Welcome to the Week in Review.
Bipartisan Patent Thicket Legislation Unanimously Clears The Senate
Marking an important victory for patients, yesterday the Senate unanimously passed the Affordable Prescriptions for Patients Act of 2023 (S. 150), a bipartisan bill aimed at curbing the drug industry’s use of patent thickets to extend monopolies, limit competition, and keep drug prices high. The bill, championed by Senators Cornyn and Blumenthal, addresses Big Pharma’s exploitation of the patent system by restricting the number of patents that can be asserted on biologic medicines. A 2023 report by Matrix Global Advisors found that patent thickets on just five drugs — Humira, Imbruvica, Eylea, Enbrel, and Opdivo — delayed competition and cost patients more than $16 billion. Yesterday’s win would not have been possible without patients, their families and allies. P4ADNow’s year-long campaign, launched in July 2023, resulted in over 27,000 letters and over 30,000 calls from patient advocates into Congressional offices who mobilized en masse to ensure the Senate’s passage of S.150 and who are continuing to work to secure the passage of other bipartisan bills to increase competition and make medicines more affordable. “Accessing the medications that I need, at the quantities that I need them, could become easier and more affordable if more competition was allowed to enter the market,” shared Jacquie Persson, a patient advocate from Waterloo, Iowa who struggles to afford the medication she needs to manage her Crohn’s disease. P4ADNow is calling for swift action from the House to continue this momentum and ensure S. 150 becomes law soon as possible to begin to deliver relief to Americans of all ages. — (P4ADNow, Inside Health Policy, First Word Pharma, Endpoints, pharmaphorum, Coalition For Affordable Prescription Drugs, Patientspushforcompetition.org)
FTC’s Scathing Report On PBMs
The Federal Trade Commission (FTC) issued a 71-page bipartisan interim report following its two year investigation into the opaque practices of pharmacy benefit managers (PBMs). Findings from the report confirmed what patients long suspected: the highly consolidated PBM industry, intertwined with insurance companies and pharmacies, wields outsized influence over drug accessibility and pricing. The report reveals how PBMs’ secretive agreements with drug manufacturers incentivize higher list prices and restrict access to cheaper generics and biosimilars. With the three most dominant PBMs – CVS Caremark, Express Scripts and OptumRx – processing 80 percent of prescriptions filled in the U.S., the FTC is poised to take legal action against the companies for their anti-competitive practices. The scrutiny on PBMs will continue to intensify later this month as executives from the big three will testify before the House Oversight Committee on July 23. Reform of the PBM industry remains a top priority for P4AD and we will continue to press for a system that prioritizes patients. — (FTC, Scripps News, P4ADNow, New York Times, Forbes, Pharmaphorum, Healthcare Finance News, Axios)
Fact V. Pharma Fear Mongering
The Inflation Reduction Act maintains key incentives for research and development of small molecule drugs, despite fear mongering from pharmaceutical industry representatives. It was reported this week that Eli Lilly is acquiring Morphic Holding, a biotech company with a small molecule drug in Phase II trials, proving yet again the industry’s continued appetite for small-molecule drugs. In the nine months following the law’s passage, there was a surge in acquisitions of small molecule drugs compared to the preceding period and industry experts are projecting nearly 8 percent annual growth in global sales of small molecule drugs from 2022-2031, demonstrating continued confidence in the value proposition of this class of drug. — (STAT, Fierce Pharma, Endpoints, Brookings Institution, Precedence Research)
In Case You Missed It
Between June 30th and July 5th, pharmaceutical companies raised prices on 195 drugs – 50 percent of which were raised higher than the rate of inflation. Watch this space as P4AD dives deeper into the drug industry’s egregious price hikes and trends throughout the month.
Welcome to the Week in Review.
