Appendix H: Clinical outcomes and disaggregated results from the model

NICE process and methods

1.1 Clinical outcomes from the model
1.2 Disaggregated results of the base-case incremental cost-effectiveness analysis

Appendix H: Clinical outcomes and disaggregated results from the model

1.1 Clinical outcomes from the model

For the outcomes highlighted in the decision problem (see section 1), provide the corresponding outcomes from the model and compare them with clinically important outcomes such as those reported in clinical trials, as suggested in the following table. Discuss reasons for any differences between the modelled results in the cost-effectiveness analysis and the observed results in the clinical trials (for example, adjustment for crossover).

**Table [X] Summary of model results compared with clinical data**
Outcome	Clinical trial result	Model result
Progression-free survival	C₁	R₁
Post-progression survival	C₂	R₂
Overall survival	C₁₊₂	R₁₊₂
Adverse reaction 1	C₃	R₃
[Add more rows as needed]

Provide (if appropriate) a graphical representation of how QALYs accrue over time in the economic model (for example, Markov trace, active partitioned survival curves or equivalent). Supply 1 for each comparator, showing the proportion of time spent in each health state over the full time horizon. Other time horizons may also be appropriate.

1.2 Disaggregated results of the base-case incremental cost-effectiveness analysis

Disaggregated results of the base-case incremental cost-effectiveness analysis

Provide details of the disaggregated QALYs and costs by health state, and of resource use predicted by the model in the base-case incremental cost-effectiveness analysis by category of cost. The following are the tables that should be completed summarising the disaggregated results (for example, QALY gain by health state, costs by health state, predicted resource use by category of cost).

**Table [X] Summary of QALY gain by health state**
Health state	QALY intervention (X)	QALY comparator (Y)	Increment	Absolute increment	% absolute increment
[Health state 1]	[X_HS1]	[Y_HS1]	[X_HS1 – Y_HS1]	[\|X_HS1 – Y_HS1\|]	[\|X_HS1 – Y_HS1\|/(Total absolute increment)]
[Health state 2]	[X_HS2]	[Y_HS2]	[X_HS2 – Y_HS2]	[\|X_HS2 – Y_HS2\|]	[\|X_HS2 – Y_HS2\|/(Total absolute increment)]
[Add more rows as needed]
Total	[X_Total]	[Y_Total]	[X_Total – Y_Total]	Total absolute increment	100%

Abbreviations: HS1, health state 1; HS2, health state 2; QALY, quality-adjusted life year. Adapted from Pharmaceutical Benefits Advisory Committee (2008) Guidelines for preparing submissions to the Pharmaceutical Benefits Advisory Committee (Version 4.3). Canberra: Pharmaceutical Benefits Advisory Committee.

**Table [X] Summary of costs by health state**
Health state	Cost intervention (X)	Cost comparator (Y)	Increment	Absolute increment	% absolute increment
[Health state 1 (_HS1)]	[X_HS1]	[Y_HS1]	[X_HS1 – Y_HS1]	[\|X_HS1 – Y_HS1\|]	[\|X_HS1 – Y_HS1\| / (Total absolute increment)]
[Health state 2]	[X_HS2]	[Y_HS2]	[X_HS2 – Y_HS2]	[\|X_HS2 – Y_HS2\|]	[\|X_HS2 – Y_HS2\| / (Total absolute increment)]
[Add more rows as needed]
Total	[X_Total]	[Y_Total]	[X_Total – Y_Total]	Total absolute increment	100%

Abbreviations: HS1, health state 1; HS2, health state 2. Adapted from Pharmaceutical Benefits Advisory Committee (2008) Guidelines for preparing submissions to the Pharmaceutical Benefits Advisory Committee (Version 4.3). Canberra: Pharmaceutical Benefits Advisory Committee.

**Table [X] Summary of predicted resource use by category of cost**
Item	Cost intervention (X)	Cost comparator (Y)	Increment	Absolute increment	% absolute increment
[Technology cost]	[X_tech]	[Y_tech]	[X_tech – Y_tech]	[\|X_tech – Y_tech\|]	[\|X_tech – Y_tech\| / (Total absolute increment)]
[Mean total treatment cost]	[X_treat]	[Y_treat]	[X_treat – Y_treat]	[\|X_treat – Y_treat\|]	[\|X_treat – Y_treat\| / (Total absolute increment)]
[Administration cost]	[X_admin]	[Y_admin]	[X_admin – Y_admin]	[\|X_admin – Y_admin\|]	[\|X_admin – Y_admin\| / (Total absolute increment)]
[Monitoring cost]	[X_mon]	[Y_mon]	[X_mon – Y_mon]	[\|X_mon – Y_mon\|]	[\|X_mon – Y_mon\| / (Total absolute increment)]
[Tests]	[X_tests]	[Y_tests]	[X_tests – Y_tests]	[\|X_tests – Y_tests\|]	[\|X_tests – Y_tests\| / (Total absolute increment)]
[Add more rows as needed]
Total	[X_Total]	[Y_Total]	[X_Total – Y_Total]	Total absolute increment	100%

Abbreviations: admin, administration; mon, monitoring; tech, technology; treat, treatment.

See sections 3.10.1 to 3.10.2.