This Week in Prescription Drug Pricing: AstraZeneca’s courtroom rejection, legislators show support for Medicare negotiation, and a new study on the high cost of insulin.
Welcome to the Week in Review.
1. Court Deals Major Blow to AstraZeneca
Yesterday, a federal judge in Delaware delivered a significant blow to AstraZeneca by ruling against the company in its effort to halt the negotiation of its diabetes drug, Farxiga, marking a pivotal moment in the ongoing battle to defend Medicare negotiations. Patients For Affordable Drugs’s Merith Basey hailed this ruling as a critical step forward in ensuring fair drug prices. “On behalf of patients across this country we are encouraged but not surprised that the court has rejected AstraZeneca’s self-serving arguments and essentially said the company didn’t have a leg to stand on,” she said. “This ruling sends a clear message that Big Pharma’s greed cannot continue to be prioritized over patients’ well-being and underscores the importance of Medicare negotiation to begin to rein in exorbitant drug prices.” Last year, AstraZeneca generated over $4 billion in revenue from Farxiga, a medication used to treat patients with type 2 diabetes, heart failure, as well as chronic kidney disease. CMS data shows that nearly 800,000 patients on Medicare Part D utilized Farxiga between May and June 2022. Patients like Karen in Colorado, who lives on a fixed income and faces a $600 bill for a three-month supply of Farxiga, will benefit from a lower negotiated price scheduled to take effect in 2026. This case was one of nine threatening Medicare negotiation and once again a judge has ruled against the drug industry and for the United States. This Thursday, March 7th, four lawsuits filed by Bristol Myers Squibb (BMS), Novo Nordisk, Novartis, and Johnson & Johnson (J&J) will present combined oral arguments to a federal judge in New Jersey. P4AD is unwavering in our commitment to fight the pharmaceutical industry’s attempts to use the U.S. legal system to undermine policies aimed at reducing drug costs and ensuring patients can access the medications they need at prices they can afford. – (Endpoints News, P4AD, BioSpace, CMS)
2. Legislators Oppose Efforts To Undermine The Inflation Reduction Act
On Thursday, the House Energy and Commerce Subcommittee on Health held a hearing on legislative proposals related to patients living with rare diseases. Several bills that were the focus of the hearing would, if implemented, undermine the drug provisions in the Inflation Reduction Act. P4ADNow’s founder, David Mitchell sent a comprehensive 21-page statement to the subcommittee ahead of the hearing debunking Big Pharma’s claims including that the Inflation Reduction Act would inhibit investment in small-molecule drug development and drugs that treat rare diseases. David, who is a patient with a rare, incurable cancer, underscored how the law actually provides key incentives for drug investment and strikes the right balance between affordability and access. During the hearing, several subcommittee members echoed David’s sentiments, expressing opposition to bills that would curtail Medicare’s negotiating authority. Rep. John Sarbanes summarized the hypocrisy of drug companies who often cry wolf about investment in research and development, citing David’s statement which revealed that “Johnson & Johnson reported an 11.8 percent increase in R&D spending in 2022, Merck reported an 11 percent increase in R&D spending, and Moderna reported a 65 percent increase in R&D spending and projected further increases in 2023.” Despite claims that the new drug price law would stifle innovation, real-world evidence suggests otherwise: Big Pharma’s primary goal is to safeguard profits from its blockbuster drugs. The opposition from other committee members including Rep. Frank Pallone, the Ranking Member of the full committee, underscores the strong opposition from many Members to undermine the Inflation Reduction Act. — (YouTube, P4ADNow, Politico, PORTAL Research)
3. The High Cost Of Insulin
A new study published in Diabetes Research and Clinical Practice highlights the escalating financial burden faced by people managing diabetes. Researchers found that from 2009 to 2018, total costs associated with diabetes care increased, with people living with type 1 diabetes experiencing the most substantial rise in out-of-pocket expenses. “Studies show that the more a patient pays out-of-pocket, the less likely they are to stick with their medication long term, which poses a serious risk to their health,” said lead author Evan Reynolds. Fortunately, the $35 monthly insulin copay cap for patients on Medicare in the Inflation Reduction Act has brought significant savings for patients. But, there’s more to be done to ensure everyone can access their insulin at prices they can afford. — (University of Michigan, KFF)
BONUS: A new report from Protect Our Care found that in 2023, 16 of the largest drug companies reported a whopping $684 billion in earnings — ”a figure that is higher than the gross domestic product (GDP) of 88 percent of the countries in the world.” Remind us again how drug companies are hurting from the new drug pricing reforms?