Court Watch: Patients Score Fifth Legal Victory
A federal judge in Connecticut dealt a fifth consecutive blow to the pharmaceutical industry’s legal campaign to halt the Medicare negotiation program. Chief Judge Michael P. Shea ruled against Boehringer Ingelheim on Wednesday, rejecting the company’s claims and emphasizing the voluntary nature of drugmakers’ participation and their ability to remain profitable even with lower prices. Jardiance, Boehringer’s blockbuster diabetes and heart failure drug, is among the first 10 drugs selected for Medicare negotiation, and in 2023, the company raked in $8 billion in sales from Jardiance alone. A lower negotiated price for Jardiance could yield hundreds of dollars in monthly savings for patients like Joy in Michigan, who is forced to go without the drug because of its price. — (FightPharma.org, pharmaphorum, First Word Pharma, Boehringer Ingelheim)
Zeroing In On Patent Abuses
The Federal Trade Commission (FTC) launched an investigation last week into Teva Pharmaceuticals over the company’s failure to remove dozens of “junk” patents on its inhalers. This probe is part of a broader and ongoing effort to end drug corporations’ exploitation of the patent system. Companies are accused of making minor tweaks to their medications for the purpose of keeping patents active and prolonging monopoly pricing power. The investigation follows the FTC’s November 2023 probe into several drug manufacturers’ improperly listed patents on medications that treat conditions like asthma, COPD, and diabetes. FTC Chair Lina Khan and Senator Dick Durbin criticized these patent abuses in an op-ed in STAT News this week and highlighted several bipartisan bills currently in Congress, backed by P4ADNOW, to address anti-competitive practices like pay-for-delay and patent thickets. These reforms recently gained renewed momentum as the Congressional Budget Office (CBO) rescoredthreebills included in this bipartisan package, projecting significantly higher savings and bolstering the case for their passage. — (The Washington Post, FTC, STAT News, PatientsPushForCompetition.org, Axios)
Expansion of Medicare Negotiation
Renewed calls to expand Medicare negotiation made headlines this week as President Joe Biden and Senator Bernie Sanders announced their shared aspirations to expand the program’s ability to negotiate drug prices directly with pharmaceutical companies. The new proposal aims to increase the number of drugs eligible for negotiation to 50 drugs per year, potentially including popular GLP-1s like Wegovy and Ozempic, and would be transformational in the continued fight for lower drug prices. These proposals would build upon hard-won victories for patients and could lead to billions in additional savings for both patients and taxpayers. — (Washington Examiner, Fierce Pharma, USA Today)
Eli Lilly’s Pricey Alzheimer’s Treatment
The Food and Drug Administration’s (FDA) approval of Kisunla this week – one of only two drugs currently approved to treat Alzheimer’s disease – offers potential hope to patients affected by this devastating illness. Its launch price however is raising concerns over access. Eli Lilly priced the treatment at $32,000 per year — higher than Leqembi, the only other drug to treat the disease which costs $26,500 annually after Aduhelm was removed from the market this year. With an estimated 6.7 million people aged 65 or older living with Alzheimer’s disease, this price would place an impossible financial strain on Medicare. — (NBC, KFF, NIH)
In Case You Missed It
This week, the Department of Health and Human Services (HHS) launched MedicamentosBajoPrecio.gov, a Spanish-language version of their Lowerdrugcosts.gov resource that breaks down the drug price reforms in the Inflation Reduction Act.
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Inflation Penalties Drive Patient Savings
Great news for Medicare as the Department of Health & Human Services (HHS) announced that the Inflation Rebate Program in the Inflation Reduction Act is already yielding significant benefits for some patients. Several drug companies that excessively hiked prices on 64 Part B medications will be required to pay rebates to Medicare, potentially benefitting more than 750,000 people who take these medications. From July 1 – September 30, 2024, these drugs will have lowered coinsurance rates, and during this time period patients could see savings of up to $4,593 per day. For instance, a patient taking Padcev, a bladder cancer drug, could save as much as $1,181 since the drug’s price increased faster than the rate of inflation every quarter since the program went into effect in 2023. The Medicare inflation rebate program aims to prevent arbitrary price increases on essential medications and protect patients from exploitative pricing tactics. — (HHS, Fierce Health Care, CNBC
TIME Magazine Highlights P4AD Patients Advocates
Yesterday, TIME ran an article showcasing the daily struggles and resilience of patients facing exorbitant medication costs – featuring the stories of several P4AD patient advocates. Jackie Trapp and Janet Karrigan, both battling multiple myeloma, Melissa Tavares, advocating for her daughter’s epilepsy medication, Bob Parant, managing diabetes and heart failure, and Jacquie Persson,navigating Crohn’s disease and migraines, all shared the strategies they are forced to employ to manage their drug costs. Fortunately, for patients on Medicare like Bob and Janet, there is already some relief from the new drug law, including a cap on out-of-pocket spending, a $35 monthly cap for insulin, and free vaccines. “The savings for patients is going to be life-changing,” Merith Basey, executive director of P4AD shared with TIME. Further, Medicare is currently negotiating with drug companies to lower prices on the first 10 of an eventual 60 medications. These patient stories are at the heart of what we do every day and serve as an important reminder of why we must continue to push for additional reforms to lower drug prices, including tackling pharmaceutical industry patent abuses and addressing exorbitant launch prices. – (TIME, FightPharma.org)
