Welcome to the Week in Review.
Trump Administration Continues Medicare Negotiation
In a promising sign for patients, the Centers for Medicare and Medicaid Services (CMS) confirmed that the Medicare Drug Price Negotiation Program remains on track, marking a critical moment for the new administration and for patients. P4AD welcomed the announcement, and in a statement released on Wednesday, founder and president David Mitchell reiterated that this was a positive step forward, but that the real test will be in the execution. Patients need negotiations that deliver price cuts similar or better than those secured in the first round – where list prices were reduced by more than 60 percent on average. P4AD is fiercely committed to protecting the historic negotiation program and ensuring its successful implementation. — (CMS, P4AD, AARP)
US v. Pharma: Patient-Led Petition Delivery
Standing outside the headquarters of The Pharmaceutical Research and Manufacturers of America (PhRMA), the powerful lobbying arm of the pharmaceutical industry, P4AD and allied organizations delivered a clear message to drug company CEOs: Drop your lawsuits and let Medicare negotiate lower prices for patients. Backed by more than 202,000 petition signatures, patients demanded an end to Big Pharma’s legal assault on the program as they urged the CEO of PhRMA, among others, to uphold the law and not interfere with the popular program supported by more than 80% of Americans on both sides of the aisle. At the demonstration, Judy Aiken, a P4AD patient advocate, who paid over $9,000 for Enbrel in 2023, shared how Medicare negotiation will provide long-overdue relief when the new lowered prices come into effect next year. As drug companies and their allies continue to threaten the 2022 prescription drug law in court, patients aren’t backing down. — (Inside Health Policy, P4AD, P4AD)
HHS Secretary Confirmation Hearings
During heated, back-to-back confirmation hearings, Health and Human Services (HHS) Secretary nominee Robert F. Kennedy Jr. provided limited details on how he plans to lower drug prices for patients — a pressing issuefor a majority of American families. If confirmed as HHS Secretary, he would shape the future of programs and policies to make prescriptions more affordable — including the historic Medicare Negotiation Program. When asked about the program, RFK Jr. vaguely committed to continuing the initiative but offered no clarity about his plans or vision for implementation. His positions could determine whether it delivers real savings or is weakened to protect Big Pharma’s profits. Additionally, when facing questions about legislation that nearly passed during the 118th Congress and would have targeted pharmacy benefit managers, RFK Jr. replied that he had not read the specific bill. In closing remarks, Senator Bernie Sanders called out the lack of clear answers from RFK Jr. on why Americans pay some of the highest prices in the world. Nine in ten Americans want more to be done to lower drug prices – but whether RFK Jr. will stand with patients or protect Pharma’s profits is becoming increasingly uncertain despite his apparent dislike of the industry. — (STAT, Politico, West Health, P4AD)
In Case You Missed It
Senators Dick Durbin and Chuck Grassley re-introduced the Drug-price Transparency for Consumers (DTC) Act, a bipartisan bill, endorsed by P4AD, that would require drug manufacturers to disclose prices on advertisements for prescription drugs.
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Welcome to the Week in Review.
