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

Results for the main outcomes from each of these analyses are reported in tables 4.9 and 4.10. The
Response to the Clarification Letter has a similar overview of results of different analyses with
explanations for differences between results (Response to Clarification Letter: A3, Table 3, page 9
and A7, Table 8, page 21).
In the Response to the Clarification Letter the manufacturer explains that “For all inconsistent
outcomes, the MTC displayed wider credibility intervals (i.e. increased uncertainty) which resulted in
no statistically significant between-treatment differences.” (Response to Clarification Letter: A7, page
20) – See also section 4.1.3.
COMMENT
The ERG agrees with the chosen doses for each treatment included in the analyses. In addition the
conclusion that the MTC is less reliable because the MTC results were inconsistent with some of the
head-to-head RCT data (MS, page 85 and 100) seems reasonable.
4.2.7 Additional clinical work conducted by the ERG
Provide details of any additional work conducted by the ERG in relation to clinical effectiveness. If
the results of any of the additional work affect the size of the ICER, refer the reader to the summary
table in Section 6.
In the MS an abstract was used for the RE-NOVATE-II study. 32 The full paper for this study was
published after completion of the MS. 22 Five outcomes were reported in the full paper, that were not
reported in the abstract: Any DVT, Symptomatic DVT, Any bleeding, CRNM bleeding and Minor
bleeding. All other outcomes were the same in the full paper as in the abstract. The original ORs and
RRs have been reproduced in the table below together with the ORs and RRs including the results
from the full paper of RE-NOVATE-II.
Table 4.11: Results with and without the full paper for RE-NOVATE-II (Comparison:
Dabigatran etexilate 220 mg od vs. Enoxaparin 40 mg od in THR)
Based on RE-NOVATE alone Based on RE-NOVATE and
Eriksson 2011 (RE-NOVATE
Outcomes:
II) 22
Any DVT event (PE analysis) OR = 0.82 (0.55, 1.22) OR = 0.85 (0.65, 1.11)
RR = 0.83 (0.57, 1.20) RR = 0.86 (0.67, 1.10)
Symptomatic DVT (ITT analysis) OR = 6.05 (0.73, 50.35) OR = 5.01 (1.10, 22.89)
RR = 6.03 (0.73, 49.97) RR = 4.99 (1.10, 22.74)
Any bleeding (ITT analysis) OR = xxxxxxxxxxxxxxx OR = 1.13 (0.93, 1.37)
RR = xxxxxxxxxxxxxxx RR = 1.11 (0.93, 1.32)
CRNM bleeding (ITT analysis) OR = xxxxxxxxxxxxxxx OR = 1.19 (0.84, 1.69)
RR = xxxxxxxxxxxxxxx RR = 1.18 (0.84, 1.66)
Minor bleeding (ITT analysis) OR = 0.95 (0.68-1.33)
OR = 1.02 (0.80, 1.32)
RR = 0.95 (0.69-1.30)
RR = 1.02 (0.81, 1.29)
Adding the results reported in the full paper for RE-NOVATE II to those from RE-NOVATE alone
produces very small changes and slightly smaller confidence intervals. These changes are unlikely to
cause significant changes to the analyses in the MS.
31
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