HTA and innovative treatments evaluation: the case of metastatic castration-resistant prostate cancer
Received 2 October 2018
Accepted for publication 13 March 2019
Published 17 April 2019 Volume 2019:11 Pages 283—300
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Amy Norman
Peer reviewer comments 4
Editor who approved publication: Professor Samer Hamidi
Alberto Bretoni, Lucrezia Ferrario, Emanuela Foglia
Centre for Health Economics, Social and Health Care Management, LIUC – Università Cattaneo, Castellanza, Italy
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.
Keywords: mCRPC, multidimensional assessment, economic evaluation, decision analysis, hormonal therapies, MCDA
This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.Download Article [PDF] View Full Text [HTML][Machine readable]