Medicare Drug Price Negotiations Will Include Patient Perspectives and Real-World Evidence
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.
First Lawsuit Against US Medicare Drug Pricing Negotiations Filed by Merck
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.
Inflation Reduction Act R&D Cost Request May Prove Problematic
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.
CMS Drug Price Negotiations Complicated by Therapeutic Alternatives Clause
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.
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.
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.
Older US Adults Skipping Meds Because of Price
A recently published study in JAMA Network OPEN found that at least 20% of adults 65 and up skipped their medication, cut back their dose, or took drugs intended for other patients due to financial reasons in 2022. The figure is a jump from 2016, when one in seven older patients reported skipping medications for the same reason. Many of those who did maintain their drug regimen faced significant financial hardships.
FTC Requests Information from Group Purchasers in PBM Probe
During its ongoing probe into the pharmacy benefit manager (PBM) industry, the US Federal Trade Commission (FTC) requested information regarding two group purchasing organizations, which negotiate discounts for PBMs. The two companies included Zinc Health and Ascent Health Services, adding to the growing list of companies interrogated in the probe.
Exploring Insulin Pricing Practices and Their Effects on Patients
Shortly after the passage of the US Inflation Reduction Act, which capped the price of insulin for some patients, three major drugmakers pledged to drop list prices for their insulin products. In a new IQVIA article, learn more about the role of insulin in diabetes management, the underlying forces driving insulin prices, and how this affects patients.
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.
ICER Announces Upcoming Value-Assessment for Pulmonary Arterial Hypertension Treatment
The Institute for Clinical and Economic Review (ICER) has announced it will perform a value-assessment for Merck’s sotatercept for the treatment of pulmonary arterial hypertension. The organization has been in talks with patient groups, clinical specialists, manufacturers, and patient advocates and will present its report at the Midwest CEPAC meeting this coming December.
Exploring the Impact of PBMs on High Drug Prices
The US pays the highest amount per capita on prescription drugs than any other nation. Several factors interact to drive prices up in the nation. Since a major portion of pharmaceutical development occurs in the US, drugmakers argue high prices are necessary to offset research costs and promote exclusivity. In addition, pharmacy benefit managers (PBMs) play a large role in setting drug prices because they negotiate formularies and drug rebates.
Bipartisan US PBM Reform Bill Moves Forward
A bipartisan bill including reforms to the Food and Drug Administration (FDA) and the pharmacy benefit manager (PBM) industry has been advanced by the US Senate Health, Education, Labor, and Pensions committee. The bill, approved with an 18-3 vote, picked up several amendments in the mark-up session before it was advanced.
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.
Talking Immunology Biosimilars and Managed Care with Dr. Colby Evans
Biosimilars have taken an increasingly prominent role in healthcare in recent years, representing a significant point of savings for patients and managed care organizations (MCOs). However, there are still some significant challenges to increase their utilization. In a new AJMC interview, Dr. Colby Evans of Evans Dermatology Partners discusses these hurdles. The first is that patients and providers are often unwilling to make the change from more expensive reference drugs.