US v. Pharma
Patients For Affordable Drugs filed a patient-focused amicus brief in the Second Circuit Court of Appeals, opposing Boehringer Ingelheim’s lawsuit to block Medicare negotiation. The amicus brief, P4AD’s third as part of our US v. Pharma campaign, highlights the transformative relief that lower negotiated prices will deliver to millions of patients and dismantles Big Pharma’s claims that the widely-supported program will stifle future innovation and limit patient access to essential medicines. It also recounts how drug industry lobbying resulted in a two-decades-long prohibition on Medicare’s negotiation authority, leaving patients to bear the burden of exorbitantly high prices dictated by the industry. Patient stories are central to the argument against Boehringer’s claims, including Oluyomi Amoye who shared his difficulty affording Jardiance, which is used to treat his type 2 diabetes, and one of the first 10 drugs selected for negotiation. As ten lawsuits have threatened this hard-fought victory, patients continue to defend lower drug prices in the courtroom and beyond. — (P4AD, Fierce Pharma, KFF, Action Network)
Trump Administration’s First Drug Pricing Action
On his first day in office, President Trump rescinded President Biden’s Executive Order that directed the Centers for Medicare and Medicaid Innovation (CMMI) to develop and test innovative payment and delivery models to reduce drug costs and promote access to drug therapies. These models include the voluntary Medicare $2 Drug List Model to standardize cost-sharing for over a hundred generic drugs at $2 per month, and the Cell and Gene Therapy (CGT) Access Model to help Medicaid patients, starting with those living with sickle cell disease, afford cutting-edge treatments. While the move doesn’t immediately end the models, it raises serious concerns about their future. Experts have called the decision “perplexing,” noting it signals a troubling start for an administration that has pledged to address high drug costs. In a conversation with Inside Health Policy, P4AD President and Founder David Mitchell emphasized the importance of these models as creative solutions consistent with bipartisan goals, urging the administration to move forward with bold initiatives to deliver meaningful relief to patients. P4AD remains committed to working with lawmakers across the political spectrum to advance reforms that make medications affordable for all. — (Politico, Pink Sheet, NBC, Inside Health Policy)
$2k OOP Cap Brings Transformative Relief
Just weeks into the new year, patients are already sharing how the $2,000 annual cap on out-of-pocket costs for people on Medicare is transforming their lives. The cap, which came into effect this month, will provide long-awaited financial relief for 11.3 million Americans struggling with high prescription drug costs. P4AD patient advocate Judy Aiken shared with NPR how she expects to save $7,000 this year on her psoriatic arthritis medication Enbrel – meaning she can consistently take her prescribed medications and finally address much-needed home repairs. Pamela of Rockford, MI, shared with P4AD that she will save $6,000 after years of paying the maximum out-of-pocket costs. “This year I can finally begin to pay down some debt rather than incurring more.” Maureen of Bridgewater, NJ, said she’s already met the cap, saving $4,000 this year. These stories represent just a fraction of the 420,000 patients on Medicare who are projected to save more than $3,000 this year thanks to this critical provision in the 2022 prescription drug law. — (Commonwealth Fund, NPR, AARP)
In Case You Missed It
This week on Capitol Hill, David Mitchell shared his story as a patient living with multiple myeloma, an incurable blood cancer. David highlighted the staggering costs of his treatments, which carry an annual list price of $1 million. Holding up a bottle of his Pomalyst – one of the drugs selected in the second round of Medicare negotiation – David emphasized the urgent need for the successful implementation of the Medicare Negotiation Program. In 2023, Pomalyst cost David over $16,000 for a year’s supply.
Photo by Rod Lamkey, freelance reporter, for The Associated Press Center
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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.
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Welcome to the Week in Review.
Big Pharma’s Price hikes Kick Off 2025
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%.
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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 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:
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.
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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:
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.
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Welcome to the Week in Review.
Pharma’s Excessive Prices Hikes
The new report from the Institute for Clinical and Economic Review (ICER) on price increases of prescription drugs in the U.S. established that five of the top 10 drugs with price hikes above the rate of inflation — Biktarvy, Darzalex, Entresto, Cabometyx, and Xeljanz — lacked significant clinical evidence to justify the price increases. These unjustified hikes drove $815 million in additional costs for patients and taxpayers in 2023, boosting pharmaceutical industry profits while burdening those who depend on these essential medicines. Notably, Entresto is among the first 10 drugs selected for Medicare negotiation, a critical step in addressing price gouging under the Inflation Reduction Act. Earlier this year, P4AD highlighted similar practices with regard to cancer drugs in a mini report, showing how pharma price hikes disproportionately harm Black and Latino patients. While Big Pharma’s price gouging has begun to be reined in by the Inflation Reduction Act, we need to continue to fight for systemic reforms to ensure that all patients can access the medicines they need at prices they can afford. — (ICER, STAT, NBC News, P4AD)
