Financial Toxicity of Withdrawn Poly (Adenosine Diphosphate Ribose) Polymerase Inhibitor Indications for Ovarian Cancer.

We sought to quantify exposure to and financial impacts of poly (adenosine diphosphate ribose) polymerase inhibitor (PARPi) treatments for eventually withdrawn ovarian cancer indications. We identified in Optum's deidentified Clinformatics® Data Mart database 1695 patients with ovarian cancer diagnoses who received olaparib, rucaparib, or niraparib between January 2015 and September 2021. We describe PARPi use and out-of-pocket, total healthcare, and PARPi spending among patients with ovarian cancer with 3 or more previous lines of therapy. Of the 1695 patients who received PARPi, 254 were estimated to have been heavily pretreated and exposed to eventually withdrawn indications. Cumulative total medical and pharmacy costs for these patients were $53 392 184; PARPi costs accounted for 34%. Median PARPi cost per patient was $43 347. Cumulative out-of-pocket costs totaled $533 281. Potential patient harm, including financial toxicity, might have been mitigated through more stringent drug approval requirements. • Starting in 2014, 3 poly (adenosine diphosphate ribose) polymerase inhibitors were approved without evidence of overall survival benefit for ovarian cancer treatment of heavily pretreated patients with recurrent disease. Ovarian cancer treatment indications were withdrawn in 2022, after trials demonstrating shorter survival among heavily pretreated patients with recurrent disease. • In addition to potential patient harm from drug exposure, conservative estimates of the number of patients treated with poly (adenosine diphosphate ribose) polymerase inhibitor for the withdrawn indications demonstrated significant financial impact for patients and the healthcare system. • Financial toxicity of Food and Drug Administration cancer drug approvals without evidence of clinical benefit must be considered. [ABSTRACT FROM AUTHOR]