The Underwater Biosimilars Coalition, led in partnership by the ACR and Coalition of State Rheumatology Organizations (CSRO), recently took another significant step toward its goal of improving patient access to underwater biosimilars.
Earlier this year, the Coalition disseminated among member organizations a survey on how underwater biosimilars are impacting physicians’ ability to provide high-quality care. This week, building off meetings last fall with the Centers for Medicare & Medicaid Services (CMS), White House and Medicare Payment Advisory Commission (MedPAC), the Coalition sent Congressional leadership a letter detailing the results of this survey.
Nearly 200 practices were queried on their experiences infusing biosimilars. Notably, 96% of respondents follow a buy and bill model, in which practices purchase medications in advance for in-office infusion, then bill payers for the costs of both the drug and the administration. Because most of these practices operate on razor-thin financial margins, inadequate reimbursement for infusion jeopardizes the quality of care they can provide.
As rheumatologists know, biosimilars were introduced to the U.S. market nearly a decade ago with hopes of making specialty drugs more affordable. However, pharmacy benefit managers (PBMs) have exerted disproportionate sway on drug formularies by pressuring pharmaceutical companies to offer significant rebates in exchange for preferred formulary placement, including “fail first” status. Rebates between pharmaceutical companies and PBMs are reflected in manufacturers’ quarterly average sales price (ASP) reporting to the CMS, artificially lowering the ASP to the point that many providers’ acquisition costs substantially exceed Medicare and other private health plan payments. This discrepancy leaves practices underwater for infusing these biosimilars.
To maintain the viability of administering drugs in the office setting, reimbursement must account for not only the drug acquisition cost, but also overhead costs such as intake and storage, equipment and preparation, staff, facilities and spoilage insurance. Reimbursement rates that do not account for these costs within the current ASP formula risk putting practices underwater.
According to the survey, nearly 100% of practice owners are underwater on several biosimilars, with rituximab and infliximab biosimilars such as Truxima, Inflectra and Avsola being the most prominent. Some practices reported being underwater by more than 70% on Inflectra, and one practice reported losing between $500-750 per infusion on certain biosimilars. However, there has been little research on how this issue impacts providers and their patients.
The Coalition hopes that these survey results will solidify its push for legislative solutions to ensure that providers are able to provide the high-quality care their patients deserve, without risking the financial viability of their practices. ACR/ARP members should email the ACR’s advocacy team at [email protected] with any questions and comments they may have on the Coalition’s progress. We will continue to update membership on underwater biosimilars and serve as an educational resource for members on regulatory or legislative endeavors that impacts their acquisition and infusion of these drugs.
