Dr. Colin Edgerton
“We continue to emphasize these topics because they are so critical to the well-being of millions of Americans living with rheumatic diseases, some of which can be quite debilitating and even lead to death,” Colin Edgerton, MD, a rheumatologist at Low Country Rheumatology in South Carolina and chair of the ACR’s Committee on Rheumatologic Care, said in a statement. “The need for patients to have access to prompt, affordable, and medically necessary treatments is ongoing and should be considered at every step of the policy making process.”
The position statement on drug pricing calls for transparency in the policies used by pharmaceutical manufacturers, pharmacy benefit managers, and health insurance companies that determine drug prices.
To illustrate the need for transparency, the ACR pointed to the cost of adalimumab (Humira), a biologic medication that is used to treat a number of rheumatologic and other inflammatory conditions, which has seen its list price increase more than 100% during the past 5 years.
“The yearly price hike has dramatically outpaced inflation despite the lack of clinically significant modifications to the medication or major changes in the production process. The overall process of pricing and contracting is hidden from public view, such that the exact nature and profit margin taken by those involved is not disclosed to the largest stakeholder in the process, the patient,” the ACR stated.
The statement also calls for continued work on a safe and efficient biosimilar approval pathway and marketplace, which it says will help to improve access to drugs through lower costs.
“Any comprehensive proposal to deal with rising drug prices must simultaneously address these primary concerns: cost to the health care system, continuity of care, and out-of-pocket affordability to patients,” the position statement on drug pricing noted, adding that the organization “supports rational policies that mitigate rapid escalations in pricing of rheumatologic drugs.”
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The position statement on step therapy notes that the ACR “does not support step therapy, fail-first policies, or tiering of medications based solely on cost,” and that access to drugs “should be timely and not impeded or delayed by unnecessary barriers.”
The organization noted that unregulated step therapy policies for targeted immune modulating agents (TIMs) “have hijacked the otherwise thoughtful and highly complex process that patients and their providers navigate when choosing appropriate therapy. While TIMs within a class may have similar effectiveness in large populations, responses by individual patients vary dramatically.”
The ACR called for transparency in the formulary decision-making process and for pharmacy review committees to include rheumatologists to help to develop formularies.
“The ACR welcomes the opportunity to provide expertise regarding rheumatic therapies to insurers,” the position statement said.
The organization also called for an end to nonmedical switching.
“Nonmedical switching between branded products and across therapeutic classes in a medically stable patient solely for cost savings and without the consent of the patient and his/her provider is inappropriate and potentially harmful to patients’ health,” the ACR said.
It expanded upon this position, noting that nonmedical switching occurs frequently and results in “adverse effects on treatment. In these situations, patients may unexpectedly be subjected to new step therapy requirements, forcing them to switch from their current medication to whatever agent is ‘preferred.’ ”
The ACR said the appeals process can take between 4 and 8 weeks and can be labor intensive, all the while putting the patient at harm for disease progression and physical damage.