Abstract

Price decreases of biologic and biosimilar products in Medicare Part B have been minimal, even with biosimilar competition. Medicare reimburses clinicians for biologics and biosimilars differently than for brand-name and generic drugs, which has generated greater price reductions. To characterize the nature of price competition among brand-name and generic drugs under Medicare Part B and to estimate the cost savings to the program of subjecting biologic and biosimilar therapies to a similar price competition. This cohort study analyzed all brand-name drugs and their approved generic versions as well as biologics and biosimilars that were reimbursed under Medicare Part B from quarter 1 of 2005 to quarter 2 of 2021. Two separate data sets were created: brand-name and generic drugs as well as biologics and biosimilars data sets. Brand-name products with generic versions that were introduced before 2005 were excluded, and so were vaccines. Number of generic and biosimilar competitors over time. Price change as a percentage of the brand-name drug or biologic price in the quarter before generic or biosimilar competition. Price change was modeled using a linear, fixed-effects time series regression, with the number of generic or biosimilar competitors as the main covariate. Time was expressed as the number of quarters since the first generic or biosimilar competitor entered the market. Savings were estimated by projecting the regression model of brand-name and generic drug competition to observed biologic and biosimilar competition and by applying the estimated price reduction to actual Medicare spending for those products from 2015 to 2019. Of the 988 Healthcare Common Procedure Coding System codes identified, 50 (5.0%) met the inclusion criteria for the brand-name and generic drug data set and 28 (2.8%) met the criteria for the biologic and biosimilar data set. The first generic competitor was associated with reduced drug prices by 17.0%, the second competitor with a 39.5% decrease, the third competitor with a 52.5% decrease, and the fourth and more competitors with a 70.2% decrease (price decline was measured from brand-name drug price before the first generic competitor rather than from price established with fewer competitors). If biologics and biosimilars were subject to the same Medicare reimbursement framework as brand-name and generic drugs, Medicare spending on these products was estimated to have been 26.6% lower ($1.6 billion) from 2015 to 2019. This study found minimal uptake of biosimilars and limited price reductions for biologics and biosimilars under the current Medicare Part B reimbursement policy. Adopting the bundled biosimilar reimbursement structure for biologic and biosimilar therapies may be associated with substantial savings and encourage greater biosimilar market entry.

Highlights

  • Biologic therapies, which are complex combinations of sugars, proteins, and/or nucleic acids, account for most of Medicare Part B’s prescription drug spending and spending growth, reaching 80% of spending in 2017 and 92% of spending growth from 2006 to 2017.1 Despite these figures, biologics in the Medicare Part B program are not subject to direct price competition from biosimilar therapies

  • If biologics and biosimilars were subject to the same Medicare reimbursement framework as brand-name and generic drugs, Medicare spending on these products was estimated to have been 26.6% lower ($1.6 billion) from 2015 to 2019

  • After excluding the outliers among all drugs in the study, the presence of 1 generic competitor was associated with a 14.9% mean price reduction in the bundled average sales price (ASP), 2 generic competitors were associated with a 32.7% mean price reduction, and 3 generic competitors were associated with a 52.0% mean price reduction

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Summary

Introduction

Biologic therapies, which are complex combinations of sugars, proteins, and/or nucleic acids, account for most of Medicare Part B’s prescription drug spending and spending growth, reaching 80% of spending in 2017 and 92% of spending growth from 2006 to 2017.1 Despite these figures, biologics in the Medicare Part B program are not subject to direct price competition from biosimilar therapies. Because of past policy choices, Medicare Part B reimbursement for biologics and biosimilars does not incorporate the price competition framework used for brand-name and generic drugs.

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