This Week in Drug Pricing: CMS announces next 15 negotiated drugs, Teva joins Big Pharma’s assault on Medicare negotiation, FTC report exposes PBM price gouging scheme, and P4ADNOW debunks Pharma misinformation.
Welcome to the Week in Review.
Next 15 Drugs Selected for Medicare Negotiations
Marking another historic step for patients, the Centers for Medicare & Medicaid Services (CMS) announced the next 15 drugs selected for Medicare negotiation. The selected medications were used by 5.3 million people on Medicare between November 2023 and October 2024 and accounted for $41 billion in Medicare spending within that period. In January this year, 12 of the 15 drugs selected for negotiation saw new list price increases, 11 of which were higher than the rate of inflation. Given the successful negotiations for the first 10 drugs, which saw an average list price reduction of more than 62%, lower negotiated prices for these additional 15 drugs will mean substantial relief to millions more patients. A lower negotiated price for Ofev, one of the selected drugs, could ensure Carole from Michigan can consistently take her treatment for chronic lung disease for which is unaffordable at $14,000 per month. A lower negotiated price for the inhaler Breo Ellipta would mean Teresa from North Carolina could finally treat her asthma with the only inhaler on that market that works for her. We remain steadfast in our commitment to supporting the successful implementation of the Medicare negotiation program, ensuring patients and taxpayers get a better deal on their life-sustaining medicines. — (P4AD, NBC News, HHS, AARP, BioPharma Dive)
Teva Joins Big Pharma’s Assault On Medicare Negotiation
Teva Pharmaceuticals has filed the 10th lawsuit representing Big Pharma and its allies aimed at blocking the drug price negotiation program. The lawsuit came just one day before Austedo and Austedo XR, Teva’s treatments for movement disorders, were officially selected for the next round of Medicare negotiations. These drugs cost patients up to $14,642 per month and generated $435 million in revenue for Teva in just three months last year. Teva’s legal argument – that Medicare shouldn’t negotiate prices for two drugs with the same active ingredient – is a new and desperate attempt to undermine negotiations. After seeing their earlier legal challenges repeatedly rejected by federal courts, the pharmaceutical industry is testing fresh claims to see if any will stick. This latest tactic is part of a broader, coordinated campaign to protect exorbitant profits at all costs, even as Americans struggle with high drug prices. Now that the next drugs up for negotiation have been announced, more lawsuits are expected. P4AD will continue to fight back, defending Medicare negotiation through amicus briefs filed in the courts, with campaigns like “US vs. Pharma,” and by mobilizing patients to protect these critical reforms. – (Bloomberg Law, FightPharma.org, Austedo, Teva Pharmaceuticals, HHS)
FTC Report Exposes PBM Price Gouging Scheme
The Federal Trade Commission’s (FTC) latest report shines a spotlight on the greed of pharmacy benefit managers (PBMs), revealing how CVS Caremark, Express Scripts, and OptumRx raked in $7.4 billion in revenue by inflating the prices of 51 lifesaving drugs between 2017 and 2022. The Big Three PBMs marked up specialty generics used to treat cancer, HIV, and heart disease, by hundreds – and in some cases thousands of dollars – at the expense of patients. For example, a month’s supply of Tadalafil, a pulmonary hypertension treatment, was acquired by pharmacies for $27 and marked up to $2,106, an increase of over 7,700%, and Tecfidera, a multiple sclerosis drug, was acquired for $177 and hiked to $3,930, a markup of more than 2,100%. The report, which expands on the FTC’s initial probe from July 2024, confirms what patients have long suspected: PBMs exploit their shadowy role in the drug supply chain to hike prices and pocket enormous profits, leaving patients to foot the bill. The findings underscore the urgent need for Congress to pass meaningful reforms to bring transparency and accountability to the PBM industry. — (FTC, Fierce Healthcare, Axios)
Debunking Pharma Misinformation About IRA The Federal Trade Commission’s (FTC) latest report shines a spotlight on the greed of pharmacy benefit managers (PBMs), revealing how CVS Caremark, Express Scripts, and OptumRx raked in $7.4 billion in revenue by inflating the prices of 51 lifesaving drugs between 2017 and 2022. The Big Three PBMs marked up specialty generics used to treat cancer, HIV, and heart disease, by hundreds – and in some cases thousands of dollars – at the expense of patients. For example, a month’s supply of Tadalafil, a pulmonary hypertension treatment, was acquired by pharmacies for $27 and marked up to $2,106, an increase of over 7,700%, and Tecfidera, a multiple sclerosis drug, was acquired for $177 and hiked to $3,930, a markup of more than 2,100%. The report, which expands on the FTC’s initial probe from July 2024, confirms what patients have long suspected: PBMs exploit their shadowy role in the drug supply chain to hike prices and pocket enormous profits, leaving patients to foot the bill. The findings underscore the urgent need for Congress to pass meaningful reforms to bring transparency and accountability to the PBM industry. — (FTC, Fierce Healthcare, Axios)
ICYMI
As the Biden-Harris administration comes to an end, never-before-seen photos were recently published in People, of P4AD’s Judy Aiken sharing her experience with the high cost of prescription drugs with President Biden and how the relief being delivered through the historic drug pricing law is truly life-changing.
