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5.4 Conclusions<br />

Describe <strong>the</strong> completeness <strong>of</strong> <strong>the</strong> MS with regard to relevant cost effectiveness studies and data<br />

described <strong>in</strong> any de novo economic evaluations. Does <strong>the</strong> submission conta<strong>in</strong> an unbiased estimate <strong>of</strong><br />

<strong>the</strong> technology’s ICERs <strong>in</strong> relation to relevant populations, <strong>in</strong>terventions comparators and outcomes?<br />

Are <strong>the</strong>re any rema<strong>in</strong><strong>in</strong>g uncerta<strong>in</strong>ties about <strong>the</strong> reliability <strong>of</strong> <strong>the</strong> cost effectiveness evidence?<br />

Reference should also be made concern<strong>in</strong>g <strong>the</strong> extent to which <strong>the</strong> submitted evidence reflects <strong>the</strong><br />

decision problem def<strong>in</strong>ed <strong>in</strong> <strong>the</strong> f<strong>in</strong>al scope.<br />

The ERG believes that <strong>the</strong> MS represents an unbiased attempt to assess <strong>the</strong> cost-effectiveness <strong>of</strong><br />

apixaban <strong>for</strong> <strong>the</strong> <strong>prevention</strong> <strong>of</strong> VTE <strong>in</strong> <strong>people</strong> undergo<strong>in</strong>g THR or TKR.<br />

The ERG comment that <strong>the</strong> absolute <strong>in</strong>cremental differences between apixaban and <strong>the</strong> comparators<br />

are small, and based on only one or two trials per comparator. New evidence from future trials may<br />

<strong>the</strong>re<strong>for</strong>e impact <strong>the</strong> current cost-effectiveness results. Also, were health providers to negotiate prices<br />

<strong>for</strong> <strong>in</strong>terventions that were markedly different to those assumed with<strong>in</strong> <strong>the</strong> analyses, <strong>the</strong>n conclusions<br />

on <strong>the</strong> <strong>in</strong>tervention that is most likely to be cost-effective may change.<br />

6 Impact on <strong>the</strong> ICER <strong>of</strong> additional cl<strong>in</strong>ical and economic analyses undertaken by <strong>the</strong><br />

ERG<br />

Where appropriate, this section should <strong>in</strong>clude a table which shows (i) <strong>the</strong> effect <strong>of</strong> any major cl<strong>in</strong>ical<br />

or cost parameter change or structural change on <strong>the</strong> size <strong>of</strong> <strong>the</strong> base-case ICER and (ii) <strong>the</strong> effect <strong>of</strong><br />

mak<strong>in</strong>g all changes simultaneously on <strong>the</strong> size <strong>of</strong> <strong>the</strong> base-case ICER.<br />

The additional analysis undertaken by <strong>the</strong> ERG resulted <strong>in</strong> a lower ICER <strong>for</strong> apixaban as opposed to<br />

fondapar<strong>in</strong>ux. This however does not change <strong>the</strong> conclusion that, based on <strong>the</strong> determ<strong>in</strong>istic results,<br />

apixaban is deemed cost-effective as opposed to fondapar<strong>in</strong>ux.<br />

7 End <strong>of</strong> life<br />

Where appropriate, this section should summarise <strong>the</strong> manufacturer’s case <strong>for</strong> us<strong>in</strong>g <strong>the</strong> NICE end <strong>of</strong><br />

life treatment criteria and discuss to what extent <strong>the</strong> manufacturer’s argument is valid.<br />

Not applicable.<br />

8 Conclusions<br />

The section should focus on any difference(s) <strong>of</strong> op<strong>in</strong>ion between <strong>the</strong> manufacturer and <strong>the</strong> ERG that<br />

might <strong>in</strong>fluence <strong>the</strong> size <strong>of</strong> <strong>the</strong> ICER. Priority should be focussed on discuss<strong>in</strong>g <strong>in</strong><strong>for</strong>mation that will<br />

be useful to <strong>the</strong> Appraisal Committee <strong>in</strong>clud<strong>in</strong>g strengths, weaknesses and rema<strong>in</strong><strong>in</strong>g uncerta<strong>in</strong>ties.<br />

Fur<strong>the</strong>r summary <strong>of</strong> evidence is not required <strong>in</strong> this section.<br />

The MS appears to conta<strong>in</strong> an unbiased estimate <strong>of</strong> <strong>the</strong> treatment effect <strong>of</strong> apixaban <strong>in</strong> relation to <strong>the</strong><br />

relevant outcomes and <strong>the</strong> comparator, enoxapar<strong>in</strong>. Overall <strong>the</strong> evidence from <strong>the</strong> three ADVANCE<br />

trials <strong>in</strong> <strong>the</strong> MS <strong>in</strong>dicates that apixaban 2.5mg bd is significantly superior to <strong>the</strong> comparator<br />

enoxapar<strong>in</strong> (40mg od) <strong>in</strong> terms <strong>of</strong> xxxxxxxxxxxx, any DVT, xxxxxxxxx. Xxxxx xxxxxxxx xxxxxx<br />

xxxxxxxxxxx xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxxxx<br />

69<br />

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

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