In its comments, the American College of Rheumatology (ACR) stressed that safe and effective treatments should be accessible to all patients at the lowest cost possible, and this mindset should be the fundamental basis for any drug-pricing policy.
The American College of Rheumatology (ACR) and other advocacy groups submitted comments to HHS Secretary Alex Azar this week concerning the Trump administration’s drug pricing blueprint.
In its comments, ACR stressed that safe and effective treatments should be accessible to all patients at the lowest cost possible, and this mindset should be the fundamental basis for any drug-pricing policy.
In keeping with these ideals, ACR summarized its comments under the 4 key themes of the blueprint:
Increasing competition. The ACR supports policies that will improve the ability of manufacturers as well as the FDA to bring safe and effective biosimilars to the market in order to maximize patient access to care. In addition, ACR also supports expanded access to off-label therapies that are supported by guidelines or clinical studies.
In terms of interchangeability, “The ACR suggests that the FDA allow ready access to pharmacovigilance data for investigators to analyze, and that the FDA promote and disseminate information about the program and the available data.”
Better negotiation. ACR supports policies that will protect patient safety and ensure patients’ safe access to Part B treatments. The organization says that “proposals such as moving Part B treatments to Part D would make necessary Part B drugs less accessible and less safe for patients, due to utilization management access barriers and lack of physician monitoring and safety controls in Part D.”
It also stressed concerns about recreating a competitive acquisition program (CAP) for Part B drugs, and stated that it would oppose a CAP program if it were similar to the previous program.
Creating incentives to lower list prices. ACR calls for transparency in how pharmaceutical companies, pharmacy benefit managers (PBMs), and payers determine the cost of prescription medicines, as well as for more transparency concerning incentives given by drug companies to PBMs or payers for using their products.
“The system would also benefit from policies requiring more uniformity or standardization in the ways PBMs structure and convey their rebate programs, including uniform definitions for terms used in disclosures by specifying what constitutes a rebate, discount, fee, and amount received from a manufacturer,” read the remarks.
Reducing patient out-of-pocket spending. In order to improve electronic health systems’ interoperability, the ACR supports preventing “data blocking.”
Additionally, the ACR has noted that “pricing, coverage, and cost sharing information for patients and physicians at the point of prescribing would revolutionize the decision-making process patients and physicians engage in when deciding on treatment.”
To make sure that patients are aware of the medications and prices that are available to them, the ACR also supports policies that would prohibit gag clauses that prevent pharmacists from notifying patients of how to pay the lowest price possible for their drugs.
“As Congress and the Administration move forward with drug pricing reforms, we look forward to working with policymakers to ensure that our concerns are addressed, and that the millions of Americans living with rheumatic diseases are able to access needed medications that allow them to maintain the quality of life they need and deserve,” said David Daikh, MD, PhD, president of ACR, in a statement.
What Stands in the Way of Biosimilar Use Across MENA Countries?
May 21st 2025Despite the clear promise of cost savings and expanded access, the path to integrating generics and biosimilars across the Middle East and North Africa (MENA) region is tangled in a web of distrust, inconsistent policies, and deep-rooted cultural preferences for branded drugs.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
The Trump Administration’s Drug Price Actions and Why US Prices Are Already Sky-High
May 17th 2025While the Trump administration’s latest executive order touts sweeping drug price cuts through international benchmarking, the broader pharmaceutical pricing crisis in the US reveals a far more complex web of development costs, profit incentives, and absent price controls—raising the question of whether any single policy, including potential drug tariffs, can truly untangle it.
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.
Targeted Reimbursement Encourages Oncology Biosimilar Use
May 7th 2025Incentivizing physicians with modest financial bonuses may seem like a small step, but in Japan’s outpatient oncology setting, it helped push trastuzumab biosimilars toward broader adoption, demonstrating how even limited reimbursement reforms can reshape prescribing behavior under the right conditions.