The Institute for Clinical and Economic Review has received industry backlash over changes to its value-assessment process it proposed in June. The changes, if implemented, would lower the threshold ranges for cost-effectiveness down to $50,000 to $100,000 a year, a net drop of $50,000 at each end of the range. The outgoing ICER president Steve Pearson noted that these changes are not going to be immediately implemented and are still under consideration.
Samsung Biologics and Pfizer have announced they are expanding their current collaboration to ramp up production of biosimilars, bringing the agreement to a value of $897 million. The announcement comes as Pfizer and another branch of Samsung both prepare for US launches of their Humira biosimilars.
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.
The Institute for Clinical and Economic Review (ICER) will perform a value-assessment on KarXT (xanomeline tartrate/trospium chloride), Karuna Therapeutics’ experimental therapeutic for schizophrenia. Public discussion of the assessment will take place next February at the 2024 New England CEPAC meeting.
Amicus Therapeutics has received approval from the European Commission (EC) for Opfolda (miglustat), its treatment for Pompe disease, a rare disorder that causes progressive muscle weakness. The approval specifically covers the drug in combination with Pombiliti (cipaglucosidase alfa). Results from a recent phase 3 study showing positive changes in mobility and breathing, both affected by the disorder, supported the EC’s decision.
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.
No matter who wins the next US presidency, it doesn’t look that there will be a friend to the pharma and biotech industries in the White House, according to a new Axios article. Donald Trump, the current Republican front-runner has already repeated his previous campaign promise of not letting the US pay more for medications than other countries, while his rival Ron DeSantis launched a Florida state grand jury to scrutinize COVID-19 vaccine producers over alleged misrepresentation of safety information.
The Institute for Clinical and Economic Review (ICER) has announced that its founder, Steve Pearson, MD, will step down from his role as president later this year. ICER’s COO Sarah Edmond will take over the position as president, while Pearson will move to an advisory position for the organization, which performs value-assessments on therapeutics.
OPKO Health and Pfizer’s Ngenla, a treatment for childhood growth hormone deficiency, has received approval by the US Food and Drug Administration (FDA). The treatment for the rare disease, which causes short stature and delayed puberty, had been rejected once by the agency with a request for more information.
One of the key therapeutic targets in Alzheimer's disease is amyloid, a sticky protein that builds up in clumps outside neurons, causing cell death and cognitive decline. However, new therapeutics targeting the protein have only shown mild efficacy in delaying disease progression. As a result, drug developers are looking for other biological targets.
Drug shortages have rocked the US, imperiling access to therapeutics for millions of patients with a wide array of diseases and conditions. A new Becker’s Hospital Review article lays out 7 of the most prominent drug shortages to watch. One is the attention deficit hyperactivity disorder (ADHD) drug Vyvanse (lisdexamphetamine dimesylate).
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.
The UK’s National Institute for Health and Care Excellence (NICE) has sent a request to Eli Lilly asking for more data regarding Mounjaro (tirzepatide) before it will cover it for NHS patients. The decision comes based on data comparing the drug’s efficacy to Novo Nordisk’s rival drug Ozempic and standard insulin therapy. While the data showed Mounjaro was more effective at weight loss and glucose control, NICE needs more information before making a coverage decision.
The US Food and Drug Administration (FDA) has approved Pfizer’s Litfulo (ritlecitinib) for use in adolescents with severe alopecia areata, an autoimmune condition that causes hair loss. The approval marks the first treatment for the psychologically damaging condition in teens. Positive results from a phase 2b/3 study, which included over 700 patients, supported the FDA’s decision..
GSK’s Arexy and Pfizer’s Abrysvo vaccines for respiratory syncytial virus (RSV) have received recommendations from the US Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP). While the committee voted almost unanimously in support of the vaccines for adults aged 60-64, the recommendation for adults over 65 was far more contentious, sitting at 9-5 for and against, respectively.
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.
Colchicine, an ancient treatment for gout, has been approved by the US Food and Drug Administration (FDA) for treating vascular inflammation present in patients with heart disease. The therapy, now produced by Agepha Pharma, is combined with a statin and reduces risk of serious cardiovascular events like stroke or heart attack.
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.
Mandy Cohen, MD, has been selected by the Biden Administration to lead the Centers for Disease Control and Prevention (CDC) as its next director. Cohen, who lead North Carolina’s response to COVID-19, will take the helm in early July, according to the White House. She is succeeding the current director, Rochelle Walensky.
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.
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.