A newly published study in the BMJ finds that almost 60% of drugs receiving new indications from the US Food and Drug Administration (FDA) do not add high therapeutic value to patients. As a result, the researchers argue that patients and providers should be aware and that prices should be set accordingly.
The Mayo Clinic, Mount Sinai, and around 150 other hospitals have joined other care centers in suing major drug manufacturers over inflated prices for generic medications. The lawsuit alleges that drugmakers like Pfizer, Sandoz, and Teva have illegally collaborated for over a decade to keep generic drug prices high.
US Senator Bernie Sanders (I – VT) is looking to include price caps on drugs developed with federal funding into a reauthorization of the 2006 Pandemic and All-Hazards Preparedness Act. The proposal would place a ceiling price that matches the lowest price for a given drug in France, Germany, Japan, Canada, the UK, or Italy.
Several new biosimilars to AbbVie’s Humira (adalimumab) have just hit the US market in the past week, bringing a new wave of competition for the expensive top-selling therapeutic of all time. The copycats come from companies like Organon, Samsung Bioepsis, Sandoz, and Boehringer Ingelheim. Hadlima, a product of Samsung and Organon, will retail for 85% less than brand name Humira.
As the upcoming Medicare drug pricing negotiations approach, the US Centers for Medicare and Medicaid Services (CMS) have released a revised guidance that better outlines the process. Pharma companies and industry groups have been anxiously awaiting such clarification, but the new information has done little to quell their concerns.
In response to a series of lawsuits from the pharma industry, the US Centers for Medicare and Medicaid Services (CMS) have announced changes to upcoming Medicare drug pricing negotiations. The agency dialed back a confidentiality policy associated with the negotiations, a sticking point for some plaintiffs who claimed it violated their First Amendment rights.
India’s National Pharmaceutical Pricing Authority (NPPA) has announced its latest round of ceiling prices for medications, this time capping the prices of 51 medications and 2 formulations for anti-coagulant therapeutics. The other drugs covered include 24 diabetes treatments. The NPPA is India’s key drug pricing regulatory body, in charge of setting ceiling prices for medications and formulations.
Merck, BMS, and three industry groups filing lawsuits against the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) may face an uphill battle in stopping upcoming Medicare drug pricing negotiations. The suits filed by the first two are based on the notion that the negotiations violate the First Amendment, freedom of speech, and the Fifth Amendment, the right against the government seizing property without just compensation.
Officials from the Biden Administration met with drugmakers this week to discuss prices of naloxone, a drug used to immediately reverse opioid overdoses. Emergent Biosolutions, the manufacturer of brand name Narcan, took heat for setting its price for 2 doses at $50. Concerns were also raised about the high cost of other formulations, which can reach $100 for uninsured people.
The pharmaceutical trade group PhRMA has entered the fray, joining BMS and Merck in filing legal challenges against the upcoming US Medicare drug pricing negotiations. Unlike the arguments raised by the two pharma giants’ complaints, which centered on the First Amendment, PhRMA’s argument hinges on fines imposed on manufacturers who do not work with the negotiation process violates the Eighth Amendment. In addition to pharma, the Global Colon Cancer Association and the National Infusion Center Association have filed their own suits.
With lawsuits recently filed by the pharma giants Merck and BMS, pharma seems set on bringing litigation over upcoming Medicare drug pricing negotiations to the US Supreme Court. Some analysts think that the companies are eyeing the highest court in the land due to some justices’ relationships with the companies.
US senators from both sides of the aisle have issued a letter calling for input on the 340B Drug Pricing Program from stakeholders. The program provides eligible care centers with reduced prices on certain prescription drugs. Some stakeholders have complained about a lack of clarity and transparency from the program.
Bristol Myers Squibb (BMS) has thrown its legal hat in the ring, filing a lawsuit against the Biden Administration over upcoming Medicare drug pricing negotiations set up by the Inflation Reduction Act. In doing so, they join Merck as legal challengers to the process, which will set the prices drug companies can charge for a select set of high-price prescription therapeutics.