Welcome to the Week in Review.
1. “The Inflation Reduction Act is a great, wonderful thing”
It’s been 18 months since the passage of the Inflation Reduction Act and we’re still buzzing about the drug price reforms that are helping millions of patients see cost savings. Patients For Affordable Drugs (P4AD)’s founder David Mitchell, who is also a patient living with multiple myeloma, shared with KFF that last year alone, he paid over $16,000 for 12 bottles of Pomalyst, one of several drugs he needs to keep his cancer at bay. Thanks to the provision that caps out-of-pocket spending for patients on Medicare who use brand-name drugs at about $3,500, David has seen savings of more than $13,000 this year. Lynn, a retired nurse, and P4AD patient advocate who relies on a patient assistance group to help cover her drug costs, explained that because of the new drug price law she’ll pay nothing this year for her costly leukemia drug Imbruvica because the foundation’s first monthly payment covered her entire responsibility. Lynn told KFF: “For Medicare patients, the Inflation Reduction Act is a great, wonderful thing.” A new analysis by the Center for American Progress (CAP) estimated cost savings for a month’s supply of the first 10 drugs being negotiated by Medicare, ranging from $30 for insulin product NovoLog FlexPen to over $6,500 for Imbruvica. Medicare negotiation will provide monumental relief to the nine million patients on Medicare who use these 10 drugs, and who face some of the highest drug prices in the world. A new survey from KFF shows that more than half of voters are increasinglyconcerned about being able to afford their prescription drug costs, underscoring the need for successful implementation of lower negotiated drug prices. Patient voices were instrumental in the passage of the historic drug price law and will continue to play a pivotal role in defending these hard-fought reforms. — (KFF, CAP, KFF, Axios, The Hill, Business Insider, P4ADNow)
2. High Cost Of Cell And Gene Therapies
The exorbitant launch prices of new cell and gene therapies entering the market are a major concern and burden to patients, and our health care system, and drive the question of who will bear responsibility for the cost. A recently approved therapy to treat advanced melanoma called Amtagvi was priced by Iovance at $515,000, which makes it the most expensive cell-based treatment in the United States. Unfortunately, this high price tag is just the tip of the iceberg in the emerging trend of specialized therapies hitting the market at astronomical prices. For Elizabeth, a professor whose four-year-old son, Eliot lives with Duchenne muscular dystrophy, a fatal neuromuscular disease, the innovation of a new gene therapy, Elevidys, was “science at its very best, close to a miracle.” Three weeks after a one-time infusion, Eliot went from experiencing extreme fatigue and limited mobility, to “marching upstairs and able to jump over and over.” Elevidys has the potential to treat this debilitating disease that affects thousands of patients, however, its $3.2 million price tag raises serious questions about the accessibility of this treatment for patients. We urgently need to address the high launch prices set by profit-hungry drug companies. Because as we know, drugs don’t work if people can’t afford them. — (Reuters, STAT, Axios, The New York Times)
BONUS: On March 7th from 10 a.m. – 2:30 p.m., combined oral arguments will be heard in New Jersey for all four lawsuits aimed at stopping Medicare negotiations —filed by Bristol Myers Squibb (BMS), Novo Nordisk, Novartis, and Johnson & Johnson (J&J). These four companies each have a drug up for negotiation: Eliquis (BMS), Entresto (Novartis), Novolog (Novo Nordisk), and Imbruvica (J&J). While Big Pharma fights tooth and nail to undermine the widely supported provision in the Inflation Reduction Act, we’re advocating alongside patients for the successful implementation of the law that will deliver long-sought relief from high prices.
Welcome to the Week in Review.
