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Apixaban for the prevention of venous thromboembolism in people ...

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The NICE cl<strong>in</strong>ical guidel<strong>in</strong>e on reduc<strong>in</strong>g <strong>the</strong> risk <strong>of</strong> VTE <strong>in</strong> patients admitted to hospital (CG92)<br />

recommends that dabigatran etexilate (start<strong>in</strong>g 1 to 4 hours after surgery), fondapar<strong>in</strong>ux sodium<br />

(start<strong>in</strong>g 6 hours after surgical closure provided haemostasis has been established), low molecular<br />

weight hepar<strong>in</strong> (LMWH) (start<strong>in</strong>g 6–12 hours after surgery), rivaroxaban (start<strong>in</strong>g 6–10 hours after<br />

surgery), or unfractionated hepar<strong>in</strong> <strong>for</strong> patients with renal failure (start<strong>in</strong>g 6–12 hours after surgery)<br />

should be <strong>of</strong>fered <strong>in</strong> comb<strong>in</strong>ation with mechanical and pharmacological methods <strong>for</strong> patients<br />

undergo<strong>in</strong>g elective knee and hip replacement surgery.<br />

The ERG has no concerns with <strong>the</strong>se choices <strong>of</strong> comparators.<br />

3.4 Outcomes<br />

Do <strong>the</strong> outcomes <strong>in</strong> <strong>the</strong> MS match <strong>the</strong> outcomes described <strong>in</strong> <strong>the</strong> f<strong>in</strong>al scope? If not, provide fur<strong>the</strong>r<br />

details. Consider cl<strong>in</strong>ical effectiveness, adverse events, quality <strong>of</strong> life and health economic outcomes<br />

and a discussion <strong>of</strong> appropriate mechanisms <strong>for</strong> measur<strong>in</strong>g <strong>the</strong>se outcomes. Is <strong>the</strong> focus <strong>of</strong> <strong>the</strong><br />

submission on appropriate outcomes or has it been limited to non-ideal outcomes?<br />

The majority <strong>of</strong> <strong>the</strong> key cl<strong>in</strong>ical outcomes are considered with<strong>in</strong> <strong>the</strong> model both <strong>in</strong> <strong>the</strong> short term and<br />

<strong>in</strong> <strong>the</strong> long term. These are VTEs, PTS, mortality and bleeds.<br />

3.5 O<strong>the</strong>r relevant factors<br />

For example: Does <strong>the</strong> MS <strong>in</strong>clude a section on equity considerations? Is <strong>the</strong>re an ongo<strong>in</strong>g Patient<br />

Access Scheme application?<br />

The ERG considers that <strong>the</strong> time horizon <strong>of</strong> <strong>the</strong> model <strong>of</strong> 35 years is appropriate <strong>for</strong> this decision<br />

problem given <strong>the</strong> mean age <strong>of</strong> <strong>the</strong> population <strong>of</strong> 65 or 68 (depend<strong>in</strong>g on sex and whe<strong>the</strong>r THR or<br />

TKR); this makes <strong>the</strong> f<strong>in</strong>al age at least 100 years, which approximates a lifetime.<br />

The ERG has listed all concerns <strong>in</strong> <strong>the</strong> previous and <strong>in</strong> <strong>the</strong> follow<strong>in</strong>g sections.<br />

13<br />

Copyright 2011 Queen’s Pr<strong>in</strong>ter and Controller <strong>of</strong> HMSO. All rights reserved.

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