Dr Paolo D’Ancona, of the National Centre for Epidemiology, Rome, says the range of vaccines provided by European governments – and the approaches taken to decide which ones to provide – is highly divergent.
Speaking to Vaccines Today about his presentation to the European Public Health conference in Copenhagen about the introduction of pneumococcal vaccination across Europe, he suggested that Health Technology Assessment (HTA) could help governments develop rational ways of deciding whether a new vaccine is worth introduction.
HTA is a way of examining the value of a health-related product based on its medical, economic, social and ethical implications.
A number of European countries already use this method when contemplating paying for new vaccines – as well as for medicines, medical devices and e-health products – but some authorities say they do not have enough information on which to base decisions.
“The differences in European use of HTA are large. Only 15 out of 28 countries have a national agency in charge of HTA. It is also possible that universities or other scientific groups decide to produce one, as is the case in Italy. However, according to our research, only 10 countries had already performed an HTA on the pneumococcal vaccine. So the use of HTA is not so widespread in Europe. [But] In our view, it should be encouraged,” he said.
Local solutions to European problems
On top of deep-rooted cultural differences, one of the barriers to ironing out differences across Europe is the fact that the EU’s role in health policy is limited. National governments are responsible for deciding how to organise and pay for their health service.
This, says Christelle Saint Sardos who spoke on behalf of the European Vaccine Manufacturers at a workshop organised by Dr Guiseppe La Torre of the Sapienza University of Rome, is unlikely to change. However, she said that while European countries will retain independence, they face similar challenges.
“There is a growing interest in the exchange of best practices regarding vaccination policy in general. This is a broader topic but perhaps the EU could facilitate these discussions,” she said, adding that the development of some general, high-level principles for vaccines could prove beneficial.
Saint Sardos called for greater transparency in how decisions are made, adding that pre-defined, science-based, and vaccine-specific criteria should be applied.
Also speaking at the workshop, Ruth Gelletlie director of local and regional services at the Health Protection Agency and President of the EUPHA section on Infectious Disease Control, observed that the existence of a national programme is a condition of population acceptance and uptake of vaccines.
Carlo Signorelli, Professor of Hygiene at Parma University and Head of the Vaccine Commission at the Italian Society of Public health, added that in Italy, the introduction of co-payment for some vaccines has led to insufficient coverage.
The population interpreted the co-payment as a sign that these vaccinations were less useful, he said, adding that a system of multiple recommendations would then require adequate communication to the public.
The following is a transcript of a Q&A interview with Dr Paolo D’Ancona
At the recent EUPHA conference you discussed the Venice II project on best practice in vaccination programmes in Europe. What were the main findings of the study on the introduction of new vaccines?
The study specifically looks at the pneumococcal vaccine so the results cannot be generalised to all the new vaccines. We collected information on the capacity to perform a Health Technology Assessment (HTA) for pneumococcal vaccines at national level in each European country. The main finding is that the degree of diversity is so high that it is not possible to have one single protocol for HTA applied in all countries because not all countries have the same information. However, some countries have enough information to perform a HTA in order to have more information which would be useful for the decision on the implementation of this vaccine.
What role does HTA play in determining whether a new vaccine is introduced?
HTA is a systematic approach to examining the medical, economic, social and ethical implications of the incremental value, diffusion and use of a biomedical technology including vaccines. It provides not only an overview but also estimates that permit economic analysis of the vaccine at national level. These values can be compared with the threshold value of cost effectiveness in that specific country.
Are there major differences across Europe?
The differences in European use of HTA are large. Only 15 out of 28 countries have a national agency in charge of HTA. It is also possible that universities or other scientific groups decide to produce one, as is the case in Italy. However, according to our research, only 10 countries had already performed an HTA on the pneumococcal vaccine. So the use of HTA is not so widespread in Europe. In our view, it should be encouraged.
How does this affect ordinary members of the public?
The process for the implementation of a new vaccine in the national immunisation plan includes the evaluation of all medical, economic, social aspects. The governments are in charge of this decision and the population will benefit from the protection offered by the vaccine, if introduced. The process should be a scientific and systematic evaluation all the aspects from the safety to the effectiveness, from the cost to the estimation of the prevented cases. For this reason the support of HTA, which offers all this information, is vital to taking these decisions.
How can these differences be addressed?
Differences can exist and the diversity can be an advantage. There are cultural, economic, social, organisational differences among the countries that cannot be removed. However a standardisation of the procedure of implementation of new vaccines could help in giving to all European citizens the same opportunities in terms of access to the vaccines. The use of HTA in each country, also keeping in mind the variation in the availability of information, can still help the process.
What role can EU institutions play given that their powers in the field of health are limited (and national governments have the most control)?
EU institutions can support the use of instruments like HTA, guidelines, guidance on the implementation of new vaccines, and can provide Member States with information which is useful in decision-making. The European institutions can, in this way, collate information from different sources and promote the exchange of information and experience among the countries to show the advantages and the disadvantages of each choice. In this way the Member States remain free in their decision but will benefit from the positive collaboration at European level. They will also save resources by avoiding the replication of scientific work in each country. HTA needs specific parameters from each single country, but part of the data can instead be shared among countries. Providing this information together with an HTA scheme could give an advantage to the countries that want to perform an HTA on a new vaccine.