Cost-effectiveness analysis comparing "PARP inhibitors-for-all" to the biomarker-directed use of PARP inhibitor maintenance therapy for newly diagnosed advanced stage ovarian cancer

Rafael Gonzalez 1, Laura J Havrilesky 2, Evan R Myers 3, Angeles Alvarez Secord 2, Joseph A Dottino 4, Andrew Berchuck 2, Haley A Moss 2

Affiliations

PMID: 32863036
DOI: 10.1016/j.ygyno.2020.08.003

Abstract

Objectives: Clinical trials evaluating universal PARP inhibitor (PARPi) frontline maintenance therapy for advanced stage ovarian cancer have reported progression-free survival (PFS) benefit. It is unclear whether PARPi maintenance therapy will universally enhance value (clinical benefits relative to cost of delivery). We compared a "PARPi-for-all" to a biomarker-directed frontline maintenance therapy approach as a value-based care strategy.

Methods: The cost of two frontline PARPi maintenance strategies, PARPi-for-all and biomarker-directed maintenance, was compared using modified Markov decision models simulating the study designs of the PRIMA, VELIA, and, PAOLA-1 trials. Outcomes of interest included overall costs and incremental cost-effectiveness ratios (ICERs) reported in US dollars per quality adjusted progression-free life-year (QA-PFY) gained.

Results: PARPi-for-all was more costly and provided greater PFS benefit than a biomarker-directed strategy for each trial. The mean cost per patient for the PARPi-for-all strategy was $166,269, $286,715, and $366,506 for the PRIMA, VELIA, and PAOLA-1 models, respectively. For the biomarker-directed strategy, the mean cost per patient was $98,188, $167,334, and $260,671 for the PRIMA, VELIA, and PAOLA-1 models. ICERs of PARPi-for-all compared to biomarker-directed maintenance were: $593,250/QA-PFY (PRIMA), $1,512,495/QA-PFY (VELIA), and $3,347,915/QA-PFY (PAOLA-1). At current drug pricing, there is no PFS improvement in a biomarker negative cohort that would make PARPi-for-all cost-effective compared to biomarker-directed maintenance.

Conclusions: This study highlights the high costs of universal PARPi maintenance treatment, compared with a biomarker-directed PARPi strategy. Maintenance therapy in the front-line setting should be reserved for those with germline or somatic HRD mutations until the cost of therapy is significantly reduced.

Keywords: BRCA; Cost-effectiveness; HRD; Ovarian cancer; PARP inhibitor.

Conflict of interest statement

Declaration of Competing Interest Dr. Secord reports grants from AbbVie, grants from Amgen, grants from Astellas Pharma Inc., grants from Astex Pharma Inc., grants and personal fees from Aztra Zeneca, grants from Boehringer Ingelheim, grants from Bristol Myers Squibb, grants and personal fees from Clovis, grants and personal fees from Eisai, grants from Endocyte, grants from Exelixis, grants from Immutep, grants from Incyte, grants and personal fees from Merck, grants from PharmaMar, grants and personal fees from Roche/Genetech, grants from Seattle Genetics, grants and personal fees from Tesaro/GSK, grants from VBL therapeutics, grants from National Cancer Trial Network, personal fees from Aravive, personal fees from Cordgenics, personal fees from Johnson & Johnson, personal fees from Mersana, personal fees from Myriad, personal fees from Oncoquest. Dr. Myers reports personal fees from Merck, Inc., personal fees from AbbVie, Inc., personal fees from Bayer, Inc. Dr. Havrilesky reports grants from Astra Zeneca, grants from Tesaro. Dr. Moss receives funding from the NIH (K12HD043446). The remainder of the authors have nothing to disclose.