Welcome to the Week in Review.
Court Watch: US v Pharma
Another judge has cast doubt on pharma’s arguments challenging Medicare negotiation. On Thursday, Boehringer Ingelheim’s high-priced lawyers presented the corporation’s case against the program in a Connecticut court, where U.S. District Judge Michael P. Shea expressed skepticism of their claims. The lawsuit is one of nine filed by the drug industry and its allies to block the wildly popular program in the Inflation Reduction Act. Boehringer’s suit aims to preserve its pricing power over blockbuster drug Jardiance, one of the first 10 drugs up for negotiation – which generated $8 billion in sales in 2023. A lower negotiated price for Jardiance would be transformational for patients like Gillian from Virginia, who is living with type 2 diabetes and was prescribed the medication to control her blood sugar, but has to forgo it because of the $680 monthly price tag. The corporation’s lawsuit is a “grab bag” of many constitutional and procedural arguments raised in several of the industry’s earlier cases. So far, these claims have failed to persuade judges, with four rulings already favoring patients over the pharmaceutical industry. As evidenced by these recent victories for patients and consumers in court, we are making progress in the battle against pharma’s monopoly power, but the fight is far from over. — (Bloomberg Law, Law360, FightPharma.org, P4ADNOW, Boehringer Ingelheim, P4AD, STAT News, BioSpace, CNBC)
Today In Big Pharma Fear-Mongering
The Inflation Reduction Act ensures robust support for orphan drug development despite the pharmaceutical industry’s claims. As David Mitchell, founder of Patients For Affordable Drugs, pointed out, “Drug companies can still make lots of money on additional indications for orphan drugs by expanding the number of patients who are treated. They don’t need unending, serial orphan drug exclusivity to make new indications profitable.” Orphan drugs with multiple indications are highly unlikely to meet the spending threshold for Medicare negotiation, thus maintaining incentives for research and development. The Inflation Reduction Act preserves critical support such as tax credits for clinical trials and priority review vouchers, ensuring continued innovation in the rare disease space. Furthermore, increased investment in small molecule drugs following the Inflation Reduction Act’s enactment contradicts industry fears and demonstrates the law’s balanced approach to lowering drug prices while fostering innovation. — (Bloomberg Law, Brookings Institute)
CBO Boost: Patent Reform Bills’ Savings Skyrocket
Those working to rein in Big Pharma’s abuse of the drug patent system received welcome news last week as the Congressional Budget Office (CBO) rescored a key bipartisan bill aimed at curbing patent thickets and product hopping. The Affordable Prescriptions for Patients Act (S. 150) now projects $3 billion in savings over a decade — nearly tripling its previous estimate of $1.1 billion. This latest update builds on the March rescoring of two other competition bills, all of which have passed through committee with bipartisan support:
Collectively, these three bills now project roughly $5 billion in savings over ten years. In addition to accelerating generic drug entry and fostering competition to lower drug prices for millions of Americans, these enhanced savings offer a timely solution to fund other crucial health care priorities in an end-of-year funding package. — (Axios, Politico, Inside Health Policy, CBO, P4ADNOW, CBO, CBO)
ICYMI
The majority of Americans over the age of 65 (54 percent) are reportingly very concerned about the cost of prescription drugs. Thankfully, several drug price reforms in the Inflation Reduction Act are already driving savings for patients on Medicare. As additional reforms go into effect in 2025, including the $2,000 out-of-pocket cap and lower negotiated drug prices on ten widely-used drugs, millions of patients on Medicare will see further savings. But more is needed to lower drug prices across the board.
Welcome to the Week in Review.
