the Cell and Gene Therapy Access Model. This voluntary model will test outcome-based agreements that tie payments to whether these multi-million dollar therapies improve health outcomes for people living with SCD on Medicaid. Given that over half of the entire community of 100,000 people in the U.S. with SCD are on Medicaid, the model is part of the Administration’s broader effort to increase access to novel therapies and drive down prescription drug costs by making it easier for states to pay.
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PREVAIL Act Narrowly Clears Senate Judiciary Committee
After several delays, members of the Senate Judiciary Committee voted to pass S. 2220, the PREVAIL Act, by a razor-thin bipartisan margin of 11 yays to 10 nays. Drawing concerns from patients and public health advocates alike, this patent bill would be detrimental if enacted into law and would weaken critical mechanisms to challenge potentially invalid patents and strengthen anti-competitive tactics wielded by drug manufacturers to block generic and biosimilar competition. The bill’s narrow committee vote, coupled with significant reservations from Senators on both sides of the aisle, suggests limited support for it to advance to the Senate floor. “While amendments made to the legislation in committee attempt to resolve concerns, they barely scratch the surface of fixing the bill’s fundamental flaws,” said P4ADNow Executive Director Merith Basey in a statement issued yesterday. “We urge the full Senate to reject PREVAIL and instead focus on the bipartisan patent reform policies currently in Congress that will increase competition and lower drug prices for all Americans.” — (Inside Health Policy, IP Watchdog, P4ADNow, Axios)
Continued Push For Competition
With just weeks left in the 118th Congress, momentum continues to build towards advancing the bipartisan Affordable Prescriptions for Patients Act of 2023 (S. 150), aimed at addressing one of Big Pharma’s key abuses of the patent system. The bill, which unanimously passed the Senate in July, would limit the number of patents a pharmaceutical company can assert on biologic drugs, curbing patent thicketing and bolstering the timely entry of biosimilars into the market. According to the Congressional Budget Office (CBO), this legislation is projected to generate $1.8 billion in savings over ten years, which could serve as a timely bipartisan offset for other critical, must-pass health care priorities as lawmakers consider an end-of-year legislative package. We urge members in the House to continue advancing this cost saving measure as millions of patients nationwide urgently need relief from high drug prices. — (Politico, Axios, Congressional Budget Office)
President-Elect Trump 2025 Appointments
President-Elect Donald Trump has tapped Robert F. Kennedy Jr. to head the Department of Human & Health Services (HHS) and Dr. Mehmet Oz as administrator of the Centers for Medicare and Medicaid Services (CMS) – both unconventional appointments that introduce a level of uncertainty in the future of drug pricing policy. At P4ADNow, we’re committed to working with the new administration to lower prescription drug prices to improve the financial well-being and health of all Americans. Despite nine in 10 American voters believing that lowering drug prices should be an important or top priority of elected officials, the incoming administration has yet to outline concrete steps to address this issue. Our focus however remains the same: we will work with any elected official who champions efforts to lower drug prices for patients, hold accountable those who prioritize Big Pharma’s interests over the American people, and emphasize to the incoming administration that lowering drug prices is essential to making America healthy again. — (Becker’s Hospital Review, Reuters)
ICYMI
Listen to P4AD’s Merith Basey on WPFW-FM discuss how Black and Latino patients are disproportionately harmed by high drug prices, and face more difficulty affording their medicines. Given that Black and Latino patients are more likely to be affected by chronic conditions, including diabetes, cancer, and heart disease, Big Pharma’s relentless price hikes exacerbate existing health disparities within these communities and lead to patients disproportionally rationing or forgoing their essential medicines altogether.
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Harmful Patent Bills Stall In Senate
The Senate Judiciary Committee’s markup of two controversial patent bills, S.2220, the PREVAIL Act, and S.2140, the Patent Eligibility Restoration Act (PERA), was postponed yet again amidst ongoing concerns from patients and public health advocates. If enacted, these bills would make it more difficult to challenge questionable patents, potentially limiting competition from lower-cost generics and biosimilars – enabling pharmaceutical companies to keep prices consistently high for patients. These bills could further entrench Big Pharma’s pricing power, allowing companies to lock in monopoly prices longer and undermining recent reforms aimed at lowering costs. “We’re encouraged by the delay on S. 2220 and S. 2140, but the threat to patients isn’t over. Even with the potential amendments, the committee is unable to fix the fundamental flaws of the bill,” said Merith Basey, P4AD executive director, after yesterday’s committee meeting. In September, when the bill was originally on the calendar for markup, Patients For Affordable Drugs Now sent a letter to the Committee urging members to vote against moving the bills forward. The markup has been rescheduled for next week. As we approach the final weeks of this Congress, legislators should instead prioritize bipartisan reforms that would improve our patent system and increase competition to lower prices for millions of patients across the country. — (Inside Health Policy, Axios, patientspushforcompetition.org)
Drug Industry Trade Association’s Waning Power
The drug industry’s top trade associations, the Biotechnology Innovation Organization (BIO) and Pharmaceutical Research and Manufacturers of America (PhRMA) have seen notable departures from their corporate members amid continued tensions since the passage of the Inflation Reduction Act in 2022. This week, GSK became the fifth company to leave BIO in the last two years and joined Pfizer, UCB, AbbVie, and Takeda in departing the trade association. Since the enactment of the IRA, PhRMA has similarly experienced an exodus of major drug companies from its membership, including AstraZeneca, AbbVie, and Teva. The IRA drug pricing reforms have sparked significant debate within the industry, leading some companies to reassess their membership in key industry groups. — (Endpoints, STAT, Fierce Pharma, Becker’s Hospital Review)
ICYMI
In a video interview with El Tiempo Latino, P4AD’s Merith Basey detailed the significant barriers facing Black and Latino communities with regard to high drug prices that force many patients to skip or forgo their essential medicines.