Digital Day of Action: Defending Medicare Negotiation
P4AD and allies hosted a panel discussion this week featuring experts and patient advocates focused on ongoing advocacy efforts to ensure the Medicare negotiation program is successfully implemented despite pharmaceutical industry lawsuits. Zachary Baron, director of the Health Policy and the Law Initiative at the O’Neill Institute, highlighted pharma’s fierce opposition to the new program and the encouraging trend of federal judges ruling in favor of patients. P4AD’s Director of Advocacy and Organizing, Temi Amoye, discussed our US v. Pharma campaign and how we’re mobilizing patients against Big Pharma’s efforts. The panel was moderated by Laura Packard of Health Care Voices and featured P4AD patient advocates Emmabella Rudd and Kaye Peterson, who shared their experiences with high drug prices and the anticipated relief for patients from Medicare negotiation. Their heartfelt stories underscored the importance of preserving this critical program and how motivated patients are to fight back against efforts to undermine it. Watch the discussion here. – (Facebook, O’Neill Institute, FightPharma.org, P4AD, P4AD)
In Case You Missed It
According to GoodRx’s tracker, prescription medication costs in the U.S. have surged 37 percent since 2014, outpacing inflation and raising out-of-pocket expenses for consumers. According to the same data, so far in 2024, consumers have spent $21 million out-of-pocket on prescription drugs.
Welcome to the Week in Review.
Court Watch: US v Pharma
Another judge has cast doubt on pharma’s arguments challenging Medicare negotiation. On Thursday, Boehringer Ingelheim’s high-priced lawyers presented the corporation’s case against the program in a Connecticut court, where U.S. District Judge Michael P. Shea expressed skepticism of their claims. The lawsuit is one of nine filed by the drug industry and its allies to block the wildly popular program in the Inflation Reduction Act. Boehringer’s suit aims to preserve its pricing power over blockbuster drug Jardiance, one of the first 10 drugs up for negotiation – which generated $8 billion in sales in 2023. A lower negotiated price for Jardiance would be transformational for patients like Gillian from Virginia, who is living with type 2 diabetes and was prescribed the medication to control her blood sugar, but has to forgo it because of the $680 monthly price tag. The corporation’s lawsuit is a “grab bag” of many constitutional and procedural arguments raised in several of the industry’s earlier cases. So far, these claims have failed to persuade judges, with four rulings already favoring patients over the pharmaceutical industry. As evidenced by these recent victories for patients and consumers in court, we are making progress in the battle against pharma’s monopoly power, but the fight is far from over. — (Bloomberg Law, Law360, FightPharma.org, P4ADNOW, Boehringer Ingelheim, P4AD, STAT News, BioSpace, CNBC)
Today In Big Pharma Fear-Mongering
The Inflation Reduction Act ensures robust support for orphan drug development despite the pharmaceutical industry’s claims. As David Mitchell, founder of Patients For Affordable Drugs, pointed out, “Drug companies can still make lots of money on additional indications for orphan drugs by expanding the number of patients who are treated. They don’t need unending, serial orphan drug exclusivity to make new indications profitable.” Orphan drugs with multiple indications are highly unlikely to meet the spending threshold for Medicare negotiation, thus maintaining incentives for research and development. The Inflation Reduction Act preserves critical support such as tax credits for clinical trials and priority review vouchers, ensuring continued innovation in the rare disease space. Furthermore, increased investment in small molecule drugs following the Inflation Reduction Act’s enactment contradicts industry fears and demonstrates the law’s balanced approach to lowering drug prices while fostering innovation. — (Bloomberg Law, Brookings Institute)
CBO Boost: Patent Reform Bills’ Savings Skyrocket
Those working to rein in Big Pharma’s abuse of the drug patent system received welcome news last week as the Congressional Budget Office (CBO) rescored a key bipartisan bill aimed at curbing patent thickets and product hopping. The Affordable Prescriptions for Patients Act (S. 150) now projects $3 billion in savings over a decade — nearly tripling its previous estimate of $1.1 billion. This latest update builds on the March rescoring of two other competition bills, all of which have passed through committee with bipartisan support:
Collectively, these three bills now project roughly $5 billion in savings over ten years. In addition to accelerating generic drug entry and fostering competition to lower drug prices for millions of Americans, these enhanced savings offer a timely solution to fund other crucial health care priorities in an end-of-year funding package. — (Axios, Politico, Inside Health Policy, CBO, P4ADNOW, CBO, CBO)
ICYMI
The majority of Americans over the age of 65 (54 percent) are reportingly very concerned about the cost of prescription drugs. Thankfully, several drug price reforms in the Inflation Reduction Act are already driving savings for patients on Medicare. As additional reforms go into effect in 2025, including the $2,000 out-of-pocket cap and lower negotiated drug prices on ten widely-used drugs, millions of patients on Medicare will see further savings. But more is needed to lower drug prices across the board.