P4AD Calls Out Big Pharma & PBMs At AHIP 2024
On Tuesday, at this year’s AHIP conference, P4AD Executive Director Merith Basey participated in a keynote panel titled, “Making Prescription Drugs Affordable and Accessible for Everyone,” where she went head-to-head with leaders from Express Scripts and Amazon Pharmacy. Merith exposed the Big Pharma tactics that are driving up drug prices – which disproportionately harmBlack and Brown communities as well as seniors and lower-income individuals. She detailed P4AD’s priorities to rein in costs through system-changing reforms to increase competition, including curbing patent abusesand ensuring successful implementation of the Inflation Reduction Act. Ahead of the panel, Merith previewed her remarks, outlining the need to also address the high cost of cell and gene therapies and increase transparency in the practices of pharmacy benefit managers (PBMs). — (AHIP, P4ADNOW, Managed Healthcare Executive, Managed Healthcare Executive)
Patent Expiration Opens The Door For Lower Prices
By 2030 key patents on several blockbuster drugs will end, presenting a potential window of opportunity for generic competitors to enter the market and help alleviate monopoly pricing. Eliquis, which has a list price seven times higher in the U.S. than in Canada, and Stelara, which costs upwards of $25,000 per month and has nearly tripled in price since entering the market — are prime examples of drugs that have seen their prices soar because of Big Pharma’s anti-competitive practices. Increasing competition is critical to lower drug prices, in fact, the Food and Drug Administration (FDA) found that generic drug prices were 39 percent lower than brand-name drug prices after one generic competitor entered the market and up to 79 percent lower with the introduction of four competitors. P4ADNOW is pushing for the passage of bipartisan bills, currently moving through Congress, that would curb anti-competitive practices and strengthen market forces to lower drug prices for patients. — (NBC News, Quartz, FDA, P4ADNOW)
Legislator Pressure Pharma To Curb Patent Abuse
The push to reform the patent system continues to gain momentum on Capitol Hill. Last week, Senators Warren and Jayapal called on eight pharma CEOs to remove 130 “junk” patents that serve to block lower-cost generics from entering the market. Meanwhile, Senate Health, Education, Labor & Pension (HELP) Chairman Sanders escalated his probe into Novo Nordisk’s patent abuses this week, calling for a vote to subpoena the drug corporation’s president. These actions follow last month’s Senate Judiciary Hearing on the pharmaceutical industry tactics to block generic and biosimilar competition and the efforts to curb these practices – which saw rare bipartisan support from committee members. With polling showing that 9 out of 10 Americans believe lowering prescription costs should be a top Congressional priority, pressure continues to mount for meaningful reform. — (The Washington Post, CNN, STAT, X, P4ADNOW)
Watch
PBMs, the shady middlemen who negotiate rebate deals with drug manufacturers, operate behind a veil of secrecy that makes it difficult to discern whether they are passing on savings to patients or blocking access to lower-cost competition. Watch this explainer video from STAT News which details the history of the PBM industry and why we need to shine a light on their practices to ensure they are operating on behalf of patients.
Welcome to the Week in Review.
Pharma V. Facts
At this year’s American Society of Clinical Oncology conference, drug industry executives and their allies continued to peddle misinformation about the Inflation Reduction Act, claiming the law will stifle investment in small-molecule drugs. However, their fear-mongering doesn’t align with the facts. In the nine months following the law’s passage, major pharmaceutical companies have shown an increased appetite for acquiring small-molecule drugs. Eli Lilly’s $2.4 billion purchase of DICE Therapeutics, a biotech company with a promising small-molecule drug in Phase II clinical trials, and Bristol Myers Squibb’s $4.8 billion acquisition of Mirati Therapeutics with its small-molecule cancer drug Krazati, demonstrate the enduring attractiveness and profitability of these therapeutic approaches. In fact, analysts have projected a significant increase in global spending on small-molecule drugs from $76 billion in 2022 to about $152 billion in 2031. Venture capital firms have similarly expressed confidence in the value proposition of small molecules, which have accounted for more than 75 percent of all new drugs since 2010. Despite warnings at the conference from industry leaders like Eli Lilly CEO David Ricks and the Pharmaceutical Research and Manufacturers of America (PhRMA) CEO Stephen Ubl about the law’s supposed “negative implications” for innovation, Medicare’s long-overdue authority to negotiate fair drug prices promises massive cost savings for patients and taxpayers, without diminishing incentives for continued investment in medical breakthroughs. — (Fierce Pharma, Brookings InstituteEndpoints, Fierce Pharma, STAT, NIH, CAP, NPR)
Americans Concerned Over High Drug Prices
A new national poll by West Health-Gallup confirms the harsh reality faced by millions of Americans: soaring drug prices. Thirty-one percent of Americans, who pay more than four times for the same brand name drugs compared to residents of other wealthy nations, are concerned about their ability to afford their medications over the next 12 months – a significant jump from 25 percent in 2022. Among adults 65 and older, the increase is even more substantial, up 11 percentage points to 31 percent from 20 percent. “The medications are very, very expensive. I’m a diabetic and a lot of the medications that I’m taking are like a hundred and something [dollars],” shared Emily G., a Texas patient highlighted in the survey report. These findings come as public opinion of the pharmaceutical industry continues plummeting. A shocking 83 percent of Americans believe profits are the primary driver of high drug prices, with the industry’s approval rating a dismal 18 percent.
