The Drug Trend Report
The Era of Biosimilars is Here
With some biosimilars on the market and more on the way, we expect – and are prepared for – a meaningful impact on specialty drug trend. With biosimilars, as with all medications, our lowest net cost strategy applies. This means we’ll choose whatever is the lowest net cost option for the plan, which could be a biosimilar or a reference branded product.
Why Biosimilars Matter to Specialty Costs
Increased competition in the drug marketplace is key to making costly drugs more affordable – and we’re taking an active role in ensuring that competition helps solve the challenge of specialty drugs. Whether the biosimilar product or its reference branded product represent the lowest net cost option, our goal is to ensure that the competition provided by biosimilars lowers costs wherever possible.
The Introduction of Infliximab Biosimilars for Remicade Have Driven Down Its Price by More Than 50% in Just 5 Years
Infliximab Average Sales Price (ASP) Evolution from 2018-2022
Chart Titled “Infliximab Average Sales Price (ASP) Evolution from 2018 - 2022 showing that the average sales price for Remicade fell from $810 to $383 between January 2018 and January 2022. During this time, two biosimilars for Remicade - Inflectra and Renflexis were introduced and their prices fell from $664 to $357 and $712 to $383 respectively in that same 5 year time period. the chart also shows that the market share for Remicade only fell from 94% to 84% over that time. The chart is designed to show that competition lowered the price of the reference product even if the biosimilar competition did not significantly affect its utilization. The chart data is cited as coming from the Center for Medicare and Medicaid Services.
Note: ASP values published by CMS lag behind the market ASP by two quarters
(e.g. ASP guidelines published in July 2018 reflect the actual sales Q1-2018).
Source: CMS Reported ASP/100 mg vial.
The Biosimilar State of Play
32
biosimilars have been approved with
14*
expected in 2022
*14 is a current estimate for 2022, and dependent on FDA responses as well as litigation/settlement outcomes
21
are currently on the market, covering 10 different drugs
Of the 11 biosimilars that are approved and not yet available, the majority are for Humira and Enbrel and will not be available until 2023 and 2029 respectively.
Maximizing the Potential of Biosimilars
We’re already in proactive discussions on how new biosimilar options coming to market may impact our clients in the future. Once approved, we conduct new-to-market product reviews and ongoing evaluations to stay abreast of this evolving marketplace given its potential, positive impact to drug spend.
As more specialty products lose marketing exclusivity over the next decade, the increase in both biosimilar and generic competition will have a material impact on the cost savings we can achieve for our clients.
Projected U.S. Market Impact of Generic/Biosimilar Competition on Top Specialty Branded Products
The chart’s Y Axis shows the percentage of biosimilar adoption and the X Axis shows the Estimated Launch Year for biosimilars and/or Loss of Exclusivity for reference products.
It shows that in 2020-2022, about $12 billion of top specialty branded drugs will be sold in the U.S., and that GDR/biosimilar adoption for these products is about 10%. During this time Tecfidera and REVLIMID are expected to lose exclusivity.
It then shows that in 2023-2025, about $12 billion of top specialty branded drugs will be sold in the U.S, and that GDR/biosimilar adoption for these products will be about 20%. During this time HUMIRA and STELARA are expected to lose exclusivity.
Finally, it shows that in 2026-2029, about $50 billion of top specialty branded drugs will be sold in the U.S, and that GDR/biosimilar adoption for these products will be about 25%. During this time KEYTRUDA and Enbrel are expected to lose exclusivity.
*Limited generic launch in 2022.
Note: Represents top branded specialty products only as defined by >$2B in annual revenue in 2020. Estimated brand sales shown for the year prior to anticipated generic/biosimilar launch (up to 2026); additional generic/biosimilar products may launch during this time.