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P4ADNow’s Commitment to Lower Drug Prices Under New Administration
With the 2024 Presidential Election called for Former President Donald Trump, P4ADNow reiterated its commitment to addressing the high cost of prescription drugs through working with the incoming administration and the new Congress. As an organization representing patients of all ages from across all 50 states, we know the burden of drug costs transcends party lines and affects Americans nationwide. Though it is futile to attempt to predict what President-Elect Trump will do on this issue over the next four years, he has previously voiced support for Medicare negotiation and exploring the “Most Favored Nations” model. However, he backed away from those proposals, leaving it unclear how he plans to deliver on his campaign promise of lowering prices. Proposals from Trump-affiliated think tanks, such as the America First Policy Institute (AFPI) and the Heritage Foundation, provide a possible roadmap – one that at best misses the mark and at worst could raise prices and undermine patient access to treatments. AFPI is advocating for trade policies to counter perceived foreign “free-riding” and supports making more prescription medications available over the counter, as well as other state-level initiatives. Meanwhile, the Heritage Foundation’s Project 2025 – a framework of highly conservative goals for the Trump Administration – explicitly calls for rescinding the Inflation Reduction Act (IRA). This would roll back Medicare’s authority to negotiate drug prices, a measure supported by 85% of Americans, as well as the out-of-pocket spending cap and the inflation rebate program. In a statement Wednesday, David Mitchell, president and founder of P4ADNow, emphasized that we will vigorously defend the IRA and stand against any efforts to roll back these reforms – whether through legislative, administrative, or legal means. Nine in ten Americans believe Congress should do more to lower drug prices, and P4ADNow will work with the new administration and the new Congress to keep this priority front and center. Simultaneously, we will hold accountable those who made promises to lower costs and continue advancing policies to bring relief to patients across the country. — (P4ADNow, Politico, Inside Health Policy, KFF, P4ADNow)
CAR-T: A Breakthrough Treatment Hindered by High Costs
Since the approval of the first chimeric antigen receptor (CAR) T-cell therapy in 2017, these groundbreaking treatments have transformed the landscape of cancer treatment, with six therapies now approved in the U.S. for 16 different indications. As awareness and demand for CAR-T therapies grow, so too have the challenges. The complex treatment process which currently takes several weeks, coupled with sky-high costs starting at $400,000 and often reaching seven figures, creates significant barriers to access for many patients. Efforts to reduce manufacturing costs and decentralize production models show promise in making CAR-T more affordable, but for now the price-tag remains a major hurdle. As Merith Basey, Executive Director of P4AD noted, “The conversation is currently about how we [are] going to pay for them, and not how we [are] going to lower the price.” As CAR-T becomes a more routine option, including potentially as a first-line treatment for certain cancers, it is crucial to prioritize efforts to bring down costs which is already a reality in countries like Spain and Brazil, helping to ensure equitable access for all patients. — (Managed Healthcare Executive)
ICYMI
Vertex has generated $2 million in revenue from its sickle cell therapy, Casgevy, after its commercial launch. So far the therapy is currently being administered to only 40 patients across 45 treatment centers.
