Welcome to the Week in Review.
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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Welcome to the Week in Review.
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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Welcome to the Week in Review.
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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P4ADNow Will Press To Keep The PREVAIL Act, Which Narrowly Cleared Committee, From A Vote On The Senate Floor
WASHINGTON, D.C. — Patients For Affordable Drugs Now is disappointed to see the Senate Judiciary Committee advance a patent bill that would harm patients: S. 2220 the PREVAIL Act. If enacted into law, the bill would weaken mechanisms to challenge potentially invalid patents and undermine existing checks on the pharmaceutical industry’s power, further limiting competition from less expensive generics and biosimilars. This would result in higher drug prices, putting more essential medications out of reach for patients nationwide.
The bill cleared the Committee on a razor-thin vote of 11 to 10, with several senators who supported its passage expressing significant reservations about the potential negative impact on patients and drug prices. Several Yes votes also indicated they would be uncomfortable supporting the bill in its current form if it was brought to the floor.
Merith Basey, Executive Director of Patients For Affordable Drugs Now released the following statement:
“Today’s markup of the PREVAIL Act is a step backward for patients. At a time when three in ten Americans struggle to afford their prescribed medications and over 20 percent have fallen into debt or bankruptcy due to healthcare costs, this bill would extend drug monopolies, stifle competition from cheaper generic and biosimilar drugs, and ultimately keep drug prices artificially high for millions of Americans.
“While amendments made to the legislation in committee attempt to resolve concerns, they barely scratch the surface of fixing the bill’s fundamental flaws. We believe that is why several Senators who voted yes today did not commit to supporting the bill on the Senate floor.
“The Inflation Reduction Act lowered drug prices for millions of Americans. PREVAIL could undermine those gains and take us in the opposite direction keeping drug prices high, and enabling drug companies to raise them further. 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.”
BACKGROUND
The Senate has already unanimously passed an amended version of S. 150. These Senate bills are estimated to save taxpayers $4.5 billion over the next 10 years.
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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.
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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Welcome to the Week in Review.
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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WASHINGTON, D.C. — Following the U.S. Presidential Election being called for Former President Donald Trump, David Mitchell, Founder of Patients For Affordable Drugs Now, issued the following statement:
“Patients For Affordable Drugs Now remains unwavering in our mission to lower drug prices for millions of Americans and we are ready to work with President-Elect Trump and the new Congress to make prescription drugs more affordable for those facing crushing costs.
“Even with the sweeping reforms ushered in under the Biden-Harris administration, one in three Americans still can’t afford their prescription drugs, and nine in ten agree that lowering drug prices should be a top priority for our elected leaders. On behalf of patients across all 50 states, we are committed to working with the Trump-Vance administration and the new Congress to expand on the gains made in recent years to lower drug prices and continue to deliver meaningful relief to patients.
“Previously, President-Elect Trump voiced support for allowing Medicare to negotiate lower prices and implementing the ‘Most Favored Nation’ model to prevent Americans from paying more than the average prices people in other countries pay for the same medications. We are hopeful that the new administration will return to these commitments or bring forward other approaches we can help enact to build upon the progress achieved in recent years.
“The Inflation Reduction Act was the most significant step forward in lowering prescription drug prices in two decades. On behalf of the patients we represent, we will vigorously defend the landmark drug pricing law against any attempts to roll back these hard-won reforms – whether through administrative action, legislation, or litigation.
“As a bipartisan organization, we know that lowering drug prices isn’t a Democratic or Republican issue – the pain of high drug prices is not limited to a single party. More than 80 percent of Americans support the principal reforms we champion. We will bring our voices to bear to keep what we have won. But we will support the new administration as it works to rein in the unchecked pricing power of drug companies, the practices of PBMs that put profits ahead of patients, and make prescription drugs affordable for every person in the U.S.”
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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.
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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