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

Summary of uncertainties Has the impact on the ICER been
Similarly, the manufacturer assumed that the
proportion of major bleeds that are IC bleeds
are the same irrespective of the initial
treatment received, but no data have been
presented to support or reject this
assumption.
Is using data by initial treatment received
(and possibly by intended treatment duration)
more appropriate? Is it likely to change the
conclusion?
There are uncertainties about the INR
monitoring for patients with VTE treated
with a VKA in England and Wales.
The manufacturer assumed 9 visits the first 3
months, and 5 visits thereafter.
Clinical advisors to the ERG suggested a less
intensive monitoring.
What is the INR monitoring for VTE patients
treated with a VKA in England and Wales?
Is it likely to change the conclusion?
examined?
This has not been formally examined by the
ERG due to the absence of data.
This has been formally examined by the
ERG assuming 6 visits the first 3 months,
and 3 visits thereafter.
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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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The ICERs are likely to change, but no analyses were
conducted due to the absence of data.
Indicative impact on the ICER:
Results will be biased in favour of the treatment that is
associated with more IC bleeds (if any).
Results of these analyses are presented in section 6.
In patients treated for 3 months, rivaroxaban remained
dominant amending the assumptions about monitoring only.
The ICER was above £20,000 per QALY gained when this
assumptions was amended (monitoring) in combination with
assuming a different split DVTs/PEs.
In patients treated for 6 months, rivaroxaban was no longer
dominant amending the assumptions about monitoring only,