The American College of Rheumatology (ACR) has updated its position on the use of biosimilars and now advises healthcare providers and clinicians to “incorporate biosimilars, where appropriate, into regimens to treat patients with rheumatologic diseases.” The policy shift was announced in a white paper written on behalf of the ACR that will appear in an upcoming issue of Arthritis & Rheumatology.
The ACR had previously advised the cautious use of biosimilars during their initial development, evaluation, and approval processes. “Now that biosimilars have been used successfully in Europe, with rigorously acquired data supporting their broader use, and as the US is on the verge of a similar transition, the ACR is poised to reconsider its position,” wrote S. Louis Bridges, Jr, MD, PhD, and colleagues in the white paper.
Dr Bridges added in a separate press release statement: “We are now confident that providers can recommend biosimilars as a safe, effective, and affordable option to patients, where appropriate.” Presently, the FDA has approved 9 biosimilar products. Six of these have indications for rheumatic diseases.
The primary advantage of a biosimilar over its reference product is cost, and the ACR, much like the FDA, expects that the injection of biosimilars into the market will provide treatment options for a lower price, therefore increasing patient access to these treatments while lowering the overall cost for the original biologics as well. The ACR acknowledged that the current business model in the US may not lead to immediate lower prices, mainly due to the role played by pharmacy benefit managers (PBMs).
Because PBMs maintain relationships with manufacturers that lead to preferred drug status for reimbursements, it is often the case that biosimilars are marginally cheaper or the same price as the original biologic. Further discounts in the form of rebates flow back to the PBM based on sales volume and market share, and manufacturers can increase their rebates to PBMs to enhance its preferred status on the PBM’s formulary lists.
“If the actual cost of a reference product were lowered to below the average wholesale cost of its biosimilar by discounts and rebates provided to PBMs by manufacturers, then the biosimilar’s cost advantage would be eliminated and biosimilar sales might effectively be stifled,” Dr Bridges and colleagues warned. However, the authors noted, having biosimilars on the market can keep the pressure on manufacturers to lower prices or keep them at a manageable cost. They believe it will take several years with biosimilars in the marketplace to achieve significant cost-savings.
“There are a variety of market-based and legislative factors that contribute to the accessibility of biosimilars,” said Angus Worthing, MD, chair of the ACR’s Government Affairs Committee and co-author of the white paper. “While we have yet to see broad cost-savings benefits in the US marketplace,” he added, “efforts from health care advocates, legislative measures, and the introduction of biosimilar options could help relieve the financial burden of patients using these therapies.”