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, benefits, safety and technical properties.
  • Price refers to the bargaining price of the vaccine.
  • Benefits refer to the decrease in disease burden caused by large scale use of the vaccine. As a result health care costs decrease and the quality of life attributed to improved health increases.
  • Safety
  • Technical properties
• The benefits of the pneumococcal conjugate vaccine are quantified by the decrease of disease forms caused by pneumococcus and the bacterium Haemophilus influenzae.
• The benefits are assessed in the entire Finnish population.

Answer

The tentative proposal is that the comparison is based on price and assessed benefits. Benefits are quantified as the expected decrease in invasive pneumococcal disease incidence due to vaccination. This tentative proposal is the basis for the conversation beginning in the summer of 2014.

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 incidence due to vaccination
• the structure of the so called carrier proteins included in the vaccine and the potential of the vaccine to protect against other than pneumococcal related diseases
• 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 (Palmu et al, 2014, in press) 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.