During the 34th International Conference on Pharamcoepidemiology and Therapeutic Risk Management, taking place from August 22 to 26 in Prague, Czech Republic, researchers will present findings that contrast the cost savings made possible by biosimilars in the US and European contexts.
During the 34th International Conference on Pharamcoepidemiology and Therapeutic Risk Management, taking place from August 22 to 26 in Prague, Czech Republic, researchers will present findings that contrast the use and cost savings made possible by biosimilars in the US and European contexts.
Medicare Patients Pay More Out of Pocket for Biosimilar Filgrastim
US researchers assessed how out-of-pocket spending for Medicare Part D enrollees will be impacted by availability of biosimilars.1 Using Medicare formulary files from CMS for the third quarter of 2016, the investigators analyzed 879 stand-alone and 1920 Medicare Advantage drug formularies, summarizing drug prices at the point of sale and estimating out-of-pocket costs for beneficiaries using filgrastim products.
They found that 96.2% of plans covered the reference filgrastim, Neupogen, and 57.2% covered the biosimilar, Zarxio. Out-of-pocket annual spending was higher for the biosimilar ($7105) than it was for the reference ($5538) by $1567.
“Generic competition and biosimilar entry in the specialty drug context may be less effective at reducing drug prices and patient out‐of‐pocket spending in the United States than anticipated,” concluded the authors.
Baseline Characteristics Play a Role in Which US Patients Receive Biosimilars
Furthermore, for US patients, baseline characteristics appear to play a role in which populations receive reference filgrastim versus the biosimilar Zarxio or follow-on tbo-filgrastim.2
Click to read more about tbo-filgrastim.
US researchers examined patient characteristics—and reported adverse events (AEs)—for new filgrastim users between 2015 and 2016. Using MarketScan data, they identified 5470 patients, 4155 of whom used the reference, 771 of whom used the follow-on, and 544 of whom used the biosimilar. More than 4% of reference use was among pediatric patients (versus less than 1% for the follow-on or biosimilar), while use among elderly patients was comparable among the 3 groups.
Patients who received the reference were more likely to be male and more likely to be diagnosed with leukemia than with other cancer types versus those who received the biosimilar or follow-on. Differences in use may be due, the authors write, to cancer type or age, provider preference, and reimbursement policies. Slight differences in AEs observed across the groups were likely to be a result of these differences in prescribing patterns, they added.
Biosimilars Reduce Economic Burden in Chronic Kidney Disease in Italy
Meanwhile, Italian researchers conducted a multi-regional, population-based study of the cost of treating patients with chronic kidney disease (CKD) using erythropoiesis stimulating agents (ESA).3 ESAs represent between 6% and 17% of total treatment costs for patients with CKD in Italy, the investigators note.
In a total population of approximately 8 million, 7810 incident ESA users were identified between the years 2009 and 2014. The yearly mean cost of ESA treatment for each patient ranged from €1551 (approximately $1794) for those with stage I to stage III disease, to €2045 (approximately $2365) for patients receiving dialysis. Assuming 50% biosimilar uptake, the annual mean cost‐savings would total between €65,730 (approximately $76,013) for patients with stage I to stage III disease to €118,769 (approximately $137,350) for patients receiving dialysis.
“ESAs have a relevant economic burden in CKD and biosimilars guarantee 25‐30% saving of ESA purchase costs in CKD patients,” concluded the authors.
References
1. Dusetzina SB, Jazowski SA, Cole AL, Nguyen J. Coverage and out-of-pocket spending on brand versus generic/biosimilar specialty drugs in Medicare Part D. Presented at the 34th International Conference on Pharamcoepidemiology and Therapeutic Risk Management, August 22-26, 2018; Prague, Czech Republic. Abstract 679. https://onlinelibrary.wiley.com/doi/10.1002/pds.4629.
2. Brady BL, Irwin DE. Adverse events with recombinant G-CSF for neutropenia in cancer. Presented at the 34th International Conference on Pharamcoepidemiology and Therapeutic Risk Management, August 22-26, 2018; Prague, Czech Republic. Abstract 1030. https://onlinelibrary.wiley.com/doi/10.1002/pds.4629.
3. Ingrasciotta Y, Formica D, Giorgianni F, et al. Evaluation of health direct costs associated with the use of biosimilar and originator erythropoiesis stimulating agents (ESAs): an Italian, multi-regional, population-based study. Presented at the 34th International Conference on Pharamcoepidemiology and Therapeutic Risk Management, August 22-26, 2018; Prague, Czech Republic. Abstract 1036. https://onlinelibrary.wiley.com/doi/10.1002/pds.4629.
Samsung Bioepis Report Signals Turning Point for US Biosimilars
May 1st 2025A wave of biosimilar approvals, aggressive pricing strategies, and a regulatory sea change are setting the stage for unprecedented momentum in the US biologics market, with 2025 already proving to be a landmark year in reshaping cost, access, and innovation across therapeutic areas.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Biosimilar Market Development Requires Strategic Flexibility and Global Partnerships
April 29th 2025Thriving in the evolving biosimilar market demands bold collaboration, early global partnerships, and a fresh approach to development strategies to overcome uncertainty and drive future success.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
President Trump Signs Executive Order to Bring Down Drug Prices
April 16th 2025To help bring down sky-high drug prices, President Donald Trump signed an executive order pushing for faster biosimilar development, more transparency, and tougher rules on pharmacy benefit managers—aiming to save billions and make meds more affordable for everyone.
How State Substitution Laws Shape Insulin Biosimilar Adoption
April 15th 2025States with fewer restrictions on biosimilar substitution tend to see higher uptake of interchangeable insulin glargine, showing how even small policy details can significantly influence biosimilar adoption and expand access to more affordable insulin.