1. Medicare Negotiation Will Deliver Relief To Millions
Marking an important step in protecting Medicare’s ability to negotiate lower prices for millions of patients, a Texas federal judge dismissed the lawsuit from trade association Pharmaceutical Research and Manufacturers of America (PhRMA) in conjunction with the National Infusion Center Association and the Global Colon Cancer Association (NICA). This is one of nine lawsuits aimed at blocking the implementation of the Medicare negotiation program in order to keep drug prices high. The ruling is the thirdtime a judge has weighed in against the drug industry’s efforts to undermine the law. This recent decision sends a strong message and comes at a time of widespread disapproval of and turmoil within the pharmaceutical industry. Despite tens of millions of dollars in lobbying efforts against the Inflation Reduction Act, patients and advocates effectively championed the passage of the Law in 2022. Additionally, a growing number of drug companies have severed ties with the trade group amid disagreement about its strategic direction. In essence, these developments underscore a dynamic shift in the landscape, from a rift within the industry itself and growing momentum for reform from patients and advocates. — (Bloomberg, Georgetown University, Axios, P4AD Now, Politico, MM+M)
2. Drug Price Reforms Drive Big Cost Savings
Patients across the country are celebrating the relief they’re already seeing from the drug price reforms in the Inflation Reduction Act. Marianna in Minnesota wrote in a letter to the editor that the drug price law is a “legislative health care miracle” and detailed how the provisions to end cost-sharing for vaccines and the $35 monthly insulin copay cap have made a huge difference to seniors on Medicare like herself. Additionally this year, many patients who take brand-name drugs on Medicare Part D will now have their out-of-pocket drug costs capped at about $3,500. In 2025 the cap will drop to $2,000 for people on Medicare. Pam, a Michigan educator living with diabetes, reflected on her experience with high insulin prices in an op-ed: “I recently calculated that I spent $1,068 last year on insulin. And this high cost doesn’t even account for my other medical treatments and prescriptions.” Thanks to the $35 insulin copay cap for patients on Medicare, Pam will spend “Iess than half” of what she spent on her insulin in the previous year and finally have some more room to breathe when paying bills every month. We’re eagerly looking ahead for the rest of the drug price provisions to be implemented — the $2,000 cap on out-of-pocket costs in 2025, and in 2026, lower prices for the first 10 negotiated drugs. — (Post Bulletin, KFF, The Gander)
BONUS: Patients For Affordable Drugs Now (P4ADNow) beganrunning a series of TV ads this week to inform constituents in Congressman Don Davis’ district (D-NC1) that he has reneged on his campaign promise to “stand up to drug companies.” Instead, Davis has become the only Democrat in the House of Representatives to sponsor a bill that would undermine Medicare’s ability to negotiate lower drug prices, a wildly popular provision in the Inflation Reduction Act that is supported by more than 80 percent of voters. (Politico, Axios, YouTube, YouTube, NC Newsline, P4ADNow, YouTube, STAT News, P4ADNow)
Welcome to the Week in Review.