Big Pharma is ringing in the New Year with more than 250 planned price hikes on essential medicines with median increases of 4.5% – well above the 2.7% inflation rate. Pfizer leads the charge with hikes on nearly 60 drugs, including a 3% increase on already expensive breast cancer medication Ibrance which was hiked from $15,982 in 2024 to $16,462 in 2025 – a nearly $500 increase monthly. Bristol Myers Squibb (BMS) is raising prices on its costly cancer cell therapies Abecma and Breyanzi by $29,904 and $43,872 respectively, per infusion – treatments that already cost patients nearly half a million dollars. Big Pharma continues to raise prices at will despite the introduction of the Inflation Rebate Program which requires manufacturers to pay Medicare back for price hikes that outpace the rate of inflation, a safeguard that currently only applies to Medicare-covered drugs. These relentless increases highlight the need for reforms to curb unchecked price gouging throughout the entire system, prevent patent abuses that stifle competition, and tackle high launch prices for new therapies coming to market. As more price hikes roll out this month, we’ll continue exposing how Big Pharma puts excessive profits over patients. Stay tuned. — (Reuters, Fierce Pharma, MM+M)
The Next 15 Drugs
The Centers for Medicare & Medicaid Services (CMS) is expected to announce the next 15 drugs selected for Medicare negotiation ahead of the February 1st deadline, offering more patients renewed hope for more affordable medicines beginning in 2027. Among the drugs likely to be included is Novo Nordisk’s blockbuster GLP-1 treatment Ozempic. Medicare spending on this treatment has skyrocketed due to its outrageous monthly list price of $969. Unsurprisingly, 54% of patients using GLP-1 treatments report difficulty affording them. A lower negotiated price for Ozempic could help to more closely align the list price of this expensive treatment with countries like Germany, where it is sold for a fraction of the U.S. price. The results of the first round of negotiations were announced in August 2024 and will lower the list price of 10 widely-used medicines by 39% to 79% in 2026. These lower prices will benefit nine million patients on Medicare who are prescribed these first 10 selected drugs, with millions more patients to benefit in 2027 and beyond. — (Axios, STAT, KFF, Reuters)
$2,000 Cap On OOP Costs In Effect
Beginning January 1, 2025, patients with Medicare Part D plans will have their annual out-of-pocket drug costs capped at $2,000. This provision, which is part of the historic 2022 prescription drug law, is estimated to save approximately 3.2 million people — who don’t receive a low-income subsidy — thousands of dollars within the first year. For patients with cancer, the cap could mean an average savings of over $7,500 per year, with some saving as much as $19,296. Patients across the country have called the cap “life-changing” and shared that it could allow them to finally retire, after decades in the workforce. — (USA Today, AARP, NBC News, P4AD, The Charlotte Observer, Bangor Daily News)
ICYMI
A new RAND study published in JAMA found that a few ultra-expensive therapies significantly inflate the average cost of developing a new drug. Researchers analyzed 38 FDA-approved drugs and found estimated median research and development costs of $150 million, compared to an average of $369 million. When just two expensive drugs were excluded, the average cost dropped by 26%.