With Medicare drug price negotiations, pharma is looking for a move to either delay or block the process and prepare for it in the meantime. Merck and the US Chamber of Commerce filed suit against the Centers for Medicare and Medicaid Services (CMS) earlier this month. Others, including the industry group PhRMA, have spelled out potential consequences of the negotiations.
According to new data released by the Drug Channels Institute, brand-name drug prices from 10 key manufacturers dropped by half last year after discounts and rebates were accounted for. The manufacturers include Eli Lilly, Johnson & Johnson, Novo Nordisk. Much of the savings, however, have gone to pharmacy benefit managers.
Senator Bernie Sanders (I – VT) will vote against the Biden’s pick for NIH director, Dr. Monica Bertagnolli, until the administration lays out plans to reduce high prescription drug prices in the US. This effectively blocks the nomination, as Sanders’ vote is necessary for it to pass. The administration argues that its commitment to lowering drug prices has already been demonstrated by the passage of the Inflation Reduction Act.
In a poster session at this year’s American Society of Health-System Pharmacists (ASHP) meeting, Atropos Health presented real-world evidence examining the impact of prescribing high-cost vs low-cost medications on patient health outcomes. The study, which looked at electronic health records (EHR) taken between 2015 and 2021, found no difference in outcomes between drugs at different price brackets.
The second volley of legal challenges over upcoming Medicare drug pricing negotiations has been fired, this time by the US Chamber of Commerce. The chamber argues that the negotiations, brought on by the Inflation Reduction Act, would violate pharmaceutical companies’ due process rights by enforcing price limits. This suit follows one filed last week by Merck and Co.
The Centers for Medicare and Medicaid Services (CMS) has expanded the list of drugs that will be subject to rebates tied to price increases that exceed the current rate of inflation. The number, which was previously 20, now stands at 43, and includes drugs for leukemia, lymphoma, and asthma from major manufacturers like Seagen, Amgen, and AstraZeneca.
Merck filed suit against the Centers for Medicare and Medicaid Services (CMS) recently, marking the first pharmaceutical company to do so. However, according to Stephen L. Carter of Bloomberg, the lawsuit may be dead in the water. The reason, he argues, is the basis of the suit, which hinges on the idea that price caps equate to the government seizing private property without fair compensation and that the language of the bill is a violation of the First Amendment.
Amid growing scrutiny of pharmacy benefit managers (PBMs) at the public and congressional level, a PBM industry group has launched an ad campaign pointing the blame back at pharma for high drug prices. The group argues that the pharmaceutical industry has spent millions of dollars on advertising and lobbying that places the onus of high drug prices on PBM practices while side skirting their own responsibility for setting list prices.
According to Medicare Director Meena Seshamani, upcoming drug pricing negotiations will take the patient perspective and real-world evidence (RWE) into account. The agency wants to incorporate information about how high prices of key therapeutics impacts patients, as well as how the drugs are used and work in real-world settings.
The pharma giant Merck & Co has filed a lawsuit against the US government over upcoming Medicare drug pricing negotiations included in the Inflation Reduction Act passed last year. The company argues that the negotiations would violate their 5th Amendment rights by forcing them to provide drugs at prices lower than market value.
The US Inflation Reduction Act requires drugmakers to justify new drug prices based on the R&D costs needed to develop a therapeutic during drug pricing negotiations. However, this policy may be short-sighted, according to some experts, as it doesn’t account for the lost investments in failed drugs or the overall value provided to patients.
As part of the upcoming drug pricing negotiations from the Inflation Reduction Act, drugmakers will need to justify high US drug prices by comparing efficacy and value with therapeutic alternatives. The problem, according to industry leaders, is that the definition of therapeutic alternatives is unclear. Beyond that, these filings have a small max word count, making applications even trickier.