1. Panel Discussion On Bipartisan Push For Competition
Senators Peter Welch and Amy Klobuchar were joined by patient advocates and health care experts for a panel discussion on Big Pharma’s use of patent thickets to extend market exclusivity and the new bipartisan legislation introduced by the Senators to make it easier for generic and biosimilar drugs to enter the market, increasing competition and lowering prescription drug prices. Jacqueline Garibay, a Patients For Affordable Drugs (P4AD) advocate and college student who lives with ankylosing spondylitis (AS), shared how drug makers used anti-competitive tactics to keep biologic drugs, like Enbrel and Humira, priced out of reach. “By using abusive tactics to prevent market competition for life-saving drugs, big drug companies are forcing people like me to pay astronomical prices that we can’t afford. P4AD’s Merith Basey explained to the panel how Big Pharma takes advantage of loopholes in our patent system and “artificially prolong their monopoly periods to keep prices high at the expense of patients.” Bipartisan legislation led by Senators Welch, Klobuchar, and Braun, as well as bipartisan legislation in the House, would tackle the systemic burden of patent thickets head on. Passage of these bills would be a step closer to restoring fairness to the U.S. patent system and pave a pathway for increased competition to deliver long-sought relief to patients. — (YouTube, Welch, Congress.gov)
2. Senate HELP Committee Examines High Drug Prices
At a hearing this week, the Senate Health, Education, Labor & Pensions (HELP) Committee asked the CEO’s from Merck, Bristol Myers Squibb (BMS), and Johnson & Johnson (J&J) to justify the higher drug prices they charge in the U.S. compared to other peer countries. A report released by the Senate HELP Committee prior to the hearing outlined the drug companies’ inflated U.S. prices, their spending on lobbying, and efforts to delay competition. One of the drugs under review by the committee was Stelara, an expensive biologic drug manufactured by J&J. P4AD patient advocate Jacquie Persson, who is 35 and living with Crohn’s disease, knows the impact of the high price tag of Stelara all too well. Stelara, which costs $25,000 per month, has tripled in price since market entry. If Jacquie had to access Stelara without insurance coverage, she would be forced to forgo the medication because of its cost and suffer painful flare-ups. Merck’s CEO, Robert Davis, had to answer questions about the company’s patent abuses that drive up prices for people like Steven Hadfield, a 71-year-old patient advocate who takes Merck’s expensive biologic Januvia to manage his type 2 diabetes. These are just two of countless stories of patients on these drugs who face financial hardship and medical uncertainty due to the exorbitant costs driven by pharmaceutical companies’ unfair pricing strategies and patent practices. The second panel featured Tahir Ahmin, Director of the Initiative For Medicines, Access, & Knowledge (I-MAK), Peter Maybarduk, Director of Public Citizen, and Dr. Darius Lakdawalla, Director of Research at the University of Southern California. Peter kicked off the panel by sharing a story from Lois, a Texas patient who critically needs diabetes drug Januvia to control their blood sugar, but is forced to go without because of its price. Lois’s story is one of over 34,000 stories that have been shared with P4AD from patients who have struggled to afford their essential medicines. — (New York Times, Commonwealth Fund, Senate HELP Committee, P4AD, P4AD)
BONUS: This past Sunday’s New York Times featured a story from Mark Miller about the profound impact of the Inflation Reduction Act on prescription drug costs for millions of seniors. The piece focused on P4AD founder and cancer patient, David Mitchell, whose story illustrates how individuals like him are for the first time paying less out-of-pocket as a result of the new drug price law.
Welcome to the Week in Review.
1. “Fewer people will have to make these tough choices”
As part of the sweeping reforms to lower prescription drug costs for millions of patients, the Centers For Medicare and Medicaid Services (CMS) sent initial price offers to drug manufacturers for the first 10 drugs selected for negotiation. Executive Director of Patients For Affordable Drugs Now (P4ADNow), Merith Basey issued a statement, marking the moment as a historic milestone for patients who face exorbitant drug prices: “We’ve listened to stories of people rationing insulin or other life-sustaining medications just to make ends meet. By advancing this process of direct negotiation with drug companies, CMS is helping ensure that fewer people will have to make these tough choices.” Lower negotiated drug prices will deliver relief to patients who