US Health and Human Services Secretary Alex Azar announced Wednesday a final rule from the Centers for Medicare & Medicaid Services (CMS) that will require direct-to-consumer television advertisements for some prescription medicine covered by Medicare or Medicaid to include the list price. Specifically, adverts for drugs must include the wholesale acquisition cost if it is equal to or greater than $35 for a month's supply or the usual course of therapy.
Azar remarked that the move "is the single most significant step any administration has taken toward a simple commitment: American patients deserve to know the prices of the healthcare they receive." Azar added that "making those prices more transparent is a significant step in President Trump's efforts to reform our prescription drug markets and put patients in charge of their own healthcare."
The rule, which was initially proposed last October, will come into force 60 days after it is published, which Azar indicated could occur as soon as May 10. Meanwhile, enforcement of the rule will be based on drugmakers filing lawsuits against each other over violations of federal law governing unfair trade practices. “There are very large legal practices built on pharma companies suing each other,” Azar remarked, adding that it is “quite effective mechanism.”
CMS Administrator Seema Verma commented "patients have the right to know the prices of healthcare services, and CMS is serious about empowering patients with this information across-the-board," continuing "equipped with information on prescription drug prices, patients will be better able to make informed decisions and demand value from pharmaceutical companies."
Commenting on the news, Pharmaceutical Research and Manufacturers of America (PhRMA) CEO Steven Ubl remarked "we are concerned that the administration's rule requiring list prices in [DTC] television advertising could be confusing for patients and may discourage them from seeking needed medical care. Ubl continued "while we are still reviewing the administration's rule, we believe there are operational challenges, particularly the 60-day implementation timeframe, and think the final rule raises First Amendment and statutory concerns."
Ubl additionally announced the launch of the Medicine Assistance Tool (MAT), which links to the websites referenced in drugmaker television advertisements. The CEO noted that the MAT includes a search tool to help patients identify financial assistance programmes.
The rule comes after US President Donald Trump, who has previously criticised drugmakers for "getting away with murder," unveiled a blueprint last year targeting drug pricing. The administration later disclosed a plan that would link drug prices paid by Medicare to an international average.
In March, Johnson & Johnson launched television commercials detailing the monthly list price for Xarelto (rivaroxaban), becoming the first drugmaker to disclose pricing information in television advertisements in the US.
For related analysis on US drug pricing, see ViewPoints: Pharma gets what it needs from Senate hearing.
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