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Abstract
Purpose: To investigate the implications of the introduction of two hormonal therapies, abiraterone acetate + prednisone (AA+P) and enzalutamide (ENZA), for the treatment of naïve patients with metastatic castration-resistant prostate cancer (mCRPC) in the Italian setting.
Methods: In 2017–2018, a Health Technology Assessment was conducted in Italy, considering the National Healthcare Service (NHS) perspective. Data were retrieved from literature evidence, economic evaluations, and qualitative questionnaires, considering the 9 EUnetHTA dimensions, and a final multi-criteria approach.
Results: On the basis of mCRPC prevalence and incidence rates in Italy, the analysis considered 11,212 males eligible to either AA+P or ENZA treatments. Both drugs led to an improvement of the patients' overall survival, with respect to the standard of care, composed of docetaxel chemotherapy. However, AA+P showed a higher rate of drug-related moderate adverse events and a monitoring activities incidence superior to ENZA (+70%, p-value=0.00), which led to a major resources absorption (€ 1,056.02 vs € 316.25, p-value=0.00), whereas ENZA showed a better cost-effectiveness average value (CEV: 54,586.12 vs 57,624.15). Economic savings ranging from 1.46% to 1.61% emerged for the NHS, as well as organizational advantages, with fewer minutes required for the mCRPC management (AA+P: 815 mins vs ENZA: 500 mins). According to experts’ perceptions, based on a 7-item Likert scale (ranging from −3 to +3), similar results emerged on ethical and social impact (ENZA: 1.35 vs AA+P: 1.48, p-value>0.05), and on legal dimension (ENZA: 0.67 vs AA+P: 0.67, p-value>0.05), since both drugs improved the patients’ quality of life and received approval for use. High-level perceptions related to ENZA adoption emerged with regard to equity (ENZA: 0.69 vs AA+P: 0.25, p-value<0.05), since it is cortisone-free. Multi-criteria approach analysis highlighted a higher score of ENZA than comparator (0.79 vs 0.60, p-value=0.00).
Conclusion: The evidence-based information underlined the advantages of ENZA and AA+P treatments as therapeutic options for mCRPC patients. In the appraisal phase, the higher score than the comparator suggested ENZA as the preferred treatment for mCRPC.
Acknowledgments
The Authors would like to thank all the professionals involved (Laura Bistocchi, Maria Cossu Rocca, Paola Salvaderi, Elena Verri, Paolo Andrea Zucali), for their valuable support to complete the questionnaire and to produce the mCRPC standard clinical pathway, leading to the success of the present research activity.
The editing of the manuscript and the editorial support was provided by Rossella Ferrari.
Abbreviations list
AA+P, Abiraterone Acetate + Prednisone; CEV, Cost-Effectiveness Value; CRPC, Castration-resistant prostate cancer; EMA, European Medicine Agency; ENZA, Enzalutamide; FDA, Food and Drug Administration; HTA, Health Technology Assessment; ICER, Incremental cost-effectiveness ratio; MCDA, Multi-Criteria Decision Analysis; mCRPC, metastatic castration-resistant prostate cancer; NHS, National Healthcare Service; OS, overall survival; PC, prostate cancer; rPFS, radiographic progression-free survival.
Author contributions
All authors contributed to data analysis, drafting or revising the article, gave final approval of the version to be published, and agree to be accountable for all aspects of the work.
Disclosure
The authors report no conflicts of interest in this work.