regularly pay some of the highest prices for drugs in the world. In fact, on the same day that CMS sent its initial price offers to drug makers, the Office of the Assistant Secretary for Planning and Evaluation (ASPE) issued a report that found that in 2022, prices in the United States (U.S). across all drugs (brands and generics) were nearly three times as high as prices in peer nations and brand drugs were at least 3.22 times as high. Thankfully, Medicare’s new negotiation authority ensures that the program will rein in high drug prices and increase access to innovative medications for people on Medicare by considering factors like a drug’s clinical benefit compared to its therapeutic alternatives as well as current unmet needs. — (P4ADNow,ASPE, Axios)
2. Legal Battle For Drug Pricing
AstraZeneca’s legal challenge against Medicare’s drug price negotiation program, amid oral arguments, faced scrutiny from the Judge, shedding light on the ongoing struggle to lower drug prices for people on Medicare. The lawsuit, part of a broader, coordinated effort by big drug companies, aims to undermine Medicare’s newfound authority to negotiate lower drug prices, as established by the Inflation Reduction Act. AstraZeneca’s contention seeks to safeguard its control over pricing for its diabetes and heart failure drug, Farxiga, which raked in $4.4 billion in revenue for the company in 2022 alone. However, the Judge’s skepticism toward AstraZeneca’s arguments underscores the questionable tactics employed by pharmaceutical giants to prioritize profits over patient access. If these lawsuits were to succeed and overturn the Inflation Reduction Act’s provisions for Medicare drug price negotiation, millions of Americans would continue to be forced to shell out for high-priced medications they need to survive and taxpayers would miss out on the potential savings of close to $100 billion over ten years. Patients For Affordable Drugs (P4AD) strongly opposes these self-serving maneuvers, advocating for policies that ensure lower drug prices for people on Medicare. In a statement, P4AD’s Executive Director, Merith Basey underscored that “Medicare was never intended to serve as a blank check for Big Pharma’s insatiable greed.” And that P4AD remains steadfast in its commitment to “thwart the pharmaceutical industry’s attempts to exploit the US legal system, ensuring essential policies aimed at reducing drug costs and guaranteeing patient access to affordable medications.” — (Georgetown Law, STAT News, Bloomberg Law, P4AD)
3.Bipartisan Solutions To Increase Competition
Big Pharma’s abuse of our patent and regulatory systems grants drug companies unlimited pricing power and drives up costs for patients and taxpayers. A prime example this week: asthma inhalers. Senator Tammy Baldwin penned a letter to the makers of asthma inhalers demanding them to remove improperly listed patents — a tactic used by big drug companies to delay competition and force patients to pay high prices. Asthma inhalers can fetch prices exceeding $600 in the U.S. — yet in other countries, these essential medications are being sold for a fraction of that list price. Novo Nordisk’s recent announcement to stop U.S. sales of Levemir insulin (vials and pens) is another example pulled from the Big Pharma patent abuse playbook. Drugmakers who engage in this tactic called “product hopping” remove viable products from the market, limiting treatment options for patients, and then replacing them with newer versions that are more expensive. Robin Feldman, a University of California law professor, described the scheme to USA Today as “a shell game in which the consumer always loses.” Lawmakers have an opportunity to advance bipartisan solutions that tackle these barriers to increased competition and lower drug prices to patients. Congress, over to you! — (The Washington Post, USA Today,The Daily Herald)
BONUS: The announcement by the Centers for Medicare and Medicaid Services regarding the focus on sickle cell disease (SCD) as the inaugural target of the Cell and Gene Therapy Access Model marks a significant step towards addressing the unmet needs of patients on Medicaid living with rare diseases and increasing the reach of potentially curative treatments in the future. The agency announced plans to negotiate with drugmakers over the prices of these gene therapies to ensure they’re accessible for the thousands of patients on Medicaid living with SCD. By facilitating access to potentially life-changing treatments and supporting outcomes-based agreements with manufacturers, this model has the potential to not only improve health outcomes for patients on Medicaid living with SCD but also alleviate financial burdens on communities facing systemic barriers to access essential medications.
Welcome to the Week in Review.