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Court Watch: US v. Pharma
Combined oral arguments brought by Bristol Myers Squibb (BMS), AstraZeneca, and Janssen Pharmaceuticals were heard by the Third Court of Appeals in Philadelphia in their efforts to halt the Medicare Negotiation Program. The arguments were considered by a three-judge panel that raised issues with the drug companies’ claim that they were being forced to participate in negotiations and that the program violated their First Amendment rights. This hearing marks the first appellate-level challenge to Medicare negotiations. In September, Patients For Affordable Drugs submitted an amicus brief in the consolidated case which highlights how lower negotiated prices will deliver transformative savings to patients. First-hand testimonies from patients like Lynn, who is forced to rely on financial assistance for her Imbruvica, and Aly, who spends nearly half of his monthly income on prescription drugs, including Eliquis, illustrate the devastating impact of high drug prices and the potentially life-changing impact of lower negotiated prices. While eight cases brought by Big Pharma and its allies have been ruled against the companies, we can’t rest on our laurels. As drugmakers continue to appeal, experts anticipate that one of the cases filed in various district courts may make its way to the Supreme Court. We are steadfast in our commitment to defending this historic program against challenges both inside and outside of the courts. — (Reuters, P4AD, Politico, P4AD, STAT)
Big Pharma Reaps Big Earnings
As we enter the last stretch of 2024, the pharmaceutical industry’s earnings underscore its continued financial strength despite their fear-mongering about the Inflation Reduction Act. Novartis — one of the drug manufacturers suing to stop Medicare negotiation — reported a striking $3.2 billion in earnings during the last quarter, an 111 percent increase from the same quarter last year. Pfizer, whose CEO Albert Bourla once described Medicare negotiations as “negotiation with a gun to your head,” outperformed analyst expectations with $4.47 billion in quarterly earnings. BMS also surpassed projections, reporting $1.21 billion in third-quarter earnings — in large part due to increased sales of Eliquis, its blockbuster blood thinner which was selected for the inaugural round of Medicare negotiation. While these companies relentlessly criticize the Inflation Reduction Act’s historic drug price reforms, their strong earnings reveal a thriving industry capable of succeeding under policies that better protect patients from sky-high drug costs. — (Accountable.US, Reuters, STAT, AP News, Washington Post, CNBC)
ICYMI
The Senate Judiciary Committee held a field hearing to examine the root causes of high drug prices and the financial burden on American seniors. During the hearing, lawmakers championed legislation that would reform our patent system and increase transparency into Pharmacy Benefit Managers (PBMs) – both critical levers to reining in spiraling drug costs. As we approach the lame-duck session, we are focused on advancing bipartisan bills to curb patent abuses and increase competition to lower prices for all patients.
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Court Watch: US v. Pharma
Marking another significant upset for Big Pharma and a critical victory for patients, Novartis faced a setback last week in its lawsuit to stop the implementation of the Medicare Negotiation Program. District Judge Zahid Quraishi rejected Novartis’ claim that the program violated the Takings Clause, compelled speech protections, and the Excessive Fines Clause, underscoring, yet again, the voluntary nature of the program. Novartis’ case was the final of four cases before Judge Quraishi, and he has now ruled in favor of the government and patients in all four. This case also marks the eighth lawsuit to be ruled against the pharmaceutical industry. Next week, oral arguments will be heard as Bristol Myers Squibb, AstraZeneca, and Janssen lay out their appeals before the Third Circuit Court of Appeals. “Behind every one of these legal challenges is a story of a patient rationing their medication or going into debt to afford life-saving drugs,” P4AD’s David Mitchell said in a statement this week. “The court’s decision last week moves us one step closer to a future where no one has to make these impossible choices.” — (Bloomberg Law, Washington Monthly)
First Patient Leaves Hospital After SCD Therapy
Kendric Cromer, a 12-year-old from Washington D.C., made headlines earlier this year when he became the first patient to receive an FDA-approved gene therapy for sickle cell disease (SCD). After nearly five months of treatment, involving intensive chemotherapy and the infusion of new modified blood cells, Kendrick left the hospital this week and is now on the road to living a life without SCD. This groundbreaking treatment offers transformative potential for children, like Kendrick, who suffer from the lifelong, painful blood condition affecting 100,000 people in the United States, most of whom are Black and Latino. However, while the promise of gene therapy is life-changing, the reality is that the newly approved SCD gene therapies, Lyfgenia by Bluebird Bio and Casgevy by Vertex Pharmaceuticals, come with staggering list prices of $3.1 million and $2.2 million per treatment, respectively. These high launch prices raise serious concerns about the financial strain on patients, insurers, hospitals, and our health care system overall. While the potential benefits of gene and cell therapies are profound, the current pricing models create barriers that limit access for many patients. As we celebrate the remarkable advancements in treatment, it is crucial to address the urgent need for a sustainable pricing structure that balances fair profits for manufacturers with accessibility and affordability for patients and the health care system as a whole. — (The New York Times, CDC, CNBC)
Legislators Tout IRA Savings
As we anticipate the drug price reforms in the Inflation Reduction Act taking effect in 2025, patients are already reaping substantial savings this year from the provisions already underway. At an event in New Hampshire, President Biden and Senator Sanders touted a new report by the Office of The Assistant Secretary for Planning and Evaluation (ASPE) that found that because of the Inflation Reduction Act, nearly 1.5 million patients on Medicare saved nearly $1 billion in out-of-pocket costs in just the first half of 2024. The report also revealed that the annual out-of-pocket cap is delivering crucial relief for patients burdened by high cancer drug costs, which comprised nine of ten of the highest-spending medications among those who reached the cap in 2024. In two months, when the out-of-pocket cap for patients on Medicare lowers to $2,000, nearly 19 million people are projected to save roughly $400 per year on prescription drug costs. As the drug price law continues to take effect, patients stand to see substantial savings on their prescription drugs, lower out-of-pocket costs, lower average premiums for patients, and a variety of plans to choose from — ensuring access to a wide range of treatments at more affordable prices. — (PBS, ASPE, HHS, KFF)
ICYMI
The pharmaceutical industry’s top trade association, The Pharmaceutical Research and Manufacturers of America (PhRMA), closed out last quarter spending $6.9 million in health care lobbying efforts ranking the group as the top spender on health care lobbying among all health trade association groups this year.
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