As public anxiety mounts, so too is the pressure on policymakers to confront Big Pharma’s profiteering head-on. While the Inflation Reduction Act was a monumental step toward lowering drug prices for millions of patients on Medicare, urgent legislative action is needed to increase competition to lower prices for more Americans. Congress has the opportunity to advance bipartisan legislation that would close loopholes and rein in Big Pharma’s patent abuses to increase savings for patients. P4ADNOW’s David Mitchell testified last month before the Senate Judiciary Committee about the urgent need for these critical reforms to ensure patients can access the medications they need at prices they can afford. — (Gallup, RAND, P4ADNOW, Forbes)
Welcome to the Week in Review.
Common cancer treatments hit the market with exorbitant list prices that typically increase faster than the rate of inflation – placing a severe financial strain on patients. Between 2019 and 2023 55 percent of new cancer drugs were launched with a price exceeding $200,000 annually and nearly 60 percent of working-age cancer survivors report facing some financial difficulty due to costs associated with their disease. This forces many patients to cut back on essentials like groceries, skip mortgage payments, and incur massive debt to afford their medication. Gwendolyn, a grandmother living with cervical cancer, shared with the Wall Street Journal how her expensive treatment left her unable to afford basic necessities like toothpaste or toilet paper. The financial burden has been particularly heavy for cancer patients on Medicare, who have often paid a percentage of these high list prices out-of-pocket, which can add up to thousands of dollars. However, the new $2,000 yearly cap on out-of-pocket costs, set to take effect in 2025 under the Inflation Reduction Act, will drastically reduce costs for people who get a brand-name cancer drug through Medicare Part D. P4AD’s Cancer Report, estimates an average saving of $7,590 annually and up to $19,296 in some cases. While the drug price law marks significant progress to lower out-of-pocket costs, continued legislative action is needed to curb drug companies’ ability to set excessively high launch prices for new cancer treatments and other conditions. — (Reuters, KFF, The Wall Street Journal, IQVIA, P4AD)
The exorbitant prices of brand-name drugs in the United States are due in part to the anti-competitive tactics used by pharmaceutical companies to extend their monopoly pricing power and obstruct cheaper generics and biosimilars from entering the market. Drug prices in the U.S. are three to eight times higher than in other comparable nations, and with approximately 53 percent of young adults in the U.S. living with a chronic condition, the financial burden is extended over a lifetime. Sneha Dave, the executive director of Generation Patient, told Think Global Health that the decisions young people with chronic conditions make “are very much centered around our ability to afford medications into the future.” Comprehensive patent reform to close these loopholes is crucial to inject true competition and provide relief for young people who will spend their lives not only managing their conditions but dealing with the financial burden of paying for their medications. P4ADNOW is continuing to push for the passage of bipartisan legislation to curb anti-competitive practices and increase competition, ultimately lowering drug prices for all patients. — (Fierce Pharma, Commonwealth Fund, CDC, Think Global Health, P4ADNOW)
Starting tomorrow, June 1st, out-of-pocket costs for inhaler products manufactured by AstraZeneca and Boehringer Ingelheim will be capped at $35 a month, thanks to pressure from advocates and lawmakers. GlaxoSmithKline’s $35 monthly out-of-pocket cap on inhalers will take effect on January 1, 2025, while Teva, the last of the four major inhaler companies, has not yet chosen to follow suit and reduce costs for patients.
