Comparison criteria

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Question

Which comparison criteria should be used in the tendering process for the selection of a pneumococcal conjugate vaccine within the national vaccination programme for children in Finland? The tendering process will be initiated during the autumn of 2014.

• Possible comparison criteria include price, effectiveness, safety and technical properties.
  • Price refers to the bargaining price of the vaccine.
  • Effectiveness refers to the decrease in disease burden caused in the total Finnish population by large scale use of the vaccine in the infant programme. As a result health care costs decrease and the quality of life attributed to improved health increases.
  • Safety
  • Technical properties

Answer

The proposal is that the comparison of vaccine products will be based on price only (see Economic_evaluation. This is based on the expected small difference in the effectiveness and costs incurred between the two licensed vaccines, when effectiveness was based on prevention of invasive pneumococcal disease. The importance of including other endpoints than invasive disease is acknowledged, however, due to lack sufficient data on vaccine-preventable (serotype-specific) incidences, such analyses were not conducted so far.

Rationale

According to the public procurement law, comparison criteria related to differences in the products can be applied if (1) the differences are clearly demonstrated and (2) the differences can be quantified in terms of increased or decreased benefits. In particular, technical differences typically fall outside of this realm. So far no credible differences in safety among the currently licensed pneumococcal conjugate vaccines have been demonstrated.

To assess the health benefits of vaccination, the following items needs to be known or assessed:

• pneumococcal serotypes included in the vaccine
• decrease in the pneumococcal disease incidences due to vaccination
• the potential protection of the vaccine against disease caused by the bacterium Haemophilus influenzae

The tentative assumption is that the use of either the 10-valent (PCV10) or 13-valent (PCV13) pneumococcal conjugate vaccine (PCV) in the childhood immunization programme significantly reduces the disease incidence attributable to the serotypes included in the vaccine and that this protection extends to the population at large. This assumption may be modified so that the vaccine also reduces disease incidence caused by certain serotypes not included in the vaccine (due to cross-protection). The predicted reduction in invasive pneumococcal disease due to vaccination is calculated using an epidemiological model.

The vaccine-preventable pneumococcal disease incidence used in the model is assumed to correspond to proven (blood culture-positive) invasive pneumococcal disease. In view of recent knowledge and if deemed feasible, also estimates of non-laboratory-confirmed IPD among children under 5 years of age can be included. For other pneumococcal disease endpoints, reliable estimates of the vaccine-preventable disease incidences are not available. Therefore, criteria or endpoints that should be considered are a) price, b) invasive pneumococcal disease, and c) technical criteria. However, if there were enough reliable data, also pneumonia and other respiratory endpoints should be included. Otitis media should be included at least as a sensitivity analysis.R↻

Related files

• GSK 02 Comparison criteria_final_for Opasnet