Introduction of vaccination against rotavirus a case study of Priority Setting in Norway Ånen Ringard MA, Ph.D. Nina Bachke MA Siv Cathrine Høymork, MD, Ph.D. Secretariat - Norwegian Council for Priority Setting
Aim: A case study of the Norwegian Priory Council s discussion on whether or not to introduce rotavirus vaccine in the national immunization program for children.
Health care in Norway: 5 million inhabitants (2012). Health Expenditure/capita 5,352 USD (2009). Total expenditure 9.6 pct of GDP (2009). Health care is publicly provided (universal coverage) and financed (general taxation).
The childhood vaccination programme: All children residing in Norway are offered vaccinations against ten diseases. All of these diseases can cause life-threatening illnesses or result in severe complications. The program was established in 1952 and is run by The National Institute of Public Health (NIP). Locally it is administered, free of cost, at public health centers and at schools. Children usually receive their first vaccinations at 3 months old and follow the programme until they are 15-16 years old (10 th grade). Vaccination is NOT compulsory but high attendance rates (from 92 to 95 per cent).
Rotavirus: Rotavirus is a leading cause of acute gastroenteritis among infants and children under 5 years. It is considered the most important cause of severe diarrhea in this age-group, and is annually estimated to cause about 0.5 million deaths. Vaccination is considered an effective intervention against rotavirus infections. WHO has recommended the introduction of the vaccine in national immunization programs.
Rotavirus and Norwegian health care: In Norway rotavirus rarely causes any deaths none had been registered during the last two decades prior to the NC discussions. At the same time acute gastroenteritis puts significant stress on the health care system, due to a significant number of hospitals stays (900 per year) and visits to general practitioners (10 000 per year). A large number (30 000 per year) of children are thought to be affected without seeking help from the health care system. On employers (i.e. society) due to parents days of absence from work. A introduction would cost approximately 16 million USD/year.
Framework for priority setting The Priority Setting Regulation is codified in the Patient s Rights Act of 1999. Three criteria should be fulfilled: Severity the patient will experience a certain reduction in prognosis with regard to life expectancy or a considerable reduction in quality of life if the provision of a health intervention is deferred Effectiveness the patient may expect to benefit from the health intervention Cost-effectiveness the expected costs are in a reasonable proportion to the effects
National Council for Priority setting in Health Care Established 2007 by the Ministry of Health and Care Services. The council is an advisory body (for MoH and the services). 26 members: Executives from central health administration and regional authorities Executives from municipalities and their organisation Executives from large patient associations Representatives from universities and colleges Chair: Director-General of the Directorate of Health. Secretariat at the Norwegian Knowledge Centre.
The problem: Should rotavirus vaccine be introduced, free of cost, into the childhood immunization program? The NC has, according to its mandate, a particular responsibility for discussing and advising on large public health interventions (i.e. vaccines/screening). Documents to support the discussion: Documentation on rotavirus in Norway (NIP) Documentation on effect of vaccine (NIP) Documentation on cost-effectiveness (NOKC) Invited public health experts (3 persons)
Key points from the NC discussion: Effect of the vaccine: The two vaccine with an MT in Norway both has a documented effect on the prevention of infections caused by rotavirus. Cost-effectiveness: The vaccines are most likely cost-effective in a societal perspective (but not in a pure health care perspective). Severity of the condition: Rota virus is NOT considered a severe condition in Norway.
Recommendation: A majority of the members of the council do not want to give priority to rotavirus vaccination in other words a NO to the vaccine. Further investigation should be done in order to find out whether certain groups of infants (i.e. those more vulnerable) should be offered immunization. As the council do see many positive effects of rotavirus vaccination, a better facilitation of distribution and information than what is the case today should be considered.
The debate still goes on: After the council made it s recommendation: The debate has continued in media and academic journals. Medical professionals, the pharmaceutical industry and governmental officials have participated. These discussions have shown that there are proponents as well as opponents to the introduction of the vaccine. The final decision still rests, however, with the MoH (as a part of the regular budget process).
Concluding remarks: Whether to introduce a new vaccine into The childhood immunization programme is an important priority setting decision. The case of rotavirus vaccination is interesting because it elicited and actually put to use two rarely discussed aspects of our priority setting criteria: The severity criteria what is severe and what is not! The perspective to base C/E-analysis upon (a pure health care vs. a societal perspective). The severity criteria tipped the decision towards a NO!
Thank you! www.prioritysetting.no