Over the last 12 months, our community of hundreds of thousands of patients and allies has taken action to protect the historic 2022 prescription drug law, debunk Big Pharma’s propaganda, and advocate for legislative solutions to curb patent abuses and increase lower-cost competition in the drug marketplace for everyone. Highlights from the year include:
Patient Advocates Celebrate Historic Drug Pricing Reforms
Throughout the year, the patient advocates at the heart of our work have been highlighting the savings brought by the drug price reforms in the Inflation Reduction Act:
Judy Aiken introduced the President and Vice President at an event celebrating Medicare’s first ten lower negotiated prices – projected to save nearly nine million patients up to $1.5 billion in out-of-pocket costs. If these negotiated prices were in effect in 2023, they would have delivered taxpayers an estimated $6 billion in savings. Judy also testified before the Senate Finance Committee about the relief brought by the out-of-pocket cap and Medicare negotiation.
Steven Hadfield and Bob Parant participated in a White House panel to discuss the $35 insulin copay cap. If the insulin copay cap had been in effect in 2020, 1.5 million patients would have saved an average of $500 a year on insulin.
Rose Keller introduced President Biden at an event focused on lowering drug costs and highlighted how the drug price law offers hope to young patients like herself who face a lifetime of managing chronic conditions with costly medications.
Patient testimonies from Bob Parant, Aly Elbaga, and Lynn Scarfuto helped shape our amicusbriefs filed in support of the government’s opposition to pharmaceutical industry lawsuits to stop Medicare negotiation.
As 2024 came to a close, patient advocates across the country, including Steven Hadfield (NC), Judy Aiken (ME), Lynn Scarfuto (NY), and Doug Lusty (UT), have celebrated the new $2,000 out-of-pocket cap by sharing their anticipated 2025 savings in letters-to-the-editor (LTEs) published by their local newspapers. Others like Jackie Trapp and Lisa McRipley expressed their excitement about the cap directly with President Biden himself.
Judy Aiken introduces President Biden and Vice President Kamala Harris at an event focused on lowering drug prices on August 16, 2024.
Continued Push For Competition
Since the launch of our “Push for Competition to Lower Drug Prices” in July 2023, advancing bills that increase competition in the drug marketplace has continued to be at the forefront of our work to lower drug prices. The campaign highlights several bipartisan legislative solutions to Big Pharma’s anti-competitive practices and has used digital ads, an online advocacy hub, videos, and letters to urge Congress to pass bills to promote generic and biosimilar competition. Since the campaign launch our community has:
sent over 42,000 letters and made 31,000 calls to Congressional offices;
nine patient advocates have flown to Washington D.C. to share their experience with high drug prices with lawmakers and urge them to pass these critical bills;
Additionally, David Mitchell, P4ADNow’s President and Founder, voiced strong support for the package of bills during his testimony before the Senate Finance Committee, urging them to rein in pharma’s patent abuses and allow for timely entry of lower-cost competition.
Disappointingly at the end of the year, despite strong bipartisan support and an opportunity to save taxpayers billions of dollars, critical measures that our community has been pushing for were eventually left out of the final version of the end-of-year spending bill, including S. 150, the Affordable Prescriptions For Patients Act of 2023 which passed the Senate unanimously in June, Q1/Q2, a provision from the Lower Costs, More Transparency Act, and S. 2973, the Modernizing and Ensuring PBM Accountability Act. While this decision angered Americans who struggle to afford their drugs, our community remains committed to mobilizing patients, holding lawmakers accountable, and fighting for system-changing reforms to lower drug prices in the next Congress.
P4ADNow patient advocates after sharing their personal stories with their legislators to urge them to pass the bipartisan package of competition bills (From Left: Jackie Trapp, Sue Lee, Karolina Chorvath, Gaile DeVore, and Janet Kerrigan)
Court Watch: US v. Pharma
In response to the pharmaceutical industry’s multi-million dollar campaign to block the Medicare Negotiation Program, P4AD has taken decisive action to defend this historic victory that patients fought hard to achieve. We mounted a powerful defense through the US vs. Pharma campaign leveraging the voices of patients who stand to benefit most from this reform. To date, we’ve filed two amicusbriefs highlighting the transformative benefits of the program, countering Big Pharma’s misinformation about access and innovation, and exposing the 20 years during which Big Pharma blocked Medicare’s ability to negotiate prices. As part of our campaign, we launched FightPharma.org and its Spanish language counterpart, Luchacontrapharma.org, to galvanize public pressure and mobilize patients across the country. Alongside our partners, Public Citizen, Social Security Works, and Health Care Voices, we continued to increase support for a petition to pressure pharma CEOs to withdraw their lawsuits to stop the program – which to date has been signed by over 200,000 people. Our micro-influencer campaign, targeted toward a younger audience, has gained significant traction on social media with 41 posts (in English and Spanish) generating over 904,000 views. Several posts were picked up and shared by the social impact company NowThis. While eight out of nine lawsuits were ruled in favor of patients, the fight is far from over as drug companies continue to appeal these rulings and aim to escalate these cases to the Supreme Court. P4AD remains committed to defending the integrity of the Medicare Negotiation Program, and ensuring that patients continue to be at the heart of this critical reform.
