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Evaluation of vaccines: guidance on evidence and modeling requirements

Vanya Nikolova | 11/30/2023

In the fourth of our series of updates examining market access for vaccines, Vanya Nikolova, Senior Consultant, summarizes the evaluation guidance from national immunization technical advisory groups (NITAG) and health technology assessment (HTA) agencies in France, Germany, Italy, Spain, the UK, and the US.

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Demonstrating the value of vaccines: global NITAG and HTA requirements

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NITAGs or HTA agencies publish guidance on evidence and modeling requirements for evaluation of vaccines.

General guidance on the vaccine evaluation process and evidence requirements is available for France, Germany, the UK, and the US. The World Health Organization (WHO) has also provided guidance on the recommended framework for the development of evidence-based vaccine recommendations.

In Italy and Spain, however, official guidance documents for conducting vaccine evaluation have not been published and instead WHO guidelines are followed in these markets.
Guidance documents with requirements and recommendation for vaccine economic and epidemiological modeling have been published by NITAGs in Germany, the UK, and the US. WHO has also issued guidance for the standardization of economic evaluations of immunization programs.

In France, HAS methodological guidelines need to be observed when vaccine economic models are being developed. However, official guidance documents for economic modeling of vaccines have not been published in Italy; instead, published economic models and existing recommendation from other national and international HTA agencies could be used for guidance.

 

NITAGs and HTA agencies publish guidance on evidence and modeling requirements for evaluation of vaccines

 

General guidance on the vaccine evaluation process and evidence requirements is available for France, Germany, the UK, and the US. The World Health Organization (WHO) has also provided guidance on the recommended framework for the development of evidence-based vaccine recommendations.

In Italy and Spain, however, official guidance documents for conducting vaccine evaluation have not been published and instead WHO guidelines are followed in these markets.
Guidance documents with requirements and recommendation for vaccine economic and epidemiological modeling have been published by NITAGs in Germany, the UK, and the US. WHO has also issued guidance for the standardization of economic evaluations of immunization programs.

In France, HAS methodological guidelines need to be observed when vaccine economic models are being developed. However, official guidance documents for economic modeling of vaccines have not been published in Italy; instead, published economic models and existing recommendation from other national and international HTA agencies could be used for guidance.

 

Systematic literature reviews and quality appraisal of the evidence are an important part of NITAG and HTA vaccine evaluations

As vaccine recommendations are evidence-based, systematic literature reviews and quality appraisal of the evidence are an important part of NITAG and HTA vaccine evaluations.

The Cochrane framework for systematic reviews is used in Germany and the US. In contrast, systematic literature reviews to support vaccine appraisals in France and the UK should be conducted in alignment with HAS and the National Institute for Health and Care Excellence (NICE) standards, respectively.

The WHO considers both the NICE and Cochrane methodological frameworks as acceptable. However, it is unclear from published literature whether the Italian Medicines Agency or the Spanish NITAG might have preferences for specific systematic literature review frameworks.

 

Watch the full presentation

Demonstrating the value of vaccines: global NITAG and HTA requirements

Watch now

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