Rivaroxaban for the treatment of deep vein thrombosis and ...

Summary of uncertainties Has the impact on the ICER been
used results from the rivaroxaban arm (from
the main analysis) and adjusted the risk of
events to reflect the increase in risk in cancer
patients vs. non cancer patients using data
from the EINSTEIN-DVT trial.
It is unclear if this is representative of the
risk of events in the cancer population?
In cancer patients, the treatment effects were
taken from the MTC. The manufacturer used
the median. The ERG believes that the mean
HR/OR would be more appropriate. The
manufacturer also used a between study
variability of U (0,5). The ERG believes this
to be high and believes that a between study
variability of U(0,2) or U(0,0.6) is more
appropriate.
Furthermore, is the analysis robust?
Is it likely to change the conclusions?
examined?
This has been partially examined by the ERG
in an exploratory analysis using the mean
treatment effect assuming a between study
variability of U(0,5), U(0,2), U(0,0.6)
The model relies on a series of assumptions
and data not specific to cancer patients were
used. It is unclear if these are appropriate.
Are results from the PSA robust? This has not been formally examined due to
time and resource constraints. Several issues
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If so, what are the results?
If not, is it possible to give any indication of the direction
of the results?
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rivaroxaban as outputs from the MTC indicated that
rivaroxaban had poorer outcomes compared with LMWH.
Exploratory analyses was undertaken by the ERG using the
mean treatment effect assuming a between study variability of
U(0,5), U(0,2), U(0,0.6). Results are presented in section 6.
It is unclear how a change in other assumptions would affect
the ICER due to the absence of data.