P4AD’s campaign microsite for US v. Pharma: Fighting To Protect Medicare Negotiation launched on April 5, 2024.
Expanding Our Spanish Language Program and Price Hike Report
In 2024, P4AD significantly expanded outreach within Latino and Black patient communities across the country. In the District of Columbia, Maryland, and Virginia area, we launched a series of bike share ads in Spanish to encourage Spanish speakers to share their experiences with high drug prices. Through a strategic partnership with El Tiempo Latino, we developed the “Medicinas Vitales, No Lujos” public education campaign to increase awareness of this issue, which disproportionately harms Latinos, as well as draw attention to the lawsuits against Medicare negotiation. In collaboration with Telemundo 62, we created the “Tu Voz Cuenta” campaign to inspire Latinos to share their stories and advocate for further action. Additionally, we expanded our existing campaigns – Push for Competition to Lower Drug Prices and US v. Pharma – into Spanish to broaden their impact. We also released a report, covered by NBC, exposing Big Pharma’s price hikes in 2024 and their disproportionate harm to Black and Latino patients. The analysis focused on price increases of five cancer medications, such as those used to treat multiple myeloma, breast cancer, and prostate cancer, diseases that are disproportionately diagnosed among these communities. We will continue to work to elevate stories of patients from Black and Latino and push for reforms that improve both the financial and health outcomes of those most harmed by Big Pharma’s greed.
P4AD’s Mini-Report on drug price hikes and its impact on Black And Latino communities released on September 24, 2024.
Critical Bipartisan Measures Cut Would Have Lowered Drug Prices For Americans And Saved Taxpayers Billions
WASHINGTON, D.C. — Patients For Affordable Drugs Now expresses deep disappointment and frustration over the failure to include key drug pricing reforms in the end-of-year continuing resolution (CR) despite strong bipartisan support. These vital reforms became collateral damage when they were cut from the proposed package that was released earlier in the week, as political maneuvering and powerful outside interests took priority over patient needs.
In the past two days, patients have sent over 1,000 letters urging House Republicans to uphold their commitment to the American people and prioritize the drug pricing reforms in the original CR package.
“These critical reforms had strong bipartisan support, saved taxpayers billions of dollars, and would have delivered real relief for patients,” said Merith Basey, Executive Director of Patients For Affordable Drugs Now. “Leaving these bills out of the end-of-year package means that Americans will continue to pay the highest drug prices in the world. Regrettably, politics and powerful outside interests took precedence over the needs of patients.
“But this setback will not deter us. P4ADNow will continue to mobilize patients, hold lawmakers accountable, and fight for system-changing reforms that will lower drug prices for all. Lawmakers have a chance to make this right during the next Congress and the incoming Trump Administration by passing these bills into law. Nine out of 10 Americans demand it.”
The reforms cut from the CR include:
S.150, the Affordable Prescriptions for Patients Act: which limits the number of patents pharmaceutical companies can assert on biologics, clearing the path for earlier entry of lower-cost biosimilars into the market. The Congressional Budget Office (CBO) estimates this reform could save taxpayers $1.8 billionover 10 years.
Q1/Q2, a provision of the Lower Costs, More Transparency Act: addresses a critical barrier to generic drug approvals by requiring the U.S. Food and Drug Administration (FDA) to provide clearer guidance on ingredient differences, saving generic manufacturers time and money in bringing affordable alternatives to market. The CBO estimates this reform would save taxpayers $871 million over 10 years.
S.2973, the Modernizing and Ensuring PBM Accountability Act: would delink pharmacy benefit manager (PBM) revenue from drug prices in Medicare Part D, curbing incentives that lead PBMs to steer patients toward more expensive prescription drugs, and would require PBMs to report on drug pricing and other information to Part D plan sponsors.
