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

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Has <strong>the</strong> source <strong>for</strong> all costs been described? Y<br />

Have discount rates been described and justified<br />

given <strong>the</strong> target decision-maker?<br />

Are <strong>the</strong> utilities <strong>in</strong>corporated <strong>in</strong>to <strong>the</strong> model<br />

appropriate?<br />

Is <strong>the</strong> source <strong>for</strong> <strong>the</strong> utility weights referenced? Y<br />

Are <strong>the</strong> methods <strong>of</strong> derivation <strong>for</strong> <strong>the</strong> utility<br />

weights justified?<br />

Have all data <strong>in</strong>corporated <strong>in</strong>to <strong>the</strong> model been<br />

described and referenced <strong>in</strong> sufficient detail?<br />

Has <strong>the</strong> use <strong>of</strong> mutually <strong>in</strong>consistent data been<br />

justified (i.e. are assumptions and choices<br />

appropriate)?<br />

Y<br />

Y/N<br />

Y/N<br />

Is <strong>the</strong> process <strong>of</strong> data <strong>in</strong>corporation transparent? Y/N<br />

If data have been <strong>in</strong>corporated as distributions,<br />

has <strong>the</strong> choice <strong>of</strong> distribution <strong>for</strong> each parameter<br />

been described and justified?<br />

If data have been <strong>in</strong>corporated as distributions, is<br />

it clear that second order uncerta<strong>in</strong>ty is reflected?<br />

Have <strong>the</strong> four pr<strong>in</strong>cipal types <strong>of</strong> uncerta<strong>in</strong>ty been<br />

addressed?<br />

If not, has <strong>the</strong> omission <strong>of</strong> particular <strong>for</strong>ms <strong>of</strong><br />

uncerta<strong>in</strong>ty been justified?<br />

Have methodological uncerta<strong>in</strong>ties been<br />

addressed by runn<strong>in</strong>g alternative versions <strong>of</strong> <strong>the</strong><br />

model with different methodological<br />

assumptions?<br />

Is <strong>the</strong>re evidence that structural uncerta<strong>in</strong>ties<br />

have been addressed via sensitivity analysis?<br />

Has heterogeneity been dealt with by runn<strong>in</strong>g <strong>the</strong><br />

model separately <strong>for</strong> different subgroups?<br />

Are <strong>the</strong> methods <strong>of</strong> assessment <strong>of</strong> parameter<br />

uncerta<strong>in</strong>ty appropriate?<br />

If data are <strong>in</strong>corporated as po<strong>in</strong>t estimates, are<br />

<strong>the</strong> ranges used <strong>for</strong> sensitivity analysis stated<br />

clearly and justified?<br />

Is <strong>the</strong>re evidence that <strong>the</strong> ma<strong>the</strong>matical logic <strong>of</strong><br />

<strong>the</strong> model has been tested thoroughly be<strong>for</strong>e<br />

use?<br />

Y<br />

Y<br />

Y<br />

Y<br />

Y<br />

N.A.<br />

Y<br />

Y<br />

Y<br />

Y/N<br />

Y<br />

Y<br />

91<br />

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

Utilities <strong>in</strong>corporated <strong>in</strong> <strong>the</strong> model are based on a<br />

wide variety <strong>of</strong> methods.<br />

Due to lack <strong>of</strong> data some utility <strong>in</strong>puts were not<br />

reference case (<strong>for</strong> <strong>in</strong>stance no preference data<br />

from <strong>the</strong> public). This was fur<strong>the</strong>r justified <strong>in</strong> <strong>the</strong><br />

clarification phase.<br />

Inclusion <strong>of</strong> trials <strong>in</strong> <strong>the</strong> <strong>in</strong>direct comparison and<br />

MTC <strong>for</strong> efficacy not safety was not clear.<br />

However, this was resolved <strong>in</strong> <strong>the</strong> clarification<br />

phase.<br />

It was stated that only parameters not <strong>in</strong>cluded <strong>in</strong><br />

<strong>the</strong> determ<strong>in</strong>istic sensitivity analyses were<br />

<strong>in</strong>cluded <strong>in</strong> <strong>the</strong> PSA. Although some parameters<br />

were <strong>in</strong>cluded <strong>in</strong> both, this <strong>in</strong>dicates that not all<br />

parameter uncerta<strong>in</strong>ty was reflected <strong>in</strong> <strong>the</strong> PSA.<br />

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