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P4AD Calls Out Big Pharma & PBMs At AHIP 2024
On Tuesday, at this year’s AHIP conference, P4AD Executive Director Merith Basey participated in a keynote panel titled, “Making Prescription Drugs Affordable and Accessible for Everyone,” where she went head-to-head with leaders from Express Scripts and Amazon Pharmacy. Merith exposed the Big Pharma tactics that are driving up drug prices – which disproportionately harmBlack and Brown communities as well as seniors and lower-income individuals. She detailed P4AD’s priorities to rein in costs through system-changing reforms to increase competition, including curbing patent abusesand ensuring successful implementation of the Inflation Reduction Act. Ahead of the panel, Merith previewed her remarks, outlining the need to also address the high cost of cell and gene therapies and increase transparency in the practices of pharmacy benefit managers (PBMs). — (AHIP, P4ADNOW, Managed Healthcare Executive, Managed Healthcare Executive)
Patent Expiration Opens The Door For Lower Prices
By 2030 key patents on several blockbuster drugs will end, presenting a potential window of opportunity for generic competitors to enter the market and help alleviate monopoly pricing. Eliquis, which has a list price seven times higher in the U.S. than in Canada, and Stelara, which costs upwards of $25,000 per month and has nearly tripled in price since entering the market — are prime examples of drugs that have seen their prices soar because of Big Pharma’s anti-competitive practices. Increasing competition is critical to lower drug prices, in fact, the Food and Drug Administration (FDA) found that generic drug prices were 39 percent lower than brand-name drug prices after one generic competitor entered the market and up to 79 percent lower with the introduction of four competitors. P4ADNOW is pushing for the passage of bipartisan bills, currently moving through Congress, that would curb anti-competitive practices and strengthen market forces to lower drug prices for patients. — (NBC News, Quartz, FDA, P4ADNOW)
Legislator Pressure Pharma To Curb Patent Abuse
The push to reform the patent system continues to gain momentum on Capitol Hill. Last week, Senators Warren and Jayapal called on eight pharma CEOs to remove 130 “junk” patents that serve to block lower-cost generics from entering the market. Meanwhile, Senate Health, Education, Labor & Pension (HELP) Chairman Sanders escalated his probe into Novo Nordisk’s patent abuses this week, calling for a vote to subpoena the drug corporation’s president. These actions follow last month’s Senate Judiciary Hearing on the pharmaceutical industry tactics to block generic and biosimilar competition and the efforts to curb these practices – which saw rare bipartisan support from committee members. With polling showing that 9 out of 10 Americans believe lowering prescription costs should be a top Congressional priority, pressure continues to mount for meaningful reform. — (The Washington Post, CNN, STAT, X, P4ADNOW)
Watch
PBMs, the shady middlemen who negotiate rebate deals with drug manufacturers, operate behind a veil of secrecy that makes it difficult to discern whether they are passing on savings to patients or blocking access to lower-cost competition. Watch this explainer video from STAT News which details the history of the PBM industry and why we need to shine a light on their practices to ensure they are operating on behalf of patients.