Welcome to the Week in Review.
1. Continued push for competition
On Tuesday, the Senate Judiciary Committee held a hearing on the anti-competitive tactics used by the pharmaceutical industry to block generic and biosimilar competition in order to keep drug prices high. P4ADNOW’s founder and cancer patient David Mitchell, testified before the committee in support of bipartisan bills currently in Congress that would address these patent abuses, including pay-for-delay deals, product hopping, and patent thickets. Committee members from both parties expressed outrage over drug makers’ persistent manipulation of the patent system at the expense of patients. Chairman Durbin condemned big pharmaceutical companies’ “skilled lawyers manipulating the patent system” to delay affordable competition, and Senator Cornyn highlighted the 165 patents on Humira as clear “abuse” of the system that resulted in AbbVie’s prolonged monopoly pricing power. The reforms are urgently needed to restore fairness to our patent system, increase competition, and provide relief to patients and taxpayers. — (Axios, Youtube, WOKV, MedPage Today, P4ADNOW, Senate Judiciary Committee, NBC News)
2. Facts V. Pharma Fearmongering
AstraZeneca’s new goal to reach $80 billion in revenue by 2030 — a 75 percent increase over 2023 — by aiming to launch 20 new medicines, undermines industry claims that the Inflation Reduction Act will stifle drug innovation. The company’s CEO Pascal Soriot even recently admitted that the impact of the drug price law is “completely manageable” yet the company is simultaneously pursuing an aggressive lawsuit to dismantle Medicare negotiation — one of the most popular and transformational provisions in the historic legislation. Major pharmaceutical companies like AstraZeneca are projecting robust growth and a flourishing pipeline of new medicines in the years to come, and drugmakers are continuing to thrive and invest in research, demonstrating that innovation can coexist with policies aimed at providing much-needed pricing relief to patients. — (The Guardian, CNBC, Fierce Pharma, Reuters, Georgetown University, STAT)
2. Launch Prices for New Diabetes Drugs Create Access Barriers
Big Pharma’s high launch prices for diabetes and weight loss drugs like Ozempic and Trulicity are creating significant access barriers. A KFF poll revealed that about 54 percent of adults who had taken a GLP-1 drug found them “difficult” to afford, with high prices disproportionately harming people from historically underserved communities. Patients are being forced to ration or forgo their essential medicines, exacerbating health conditions and leading to devastating but preventable consequences such as kidney failure and blindness. We must address launch prices to balance the need for fair profits while ensuring accessibility and affordability. — (KFF, KFF, Fox 5)
PhRMA Lobbying: The Pharmaceutical Research and Manufacturers of America (PhRMA) spent $9.4 million on federal lobbying in the first quarter of 2024. This heavy spending underscores the industry’s determination to protect its power to set prices despite ongoing efforts from patients and allies.
Welcome to the Week in Review.