1. Fighting Against Lawsuits To Stop Negotiations
On Wednesday, January 31st, oral arguments will be heard in AstraZeneca’s legal challenge against Medicare’s ability to negotiate the price of the company’s diabetes and heart failure drug, Farxiga. Amidst this legal battle, Patients For Affordable Drugs Now (P4ADNow) has thus far signed onto seven amicus briefs led by Public Citizen and supported by AARP, Protect Our Care, Doctors for America, and Families USA to support the government’s opposition and explain the harm high drug prices have on people on Medicare. Meanwhile, by February 1st, the Centers for Medicare & Medicaid Services (CMS) are set to dispatch initial offers to the manufacturers of the first 10 drugs selected for negotiation. Drugmakers will then have 30 days to agree on the maximum fair price or provide a counteroffer. This next step marks a historic stride towards lower negotiated prices for millions of people on Medicare in 2026 and increased access to medications at prices they can afford. — (O’Neill Institute, Public Citizen, ALM BenefitsPro)
2. Big Pharma Greed: Wheeling and Dealing
New figures show that drug corporations are pulling in record profits and have been cashing out on billion-dollar biotech deals. Johnson & Johnson, manufacturer of three of the drugs selected for Medicare negotiation, announced $4.8 billion in Q4 earnings which is nearly double their earnings from the previous year, according to Accountable.US. Sanofi, one of the big three insulin makers that monopolize the industry, announced a multi-billion dollar acquisition of a biotech company, making it the sixth drugmaker buyout valued at $50 million or more this year. Despite all the huffing and puffing from drug industry CEOs about recent drug price reforms slowing down investment, Big Pharma is making huge returns on drug sales and new drug development is doing just fine! In fact, a report published by S&P Global Ratings projects that the global pharmaceutical industry will have “healthy revenue growth through 2027.” It’s clear that drug corporations put profit over the well-being of patients and we’ll continue to expose their shady behavior until everyone can access medications at prices they can afford. — (Accountable.US, Biopharma Dive, S&P Global)
3.Push For Competition
Big drug companies exploit our patent and regulatory systems to extend their monopolies and keep prices high, at the expense of patients. Big Pharma wields anti-competitive tactics like patent thickets and pay-for-delay deals to extend their timed monopolies and block competition from the market. Right now, there is a critical window of opportunity to pass legislation to curb these patent abuses and bolster competition to lower drug prices for all patients. These competition bills have critical bipartisan support from influential legislators: “Some of the most liberal Democrats in Congress and the House GOP’s lead budget writer are backing a plan to keep drugmakers from gaming the patent system,” wrote Axios reporter Peter Sullivan. Patients urgently need legislators to pass these reforms to curb anti-competitive practices and strengthen market forces to drive down steadily increasing drug prices. — (Chicago Tribune, Reuters, Endpoints, Axios)
Welcome to the Week in Review.
1. Pushing for Transparency
In the health care policy arena, the focus centers around the passage of the Lower Costs, More Transparency Act (HR 5378). With bipartisan backing, this legislation seeks to increase transparency and affordability in healthcare pricing practices. One important provision of the bill requires the Food and Drug Administration (FDA) to streamline the approval process for generic drugs by mandating that the FDA explain to generic drug companies why their applications were not approved and therefore better enable them to address issues that might stand in the way of their future approval. If passed, this provision would not only help increase competition but is also projected to result in over $800 million in cost savings. Facilitating generic entry is a key step toward reshaping the pharmaceutical landscape to lower costs for patients. Ironically, current negotiations between the House and Senate underscore the lack of transparency in the dynamics themselves that are shaping healthcare policies for patients. (MoneyTalks News, STAT News)
2. Easing the Burden for People on Medicare
In a significant development for many people on Medicare, the 2022 Inflation Reduction Act cap on out-of-pocket expenses for Part D drugs has gone into effect. This year, many individuals on Part D plans and who only take brand-name drugs will pay no more than $3,300 out of pocket annually for their medications, eliminating the 5 percent coinsurance after reaching the catastrophic spending threshold. The cap is expected to bring relief to approximately 1.5 million people, leading to substantial savings for patients. By 2025, the cap will further decrease to $2,000. In a piece from the Wall Street Journal, Patients For Affordable Drugs patient advocate Judy Aiken, who faced over $9,000 in out-of-pocket costs last year for her medication, Enbrel, expressed relief, emphasizing the positive financial impact of the cap on her well-being. David Mitchell, founder and president of P4AD, highlighted the remarkable savings this change brings and the crucial protection it offers to people on Medicare. These savings come at the same time as a notable escalation in list prices for a range of widely prescribed medications, including those by pharmaceutical giants like Novo Nordisk and Eli Lilly. This is despite the outlier in some of the older and competing insulins which saw a January 1 price drop for some of their older competing insulins timed to avoid paying additional rebates and following years of patient advocacy to lower the price of insulin. (KFF, WSJ, P4ADNow, NPR, Forbes, WSJ, CNN)
BONUS: Public Citizen and AARP, both prominent advocates for lowering drug prices, have released reports this week. Public Citizen’s report emphasizes the pharmaceutical industry’s disingenuous opposition to drug pricing regulations, revealing that major drug manufacturers spent billions more on activities such as stock buybacks and executive compensation than on research and development. Meanwhile, AARP’s Rx Price Watch series provides a comprehensive analysis of prescription drug pricing trends, highlighting the staggering annual costs faced by Americans, particularly older adults, and the disproportionate impact on people on Medicare. These reports are important tools for the ongoing conversation on drug costs and the need for comprehensive reforms. (Public Citizen, AARP)
Welcome to the Week in Review.
