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Relapsed Metastatic Prostate Cancer [ID1640] Committee Papers Single Technology Appraisal Olaparib for previously treated hormone- relapsed metastatic prostate cancer [ID1640] Committee Papers © National Institute for Health and Care Excellence 2021. All rights reserved. See Notice of Rights. The content in this publication is owned by multiple parties and may not be re-used without the permission of the relevant copyright owner. NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE SINGLE TECHNOLOGY APPRAISAL Olaparib for previously treated hormone-relapsed metastatic prostate cancer [ID1640] Contents: The following documents are made available to consultees and commentators: The final scope and final stakeholder list are available on the NICE website. 1. Company submission from AstraZeneca 2. Clarification questions and company responses 3. Patient group, professional group and NHS organisation submissions from: a. Prostate Cancer UK b. Tackle Prostate Cancer 4. Expert personal perspectives from: a. Peter Isard – patient expert, nominated by Prostate Cancer UK 5. Evidence Review Group report prepared by Warwick Evidence 6. Evidence Review Group – factual accuracy check 7. Technical Report 8. Technical engagement responses from experts: a. Professor Johann de Bono – clinical expert, nominated by AstraZeneca b. Dr Sree Rodda – clinical expert, nominated by the British Uro-Oncology Group 9. Technical engagement responses from consultees and commentators: a. Prostate Cancer UK b. Tackle Prostate Cancer 10. Technical engagement response from AstraZeneca 11. Clarification questions on the company technical engagement response and company responses 12. Evidence Review Group critique of company response to technical engagement prepared by Warwick Evidence 13. Factual accuracy check of ERG critique © National Institute for Health and Care Excellence 2021. All rights reserved. See Notice of Rights. The content in this publication is owned by multiple parties and may not be re-used without the permission of the relevant copyright owner. Any information supplied to NICE which has been marked as confidential, has been redacted. All personal information has also been redacted. © National Institute for Health and Care Excellence 2021. All rights reserved. See Notice of Rights. The content in this publication is owned by multiple parties and may not be re-used without the permission of the relevant copyright owner. NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE Single technology appraisal Olaparib for previously treated hormone- relapsed metastatic prostate cancer [ID1640] Document B Company evidence submission June 2020 File name Version Contains Date confidential information ID1640_olaparib_Doc 0.2 No 11 June 2020 B_11June2020 REDACTED Company evidence submission template for olaparib for previously treated hormone-relapsed metastatic prostate cancer [ID1640] © AstraZeneca 2020 All rights reserved Page 1 of 208 Contents NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE .......................... 1 Single technology appraisal ....................................................................................... 1 Olaparib for previously treated hormone-relapsed metastatic prostate cancer [ID1640] ...................................................................................................................... 1 Document B ............................................................................................................... 1 Company evidence submission .................................................................................. 1 Contents ..................................................................................................................... 2 Tables ........................................................................................................................ 3 Figures ....................................................................................................................... 5 B.1 Decision problem, description of the technology and clinical care pathway .. 7 B.2 Clinical effectiveness ................................................................................... 23 B.3 Cost effectiveness ..................................................................................... 106 References ............................................................................................................. 197 Company evidence submission template for olaparib for previously treated hormone-relapsed metastatic prostate cancer [ID1640] © AstraZeneca 2020 All rights reserved Page 2 of 208 Tables Table 1. Technology being appraised. ..................................................................... 11 Table 2. The decision problem. ................................................................................ 17 Table 3. Clinical effectiveness evidence overview of PROfound and CARD studies. ................................................................................................................................. 27 Table 4. Key inclusion and exclusion criteria for the PROfound study. .................... 31 Table 5. Patient characteristics for PROfound Cohort A+B, Cohort A, prior taxane subgroup .................................................................................................................. 38 Table 6. Definition of populations. ............................................................................ 44 Table 7. Description of outcomes and methodology for statistical analysis. ............. 46 Table 8. Overview of quality assessments for the PROfound study ......................... 49 Table 9. Key efficacy outcomes in Cohort A, Cohort A+B, Cohort A+B prior taxane subgroup (used in ITC analysis). .............................................................................. 53 Table 10. Median OS and HR for investigators’ choice of NHA arm, adjusted for treatment switching; overall HRRm (Cohort A+B) and Cohort A .............................. 63 Table 11. Time to first SSRE in patients in Cohort A+B. .......................................... 69 Table 12. OS data in the prior taxane subgroup of PROfound at DCO2 (Cohort A+B) ................................................................................................................................. 79 Table 13. Summary of the covariates available for testing for effect modification .... 85 Table 14. Assessment of effect modifiers for switching adjusted anchored analysis. ................................................................................................................................. 87 Table 15. Summary of results for rPFS and OS: Bucher anchored ITC olaparib versus cabazitaxel .................................................................................................... 91 Table 16. Summary of treatment exposure, dose interruptions, and dose modifications: Cohort A + B SAS and prior taxane subgroup, DCO1 (4th June 2019) ................................................................................................................................. 94 Table 17. Adverse events in any category, DCO1 (4th June 2019) in Cohort A+B SAS/prior taxane subgroup. ..................................................................................... 96 Table 18. End-of-life criteria ................................................................................... 105 Table 19. Description of modelled patient population ............................................. 107 Table 20. Features of the economic analysis ......................................................... 114 Table 21. Summary of main clinical efficacy data sources for each intervention in the economic analysis. ................................................................................................. 117 Table 22. Number of events in the HRRm (Cohort A+B) prior taxane subgroup of PROfound. ............................................................................................................. 119 Table 23. AIC and BIC values for parametric models for rPFS (HRRm [Cohort A+B] – prior taxane). .......................................................................................................... 121 Table 24. Number of events in the HRRm (Cohort A+B) prior taxane subgroup of PROfound. ............................................................................................................. 123 Table 25. AIC and BIC values for parametric models for OS (HRRm [Cohort A+B] – prior taxane, olaparib). ........................................................................................... 124 Table 26. OS estimates for olaparib (HRRm [Cohort A+B] - prior taxane, olaparib) ............................................................................................................................... 126 Table 27. OS for cabazitaxel (predicted via ITC) .................................................... 129 Table 28. Final rPFS and OS models selected for economic evaluation (HRRm [Cohort A+B] – prior taxane)................................................................................... 130 Table 29. Summary of TTD approach selected for base case and scenario analysis ............................................................................................................................... 133 Company evidence submission template for olaparib for previously treated hormone-relapsed metastatic prostate cancer [ID1640] © AstraZeneca 2020 All rights reserved Page 3 of 208 Table 30. AIC and BIC values for parametric models for TTD (HRRm – prior taxane, olaparib) ................................................................................................................
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