CMS Seeks Answers for Slower-Than-Expected Biosimilar Adoption, Rawal Says

An official with the Center for Medicare and Medicaid Innovation (CMMI) told leaders from the generic and biosimilars industries that CMS is committed to policies that will expand the use of biosimilars, given the need to make drugs more affordable and “the potentially important role biosimilar adoption may have for the success of our value-based payment models.”

Purva Rawal, PhD, senior advisor and chief strategy officer for CMMI, spoke during the Association for Accessible Medicines (AAM) Access! annual meeting, which gathered in Orlando, Florida, February 15-16.

Most of Rawal’s talk focused on the “strategy refesh,” a process that CMMI has undertaken to revamp how it implements alternative payment models; this is CMMI’s core mission under the Affordable Care Act. In an essay in Health Affairs and in a white paper published last fall, CMS spelled out plans to add health equity to all models, and—of concern to the AAM audience—to renew its focus on limiting spending in Medicare and Medicaid.

“Importantly, we also want to increase the momentum and the movement toward value-based care and reignite that sense of inevitability that many of us felt 10 years ago,” Rawal said.

However, CMMI has been criticized for allowing the Oncology Care Model (OCM) to run out this summer with no successor in its place, despite the investment made by practices to transition to value-based care. Rawal highlighted the OCM’s success in promoting biosimilar use while noting the model is set to expire.

“We're hearing about success in terms of participants prescribing lower-cost biosimilars, achieving savings in total cost of care, and maintaining quality outcomes, which is critical,” Rawal said. “So, we're hoping that these anecdotal reports of success show through in our future evaluation results.”

She explained how the payment policy that aimed to give specialty practices, including oncologists, incentives to prescribe biosimilars isn’t working as hoped. Under Medicare Part B, a practice would normally be paid less to prescribe a lower-priced alternative under the average sales price + 6% formula, but the law was written to prevent this revenue drop.

“The statutory payment policy theoretically incentivizes biosimilar use by making the drug add-on amount comparable across the reference biological and each biosimilar product. But this payment approach doesn't ensure that the prescribers’ margin on a biosimilar is comparable to the margin they may be able to obtain on the reference biological,” Rawal said. “So, we're starting to see some market competition, overall lowering of drug prices for biologicals, where biosimilars have been introduced. But the uptake of biosimilars has been slower than we anticipated, as many of you are aware, even with the add-on being based on the reference biologic.”

Rawal said the barriers that remain to biosimilar uptake are “concerning,” and CMMI seeks to remove them; some may be related to provider education, she said.

Acceptance among providers is complex, however. A recent survey by Cardinal Health found that acceptance of biosimilars is much higher among oncologists than among rheumatologists. And oncologists have said that even when they prefer biosimilars, resistance may come from pharmacy benefit managers who demand that the practice use a higher-priced reference product.

Prioritizing affordability will work in biosimilars’ favor, she said, while crediting the AAM for providing ideas to promote biosimilar and generic use. Value-based care, she said, proved its worth during the pandemic and will do so going forward.

“We've seen early evidence that providers in population-based payments and alternative payment models were more resilient,” Rawal said. “That resilience allowed them to continue to provide access to patients, such as through telehealth.

“So, we have new evidence on the value of value-based payment, and value-based care from the pandemic, and we want to use this experience to accelerate our work to drive accountable care.”