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described and justified?<br />

Do <strong>the</strong> disease states (state transition model) or<br />

<strong>the</strong> pathways (decision tree model) reflect <strong>the</strong><br />

underly<strong>in</strong>g biological process <strong>of</strong> <strong>the</strong> disease <strong>in</strong><br />

question and <strong>the</strong> impact <strong>of</strong> <strong>in</strong>terventions?<br />

Is <strong>the</strong> cycle length def<strong>in</strong>ed and justified <strong>in</strong> terms<br />

<strong>of</strong> <strong>the</strong> natural history <strong>of</strong> disease?<br />

Are <strong>the</strong> data identification methods transparent<br />

and appropriate given <strong>the</strong> objectives <strong>of</strong> <strong>the</strong><br />

model?<br />

Where choices have been made between data<br />

sources, are <strong>the</strong>se justified appropriately?<br />

Has particular attention been paid to identify<strong>in</strong>g<br />

data <strong>for</strong> <strong>the</strong> important parameters <strong>in</strong> <strong>the</strong> model?<br />

Has <strong>the</strong> quality <strong>of</strong> <strong>the</strong> data been assessed<br />

appropriately?<br />

Where expert op<strong>in</strong>ion has been used, are <strong>the</strong><br />

methods described and justified?<br />

Is <strong>the</strong> data modell<strong>in</strong>g methodology based on<br />

justifiable statistical and epidemiological<br />

techniques?<br />

Is <strong>the</strong> choice <strong>of</strong> basel<strong>in</strong>e data described and<br />

justified?<br />

Are transition probabilities calculated<br />

appropriately?<br />

Has a half-cycle correction been applied to both<br />

cost and outcome?<br />

If not, has this omission been justified? Y<br />

If relative treatment effects have been derived<br />

from trial data, have <strong>the</strong>y been syn<strong>the</strong>sised us<strong>in</strong>g<br />

appropriate techniques?<br />

Have <strong>the</strong> methods and assumptions used to<br />

extrapolate short-term results to f<strong>in</strong>al outcomes<br />

been documented and justified?<br />

Have alternative extrapolation assumptions been<br />

explored through sensitivity analysis?<br />

Have assumptions regard<strong>in</strong>g <strong>the</strong> cont<strong>in</strong>u<strong>in</strong>g effect<br />

<strong>of</strong> treatment once treatment is complete been<br />

documented and justified?<br />

Have alternative assumptions regard<strong>in</strong>g <strong>the</strong><br />

cont<strong>in</strong>u<strong>in</strong>g effect <strong>of</strong> treatment been explored<br />

through sensitivity analysis?<br />

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

justified?<br />

Y/N Not <strong>for</strong> PTS (see earlier comment)<br />

Y<br />

Y<br />

Y<br />

Y<br />

Y<br />

N.A.<br />

Y<br />

Y<br />

Y<br />

N<br />

Y<br />

Y<br />

Y<br />

Y<br />

Y<br />

Y<br />

90<br />

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

Costs and cl<strong>in</strong>ical outcomes are extrapolated<br />

beyond <strong>the</strong> end <strong>of</strong> <strong>the</strong> trial. Patients who<br />

experience an event are at risk <strong>of</strong> recurrence <strong>of</strong> a<br />

VTE event or complication over a longer<br />

timeframe. These risks are not assumed to be<br />

treatment dependent.

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