HPV vaccination policies in Slovenia

• Abstract
• Purpose of health policy or idea
• Characteristics of this policy
• Political and economic background
• Purpose and process analysis
• Expected outcome
• References

Abstract

Initiatives for HPV vaccine reimbursement from public funds were launched early in 2007. As it had not materialised, civil society initiative groups organised funding in several municipalities from local public sources. But the pressure on a national decision mounted, also through the involvement of women MPs. The Minister of Health commissioned an opinion from the National Institute of Public Health which was presented at the Health Council. There the proposal was provisionally approved.

Purpose of health policy or idea

The idea is to include HPV vaccine into regular funding from public sources. Concurrently, it would become part of the regular national immunisation programme. Pressure groups, which were organised within the civil society, together with the support of the influential women politicians and other important figures, proposed this step as a necessary fulfilment of women's right to health. This proposal followed the previous reimbursement of HPV vaccinations by several municipalities.

There were two main controversial points around this proposal:

1. the extremely high cost of vaccine, which would exceed the total sum of all other vaccinations in the current national immunisation programme,
2. uncertainties surrounding the duration of the longterm protection, the role of catch-up cohorts and the effects in the system regarding cervical cancer screening.

As HTA capacity in Slovenia is currently minimal and since public pressure was rising, it was difficult to imagine a consistent national HTA study for the HPV vaccine. The National Institute of Public Health (NIPH) presented a proposal of the introduction of a regular, non-compulsory, but publicly reimburseable national vaccination programme for HPV, involving complete vaccination of 12 year old girls. In the original proposal catch-up cohorts were not mentioned. The total cost of vaccinating around 10,000 girls with the three doses each would be just under 3 million Euro - an amount that would exceed the total of all other current vaccinations under the national vaccination programme.

Cervical cancer - very rare in Slovenia

An additional concern was that due to an intensified screening programme for cervical cancer, both incidence and mortality are declining anyway - in 2006, there were around 150 incident cases of invasive cervical cancer and 35 deaths, making cervical cancer a rather rare disease in Slovenia. The proposal of the NIPH was circulated through the so-called 'Broader Professional Colleges', which are consultative professional bodies of the Ministry of Health. After their individual decisions were taken the proposal was presented to the main consultative body of the Minister of Health, the Health Council. After some controversy in the discussion, the decision of provisionally approving the inclusion of HPV vaccination in the public funding scheme was reached, but pending some preconditions:

1. determination of the number of catch-up cohorts,
2. calculation of the potential caveats, esp. possible undesirable declines in screening coverage,
3. comparative analysis of the two existing vaccines and proposing the more cost-efficient one,
4. deciding on the possible later beginning of vaccination (given the sexual initiation age in Slovenia) and the decision on revaccinations.

The analysis of these four points is expected to be ready by the end of November when it will be submitted to the Health Council for the second round of consultations.

Main points

Main objectives

• Introduction of a publicly reimbursed non-compulsory vaccination against HPV infection
• Definition of the target population for vaccination by determining the initial age for primary vaccination, for revaccination and for catch-up cohorts

Type of incentives

The main financial incentive is to have the entire target population of girls vaccinated against HPV covered by compulsory health insurance.

Groups affected

Health Insurance Institute of Slovenia, Pre-pubertal and adolescent girls in Slovenia, Health care providers

Degree of Innovation	traditional		innovative
Degree of Controversy	consensual		highly controversial
Structural or Systemic Impact	marginal		fundamental
Public Visibility	very low		very high
Transferability	strongly system-dependent		system-neutral

Political and economic background

There was pure contextual pressure, given the international expertise and example and following the nationally well-organised civil society groups, supported by women politicians and other influential public figures. This pressure targetted both on professional groups and on the scientific community as well as on the political arena.

The main problem in this issue is the rather expensive vaccine, which will represent a significant additional financial burden and will effectively indirectly affect other newly proposed programmes. A balance and a compromise solution will have to be found bearing these caveats in mind.

Complies with

Following the trends in several other countries and the international developments in general, including the existing guidelines for HPV vaccination (ECDC and ACS).

