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)
The Ads Tell Constituents That After Vowing “To Stand Up To Drug Companies,” Don Davis Is “the Lone Democrat Willing To Weaken Medicare’s Power To Negotiate Drug Prices”
Washington, D.C. – Patients For Affordable Drugs Now (P4ADNow) today began running a series of TV ads to inform constituents in Congressman Don Davis’ district (D-NC1) that he has reneged on his campaign promise regarding prescription drug pricing. Congressman Davis pledged he would “stand up to drug companies.” Instead, Davis has become the only Democrat in the House of Representatives to sponsor legislation 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 and would lower drug prices for millions of people on Medicare.
His betrayal of his promise to patients comes after he accepted tens of thousands of dollars from drug companies including Gilead, Astellas, Genentech, Bayer, Pfizer, Novo Nordisk, GSK, Bristol Myers Squibb, Amgen, Boehringer Ingelheim, Merck, AbbVie, and Eli Lilly.
“Voters overwhelmingly support Medicare negotiation to lower prescription drug prices,” said David Mitchell, a cancer patient and founder of Patients For Affordable Drugs Now. “The voters in Congressman Davis’s district need to know that he reneged on his campaign promise to stand up to drug companies and is sponsoring legislation that, if enacted, would weaken Medicare’s ability to negotiate and lead to higher prices for roughly 90 percent of the drugs Americans need.
P4ADNow has heard from dozens of patients within Congressman Davis’s district who are struggling under the weight of high drug prices. One constituent revealed the heartbreaking reality of having to forego essential medications despite being insured, simply due to financial strain. Another shared the daily struggle of managing a chronic disease while grappling with the prohibitive cost of medications, often relying on the goodwill of friends for assistance. Additionally, a third constituent’s plea for affordable access to life-saving heart medications for her husband underscores the urgent need for Congressman Davis to honor his campaign promises and prioritize the well-being of his constituents over corporate interests.
These personal stories serve as an important reminder of the human toll of high drug prices and the critical importance of Medicare negotiation to alleviate the burden for millions of Americans.
The ads–which can be viewed here and here–will be broadcast across local television and digital platforms starting February 13th.
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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.
CMS Takes On Big Pharma And Makes First Offers To Manufacturers Of The First Ten Drugs Selected For Drug Price Negotiation To Lower Prices For Prescription Drugs
Patients For Affordable Drugs Now, applauds the Centers for Medicare & Medicaid Services (CMS) as it takes the huge next step towards negotiating fair prices for essential medications. Today, CMS sent out its initial fair pricing offers to pharmaceutical manufacturers for the first 10 drugs selected for Medicare negotiations.
The 10 drugs chosen were identified as the top spending drugs covered under Medicare Part D without generic or biosimilar equivalents that have been on the market for at least seven years and also meet other selection criteria. These essential medications include cancer treatments, blood thinners, autoimmune disease treatments, and some diabetes drugs. Between June 2022 and May 2023, 8.3 million Medicare Part D enrollees used one or more of these medications. With 84 percent of voters backing Medicare negotiations, it’s clear CMS is doing work that is urgently demanded by the American public.
Merith Basey, Executive Director of Patients For Affordable Drugs Now, released the following statement:
“Patients For Affordable Drugs Now stands firmly in support of Medicare negotiation and efforts to curb the unjustified costs of prescription medications. We hear from patients everyday who are grappling with the crushing weight of exorbitant drug prices, forced to make impossible decisions between their health and financial well-being. 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. Drugs don’t work if people can’t afford them, and today marks a historic milestone in the fight to lower drug prices for everyone.”
Background in Medicare negotiations:
In 2022, Big Pharma charged Americans two to three times more than what they charged people in other OECD countries for the same drugs, even when accounting for rebates and discounts.
For the first time in history, Medicare has the authority to negotiate prices for certain high-cost drugs, breaking a nearly 20-year ban on utilizing its purchasing power to secure better deals for Americans.
The Medicare negotiation provision was established through the Inflation Reduction Act to lower the cost of expensive prescription drugs, rather than continuing to allow drug companies to raise prices indefinitely at will.
Unlike every other sector in health care where Medicare sets prices such as doctor fees, hospital costs, and equipment, pharmaceutical companies have been exempt from any form of negotiation. Pharmaceutical companies have the option to participate in Medicare voluntarily. They can accept slightly lower negotiated prices if they want to tap that huge market worth billions.
Negotiation will reward innovation. Factors such as therapeutic advances and meeting unmet needs will be considered in the negotiation process, rewarding more innovative drugs. Drug companies will continue to innovate to access this lucrative market, as they are rewarded for investment by still being able to set launch prices and maintain FDA-awarded periods of exclusivity.
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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)
