The industry group for pharmacy benefit managers (PBMs) launched a public relations blitz in the wake of scrutiny regarding their role in prescription drug prices.
The industry group for pharmacy benefit managers (PBMs) launched a public relations blitz in the wake of scrutiny regarding their role in prescription drug prices.
The Pharmaceutical Care Management Association (PCMA) created a print and digital ad campaign called "Protect the Savings," which claims that if a proposal from HHS is finalized, pharmaceutical firms will reap the benefits while taxpayers’ costs rise, as will Medicare drug premiums.
In January, HHS announced a plan to exclude rebates from safe harbor protections that currently shelter drug makers’ rebates from penalties under the federal Anti-Kickback Statute, and said it intends to create new safe harbor for discounts offered to patients, as well as fixed-fee service arrangements between drug makers and PBMs.
And this week, rebates were a prime topic at a Senate Finance Committee hearing on drug pricing, where 7 drug company executives testified about the high prices of their products. Some executives laid the blame for pricing issues with PBMs.
The ads released this week from PCMS defend the rebates as a way of saving money through negotiations with payers, and, using pictures of worried-looking Medicare beneficiaries, say that Part D premiums could rise 25%. America’s Health Insurance Plans, the lobbying group representing insurers, also has said that without PBM-payer contracts, drug prices would be even higher.
"We agree that drug company list prices must be addressed, and that more can be done to increase access and affordability. Unfortunately, this new proposal will not lead to lower prescription drug prices, but could have severe unintended consequences such as destabilizing the Medicare Part D program at a significant cost to taxpayers," said JC Scott, PCMA president and chief executive officer, in a statement. "We should focus on solutions that protect the important role of negotiations and the savings that are critical to keeping down consumer costs, including premiums."
HHS says that the new rule will counteract incentives behind higher list prices; currently, when a list price rises, patients who pay a percentage or all of the list price for a drug see their out-of-pocket expenses increase while PBMs reap financial rewards. According to HHS, rebates that today equal 26% to 30% of a drugs’ list price may be passed directly to patients and reflected in what individuals pay at the pharmacy counter.
While those with commercial insurance will likely need to wait for Congress to act to block rebates from their plans, individuals covered under federal plans like Medicare could see substantial changes to their costs; HHS estimates that one-fourth of Part D plans require coinsurance for preferred drugs, and nearly all use coinsurance for nonpreferred drugs. Furthermore, lower list prices and upfront discounts will translate into savings during the deductible, coinsurance, and coverage gap phases of the benefit.
PCMA, on the other hand, says the proposal will cost taxpayers $196 billion.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Review Calls for Path to Global Harmonization of Biosimilar Development Regulations
March 17th 2025Global biosimilar regulatory harmonization will be needed to reduce development costs and improve patient access, despite challenges posed by differing national requirements and regulatory frameworks, according to review authors.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
From Amjevita to Zarxio: A Decade of US Biosimilar Approvals
March 6th 2025Since the FDA’s groundbreaking approval of Zarxio in 2015, the US biosimilars market has surged to 67 approvals across 18 originators—though the journey has been anything but smooth, with adoption facing hurdles along the way.