Cost-utility analysis of adding abiraterone acetate plus prednisone/prednisolone to long-term hormone therapy in newly diagnosed advanced prostate cancer in England: Lifetime decision model based on STAMPEDE trial data

�� 2022 The Authors. Published by PLoS. This is an open access article available under a Creative Commons licence. The published version can be accessed at the following link on the publisher���s website: https://doi.org/10.1371/journal.pone.0269192Adding abiraterone acetate (AA) plus prednisolone (P) to standard of care (SOC) improves survival in newly diagnosed advanced prostate cancer (PC) patients starting hormone therapy. Our objective was to determine the value for money to the English National Health Service (NHS) of adding AAP to SOC. We used a decision analytic model to evaluate cost-effectiveness of providing AAP in the English NHS. Between 2011���2014, the STAMPEDE trial recruited 1917 men with high-risk localised, locally advanced, recurrent or metastatic PC starting first-line androgen-deprivation therapy (ADT), and they were randomised to receive SOC plus AAP, or SOC alone. Lifetime costs and quality-adjusted life-years (QALYs) were estimated using STAMPEDE trial data supplemented with literature data where necessary, adjusting for baseline patient and disease characteristics. British National Formulary (BNF) prices (��98/day) were applied for AAP. Costs and outcomes were discounted at 3.5%/year. AAP was not cost-effective. The incremental cost-effectiveness ratio (ICER) was ��149,748/QALY gained in the non-metastatic (M0) subgroup, with 2.4% probability of being cost-effective at NICE���s ��30,000/QALY threshold; and the metastatic (M1) subgroup had an ICER of ��47,503/QALY gained, with 12.0% probability of being cost-effective. Scenario analysis suggested AAP could be cost-effective in M1 patients if priced below ��62/day, or below ��28/day in the M0 subgroup. AAP could dominate SOC in the M0 subgroup with price below ��11/day. AAP is effective for non-metastatic and metastatic disease but is not cost-effective when using the BNF price. AAP currently only has UK approval for use in a subset of M1 patients. The actual price currently paid by the English NHS for abiraterone acetate is unknown. Broadening AAP���s indication and having a daily cost below the thresholds described above is recommended, given AAP improves survival in both subgroups and its cost-saving potential in M0 subgroup.This cost-effectiveness analysis was supported by Cancer Research UK (https://www.cancerresearchuk.org/) (awarded to CSC and RMH) and the MRC Clinical Trials Unit at UCL (https://www.mrcctu.ucl.ac.uk) as an add-on to CRUK/06/019 (awarded to NDJ). STAMPEDE grant codes: CRUK_A12459; Medical Research Council (https://mrc.ukri.org), MRC_MC_UU_12023/25 (awarded to NDJ). STAMPEDE is registered on http://www.clinicaltrials.gov (NCT00268476; first posted: 22 December 2005) (http://www.stampedetrial.org).Published onlin