Amgen, Eli Lilly, and Merck, together with the Association of National Advertisers, have filed a lawsuit against HHS and CMS over the Trump administration’s rule requiring disclosure of list prices for drugs in direct-to-consumer television advertisements.
Amgen, Eli Lilly, and Merck, together with the Association of National Advertisers, have filed a lawsuit against HHS and CMS in the United States District Court for the District of Columbia over the Trump administration’s rule requiring disclosure of list prices for drugs in direct-to-consumer television advertisements.
The rule, finalized in April 2019, requires drug manufacturers to disclose their list prices for pharmaceutical products or biologics in television ads for drugs covered by Medicare or Medicaid if the wholesale acquisition cost, or list price, is $35 or more for a month’s supply. HHS says that the rule, part of the administration’s blueprint to lower drug prices, aims to improve the quality, accessibility, and affordability of government healthcare programs.
However, according to the drug makers, the rule relies on “unprecedentedly broad construction of the agency’s statutory authority,” constitutes a violation of the First Amendment, and could create confusion among consumers because most patients will not likely pay list prices for their therapies.
As a result of such confusion, says the June 14 complaint, patients may overestimate how much they would have to pay for treatment, and they incorrectly conclude that they should not discuss a given therapy with their healthcare professionals. Approximately half of Americans, says the complaint, are only responsible for copayments on prescriptions, while those covered under Medicaid pay $8 or less for drugs under their plans. The complaint states that even for the approximately 9% of Americans without insurance, out-of-pocket costs may be lower than the list price of a drug if a given patient is eligible for need-based assistance.
The drug makers point to Pharmaceutical Research and Manufacturers of America guidelines for advertisements, which have led some drug makers to voluntarily provide patient information to help determine out-of-pocket costs, as 1 alternative to the administration’s rule. Some drug makers, such as Johnson & Johnson, had already begun to roll out patient cost information in advertising prior to the rule’s finalization.
HHS’ list of drugs with the highest direct-to-consumer advertising expenditures includes Lilly’s diabetes drug Jardiance (with a list price of $493 per month), Amgen’s rheumatology drug Enbrel (which carries a list price of $5174 per month and which has 2 approved but unlaunched biosimilar competitors in the United States), and Merck’s oncology drug Keytruda (with a list price of $4719 per month).
Eye on Pharma: EU Ustekinumab Approval; New Golimumab Data; Evernorth Adds Humira Biosimilar
April 29th 2024The European Union gained a new ustekinumab biosimilar; Alvotech released positive results from a clinical trial evaluating a golimumab biosimilar and the reference products (Simponi and Simponi Aria), and Evernorth announced that it is set to cover an adalimumab biosimilar at zero cost to patients.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
The 6 Key Policy Factors to Ensure Biosimilar Market Sustainability
April 16th 2024Magnus Bodin, senior director and head of international access and policy at Biogen, presented warning signs for unsustainable biosimilar markets as well as key factors needed to create effective policies and future-proof biosimilar markets globally.
What AmerisourceBergen's Report Reveals About Payers, Biosimilar Pricing Trends
May 28th 2023On this episode of Not So Different, Tasmina Hydery and Brian Biehn from AmerisourceBergen discussed results from a recent survey, that were also presented at Asembia 2023, diving into the payer perspective on biosimilars and current pricing trends across the US biosimilar industry.
Biosimilars Council: PBM Rebate Schemes Cost Americans, Payers $6 Billion
April 10th 2024A report from the Biosimilars Council evaluating IQVIA data found that rebate schemes orchestrated by pharmacy benefit managers (PBMs) are costing US patients and payers billions of dollars by suppressing biosimilar adoption.
Rising Biosimilar Adoption for an Italian Payer Will Benefit National Health Care System, Patients
April 9th 2024Data from 2021 and 2022 indicates increasing biosimilar use in an Italian health care company, with potential for full adoption in the future, benefiting both the National Health System and citizens through efficient and sustainable health care policies.