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).
Challenges and Guidance in Biosimilar Assessment: An ISPOR Report on HTA Agency Approaches
May 14th 2024The ISPOR report highlights the urgent need for clear guidance on when and how to conduct health technology assessments (HTAs) for biosimilars, emphasizing the challenges faced by HTA agencies and the evolving role of HTAs in evaluating biosimilar value.
Biosimilars Policy Roundup for April 2024—Podcast Edition
May 5th 2024On this episode of Not So Different, The Center for Biosimilars® glances back at all the major biosimilar policy updates from April, including 2 FDA approvals, 1 European approval, and several insights into possible policy changes from the Festival of Biologics USA conference.
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.
Dr Sophia Humphreys Provides Calls to Action to Ensure Biosimilar Market Sustainability
April 30th 2024During her presentation during Festival of Biologics USA, Sophia Humphreys, PharmD, director of formulary management at Sutter Health, gave an overview of current challenges and opportunities for the biosimilar market and offered calls to action for multiple stakeholders.