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.
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.