Welcome to the Week in Review.
Pharma V. Facts
At this year’s American Society of Clinical Oncology conference, drug industry executives and their allies continued to peddle misinformation about the Inflation Reduction Act, claiming the law will stifle investment in small-molecule drugs. However, their fear-mongering doesn’t align with the facts. In the nine months following the law’s passage, major pharmaceutical companies have shown an increased appetite for acquiring small-molecule drugs. Eli Lilly’s $2.4 billion purchase of DICE Therapeutics, a biotech company with a promising small-molecule drug in Phase II clinical trials, and Bristol Myers Squibb’s $4.8 billion acquisition of Mirati Therapeutics with its small-molecule cancer drug Krazati, demonstrate the enduring attractiveness and profitability of these therapeutic approaches. In fact, analysts have projected a significant increase in global spending on small-molecule drugs from $76 billion in 2022 to about $152 billion in 2031. Venture capital firms have similarly expressed confidence in the value proposition of small molecules, which have accounted for more than 75 percent of all new drugs since 2010. Despite warnings at the conference from industry leaders like Eli Lilly CEO David Ricks and the Pharmaceutical Research and Manufacturers of America (PhRMA) CEO Stephen Ubl about the law’s supposed “negative implications” for innovation, Medicare’s long-overdue authority to negotiate fair drug prices promises massive cost savings for patients and taxpayers, without diminishing incentives for continued investment in medical breakthroughs. — (Fierce Pharma, Brookings InstituteEndpoints, Fierce Pharma, STAT, NIH, CAP, NPR)
Americans Concerned Over High Drug Prices
A new national poll by West Health-Gallup confirms the harsh reality faced by millions of Americans: soaring drug prices. Thirty-one percent of Americans, who pay more than four times for the same brand name drugs compared to residents of other wealthy nations, are concerned about their ability to afford their medications over the next 12 months – a significant jump from 25 percent in 2022. Among adults 65 and older, the increase is even more substantial, up 11 percentage points to 31 percent from 20 percent. “The medications are very, very expensive. I’m a diabetic and a lot of the medications that I’m taking are like a hundred and something [dollars],” shared Emily G., a Texas patient highlighted in the survey report. These findings come as public opinion of the pharmaceutical industry continues plummeting. A shocking 83 percent of Americans believe profits are the primary driver of high drug prices, with the industry’s approval rating a dismal 18 percent.
As public anxiety mounts, so too is the pressure on policymakers to confront Big Pharma’s profiteering head-on. While the Inflation Reduction Act was a monumental step toward lowering drug prices for millions of patients on Medicare, urgent legislative action is needed to increase competition to lower prices for more Americans. Congress has the opportunity to advance bipartisan legislation that would close loopholes and rein in Big Pharma’s patent abuses to increase savings for patients. P4ADNOW’s David Mitchell testified last month before the Senate Judiciary Committee about the urgent need for these critical reforms to ensure patients can access the medications they need at prices they can afford. — (Gallup, RAND, P4ADNOW, Forbes)
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Common cancer treatments hit the market with exorbitant list prices that typically increase faster than the rate of inflation – placing a severe financial strain on patients. Between 2019 and 2023 55 percent of new cancer drugs were launched with a price exceeding $200,000 annually and nearly 60 percent of working-age cancer survivors report facing some financial difficulty due to costs associated with their disease. This forces many patients to cut back on essentials like groceries, skip mortgage payments, and incur massive debt to afford their medication. Gwendolyn, a grandmother living with cervical cancer, shared with the Wall Street Journal how her expensive treatment left her unable to afford basic necessities like toothpaste or toilet paper. The financial burden has been particularly heavy for cancer patients on Medicare, who have often paid a percentage of these high list prices out-of-pocket, which can add up to thousands of dollars. However, the new $2,000 yearly cap on out-of-pocket costs, set to take effect in 2025 under the Inflation Reduction Act, will drastically reduce costs for people who get a brand-name cancer drug through Medicare Part D. P4AD’s Cancer Report, estimates an average saving of $7,590 annually and up to $19,296 in some cases. While the drug price law marks significant progress to lower out-of-pocket costs, continued legislative action is needed to curb drug companies’ ability to set excessively high launch prices for new cancer treatments and other conditions. — (Reuters, KFF, The Wall Street Journal, IQVIA, P4AD)