Change based on an overall national health policy statement

Favouring policies that are evidence-based and proven to bring a significant improvement in the quality of life and survival.

Purpose and process analysis

Current Process Stages

	Idea	Pilot	Policy Paper	Legislation	Implementation	Evaluation	Change
Implemented in this survey?

Origins of health policy idea

The initiative and the approval process are a result of a systematic lobbying by the pharmaceutical companies through different pressure groups. Following approvals in other countries the pressure mounted, although there is not universal agreement across different medical specialties about its justification. Public health experts warn of the following consequences:

1. a potential threat to the existing sexual and reproductive health promotion campaigns
2. a decline in screening coverage rates
3. too early onset of vaccination in life may later require early (and therefore also unnecessary revaccinations)
4. extremely high costs per intervention, including an expected very high cost per QALY (and rising).

Initiators of idea/main actors

• Civil Society

Approach of idea

The approach of the idea is described as:
new:

Innovation or pilot project

Local level - municipalities

Stakeholder positions

The Ministry of Health was faced with an almost unprecedented pressure to rapidly introduce publicly reimbursed HPV vaccination of girls aged 12 or 13 years. The main concern was about the extremely high costs of vaccine and the related complex information system that would be needed to support adequate monitoring. The Minister of Health decided to gain some extra time by opening a wide professional consultation in this matter.

Opportunity costs

The Health Insurance Institute of Slovenia (HIIS) was reserved in this matter as they would be the main financier of this introduction as the national budget cannot accommodate such interventions. It is clear that introducing this vaccination would reduce the available financing for any other additional programmes that are usually approved later in the year. In this sense approving HPV vaccination will indirectly affect certain other patient categories.

The pharmaceutical industry obviously played a partly overt and partly covert lobbying role in the process, supporting civil groups and, in some instances, even the NIPH. This led to very energetic reactions of the Ministry of Health, resulting in a step back in these activities.

Actors and positions

Civil Society
Kala - civil initiative group	very supportive		strongly opposed
Women parliamentarians	very supportive		strongly opposed
Influential public personalities	very supportive		strongly opposed
Gynaecologists	very supportive		strongly opposed

Influences in policy making and legislation

No, there will be no formal piece of legislation. However, as a consequence of approving the vaccine for public reimbursement, the vaccination will then be included in the annual national immunisation programme, which is published as a by-law by the Ministry of Health.

Legislative outcome

pending

Actors and influence

Civil Society
Kala - civil initiative group	very strong		none
Women parliamentarians	very strong		none
Influential public personalities	very strong		none
Gynaecologists	very strong		none

Positions and Influences at a glance

Monitoring and evaluation

Monitoring and evaluation of the introduced HPV  vaccination programme are not yet clearly defined. It is clear that monitoring of both the vaccinated girls/women as well as of those who are not going to be vaccinated will be needed in order to support an intense screening programme, which will have to remain available for all women, regardless of their vaccination status against HPV.

Expected outcome

It is expected that, due to the examples of several other countries and  the mounting public pressure in this matter, public funding for basic vaccination of 12-year-old girls will be approved and included in the regular immunisation programme from 2010 onwards. A consistent information system will have to be established for the monitoring of coverage and for the reporting of screening coverage for the vaccinated girls/women. This will have to be linked to the existing cancer registry at the Institute of Oncology in Ljubljana. Only such a supportive system in place will help the efficient and effective monitoring of the effects of a HPV vaccination programme.

Impact of this policy

Quality of Health Care Services	marginal		fundamental
Level of Equity	system less equitable		system more equitable
Cost Efficiency	very low		very high

References

Sources of Information

1. Proposal for HPV vaccination in Slovenia. Institute of Public Health of the Republic of Slovenia 2007.
2. Opinions of the Broader Professional Colleges (public health, pathology, microbiology, paediatrics and family medicine) on the inclusion of HPV vaccination into a public funding scheme

 

Author/s and/or contributors to this survey

Tit Albreht

Suggested citation for this online article

Tit Albreht. "HPV vaccination policies in Slovenia". Health Policy Monitor, October 2008. Available at http://www.hpm.org/survey/si/a12/3