1. Urgent Need for Drug Negotiations
A recent report from The Commonwealth Fund underscores the issue at the heart of our work at Patients For Affordable Drugs: Americans are paying 3 to 8 times more for brand-name prescription medications than residents of comparable countries. For instance, diabetes treatment, Novolog Flexpen, is “$19.86 per unit after rebates, which is more than 3 times higher than Switzerland’s second-highest list price of $5.36”. This stark contrast, revealed in an analysis of the 10 drugs selected for negotiation under the Inflation Reduction Act, emphasizes, once again, the pressing need for effective drug price negotiations to lower costs for patients. We know drugs don’t work if people can’t afford them. The new drug prices coming out of Medicare drug price negotiations, anticipated to be disclosed by September, carry substantial implications for healthcare costs among the millions of people on Medicare. Meanwhile, as Medicare prepares to continue negotiations in 2024, nine pharmaceutical companies are actively pursuing legal challenges to block the process and keep prices high. Oral arguments in the AstraZeneca case in Delaware will be heard on January 31st. (Commonwealth Fund, AJMC, Bloomberg, STAT, Georgetown University)
2. New Bipartisan Legislation Targets Patent Thickets
Drug companies secure as many patents as possible to artificially prolong monopoly periods and deter competitors. These “patent thickets” can prevent competition for years, keeping prices high and drugs out of reach for patients. On January 11th, Senators Braun, Klobuchar, and Welchintroduced bipartisan legislation in the Senate aimed at addressing patent thickets, a move that would limit pharmaceutical companies asserting just one patent per thicket in litigation. Patients For Affordable Drugs joins Protect Our Care to endorse this crucial legislation, recognizing it as a significant complement to other bipartisan bills, such as Cornyn-Blumenthal, currently advancing through the Senate. The endorsement underscores our commitment to ensuring that patents are wielded to encourage innovation rather than prolong unjustified monopolies and safeguard quality patents that improve existing drugs, benefiting patients, while lowering the litigation barrier for generics and biosimilars to enter the market. (i-MAK, S.3583, S.150)
3. Debunking Pharma’s Claims
Amidst discussions at the J.P. Morgan Healthcare Conference, pharmaceutical stakeholders advocated for a 13-year grace period for small-molecule drugs (which currently have 9 years) before they are eligible for price negotiations, which would equalize the periods for small-molecule drugs and biologics, which currently have 13. However, if pharma wants incentives for all drugs to be equal, Congress should put them both at no more than nine years of exemption from negotiation, which is the current exclusivity period for small-molecule drugs. David Mitchell, P4AD founder and a cancer patient, challenged the pharmaceutical industry’s claims in an op-ed for STAT last year. Mitchell debunked the notion that the Inflation Reduction Act disadvantages small-molecule drugs, emphasizing that many drug companies continue to invest in small-molecule drugs due to their value. Biologics were given additional years of market and data exclusivity compared to small-molecule medicines because the pharmaceuticalindustryinsisted on receiving seven years more market exclusivity for biologics than for small-molecule drugs when the Biologics Price Competition and Innovation Act (which was included in the Affordable Care Act) was being structured. The Inflation Reduction Act achieves a fair solution for the benefit of patients with a balanced approach in incentives since both small-molecule and biologic drugs are crucial for the benefit of patients. (Biospace, STAT News, STAT News, FDA)
BONUS: Senate Democrats, led by Sen. Bernie Sanders, are investigating soaring asthma inhaler costs. The probe addresses the stark U.S. price disparities, emphasizing concerns for patients who often face high costs and rationing. The inhalers sell for hundreds of dollars in the U.S. but much less abroad. (The Hill)