1. Bearing The Cost Of Gene Therapies
A major milestone was reached earlier this month as 12-year-old Kendric from Washington, D.C. became the first patient living with sickle cell to begin a Food and Drug Administration (FDA) approved gene therapy with the potential to cure his disease. Sickle cell disease is a lifelong blood condition that affects 100,000 people in the United States and 20 million people worldwide — most of whom are Black and Brown. However, the newly approved sickle cell gene therapies, Lyfgenia and Casgevy, are currently priced at $3.1 million and $2.2 million per patient respectively. Such exorbitant launch prices will create unsustainable budget pressures for governments, insurers, and employers — and most critically will limit patient access to these treatments. While gene and cell therapies have the potential to transform medicine and patients’ lives, potentially offering cures for previously intractable diseases like sickle cell, and leukemia or lymphoma, there is an urgent need to find sustainable pricing models. These models must strike a balance between incentivizing innovation and improving access and affordability, because everyone deserves access to the medicines they need at prices they can afford. — (The New York Times, Press-Telegram, X)
2. Public Awareness Of Relief From The Inflation Reduction Act Grows
A KFF poll released this week highlights the growing awareness among older voters of the drug pricing provisions in the Inflation Reduction Act — which enjoys support from 71 percent of all voters. Between November 2023 and May 2024, the share of voters ages 65 or older who knew about Medicare’s authority to negotiate drug prices increased from 36 to 48 percent, those aware of the $35 monthly insulin copay cap increased from 45 to 52 percent, and those familiar with the $2,000 cap on out-of-pocket costs went up from 27 to 40 percent. Notably, a majority of voters across the political spectrum support extending certain provisions of the monumental drug price law to all adult patients with insurance, as well as increasing the number of drugs subject to Medicare negotiation. However, the reality remains that only 45 percent of Americans have heard about the drug price reforms in the Inflation Reduction Act, underscoring the ongoing need to ensure patients are not only aware of the benefits of the drug price provisions, but are able to access them. — (KFF, The Washington Post, Navigator Research, KFF)
P4ADNOW ON THE HILL: On Tuesday, May 21st at 10 a.m. P4ADNOW’s founder and cancer patient David Mitchell will testify before the Senate Judiciary Committee at a hearing titled “Ensuring Affordable & Accessible Medications: Examining Competition in the Prescription Drug Market.” In his testimony, David will highlight how drug companies use anti-competitive tactics and abuse loopholes in the patent system to prolong their monopolies on drugs, blocking competition and keeping prices high for patients.
WATCH: Major drug companies have launched aggressive lawsuits seeking to dismantle the new Medicare negotiation program and regain their complete pricing power. P4AD’s Merith Basey joined RJ Eskow on “The Zero Hour” to talk about Big Pharma’s legal assault and the recent rulings in favor of patients.
Welcome to the Week in Review.
1. Drug Companies Game The Patent System
As blockbuster drugs approach patent expiration, major pharmaceutical companies are deploying manipulative tactics to extend their monopoly pricing power and delay or prevent lower-cost competition. In 2023, the cancer drug Keytruda was the top seller with $23 billion in sales, in 2028 the manufacturer Merck is set to lose a key patent on the drug which would allow biosimilar alternatives into the market and reduce the corporation’s revenues. Merck is not alone in exploiting the patent system. AbbVie, the maker of best-selling Humira, notoriously constructed a “thicket” of more than 160 patents around the drug, delaying affordable biosimilar alternatives for decades and forcing patients to bear exorbitant prices. While the drug companies stop at nothing to maximize their profit margins, even at the expense of patients, P4ADNOW is working to advance bipartisan legislation to curb these anti-competitive practices and secure lower drug prices for all Americans. — (Quartz, The New York Times, P4ADNOW)
2. Big Pharma’s Actions Belie R&D Claims
In the first quarter of 2024, the ten drugs selected for Medicare negotiation brought in $16.5 billion in revenue, contributing to $25.4 billion in combined profits for the drug manufacturers. An Accountable.US report revealed this week that in 2023, the eight drug companies that manufacture these 10 drugs collectively spent $95.9 billion on research and development (R&D), while also shelling out $162 billion, almost twice as much, for stock buybacks, dividends, and marketing and administrative costs and nearly $500 million on executive compensation. The findings expose the continued hypocrisy of the pharmaceutical corporations that are challenging the Medicare negotiation program in court. While claiming that lower negotiated drug prices will severely impact their ability to innovate and invest in new drugs, these companies dedicated a disproportionate amount of their resources for payments to executives and shareholders and have plenty of capital to spare to invest in new R&D. — (Protect Our Care, Accountable.US, The Hill)
BONUS: According to a national poll conducted by the University of Michigan, 54 percent of adults over the age of 50 said they were “very concerned” about the cost of prescription drugs. While the drug price reforms in the Inflation Reduction are already lowering drug costs for millions of patients on Medicare there are more victories to be won that will lower drug prices for everyone in the US.
