ITC/MTC checklist final v5 27.10.16

INDIRECT TREATMENT COMPARISONAND MIXED TREATMENT COMPARISON (ITC/MTC) CHECKLIST

Pharmacist:
Health Services Researcher:
Economist:
Lead Assessor:
Date of NDC Meeting:
Full submission or resubmission:

Section 1

1.1 Name of medicine
1.2 Submitting company
1.3 Brief description of indirect comparison
1.4 What type of comparison was performed?
Type / Tick
Naïve (unadjusted) indirect comparison
Adjusted/anchored indirect comparison(single pairwise [Bucher] and extended/many pairwise [network])
Network meta-analysis or mixed treatment comparison
Indirect evidence only
Network meta-analysis or mixed treatment comparison
Indirect and direct evidence
Other:
Further/other information
Was a fixed or random effects model or was a meta-regression model used?
Detail:
1.5 SUMMARY
Issue / Comment
Target population / Satisfactory / weakness [delete as necessary]
Comparator / Satisfactory / weakness
Internal validity / Search strategy / Satisfactory / weakness
Included/excluded studies / Satisfactory / weakness
Quality of studies / Satisfactory / weakness
Heterogeneity / Satisfactory / weakness
Check for consistency / Satisfactory / weakness / not relevant
External validity / Satisfactory / weakness
Choice of outcome(s) / Satisfactory / weakness
Reporting of outcome(s) (credible intervals, ranking etc) / Satisfactory / weakness
Relevance to economic analysis / Satisfactory / weakness

Section 2: Assessment of indirect comparison

2.1 TARGET POPULATION
Was the target patient population clearly defined?
2.2 COMPARATORS
Are the comparators relevant (ie, those identified in the clinical checklist and clinical expert feedback, and included in the economic case)?
2.3INTERNAL VALIDITY
2.3.1 Appropriate identification of studies
Review of search strategy by KST
Were inclusion/exclusion criteria specified and appropriate?
Study selection
Total number of studies identified =
Number of studies excluded from the indirect comparison =
Number of studies included in the indirect comparison =
Was study selection process (ie,included/excluded studies) appropriate?
2.3.2Quality and Clinical relevance of individual studies
Was there a quality/validity assessment of individual studies (if no summarise study types)?
Are the studies clinically relevant?
2.3.3Similarity between studies(heterogeneity)
Were patient/study characteristics similar in the included studies (refer to section in company’s submission if these data have been summarised), eg:
  • patients characteristics
  • interventions
  • settings
  • length of follow-up
/
  • primary outcome(s) measured
  • baseline severity of the condition
  • additional medication used to supplement the trial drug, etc.

If there are differences has the submitting company described them carefully and accurately and not dismissed them as “similar”?
Were measures of heterogeneity (eg, I2, Q statistic, Tau2) reported?
Were the outcomes in the common control arms of the studies similar?
2.3.4For mixed treatment comparisons - coherency between direct and indirect comparisons (evidence inconsistency)
Were the outcome estimates between direct and indirect comparisons similar (ie, have adequate checks for inconsistency been made)?
If outcomes estimates were not similar (ie,there is inconsistency between direct and indirect comparisons), was it accounted for?
2.4 EXTERNAL VALIDITY
Can results be extrapolated to population of interest?

Section 3: Results

3.1 What outcome measure(s) were reported for the indirect/mixed treatment comparison? Are they clearly defined, appropriate and the same in the included studies?
3.2 Have any key outcomes from the included studies not been reported for the indirect/mixed treatment comparison?
3.3 Have different outcomes been combined?
3.4 If fixed effects used in the model was there important statistical heterogeneity?
3.5 If random effects used in the model was this justified?
3.6 Are the results of the indirect/mixed treatment comparisonclearly presented?
3.7 What are the results? (may refer to section in company’s submission)
3.8 Were sensitivity/scenario analyses findings included?

Section 4: Conclusion

4.1 What was the submitting company’s conclusion?
4.2 What are the limitations affecting this conclusion?

Section 5: References

The NDC Indirect Comparison Checklist is provided to the manufacturer, in confidence, for information purposes only. Publication of this checklist, or parts thereof, is prohibited. In accordance with the Data Protection Act 1998 and any other applicable data protection legislation all personal information has been removed from the checklist prior to release to the manufacturer.

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