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Demonstrating the value of vaccines: global NITAG and HTA agency requirements

In this article, we will describe global requirements that national immunization technical advisory groups (NITAGs) and health technology assessment (HTA) agencies use for vaccine evaluation with consideration of some of the variations observed across countries.

This has become a hot topic of interest in more recent times, as market approval of vaccines has been followed more closely, with the differences in practices between countries becoming more apparent.

Multiple stakeholders are involved in the approval of new vaccines

The approval of vaccines follows a similar process to pharmaceuticals, with multiple stakeholders having a role to play. First, regulatory approval is required in the form of the marketing authorization confirming the safety and efficacy of the vaccine; this is typically granted by the Food and Drug Administration (FDA) in the USA, the European Medicines Administration (EMA) in Europe, or the Therapeutic Goods Administration (TGA) in Australia, for example.

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This is followed by national appraisal of the value of a vaccine to provide recommendations for inclusion in the country’s immunization program, and it is from this stage that we start to see some of the intra-country variation.

Vaccine evaluations can be conducted by NITAGs, which are a panel of vaccine-related experts; a local HTA agency that typically assess pharmaceutical products; or a combination of both agencies. A decision-maker is also involved, which in many cases is the Ministry of Health.

Following recommendations there is a further step—implementation—and this can involve agencies with a remit to implement the national immunization program (NIP) on a national or regional basis.

NITAGs are critical stakeholders in decision-making for vaccines

NITAGs are a critical stakeholder in decision-making relating to vaccines. A NITAG is a multidisciplinary panel comprised of a range of experts, that brings together a balanced range of expertise from across disciplines. This typically includes epidemiologists, infectious disease experts, public health officials, clinicians, and health economists.

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The NITAG operates in an independent manner and the intent is that recommendations by a NITAG will be based on its critical evaluation of information relating to local disease burden, epidemiology, safety and efficacy of the vaccine candidate, and the overall cost-effectiveness.

NITAG recommendations tend to be advisory and are not legally binding (apart from in the UK); however, deviation from NITAG guidelines would be atypical.

NITAG recommendations for vaccines are usually respected by decision-makers

On a country-specific basis, when we review the NITAG and decision-maker agencies, we can see that the specific agency names vary from country to country but the overall dynamic of NITAG and decision-makers remains similar across these markets, with NITAG recommendations typically being respected by the decision-maker.

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The NITAG and decision maker agencies in France are the Technical Committee on Vaccinations and the Ministry of Health; in Germany it is the Standing Committee on Vaccinations and the Federal Joint Committee (Gemeinsamer Bundesausschuss; G-BA); in Spain the Working Group on Vaccines and the Inter-territorial council; in the UK the Joint Committee on Vaccination and Immunisation (JCVI) recommendation is binding for the Department of Health, and in the US the NITAG is the Advisory Committee on Immunization Practices (ACIP) and the decision-maker is the Centers for Disease Control and Prevention (CDC), or the US Department of Health and Human Services.

The varying role of HTA agencies in the vaccine appraisal process

The relationship between HTA agencies and NITAGs in the vaccine appraisal process varies, however.

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In Germany, Spain, the UK, and the USA, the NITAG has sole responsibility for this. In France, both the HTA agency and NITAG appraise new vaccines in parallel, with both appraisals feeding into the final recommendations.

It might be helpful now to look at a country-specific example in some more detail; the next update in the series takes us through this.

Watch the full presentation: Demonstrating the value of vaccines