Apixaban for the prevention of venous thromboembolism in people ...

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5.2 Summary and critique of manufacturer’s submitted economic evaluation by the ERG Summarise and critique the cost effectiveness evidence submitted by the manufacturer (headings 5.2.1 to 5.2.11 are suggested headings). It is noted that the ERGs may prefer NOT to combine the summary and critique of the submitted economic evidence and instead report summary and critique sections separately. Summarise and critique the cost effectiveness evidence submitted by the manufacturer (headings 5.2.1 to 5.2.11 are suggested headings). It is noted that the ERGs may prefer NOT to combine the summary and critique of the submitted economic evidence and instead report summary and critique sections separately. 5.2.1 NICE reference case checklist (TABLE ONLY) Elements of the economic evaluation Reference Case Included in submissio Comparator(s) Therapies routinely used in the NHS, including technologies regarded as current best practice 36 n Comment on whether de-novo evaluation meets requirements of NICE reference case Yes Comparison with fondaparinux was deemed not possible by manufacturer because data were lacking. Upon request by the ERG, fondaparinux was included as a comparator in the analysis of THR. Also, upon request a full incremental cost-effectiveness analysis on both TKR and THR was provided Type of economic evaluation Cost-effectiveness analysis Yes Perspective on costs NHS and PSS Yes No significant PSS costs were identified Perspective on outcomes All health effects on individuals Yes Time horizon Sufficient to capture differences in Yes At a maximum 60 years, at which costs and outcomes moment 99.99% of the population has died Synthesis of evidence on outcomes Systematic review Yes Measure of health effects QALYs Yes Source of data for Reported directly by patients and/or Yes HRQoL was reported by patients, measurement of HRQL carers but from different populations Source of preference Representative sample of the public Yes / No Some health states were valued data for valuation of by a representative sample of the changes in HRQL public, others were valued by patients Discount rate Annual rate of 3.5% on both costs and health effects Yes Equity weighting An additional QALY has the same weight regardless of the other characteristics of the individuals receiving the health benefit Yes Sensitivity analysis Probabilistic sensitivity analysis Yes Not for all parameters but only those not included in the one way sensitivity analysis Copyright 2011 Queen’s Printer and Controller of HMSO. All rights reserved.
5.2.2 Model structure The manufacturer submitted a model in Microsoft Excel. A two stage modelling approach was adopted. A decision tree was used to model treatment in the acute phase (surgery to 90 days post surgery) and a Markov process model was used to model the long-term events (90 days post surgery and beyond). The differential effects of treatment are only realised in the acute phase of the model. The decision tree and long-term Markov model are depicted in Figures 5.1 and 5.2 respectively. Figure 5.1 Decision tree (Fig 8 MS-page128) Note: Other deaths refer to non-VTE and non-treatment-related deaths. Abbreviations: THR, total hip replacement; TKR, total knee replacement; VTE, venous thromboembolism; PE, pulmonary embolism; DVT, deep vein thrombosis; Sym/Symp, symptomatic, Asym, asymptomatic; Tmt, treatment 37 Copyright 2011 Queen’s Printer and Controller of HMSO. All rights reserved.
Page 1 and 2: in collaboration with: Apixaban for
Page 3 and 4: Abbreviations AAOS American Academy
Page 5 and 6: 1. SUMMARY ........................
Page 7 and 8: 1. SUMMARY 1.1 Scope of the manufac
Page 9 and 10: The three identified trials, which
Page 11 and 12: Table 2.1. Summary of Annual TKR an
Page 13 and 14: The NICE clinical guideline on redu
Page 15 and 16: Indirect and mixed treatment compar
Page 17 and 18: 4.1.2 State the inclusion/exclusion
Page 19 and 20: APROPOS 2 0 Phase II, randomised, e
Page 21 and 22: 4.2 Summary and critique of submitt
Page 23 and 24: Table 4.5: Results for Apixaban ver
Page 25 and 26: Trial no. (acronym) ADVANCE 1 ADVAN
Page 27 and 28: 4.2.4 Describe and critique the man
Page 29 and 30: Table 4.9: Results from indirect co
Page 31 and 32: Results for the main outcomes from
Page 33 and 34: 5 COST EFFECTIVENESS 5.1 ERG commen
Page 35: Table 5.1 Main findings of studies
Page 39 and 40: died in the decision tree enter the
Page 41 and 42: Administration of apixaban is oral,
Page 43 and 44: A mixed treatment comparison (MTC)
Page 45 and 46: Long term recurrent risks of VTE an
Page 47 and 48: 5.2.7 Health related quality of lif
Page 49 and 50: on assumptions, and not further jus
Page 51 and 52: Table 5.12 Costs for health states
Page 53 and 54: Table 5.14 Drug and administration
Page 55 and 56: Comment - The ERG restructured the
Page 57 and 58: 5.2.10 Sensitivity analyses Methods
Page 59 and 60: Figure 5.3 Cost-effectiveness accep
Page 61 and 62: Figure 5.6 Cost-effectiveness accep
Page 63 and 64: Cost-Effectiveness Acceptability Cu
Page 65 and 66: Cost-Effectiveness Acceptability Cu
Page 67 and 68: number of QALYs gained by dabigatra
Page 69 and 70: 5.4 Conclusions Describe the comple
Page 71 and 72: References [1] White RH. The epidem
Page 73 and 74: [23] Eriksson BI, Dahl OE, Rosenche
Page 75 and 76: ISPOR 11th Annual European Congress
Page 77 and 78: Appendix 1A: ERG Search Strategies
Page 79 and 80: 85 84 not 83 (88613) 86 1 or 2 or 3
Page 81 and 82: 76 Comment/ (451657) 77 Letter/ (72
Page 83 and 84: 68 Motion Therapy, Continuous Passi
Page 85 and 86: 23 pentasaccharide*.mp. (2192) 24 e
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Appendix 1B: Review of search strat
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Question(s) Appendix 2: Phillips et
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Has the source for all costs been d
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