​​​​​​​​​​1 SCOPE OF THE ASSESSMENT

​P
Population, patients​​​
​I
​Intervention
​C
Comparison, comparators
​O 
​Outcomes
​(T)
Time​
​(S)
​Setting

1 DESCRIPTION OF THE INTERVENTION TO BE ASSESSED AND ITS COMPARATORS

This section answers the following questions:
1.1 What is the medicinal product to be assessed and for what purposes is it used? 
1.2 How is the medicinal product to be assessed used?
1.3 What are the currently available treatment options?

2 CLINICAL EFFECTIVENESS AND SAFETY

This section answers the following questions:
2.1 What are the published clinical studies of the medicinal product being assessed?
2.2 What are the ongoing and unpublished clinical studies of the medicinal product being assessed?
2.3 What is the effect of the medicinal product being assessed on overall survival compared to its comparators?
2.4 What is the effect of the medicinal product being assessed on clinical endpoints compared to its comparators?
2.5 What is the effect of the medicinal product being assessed on the patient-reported outcomes compared to its comparators? (for example, the quality of life)
2.6 What is the effect of the medicinal product being assessed on surrogate outcomes compared to its comparators? 
2.7 Is the effect of the intervention consistent between different patient groups (subgroups)?
2.8 How safe is the treatment compared to other treatment options  ?
2.9 What type of uncertainty is potentially associated with the clinical effectiveness and safety?

3 COST-EFFECTIVENESS (only applicable parts will be jointly assessed)

The section answers the following questions:
3.1 What are the major determinants of expected benefits and costs associated with the medicinal product being assessed and its comparators?
3.2 What type of uncertainty (methodological, structural and    statistcial) is associated with the cost-effectiveness?
3.3 Is the cost-effectiveness of the intervention likely to be different between patient groups?

4 OTHER FACTORS (when necessary)

This section answers the following questions where necessary:
4.1 Are there any ethical, organisational, social or legal aspects specific to the intervention that should be taken into consideration during the assessment?
4.2 Is the intervention associated with any specific patient perspectives that should be taken into consideration during the assessment?

This joint report will be complemented with local data and analysis. This may include national budget impact analysis cost-effectiveness results based on national price, etc.

Publisert: 21.06.2022

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