ASCO Value Framework for CLL Has Limitations
Although the American Society of Clinical Oncology (ASCO) Value Framework can help quantify the health value and benefit of various cancer therapies, it has essential limitations for its use in the treatment of chronic lymphocytic leukemia (CLL), according to a recent study.
Erlene K Seymour, MD, Karmanos Cancer Institute, Wayne State University, and colleagues reviewed the current guidelines set forth by the National Comprehensive Cancer Network (NCCN) and screened referenced studies. Of these studies, only randomized controlled prospective trials were included.
Net health benefit (NHB) was calculated using the revised ASCO Value Framework, and the cost of therapies were determined using Medicare drug pricing.
Of the 49 studies that were screened, only 10 (20%) could be assessed. Results indicated that, when comparing regimens that had been evaluated against the same control arm, ranking NHB scores were similar to their preference in guidelines. Additionally, the researchers found that NHB scores varied based on the variables used (overall survival, progression-free survival, and overall response rate). There had been no clinically validated thresholds for high or low values.
The researchers noted that treatment-related mortality was not accounted for in the toxicity scores and that six studies had used less potent control arms (ranked as the least-preferred regimens recommended by the NCCN).
“The ASCO Value Framework is an important initial step to quantify value of therapies,” the researchers concluded. “Essential limitations include the lack of clinically relevant validated thresholds for NHB scores and lack of incorporation of grade 5 toxicities/treatment-related mortality into its methodology. To optimize its application for clinical practice, we urge investigators/sponsors to incorporate and report the required variables to calculate the NHB of regimens and encourage trials with stronger comparator arms to properly quantify the relative value of therapies.”—Christina Vogt