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

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5 COST EFFECTIVENESS ....................................................................................................... 33 5.1 ERG comment on manufacturer’s review of cost-effectiveness evidence ............................ 33 5.1.1 State objective of cost effectiveness review. Provide description of manufacturers search strategy and comment on whether the search strategy was appropriate. If the manufacturer did not perform a systematic review, was this appropriate? ................................ 33 5.1.2 State the inclusion/exclusion criteria used in the study selection and comment on whether they were appropriate. ................................................................................................ 33 5.1.3 What studies were included in the cost effectiveness review and what were excluded? Where appropriate, provide a table of identified studies. Please identify the most important cost effectiveness studies. ............................................................................................................... 33 5.1.4 What does the review conclude from the data available? Does the ERG agree with the conclusions of the cost effectiveness review? If not, provide details......................................... 34 5.2 Summary and critique of manufacturer’s submitted economic evaluation by the ERG ....... 36 5.2.1 NICE reference case checklist (TABLE ONLY) ....................................................... 36 5.2.2 Model structure ........................................................................................................ 37 5.2.3 Population ................................................................................................................ 40 5.2.4 Interventions and comparators .................................................................................. 40 5.2.5 Perspective, time horizon and discounting ................................................................ 41 5.2.6 Treatment effectiveness ............................................................................................ 42 5.2.7 Health related quality of life ..................................................................................... 47 5.2.8 Resources and costs .................................................................................................. 49 5.2.9 Cost effectiveness results .......................................................................................... 53 5.2.10 Sensitivity analyses .................................................................................................. 57 5.2.11 Model validation ...................................................................................................... 66 5.3 Additional work undertaken by the ERG ........................................................................... 66 5.4 Conclusions ..................................................................................................................... 69 6 Impact on the ICER of additional clinical and economic analyses undertaken by the ERG ....... 69 7 End of life ............................................................................................................................... 69 8 Conclusions ............................................................................................................................ 69 8.1 Implications for research ................................................................................................. 70 References....................................................................................................................................... 71 Appendix 1A: ERG Search Strategies .............................................................................................. 77 Appendix 1B: Review of search strategies for Apixaban studies ...................................................... 87 Appendix 2: Phillips et al. Checklist ................................................................................................ 89 6 Copyright 2011 Queen’s Printer and Controller of HMSO. All rights reserved.
1. SUMMARY 1.1 Scope of the manufacturer submission The Manufacturer’s Submission (MS) generally reflects the scope of the appraisal issued by NICE, and is appropriate to the NHS. The MS reports on the use of apixaban in adults who have elective total hip replacement (THR) or elective total knee replacement (TKR) surgery. The intervention is defined as apixaban (Eliquis®) for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective THR or TKR surgery. The MS considered enoxaparin, a low molecular-weight heparin (LMWH), as the most relevant comparator, as reflected in the scope. Indirect comparisons as well as mixed treatment comparisons with alternative standard care (including other LMWHs, as well as the other stated comparators, rivaroxaban, dabigatran and fondaparinux) were undertaken. The outcome measures identified in the scope were all relevant and the majority of these efficacy outcomes (mortality, incidence of symptomatic and asymptomatic deep vein thrombosis (DVT), and pulmonary embolism (PE)), and safety outcomes (bleeding events), were reported. However, outcomes relating to post DVT complications, length of hospital stay, joint outcomes and health related quality of life, although identified in the scope, were not reported. The ERG would like to comment on the quantity of the MS. The MS contains 217 pages, this is much longer than the 70-100 pages recommended by NICE. In addition, separate documents with appendices with a total of 630 pages were submitted by the manufacturer. The length of the MS make the review by the ERG more difficult than it should have been. The main document contained direct evidence and the main conclusions from the indirect comparisons. Details of the indirect comparisons were presented in appendix 15 and the mixed treatment comparisons were presented in appendix 16. Appendices 15 and 16 were two large documents produced by organisations independent to the manufacturers (384 pages in total). This information should have been contained within the main document of the MS. 1.2 Summary of clinical effectiveness evidence submitted by the manufacturer The MS appears to contain an unbiased estimate of the treatment effect of apixaban in relation to the relevant outcomes and the comparator, enoxaparin. Overall the evidence from the three ADVANCE trials in the MS indicates that apixaban 2.5mg bd is significantly superior to the comparator enoxaparin (40mg od) in terms of xxxxx xxxxxxx xxxxxxxxxx xxxxx, any DVT, xxxx xxxxx xxxxx. xxx xxxxxx xxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxxxx xxxxxx xxxxxxxxxxxxxxxxxx xxxxxx x xxxxxxxxxxx These results were the same for THR and TKR. The results of the indirect comparisons showed that apixaban: when compared to rivaroxaban showed no significant differences in terms of xxxx xxxxx xxxx any DVT. Xxxx xxxxxx xxxxxx xxxxxx xxxxx xxxx xxxx xxxxxx xxx xxxxx xxxxx xxxx xxxxxxxxxx when compared to dabigatran was significantly superior in terms of xxx xxxxx xxxxx xxx xxxx any DVT; xxxx xxxxx xxxxx xxxx xxxxxxx xxxxx. These results were the same for THR and TKR. 7 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: 1. SUMMARY ........................
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
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5.2.10 Sensitivity analyses Methods
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Figure 5.3 Cost-effectiveness accep
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Figure 5.6 Cost-effectiveness accep
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Cost-Effectiveness Acceptability Cu
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Cost-Effectiveness Acceptability Cu
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number of QALYs gained by dabigatra
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5.4 Conclusions Describe the comple
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References [1] White RH. The epidem
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[23] Eriksson BI, Dahl OE, Rosenche
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ISPOR 11th Annual European Congress
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Appendix 1A: ERG Search Strategies
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85 84 not 83 (88613) 86 1 or 2 or 3
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76 Comment/ (451657) 77 Letter/ (72
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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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