The phase III PRIMA/ENGOT-OV26/GOG-3012 trial evaluated the efficacy of first-line niraparib vs placebo among patients with advanced ovarian cancer who responded to first-line platinum-based chemotherapy. The study showed that the introduction of an individualized starting dose (ISD) of niraparib based on patients’ body weight and platelet count reduced the incidence of hematologic adverse events (AEs) while maintaining niraparib’s benefits on progression-free survival. 

The study’s findings prompted the approval of niraparib ISD for first-line maintenance therapy in the US. Researchers examined the economic ramifications of implementing ISD by conducting a comprehensive analysis that compared the costs of managing hematologic AEs between fixed starting dose (FSD) and ISD regimens from the perspective of US payers.

By analyzing data from the double-blind, placebo-controlled PRIMA trial, researchers identified grade ≥3 hematologic AEs associated with niraparib, including thrombocytopenia, anemia, decreased platelet count, neutropenia, and decreased neutrophil count. Unit costs for managing these AEs were derived from the 2017 Agency for Healthcare Research and Quality (AHRQ) Healthcare Cost and Utilization Project (HCUP) database, adjusted to 2020 US dollars.

The results revealed a substantial cost differential between the two dosing strategies. For niraparib, the estimated cost of managing hematologic AEs per patient in the US was markedly lower with the ISD compared to the FSD. Specifically, the total mean calculated cost per patient amounted to $12,987.71 with FSD but decreased significantly to $6,744.93 with ISD. Implementing ISD led to a 48% reduction in the total cost of hematologic AE management compared to FSD.

These findings underscore the importance of individualized dosing and the economic benefits associated with niraparib ISD in managing hematologic AEs in patients with advanced ovarian cancer. The cost reduction aligns with improvements in safety, further supporting the adoption of niraparib ISD in clinical practice.

Source: 
Graybill WS, Vergote I, Pothuri B, et al. Use of individualized starting dose and niraparib hematologic adverse event management costs in ovarian cancer. Presented at the 2024 Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer; March 16-March 18, 2024. San Diego, California.