Inhaler Pricing Schemes
GlaxoSmithKline (GSK) continues to face backlash from patients and legislators over its decision last year to discontinue its popular Flovent asthma inhaler, used widely by children living with asthma, and replace it with a more costly generic version that lacks coverage from many insurers. Senator Elizabeth Warren sent another letter to GSK this week, raising concerns about the decision and highlighting findings from Johns Hopkins University that the discontinuation of Flovent HFA cost Medicaid programs nearly $1 billion in 2024. This move by GSK has left families scrambling to find affordable inhaler alternatives and disproportionately harms Black and Latino children who are diagnosed with asthma at higher rates. This blatant profiteering not only undermines patient access but also exacerbates health disparities, underscoring the urgent need for stronger oversight to hold pharmaceutical companies accountable and legislation to crack down on anti-competitive tactics. — (USA Today, Sierra Sun Times, Managed Healthcare Executive, US News)
Big Pharma’s Patent Abuses Cost Patients & Taxpayers
A new report from Public Citizen found that manufacturers of nine of the 10 drugs selected for negotiation by Medicare engaged in rampant anti-competitive tactics to block generic competition and artificially prolong monopoly periods. The report also highlighted that four of the selected drugs — Stelara, Xarelto, Januvia, and Enbrel — would likely have faced generic competition before negotiated prices went into effect, potentially saving Medicare up to $5.4 billion during that period — almost as much as the $6 billion of expected savings from negotiations in the first year. These inflated prices force patients to make impossible choices, like skipping doses or draining their savings, just to access the medicines they need. To achieve truly fair pricing, the Center for Medicare and Medicaid Services (CMS) must account for these anti-competitive tactics during the negotiation process and ensure the final prices reflect the harm caused by such abuses. — (Public Citizen, CMS)
ICYMI
P4ADNOW was disappointed by the United States Patent and Trademark Office’s (USPTO) decision to withdraw its proposed rule on “terminal disclaimer practice” to address drug manufacturers’ nonstatutory double patenting. This commonsense rule had the potential to curb the use of patent thickets, an abusive tactic used by the pharmaceutical industry to block competition and keep prices high for patients.
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Welcome to the Week in Review.
Patient Advocate Of The Year
P4AD proudly began a new tradition: our Patient Advocate of the Year Award. The award honors a patient advocate who has gone above and beyond in the fight for lower drug prices. This year’s recipient was Judy Aiken — a name that should be familiar to Week In Review readers and who was presented with the award yesterday in Washington, DC. Judy is a retired nurse from Maine who has been living with psoriatic arthritis and psoriasis for over four decades. She made headlines earlier this year when she introduced President Biden and Vice President Harris and shared her experience with high drug prices at an event celebrating Medicare’s first 10 new, lower negotiated prices. Judy also testified before the Senate Finance Committee this year to share how the Inflation Reduction Act’s annual $2,000 out-of-pocket cap would rein in the cost of her prescribed medications. Judy’s unwavering commitment to this cause and her willingness to share her personal story continues to help P4AD have a measurable impact. She inspires us all to keep up the fight. — (Portland Press Herald, The New York Times, Fierce Pharma)
EOY Health Care Package Negotiations
As Congress approaches a deadline to pass critical funding bills, negotiations over a health care package are intensifying, with new developments from both parties. Congressional Republicans provided an initial proposal that included provisions that would address the lack of transparency within the pharmacy benefit manager (PBM) industry and delink PBM compensation from list prices. In response, Democrats have put forward a counteroffer that builds on these PBM policies while adding additional drug pricing measures, including S.150, the Affordable Prescription for Patients Act. This bipartisan legislation, which passed the Senate unanimously, targets patent thickets on biologics to accelerate biosimilar competition, lowering costs for patients and potentially generating $1.8 billion in federal savings over 10 years. On Wednesday, P4ADNow, AARP, The ERISA Industry Committee, CSRxP, and The National MS Society sent a letter to House and Senate Leadership urging them to pass S.150 to lower drug costs and generate savings to offset other critical healthcare priorities. Another provision still on the table is Q1/Q2, which P4AD supports, which would expedite the approval process of generic drugs and generate $871 million in government savings over 10 years. These measures align with P4AD’s mission and would help rein in the shady practices of the industry middlemen – while also holding drug manufacturers accountable for their role in setting high list prices. — (STAT, Congressional Budget Office, DC Journal)
ICYMI
The Biden-Harris administration announced that Bluebird Bio and Vertex Pharmaceuticals, two drug makers with FDA-approved gene therapies for sickle cell disease (SCD), have agreed to participate in the Cell and Gene Therapy Access Model. This voluntary model will test outcome-based agreements that tie payments to whether these multi-million dollar therapies improve health outcomes for people living with SCD on Medicaid. Given that over half of the entire community of 100,000 people in the U.S. with SCD are on Medicaid, the model is part of the Administration’s broader effort to increase access to novel therapies and drive down prescription drug costs by making it easier for states to pay.
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