“This decision feels like a betrayal to millions of patients who spoke out, hoping to rein in an industry that has always put profits first,” said Jacquie Persson, a patient advocate from Cedar Falls, Iowa who struggles to afford the medication for her Crohn’s disease. “It’s disheartening to see industry interests prioritized over the well-being of people once again. We won’t stop fighting until Big Pharma is held accountable and patients can access the affordable, life-saving medications they need and deserve.”
The exclusion of these measures means the next opportunity to pass them will be during the next Congress – a timeline that delays relief for millions of people with high drug costs. Despite this setback, P4ADNow is committed to its mission to lower drug prices for patients and continuing its advocacy:
Partnering with allies to hold lawmakers accountable and keep drug pricing reform at the forefront of legislative priorities.
Mobilizing patient advocates to demand the passage of these reforms during the next Congress.
Building on the momentum of 42,000 letters and 31,000 calls to Congress, urging bipartisan action on these bills.
### 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.
End-Of-Year Spending Bill And Key Drug Price Reforms Still In Flux
In a turbulent week of negotiations, House leadership continues to grapple with internal divisions and external political pressures ahead of tonight’s midnight government funding deadline. The initial continuing resolution (CR) package, released Tuesday, included bipartisan drug pricing measures that would have saved taxpayers billions and lowered drug costs for Americans. But by Thursday night, a pared-down CR – stripped of drug price reforms and many other health care provisions – was brought forward and failed decisively on the House floor. As of 3 P.M. Friday, the most recent bill proposal also excluded the drug price reform bills that the P4ADNow community has been championing for the last 18 months. Those reforms include:
S.150, the Affordable Prescriptions for Patients Act: which limits the number of patents pharmaceutical companies can assert on biologics, clearing the path for earlier entry of lower-cost biosimilars. The Congressional Budget Office (CBO) estimates this reform could save taxpayers $1.8 billion over 10 years.
Q1/Q2, a provision of the Lower Costs, More Transparency Act: addresses a critical barrier to generic drug approvals by requiring the U.S. Food and Drug Administration (FDA) to provide clearer guidance on ingredient differences, saving generic manufacturers time and money in bringing affordable alternatives to market. The CBO estimates this reform would save taxpayers $871 million over 10 years.
S.2973, the Modernizing and Ensuring PBM Accountability Act: would delink pharmacy benefit manager (PBM) revenue from drug prices in Medicare Part D, curbing incentives that lead PBMs to steer patients toward more expensive prescription drugs, and would require PBMs to report on drug pricing and other information to Part D plan sponsors.
As of this newsletter, negotiations remain in flux, and it’s still unclear when a vote will happen. While the outcome remains uncertain, P4ADNow is keeping an eye on developments and is hopeful that Congress will still deliver long-overdue relief for patients struggling with the high cost of prescription drugs. No matter what happens, we will continue mobilizing our community of patients and allies, and holding lawmakers accountable to ensure these reforms and others like them become a reality as soon as possible. Millions of Americans are counting on it.
Court Watch: US V. Pharma
Patients For Affordable Drugs filed an amicus brief yesterday in the Third Circuit Court of Appeals, defending Medicare’s authority to negotiate lower drug prices in a case filed by Novo Nordisk, one of the Big Three insulin manufacturers that is challenging the program. This case is part of a coordinated, multimillion-dollar legal campaign by Big Pharma and its allies to overturn the historic program and regain its complete control over drug pricing. The amicus brief, P4AD’s second as part of our US v. Pharma campaign, highlights the transformative benefits of the Medicare Negotiation Program and counters Big Pharma’s misinformation surrounding access to and innovation of essential medicines. Further, it exposes the corrupt origins of the “non-interference” clause inserted into the Medicare Modernization Act of 2003 via pharmaceutical industry influence in order to block Medicare from negotiating drug prices. By overturning this loophole the program will lower costs on up to 60 of the most expensive and most used drugs on Medicare, weaken pharma’s monopoly power, and ensure billions in savings for American taxpayers. Patient advocate, Bob Parant, has lived with type 1 diabetes for over 50 years and shared his experience which was included in the amicus brief: that despite having better results using Novolog, Bob had to switch to a less effective medication because of the price Novo Nordisk was demanding. Lower negotiated prices will ensure that patients like Bob, who’ve had to make these difficult decisions, can access their life-sustaining medicine at an affordable price. — (P4AD, Georgetown Litigation Tracker, CBO)
ICYMI
Yesterday, Senators Hickenlooper, Welch, and Collins introduced the “Skinny Labels, Big Savings Act,” a bipartisan reform that would codify skinny labels, a critical pathway for market entry of generic medications, and increase savings for patients and taxpayers. P4ADNow is proud to support this bipartisan reform that reserves a crucial pathway for ensuring patients can continue to access life-saving generic medicines at prices they can afford.
