A study based on claims data and adverse event reports compared the medical costs linked to infections in patients taking 3 different biologics: certolizumab (Cimzia), adalimumab (Humira), and etanercept (Enbrel).
According to the poster, presented at the ISPOR Annual Meeting in Boston, MA, this week, adverse drug events (ADEs) are a dangerous and common occurrence, as they represent the fourth leading cause of death in the United States and are responsible for 700,000 emergency department (ED) visits per year. However, it can be challenging to determine the medical costs related to ADEs using claims databases.
Researchers from Advera Health Analytics and WEA Trust gathered data from Advera’s analytics platform on ADEs reported to the FDA and compared it to the WEA Trust’s claims database “to determine whether spontaneous ADE reporting analysis could be used as a proxy for claims-based outcomes studies.” They used data from both sources for the time period of August 2013 through July 2015, as well as drug usage information and the medical costs specific to each ADE.
Using the WEA Trust data, the authors determined that certolizumab had a drastically higher rate of associated pneumonia than adalimumab and etanercept (13.6% vs 0.5% and 0.9%, respectively). Not surprisingly, certolizumab was also responsible for increased costs to the healthcare system. Each prescription of certolizumab was associated with $522 in ED costs and $156 in hospitalization costs, about double the expenses associated with adalimumab ($256 in ED costs and $79 in hospitalization costs). The costs associated with etanercept were the lowest of the 3 drugs, at $190 in ED costs and $57 in hospitalization costs.
The ADE data provided to the FDA confirmed that certolizumab was responsible for significantly more reports of pneumonia. It also indicated that certolizumab resulted in higher downstream costs per prescription from both serious ADEs and patient outcomes than the other 2 drugs. When comparing the costs calculated with claims data to the FDA-reported events, the researchers found that the “per dispense medical cost in the WEA Trust claims data correlated to Advera Health’s calculated downstream medical cost from FAERS [FDA Adverse Events Reporting System] data.”
Tumor necrosis factor (TNF) inhibitors, are widely prescribed to treat autoimmune diseases like rheumatoid arthritis, psoriasis, and inflammatory disorders. The WEA Trust, an insurer in Wisconsin, plans to use these findings to work with providers so they can modulate TNF-α inhibitor prescriptions to lower cost and improve safety.
In 2016, biosimilars of both etanercept and adalimumab were approved by the FDA. However, marketing of both has been delayed by legal disputes, as Amgen’s Amjevita (adalimumab) is being challenged by AbbVie, the maker of Humira. Simultaneously, Amgen is involved in a patent fight over Novartis’s Erelzi (etanercept), the biosimilar of Enbrel.
The FDA has not yet approved any biosimilars of certolizumab, although a version being developed by PFEnex is currently in the preclinical stages of the pipeline.