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

Table 36: Summary of uncertainties
Summary of uncertainties Has the impact on the ICER been
The original MS used data estimated from
the whole trial population. Additional
analyses were provided by the manufacturer
following a request from the ERG using data
on the baseline risk of events, and treatment
effect by intended treatment duration.
Is using data by intended treatment duration
for the acute phase of treatment appropriate?
Is it likely to change the ICER?
The manufacturer assumed that the
proportions of VTEs that are PEs are the
examined?
This has been formally examined by the
manufacturer following a request from the
ERG
This has been formally examined by the
ERG, using data by initial treatment received
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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?
Rivaroxaban remained dominant compared with
LMWH/VKA in all the analyses provided by the
manufacturer (primary analyses).
The impact in terms of QALYs and Costs are described
below;
3 months group
Using data by intended treatment duration, rivaroxaban was
associated with a smaller gain in QALYs but a greater saving
in costs compared with using data for the whole population.
6 months group
Using data by intended treatment duration, rivaroxaban was
associated with a smaller gain in QALYs and a lower saving
in costs compared with using data for the whole population.
12 months group
Using data by intended treatment duration, rivaroxaban was
associated with a greater gain in QALYs and a greater saving
in costs compared with using data for the whole population.
Results of these analyses are presented in section 6 of the
ERG report.
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