US Congressional Research Service Asks When Pharma Can Challenge Drug Pricing Reform
The Congressional Research Service (CRS), a nonpartisan public policy research institute, released a report asking for more clarity on when lawsuits over upcoming Medicare drug pricing reform can commence. The report comes as industry groups also seek more transparency on time windows as they prepare their legal challenges in advance.
Eli Lilly Reaches $13.5 Million Settlement in Insulin Pricing Case
Eli Lilly has settled a case with patients using insulin, who accused the company and others of artificially inflating prices of the lifesaving drug. Lilly will pay out a total of $13.5 million and will maintain their $35 a month out-of-pocket price cap for four years at minimum. The company, which claims no wrongdoing occurred, will apply this cap to three insulin products, Humalog, Humulin, and Basaglar.
Canadian Health Officials Tried to Hide Evidence Health Minister Stalled Drug Pricing Reform
Recently released emails show that Health Canada officials tried to hide a letter from Health Minister Jean-Yves Duclos to the Patented Medicines Prices Review Board (PMPRB), Canada’s independent drug pricing agency, asking them to delay drug pricing reform last year. The letter mirrored the pharma industry’s concerns and led to the reform being postponed.
Speaking with the Person Behind the Inflation Reduction Act Drug Price Negotiations
The US drug pricing reform in the Inflation Reduction Act was concocted by John Barkett of the Berkely Research Group. In a new interview, Politico’s Ben Leonard spoke to Barkett to talk about the process and the next steps for the Centers for Medicare and Medicaid Services (CMS). Barkett first spoke about pharma’s criticism of the move and the agency.
Part D Out-of-Pocket Prescription Drug Price Cap Will Help New Part D Recipients
A newly published study in JAMA Health Forum found that new Medicare Part D price caps on out-of-pocket prescription drug costs will help new beneficiaries switching from commercial plans. The study found that the $2000 price cap in the provision, included in the Inflation Reduction Act, would save people switching from commercial plans to Part D.
India’s NPPA Cuts Off-Patent Drug Ceiling Prices by Half
The National Pharmaceutical Pricing Authority (NPPA), India’s drug pricing agency, has announced it will cut the ceiling price of off-patent drugs by half to address profiteering in the pharmaceutical industry. The list of drugs covers much of the country’s National List of Essential Medicines (NLEM). Many pharma companies have lambasted the plan, saying it will negatively impact their profits.
US CMS Announces New Strategy to Lower Medicaid Drug Prices
The US Centers for Medicare and Medicaid Services (CMS) has announced a new proposal to help lower prescription drug prices for Medicaid. The rule would establish a survey for drugmakers about drug manufacturing costs and would ensure that Medicaid payments for therapeutics, especially high-price cell and gene therapies, are reasonable via the Medicaid Drug Rebate Program (MDRP).
CMS Using Real-World Evidence in Medicare Drug Pricing Negotiations
The US Centers for Medicare and Medicaid Services (CMS) noted in a recent guidance that it will consider real-world
Biden Admin Proposes CMS Rule to Make Drug Manufacturing Costs Transparent
The Biden administration and the Centers for Medicare and Medicaid Services (CMS) have put forward a new rule intended to bolster drug price transparency by highlighting drug manufacturing and transportation costs. This would be performed via a variety of tools, including a drug price verification survey that would be issued when new drugs are priced or existing drugs see price hikes.
Orphan Drug Status Plays into Drug Pricing
Orphan drugs, treatments for rare diseases with limited therapeutic options, are usually less profitable for pharma companies due to high development costs and small patient populations. However, orphan drug designation (ODD) offers monetary incentives to companies developing drugs for rare diseases. As a result, ODD plays a role in pharma drug pricing decision-making.
Indian Pharma Group Petitions NPPA to Establish Prospective Batch Pricing
When India’s National Pharmaceutical Pricing Authority (NPPA) sets ceiling prices for drugs, pharma companies can be fined if even one pharmacist charges higher. As a result, the Indian Drug Manufacturer’s Association (IDMA), should put in place prospective price batching that would apply the new price to the next batch of drugs being released.
Only Some US Prescription Drug Prices are 10X Higher than Other Countries
A common talking point in US drug pricing discussions is that US residents pay 10 times as much for prescription medicines than people in other nations. While this is true for many drugs, the picture is more complex. Making such an analysis is complicated by the comparator nations, the drugs studied, and whether they are brand name.
Price of Multiple Sclerosis Disease Modifying Therapies Keeps Creeping Up
Disease modifying therapies (DMTs) for multiple sclerosis (MS) have a significant positive impact on patient outcomes but are often expensive. A recent report by GlobalData finds that prices for MS DMTs are on a steady increase, with drugs like Tysabri by biogen or Gilenya by Novartis increasing by 12%. This impacts patients, according to many experts.
