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.

Adding 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.
Competing Interests: Besides the funding declared above, • CDB reports grants from Novartis, Sanofi-Aventis, Pfizer, Janssen Pharma, Cancer Research UK, and Medical Research Council. • DD reports personal fees from The Institute of Cancer Research, grants from Cancer Research UK Program Grant and personal fees from Janssen. In addition, DD has a patent EP1933709B1 issued. • GA reports receiving commercial research grants from Janssen and AstraZeneca; has received honoraria and/or travel support from the speakers’ bureaus of Janssen, Astellas, Pfizer, Ferring, Sanofi-Aventis and Roche/Ventana; and has served as a consultant for/advisory board member of Janssen, Bayer, Astellas, Pfizer, Novartis, AstraZeneca, Orion, and Essa. GA has an ownership interest (including patents) in The Institute of Cancer Research Rewards to Discoverers for abiraterone acetate. • RJJ reports grants and personal fees from Astellas, AstraZeneca, Exelixis, and Roche; grants, personal fees and non-financial support from Bayer; personal fees and non-financial support from Bristol Myers Squibb, Janssen, Ipsen, and MSD; and personal fees from Merck Serono, Novartis, Pfizer, Sanofi Genzyme, and EUSA. • WC reports grants from Myriad Genetics. • CP reports personal fees from Bayer, Clarity, ITM (Isotopen Technologien Muenchen AG), Janssen, and Myovant. • SG reports personal fees from Sanofi, Orion, Roche, Janssen Cilag, and Amgen; other benefits from Menarini Silicon Biosystems, Bayer, AAA International, ProteoMediX, Toledo, and MSD; personal fees and other benefits from Astellas Pharma; and grants from Astellas Pharma. • ZM reports involvement in consultancy and advisory boards at Janssen and Sanofi, in advisory boards at Astellas, and sponsorship to attend medical conferences from Astellas, Bayer and Janssen. • NWC reports receiving research grants AstraZeneca and Janssen; honoraria and/or travel support from the speakers’ bureaus of Janssen, Astellas, Ferring, Sanofi-Aventis and has served as a consultant for/advisory board member of Janssen, Bayer, Astellas, Ferring, and AstraZeneca. • MKBP reports unrestricted grant funding to contribute to STAMPEDE overall from Astellas, Clovis Oncology, Novartis, Pfizer and Sanofi. • MRS reports grants from Clovis, grants and non-financial support from Astellas, Janssen, Novartis, Pfizer, and Sanofi to support the running of STAMPEDE; and personal fees from Lilly Oncology and Janssen for educational events unconnected to the submitted work or the underpinning trial. • NDJ reports grants and personal fees from Janssen, Astellas, and Sanofi, and personal fees from AstraZeneca, during the conduct of the study. • CSC, RMH, AG, FCI, DM, HLR, JMR, RM, JFL and JW have nothing to disclose. This does not alter our adherence to PLOS ONE policies on sharing data and materials.