HHS Inspector General to examine biosimilars use in Medicare Part B
Biologic drugs are among the most expensive drugs on the US market, outlined the agency.
"Biosimilar drugs are highly similar and have no clinically meaningful difference from their reference biologics and also tend to be less expensive."
Medicare Part B pays for physician-administered drugs used to treat some of the most serious and debilitating illnesses, including cancer and Alzheimer’s. "Medicare Part B and beneficiaries have the potential to spend less on prescription drugs with the increased use of biosimilars rather than their reference biologics, but their use remains low."
Limited biosimilar use in Part B may be related to how providers are reimbursed for these drugs, according to the HSS OIG. "Currently, providers do not have strong financial incentives to use less expensive biosimilars."
The study, said the HHS OIG, will describe use and cost trends of biosimilars and reference biologics covered by Part B over time.
The review is also set to determine how much Medicare and beneficiaries paid for biosimilars and reference biologics covered by Part B in 2021, and then the team will determine how much could have been spent with increased use of biosimilars or with different reimbursement policies.
Juliana M Reed, executive director of the Biosimilars Forum, a non-profit organization to advance biosimilars in the US in terms of expanding access and availability of biological medicines, said such an evaluation was another important step in addressing slow uptake rates for biosimilars in Medicare Part B.
“This lack of use hinders Americans’ access to lower-cost safe and effective biosimilars, which should be widely available to all who need them.
“HHS officials rightly identify the lack of provider reimbursement incentives as possible obstacles to better biosimilar uptake rates. The Biosimilars Forum has been advocating for Congress to address these misaligned incentives as one way to increase patient access to lower cost medicines.”
Reasons for sluggish uptake of biosimilars
A study published in March last year noted that the current difficulty in achieving interchangeability status, the payment structure in Part B of the Medicare program, aggressive industry actions with respects to patenting, and insurance contracts all contribute to sluggishness in the evolution of biosimilar competition.
Last July, US president, Joe Biden, called on federal agencies and policymakers to promote biosimilars.
“It is now more important than ever that agencies and lawmakers advance access to biosimilars through incentives and education to patients and providers,” added Reed.
The Biosimilars Forum stressed that more competition is paramount to achieving the full cost-savings potential of biosimilars. US drug costs could be reduced by US$133bn over the next five years if the use of biosimilars increases, said the organization.