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Infliximab biosimilar 'only moderately' less costly vs. biologic under Medicare Part D
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Under Medicare Part D drug benefits, the biosimilar infliximab-dyyb was only 18% less expensive than the infliximab reference product, exceeding $14,000 annually, according to a research letter published in JAMA.
The researchers noted that without biosimilar gap discounts, annual out-of-pocket costs for beneficiaries would actually be higher for infliximab-dyyb (Inflectra, Celltrion/Pfizer) than infliximab (Remicade, Janssen).
Although Congress empowered the FDA to approve biosimilars to foster competition and lower costs, “for the more than 43 million beneficiaries with Medicare Part D drug benefits, it is unclear whether biosimilars lower out-of-pocket costs given Part D’s complex cost-sharing structure,” Jinoos Yazdany, MD, MPH, associate professor at the University of California, San Francisco School of Medicine, and colleagues wrote. “Currently, beneficiaries receive a 50% manufacturer discount during the gap for brand-name drugs and biologics, but not for biosimilars.”
To determine how the recent Bipartisan Budget Act, which requires gap discounts for biosimilars beginning in 2019, is expected to impact patients’ out-of-pocket costs, the researchers assessed coverage and cost-sharing for infliximab-dyyb, the second biosimilar to be approved in the United States, compared with its reference product, infliximab.
To assess mean total cost and out-of-pocket requirements for infliximab-dyyb and infliximab, Yazdany and colleagues examined benefit design data for all Part D plans from the June 2017 Medicare Prescription Drug Plan Formulary, Pharmacy Network and Pricing Information Files, assuming each patient adhered to a standard 8-week dosing regimen or 6.5 prescriptions annually.
The researchers then used these national means to extrapolate maximum annual out-of-pocket costs if Medicare beneficiaries used each drug under a standard 2017 Part D benefit, which included a $400 deductible, coverage gap beginning at $3,700 in drug costs, as well as catastrophic coverage when out-of-pocket costs exceeded $4,950.
According to the researchers, infliximab-dyyb exhibited moderately lower mean total cost compared with infliximab, for both 8-week ($2,185 vs. $2,667) and yearly ($14,202 vs. $17,335) prescriptions. However, all Part D plans required coinsurance cost-sharing for infliximab-dyyb, and set coinsurance rates comparable to infliximab (26.6% vs. 28.4% of drug cost). Yazdany and colleagues noted that without the coverage gap discounts, projected annual out-of-pocket costs were, in fact, higher for infliximab-dyyb than infliximab ($5,118 vs. $3,432).
In addition, among the 2,547 Part D plans examined by the researchers, significantly fewer plans covered infliximab-dyyb (10%) than infliximab (96%).
“Without biosimilar gap discounts in 2017, beneficiaries would have paid more than $5,100 for infliximab-dyyb or nearly $1,700 more in projected out-of-pocket costs than infliximab,” Yazdany and colleagues wrote. “Although biosimilar gap discounts begin in 2019, infliximab-dyyb may still not significantly reduce Part D beneficiaries’ out-of-pocket costs given its high price and coinsurance cost-sharing similar to infliximab. Further policies are needed to address affordability and access to specialty drugs.”– by Robert Stott
Disclosure: Yazdany reports receiving an independent investigator award from Pfizer. The other authors report no relevant financial disclosures.
Perspective
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Suneya Hogarty, DO
In their study, Yazdany and colleagues studied a phenomenon that rheumatologists across the U.S. have observed firsthand for the last couple of years: Access to biosimilars is challenging. There is significant access limitation secondary to lack of approval in the Medicare Part D space because of the specialty pharmacy/pharmacy benefit manager rebate structure. Many PBMs and their specialty pharmacies do not give approval for biosimilars because doing so would cost them the financial benefit of rebates from trade biologics.
On the other hand, many Medicare recipients use Part B coverage to access biosimilars, which are approved without restrictions for FDA-approved indications under Part B; a Medicare recipient with Part B supplemental insurance has 100% coverage for RA biosimilars. For this reason, HHS Secretary Azar’s suggestion that Part B drug management be turned over to PBMs raises real concern that access to biosimilars will subsequently become more restricted under Part B, if his proposal takes effect.
The authors primary point, however, is that the price of biosimilars has been disappointingly high. There was some price reduction in 2017 among biosimilars, which has spurred more use, but generally the U.S. biosimilar market has not offered significant price concessions. Under Part B coverage, where Medicare beneficiaries without supplemental insurance are responsible for 20% of cost, biosimilar 2018 prices have translated into approximately $3500 per year savings for the average RA patient receiving the infliximab biosimilar.
While this is not as substantial as rheumatologists would have liked, trends in this direction are encouraging. In our system, increasing biosimilar use is the only mechanism rheumatologists have to encourage more biosimilar manufacturers, which will hopefully drive down cost further.
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