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

Table 2: Statement of the decision problem, reproduced from the MS, page 27.
Population
Intervention
Comparator(s)
Final scope issued by NICE Decision problem addressed in the
submission
People with confirmed symptomatic
DVT
17
Rationale provided by the manufacturer, if
different from the scope
Adults with an acute DVT To match wording of licensed indication
Rivaroxaban Rivaroxaban NA
Initial treatment with UH or a LMWH
(such as enoxaparin) with continued
therapy as follows:
VKA (such as warfarin)
UH or LMWH for people for whom
a VKA is not considered an
appropriate treatment
No preventative therapy
Outcomes Mortality
Recurrent VTE
Complications following DVT
including post thrombotic syndrome
(PTS) and chronic thromboembolic
pulmonary hypertension (CTEPH)
Adverse events of treatment
including bleeding events
Health-related quality of life
Economic analysis
The reference case stipulates that the
cost effectiveness of treatments should
Initial treatment with LMWH with
continued VKA therapy for the
remainder of 3, 6 or 12 months,
followed by no active therapy
VKA is not considered an appropriate
treatment in patients with cancer, and in
this subgroup, the use of LMWH will be
evaluated
As final scope NA
As final scope. A lifetime horizon will NA
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Guidelines consistently recommend treatment
with VKA (or LMWH in cancer patients) for at
least 3 months, after initial stabilisation with
LMWH. `No therapy’ is not a recommended
option. Treatment and prevention are recognised
as being at alternate ends of a continuum of care.
UH is generally only recommended over LMWH
if there is severe renal impairment (creatinine
clearance < 30 mL/min). Such patients were
excluded from the principle phase III trials of
rivaroxaban and the use of rivaroxaban in such
patients is cautioned against in the draft SmPC.