Patient Advocacy Drives Progress On Patent Reform, Generic Drug Access, And PBM Accountability To Lower Drug Prices For Patients
WASHINGTON, D.C. — Patients For Affordable Drugs Now (P4ADNow) is pleased to see critical drug pricing reforms included in the health care package attached to the continuing resolution (CR) released today. These measures are a significant step towards lowering prescription drug prices for millions of Americans by tackling Big Pharma’s patent abuses, enabling generic competition, and reforming the drug supply chain.
The CR includes: – S.150, the Affordable Prescriptions for Patients Act: which limits the number of patents pharmaceutical companies can assert on biologics, clearing the path for earlier entry of lower-cost biosimilars into the market. The Congressional Budget Office (CBO) estimates this reform could save taxpayers $1.8 billionover 10 years. – Q1/Q2, a provision of the Lower Costs, More Transparency Act: addresses a critical barrier to generic drug approvals by requiring the U.S. Food and Drug Administration (FDA) to provide clearer guidance on ingredient differences, saving generic manufacturers time and money in bringing affordable alternatives to market. The CBO estimates this reform would save taxpayers $871 million over 10 years. – S.2973, the Modernizing and Ensuring PBM Accountability Act: would delink pharmacy benefit manager (PBM) revenue from drug prices in Medicare Part D, curbing incentives that lead PBMs to steer patients toward more expensive prescription drugs, and would require PBMs to report on drug pricing and other information to Part D plan sponsors.
“The inclusion of these bills is an important step toward reforming the whole U.S. drug price system which has been rigged against patients. These reforms are critical to further lowering drug prices for all and signal that Congress listened to patients and an overwhelming majority of Americans who have been calling for further action to address the root causes of high drug costs,” said Merith Basey, Executive Director of Patients For Affordable Drugs Now. “We commend the bipartisan leaders who championed these measures and the patients who continue to drive forward the change they deserve. Now, Congress must act swiftly to make these reforms law and deliver meaningful relief to those struggling to afford their medications.”
In July 2023, P4ADNow launched the “Push for Competition to Lower Drug Prices” campaign, which highlighted the harmful impact of Big Pharma’s anti-competitive practices. The campaign included digital ads, an online advocacy hub, as well as videos urging Congress to pass bipartisan bills, including S. 150 and Q1/Q2, to promote generic and biosimilar competition. Over the last nearly 18 months, key efforts by patients and advocates have included: – Nearly 42,000 letters were sent to Congress urging action on these bipartisan patent reform bills. In the final week leading up to the CR’s passage, over 4,500 letters were sent to push for the inclusion of S.150. – Since the launch of the campaign, advocates have made more than 31,000 calls to Congressional offices to encourage the passage of these reforms. – Nine patient advocates have flown to Washington, D.C. to meet directly with lawmakers, sharing their struggles with high drug prices and urging them to act on these bills. – Patients have shared their stories through interviews, press conferences, on Hill panels, and in op-eds, and in news outlets nationwide. – P4ADNow sent multipleletters, alongside allies like AARP, CSRxP, The ERISA Industry Committee, The National MS Society, and Purchaser Business Group on Health, in support of S. 150 and other reform bills.
Additionally, in May, David Mitchell, Founder and President of P4ADNow and himself a patient with an incurable rare cancer, testified before the Senate Judiciary Committee. His testimony emphasized how Big Pharma’s anti-competitive practices harm patients and taxpayers, and urged Congress to act on a bipartisan package of reforms – including some provisions included today. These changes would realign incentives to spur true innovation while ensuring timely market entry for generics and biosimilars to lower prices.
### 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.
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 bythe 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.
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.