India’s NPPA Announces New Price Caps for Similar Drugs Sold by Same Drugmaker
India’s National Pharmaceutical Pricing Authority (NPPA) has rolled out a new policy capping prices on similar drugs sold by the same pharma company to the price of the least expensive version. The agency made the move based on the Drug Price Control Order, which it used previously to make medical devices like stents and knee implants more affordable to patients.
PBMs and Pharma Leaders Point Fingers During US Senate HELP Committee
At yesterday’s US Senate Health, Education, Labor, and Pensions (HELP) Committee hearing, representatives from pharma and the pharmacy benefit manager (PBM) industry are blaming one another for high prescription drug prices. While PBMs argue that drugmakers could lower list prices on their own, pharma reps argue that PBMs’ practices drive drug prices up.
Pharma Prepares for Legal Battle Over US Drug Price Reform
As the upcoming Medicare drug pricing negotiations loom large over the industry, pharma companies are preparing to challenge the government in court. One sticking point for the companies is that they aren’t allowed to talk about negotiations, facing heavy fines for any infractions. Another issue is how drugs to be negotiated are chosen.
EQRx Dashes Plans to Drive US Drug Pricing Reform
EQRx is moving on from its previous goal to change the drug pricing landscape in the US, letting go of over half its employees in the process. The company’s mission was to cut costs through developing drugs in categories with known safety profiles, cutting research timelines and expenses by up to 50%. They are now moving towards a market-based pricing strategy moving forward.
India Negotiating Generic Export Prices with UAE
The Indian government is currently negotiating drug external reference pricing (ERP) with the United Arab Emirates (UAE). To cap drug prices, the UAE uses an ERP based primarily on wealthy European nations and the US. Officials contend that this practice and vaccine import rules that exclude Indian generics barriers to exporting generics and vaccines.
External Reference Pricing Doesn’t Lower High Drug Launch Prices
A recently published paper in Health Policy OPEN finds that external reference pricing (ERP) policies don’t result in lower drug launch prices. The study, which investigated 100 high-priced drugs, also reported that ERP policies slowed the launch of new drugs, lowering the odds of them hitting the market within 9 months of approval by 73%. ERP policies were, however, associated with decreases in annual cost.
US Senators Weighing Approaches to Lowering Insulin Prices for All
As US Senators continue to debate over plans to lower insulin prices for all Americans, two bills have taken the forefront. One, by Sen. Susan Collins (R-ME) and Sen. Jeanne Shaheen (D-NH) would cap monthly cost-sharing at 25% of list price or $35. It would also force pharmacy benefit managers (PBMs) to make sure 100% of manufacturer rebates and discounts go to payers.
UN Negotiating Price of Takeda’s New Dengue Vaccine
The World Health Organization’s (WHO’s) Pan American Health Organization (PAHO) is working with Takeda to negotiate pricing for the manufacturer’s new dengue vaccine Qdenga, the only one for the widespread illness. A key strategy being proposed is that large nations can pool their resources to purchase the vaccines in bulk at a lower price.
US Congress Continues Push for Lower Prescription Drug Prices
Members of the US Congress aren’t slowing down in the effort towards lowering prescription drug prices, following last year’s Inflation Reduction Act that established the upcoming Medicare drug price negotiations. One bill put forward by Democrats would shorten the timeframe before a drug can be negotiated. A bipartisan effort led by Bernie Sanders (I-VT) and Bill Cassidy (R-LA) will propose four bills related to reducing high drug prices.
Low Value, High Prices: Which Therapeutics Are Worth It?
Two recent value-assessment analyses found that many of the highest priced drugs in the US do not deliver enough beneficial effects to justify their list price. The first analysis came from the Institute for Clinical and Economic Review (ICER), which showed that the newly approved Alzheimer’s drug lecanemab was almost 20% higher than the maximum justified cost based on potential therapeutic benefits. The second analysis was published recently in JAMA examined Medicare spending on the top-selling prescription name brand drugs.
US Democrats Introduce Bill to Expand Medicare Prescription Drug Price Negotiations
A group of 21 US Democrats introduced a new bill that seeks to strengthen the upcoming Medicare pricing negotiations with the Centers for Medicare and Medicaid Services (CMS) instantiated by the Inflation Reduction Act. The bill, if passed, would shorten the timeframe for drug pricing negotiations to begin to 5 years, a significant departure from the 9 years currently established for small molecule drugs and the 13 years set for biologics.
The Fight Between Pharma and CMS Over Drug Pricing Reform Has Only Just Begun
Despite efforts by the pharma industry to stop it, Medicare prescription drug pricing negotiations from the US Inflation Reduction act still loom on the horizon. As a result, the industry is shifting its approach, now focusing on changing the law to its favor. Although pharma is putting energy into lobbying, litigation is soon to come.
