The FDA recommends a 200-mg dose of pembrolizumab every 3 weeks, but researchers disagree.
Personalized dosing of pembrolizumab (Keytruda) in firstline setting of metastatic non-small cell lung cancer (NSCLC) could save the United States more than $800 million per year compared with fixed dosing.
Based on data from the KEYNOTE 024 trial, pembrolizumab was approved by the FDA in 2016 to treat patients with metastatic NSCLC whose tumors expressed programmed death ligand 1 in at least 50% of cells.
The recommended dose is 200 mg every 3 weeks, but several studies have demonstrated equal efficacy with weight-based doses between 2 mg and 10 mg.
In a study published in the Journal of the National Cancer Institute, investigators sought to compare the economic impact of personalized dosing (2 mg) versus fixed dosing (200 mg) in the firstline setting of metastatic NSCLCs.
The investigators conducted a budget impact analysis from the US societal perspective to compare fixed dosing with personalized. They calculated the target population and weight of patients who would be treated annually with pembrolizumab.
Using survival curves from the KEYNOTE 024 trial with Weibull extrapolation, the investigators estimated the mean number of treatment cycles patients would receive. To calculate the difference in cost between the 2 dosing methods, they used the Medicare average sales price.
The results of the study showed that with fixed dosing, the total annual US cost of pembrolizumab is $3.4 billion versus $2.6 billion with personalized dosing.
Based on the calculations, the use of personalized dosing would save approximately $825 million in the United States, or 24% annual savings.
“This option [personalized dosing] should be considered for the firstline management of PD-L1-positive advanced lung cancer,” the authors concluded.