Some Psoriasis Patients Treated with Above-Label Use of Biologics, Leading to Higher Costs

A retrospective study using a large US claims database of patients with moderate to severe psoriasis suggests that extensive above-label use of etanercept, adalimumab, and ustekinumab occurs in 20%, 2.6%, and 14.8% of patients, respectively, who take these biologics.

The practice of above-label use (defined as dosing at least 10% higher than indicated on a product’s label for 180 days or more over a 12-month period following the maintenance period) was associated with additional costs beyond those that would have been incurred with on-label use, according to the researchers, who were led by Steven R. Feldman, MD, PhD. The study, sponsored by Novartis, appears in the Journal of Managed Care & Specialty Pharmacy.

The authors said it is important to know how often off-label and above-label dosing occurs in order to gain a better understanding of real-world costs, because cost-of-treatment estimates are often based on labeled dosing, especially in budget impact and cost-effectiveness analyses.

The study used data from the Truven Health MarketScan Commercial Encounters Database and the Medicare Supplemental Database for the period between January 1, 2010, and December 31, 2013. Data were from 3310 patients with psoriasis who were aged 18 or older and had at least 1 claim for a biologic of interest. Patients had at least 1 prescription filled for the biologic during the “look-forward” period (extending for 18 months after the end of the maintenance period) to ensure that patients were on a continuous treatment with the biologic. Patients began receiving treatment with etanercept (n = 1443), adalimumab (n = 1447), or ustekinumab (n = 420).

The mean duration of extensive above-label use was roughly similar for the 3 treatments. Additional annual costs per patient that resulted from extensive above-label use were $19,458 for etanercept, $18,972 for adalimumab, and $21,045 for ustekinumab. The total additional annual costs incurred were $5,623,362 for etanercept, $701,964 for adalimumab, and $1,304,790 for ustekinumab.

The researchers said that the mean duration of extensive above-label use was high with all 3 of the biologics, and exceeded 275 days over the 12-month follow-up period. They also noted that, because the additional costs assessed in their study only capture extra treatment costs, the other costs are not included. These additional costs include increased medical costs, costs of office visits, and costs due to treatment of adverse events or worsened side-effects from above-label dosing. “The real additional total costs associated with above-label dosing will be higher than reported in this study, and future studies are needed to look into the overall economic impact,” they said.

The researchers noted that their pharmacy claims database approach did not allow them to speculate on why above-label use was substantially less prevalent with adalimumab than with etanercept or ustekinumab, and whether that use was a result of differential efficacy or other factors. It is possible that some individuals require higher dosing to achieve the same results. “This subject warrants further research because it has implications for maximizing the cost-effectiveness of biologic therapy,” they concluded.