The exorbitant prices of brand-name drugs in the United States are due in part to the anti-competitive tactics used by pharmaceutical companies to extend their monopoly pricing power and obstruct cheaper generics and biosimilars from entering the market. Drug prices in the U.S. are three to eight times higher than in other comparable nations, and with approximately 53 percent of young adults in the U.S. living with a chronic condition, the financial burden is extended over a lifetime. Sneha Dave, the executive director of Generation Patient, told Think Global Health that the decisions young people with chronic conditions make “are very much centered around our ability to afford medications into the future.” Comprehensive patent reform to close these loopholes is crucial to inject true competition and provide relief for young people who will spend their lives not only managing their conditions but dealing with the financial burden of paying for their medications. P4ADNOW is continuing to push for the passage of bipartisan legislation to curb anti-competitive practices and increase competition, ultimately lowering drug prices for all patients. — (Fierce Pharma, Commonwealth Fund, CDC, Think Global Health, P4ADNOW)
Starting tomorrow, June 1st, out-of-pocket costs for inhaler products manufactured by AstraZeneca and Boehringer Ingelheim will be capped at $35 a month, thanks to pressure from advocates and lawmakers. GlaxoSmithKline’s $35 monthly out-of-pocket cap on inhalers will take effect on January 1, 2025, while Teva, the last of the four major inhaler companies, has not yet chosen to follow suit and reduce costs for patients.
Welcome to the Week in Review.
1. Continued push for competition
On Tuesday, the Senate Judiciary Committee held a hearing on the anti-competitive tactics used by the pharmaceutical industry to block generic and biosimilar competition in order to keep drug prices high. P4ADNOW’s founder and cancer patient David Mitchell, testified before the committee in support of bipartisan bills currently in Congress that would address these patent abuses, including pay-for-delay deals, product hopping, and patent thickets. Committee members from both parties expressed outrage over drug makers’ persistent manipulation of the patent system at the expense of patients. Chairman Durbin condemned big pharmaceutical companies’ “skilled lawyers manipulating the patent system” to delay affordable competition, and Senator Cornyn highlighted the 165 patents on Humira as clear “abuse” of the system that resulted in AbbVie’s prolonged monopoly pricing power. The reforms are urgently needed to restore fairness to our patent system, increase competition, and provide relief to patients and taxpayers. — (Axios, Youtube, WOKV, MedPage Today, P4ADNOW, Senate Judiciary Committee, NBC News)
2. Facts V. Pharma Fearmongering
AstraZeneca’s new goal to reach $80 billion in revenue by 2030 — a 75 percent increase over 2023 — by aiming to launch 20 new medicines, undermines industry claims that the Inflation Reduction Act will stifle drug innovation. The company’s CEO Pascal Soriot even recently admitted that the impact of the drug price law is “completely manageable” yet the company is simultaneously pursuing an aggressive lawsuit to dismantle Medicare negotiation — one of the most popular and transformational provisions in the historic legislation. Major pharmaceutical companies like AstraZeneca are projecting robust growth and a flourishing pipeline of new medicines in the years to come, and drugmakers are continuing to thrive and invest in research, demonstrating that innovation can coexist with policies aimed at providing much-needed pricing relief to patients. — (The Guardian, CNBC, Fierce Pharma, Reuters, Georgetown University, STAT)
2. Launch Prices for New Diabetes Drugs Create Access Barriers
Big Pharma’s high launch prices for diabetes and weight loss drugs like Ozempic and Trulicity are creating significant access barriers. A KFF poll revealed that about 54 percent of adults who had taken a GLP-1 drug found them “difficult” to afford, with high prices disproportionately harming people from historically underserved communities. Patients are being forced to ration or forgo their essential medicines, exacerbating health conditions and leading to devastating but preventable consequences such as kidney failure and blindness. We must address launch prices to balance the need for fair profits while ensuring accessibility and affordability. — (KFF, KFF, Fox 5)
PhRMA Lobbying: The Pharmaceutical Research and Manufacturers of America (PhRMA) spent $9.4 million on federal lobbying in the first quarter of 2024. This heavy spending underscores the industry’s determination to protect its power to set prices despite ongoing efforts from patients and allies.