Welcome to the Week in Review.
1. Pharma Faces Setback in Legal Battles To Stop Medicare Negotiation
Big Pharma’s bid to obstruct the implementation of the Medicare Negotiation program suffered a significant setback on Monday as a federal judge ruled against Bristol Myers Squibb and Janssen Pharmaceuticals in their lawsuits challenging the constitutionality of the program – marking the fourth time a judge has ruled against the drug industry and in favor of patients. “There is no doubt that this ruling is a win for patients. It eviscerates the strongest arguments in Big Pharma’s coordinated multi-million dollar attack on Medicare negotiation,” shared P4AD’s Merith Basey following the decision. Since the ruling, both drug companies have indicated that they will appeal the ruling, despite the judge’s unequivocal rejection of their central arguments. On the same day, AstraZeneca filed a separate notice to appeal a judge’s March decision rejecting the corporation’s lawsuit challenging the program. On Wednesday, the Pharmaceutical Research and Manufacturers of America (PhRMA), alongside the Global Colon Cancer Association and the National Infusion Center Association (NICA), presented oral arguments in their appeal in Texas. Currently the scoreboard reads patients: 4, Big Pharma: 0. — (Reuters, Patients For Affordable Drugs, Fierce Pharma, Patients For Affordable Drugs, CNN)
2. Drug Price Reforms Enjoy Broad Support Despite Low Awareness
A Navigator Research poll released this week revealed robust bipartisan support for the drug price reforms in the Inflation Reduction Act, with 71 percent of voters backing the historic law. Across the political spectrum, a majority of voters strongly support key provisions benefiting patients on Medicare: 87 percent support capping insulin out-of-pocket costs at $35 a month, 83 percent support penalizing drug companies that raise prices faster than the rate of inflation, and 74 percent support the $2,000 cap on out-of-pocket costs taking effect next year. Despite widespread support, less than a third of respondents report awareness about these reforms, highlighting the need for broader education efforts. In a Washington Post column this week, Leana S. Wen, a professor at George Washington University, outlined the key provisions of the drug price law and emphasized the urgent need they seek to address: one in five older adults forgo their prescriptions due to cost. — (Navigator Research, The Washington Post)
3. The Looming Cost of Inhalers
GlaxoSmithKline (GSK) is facing criticism over its decision to discontinue its popular Flovent asthma inhaler, one of the most commonly prescribed inhalers for children, and replace it with a costly generic inhaler not covered by many insurers — forcing thousands of families to pay its full list price ranging from $150 to $250 per month. Given that asthma is more common and often more severe for Black, Latino, and low-income children, it is these families who are disproportionately harmed when already high inhaler prices increase. Exploiting loopholes in the patent system, these companies routinely withdraw effective treatments from the market and force patients to transition to newer, more expensive versions. This deceptive practice of “product hopping” is one of the drug industry’s favorite tactics. Fortunately, several bipartisan bills in Congress, supported by P4ADNOW, are poised to address such tactics and bring down costs for patients. — (The Washington Post, CNN, US News)
BONUS: New data released by the Department of Health and Human Services (HHS) showed that more than 10 million people on Medicare received a free vaccine in 2023 thanks to the Inflation Reduction Act, a significant increase from 2021 when just 3.4 million people received a vaccine covered under Medicare.
Patients for Affordable Drugs NOW, the C4 arm of P4AD, is the only national, bipartisan patient advocacy organization focused exclusively on policies to lower drug prices. We help educate and mobilize patients in support of legislation to fix our broken system. P4ADNOW does not accept funding from organizations that profit from the development and distribution of drugs.