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

2 BACKGROUND
2.1 Critique of manufacturer’s description of underlying health problem.
The evidence review group (ERG) and clinical advisors to the ERG believe that the manufacturer’s
description of the underlying health problem is appropriate and relevant to the decision problem. The
relevant sections from the manufacturer’s submission (MS) 1 are as follows.
‘Venous thromboembolism (VTE) is a common disorder, with about 1 per 1,000 people per year in
the general population presenting with clinical symptoms. 2-4 The incidence of VTE varies
substantially with age - for people under 40 years the annual incidence of venous thromboembolism is
1 in 10,000, whereas for people over 80 years the incidence rises to 1 in 100. 2,4
Approximately two-thirds of cases of VTE present as deep vein thrombosis (DVT), the formation of a
thrombus in a deep vein, usually of the lower limbs 5 Around one third of VTE cases present as
pulmonary embolism (PE), occurring when dislodged thrombi (from a DVT) travel to the lungs. PE
can cause sudden death and those who survive an episode occasionally require intensive care, with
recovery taking several weeks or months. The clinical course of DVT may also be complicated by
recurrent episodes of DVT, the development of post-thrombotic syndrome (PTS), as well as chronic
thromboembolic pulmonary hypertension (CTEPH). 6
NICE clinical guideline 92 (Reducing the risk of venous thromboembolism in patients admitted to
hospital) 7 identifies various risk factors for venous thromboembolism. These include active cancer or
cancer treatment, age over 60 years, critical care admission, dehydration, known thrombophilias,
obesity, the presence of comorbidities such as heart disease and metabolic pathologies, family history
of thromboembolic disease, use of hormone replacement therapy or oestrogen containing
contraceptive therapy and varicose veins with phlebitis. 7 Other risk factors include recent surgery,
trauma and immobilisation.
Treatment for venous thromboembolism is usually initiated with anticoagulant drugs (...). Despite
anticoagulation treatment, patients with a DVT or PE remain at risk of recurrence. This risk can
continue for months into years, depending on each patient’s underlying risk factors. Prandoni et al
reported a cumulative incidence of recurrent VTE of 11% after one year and 50% after ten years; 8 a
cumulative incidence of 24.6% at two years and 31.8% after ten years has been reported in a large
cohort from Vienna. 9
11
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