We need a programme of vaccination against cervical cancer, writes Dr Jack Lambert
A NUMBER of recent articles have focused on the human papillomavirus (HPV) vaccine. In my view, the HPV vaccine is one of the greatest successes in vaccinology in the history of this specialty, and the efficacy of this vaccine is outstanding.
Most European countries have developed a plan for the use of this vaccine, and indeed Ireland was one of the last in Europe to convene a group of specialists to deal with the issue of an HPV vaccine for Ireland.
The Health Information and Quality Authority (HIQA) released the results of this report in February 2008, and its recommendation was one proposing immunisation of all 12-year-old girls and catch up for 13 to 15-year-old girls.
Other countries have been more generous in their recommendations, with the US recommending immunisation of all 12 year olds with catch up to 26 years; and the UK recommendation of immunisation of all 12-year-old girls, with catch up to 18 years.
Subsequently there were reports that Health Minister Mary Harney had said she believed the vaccine should be introduced in Ireland. It should be done in conjunction with, not simultaneous with but in the same period, with the roll-out of the cervical screening programme. The recommendation agreed with the vaccination of all 12-year-old girls, but fails to uphold the recommendations of HIQA to perform a catch up to 15 years.
Subsequently, with the economic downturn, Harney reversed this decision, and said that she would delay the HPV-vaccine programme, and focus on the cervical-screening programme.
Cervical cancer is the eighth most frequently diagnosed cancer in women in Ireland. In 2004, 200 women were diagnosed with cervical cancer, with more than 90 women dying from the disease.
On average, these women were 56 years old at the time of death, and 44 years at the time of diagnosis. Infection with HPV is the main cause of cervical cancer. The number of cases of cervical cancer has been rising steadily in the Republic over recent years.
The failure to introduce a comprehensive, population-based cervical-screening programme has led to many unnecessary deaths. Cervical screening programmes have been in place in many other countries and there is clear evidence that such programmes save lives.
It is a clear embarrassment that a comprehensive national cervical screening programme did not start until 2008; other developed countries in Europe and the Americas have had programmes established 10-30 years previously.
Two vaccines are licensed in Ireland to prevent HPV infections: Gardasil (Sanofi Pasteur MSD), which was licensed in September 2006, and Cervarix (GSK Biologicals), which was licensed in September 2007. Both vaccines target HPV type 16 and 18. Gardasil also targets HPV type 6 and 11, which cause anogenital lesions (warts).
The vaccines are given as a course of three injections over a six-month period.
HIQA is an independent authority reporting to the Minister for Health. The authority is the statutory organisation in Ireland with a remit to carry out national health technology assessments (HTAs) and to develop standards for the preparation of these HTAs across our health system.
In July 2007 the HIQA agreed to carry out a health technology assessment on the role of vaccination against HPV in reducing the risk of cervical cancer in Ireland in response to a request by the National Cancer Screening Service Board.
The purpose of this assessment was to establish the cost effectiveness of a combined national HPV vaccination and cervical cancer screening programme, compared with a cervical cancer screening programme alone in the prevention of cervical dysplasia (the condition that can lead to cervical cancer) and cervical cancer due to HPV types 16 and 18 in Ireland.
The findings said that vaccination of 12-year-old girls alone against HPV types 16 and 18, assuming eight out of 10 girls receive the vaccine, results in an incremental cost effectiveness ration (ICER) of approximately €17,383/life year gained (LYG). This compares favourably with the recent economic evaluations of universal infant pneumococcal conjugate vaccination (€5,997/LYG) and universal infant hepatitis B vaccination (€37,018/LYG ) in the Irish setting.
The cost effectiveness of implementing a catch-up programme for the following age groups in the first year of vaccination only was investigated: 13-to-15 years, 13-to-17 years, 13-to-19 years and 13-to-26 year olds.
Although, the most cost-effective strategy is vaccination of 12-year-old females only, vaccination of 13-15 year-old females in the first year of the programme was identified as likely to be the most cost-effective catch-up scenario. The catch-up scenario for 13-15 year olds is associated with a relatively large increase in health benefits compared with the other catch-up scenarios.
Setting up a catch-up programme for 13-15 year olds would incur an extra one-off cost of €29.2 million in the first year of the vaccination programme. Following that, the cost of HPV vaccination of all 12-year-old girls is estimated at €9.7 million per annum.
Vaccination against HPV types 16 and 18 is a long-term investment, as the initial costs of vaccination will only be offset by improved health outcomes and treatment savings 15-30 years in the future.
Trials of these vaccines have demonstrated excellent safety and almost complete protection against the two most common strains of HPV known to cause cervical cancer.
The prevention of cervical cancer is therefore emerging as a major public health advance, and one that has implications for women worldwide.
Many governments have now acted promptly by introducing a HPV-vaccination programme, including Canada, Australia, several states in the US and the majority of European countries.
The UK recently initiated a school-based vaccination programme in 2008, with vaccination of 12-year-old girls and catch up to 18 years of age
Urgent action is needed now on how to implement a national HPV immunisation programme, a HPV-preventive vaccine programme will be complementary to the roll-out of the national cervical screening programme. Thus we can begin to make up for many years of inaction in cervical cancer prevention and join other nations in pioneering this important cancer- prevention advance.
The cost of not doing so promptly is to put at risk another generation of young women who will bear the cost in lives lost to this most preventable of diseases.
The decision of the HSE to not agree to a catch-up programme is clearly short-sighted; and the decision to “postpone” the vaccination programme for 12 year olds without further guidance is lacking vision.
While we all need to tighten up our budget in today’s climate, linking essential healthcare to the vagaries of the world economy is wrong. The lack of a national sexual health strategy in Ireland, which should be initiated and supported by the HSE, is unacceptable. HPV is a viral infection that can be significantly prevented by an HPV immunisation programme.
So, while it is nice to see the HSE tightening its belt over health-related financial expenditures, targeting the HPV vaccine programme is clearly short-sighted.
It is an insult to the members of HIQA and its panel of experts who have worked so hard to come up with a position document to have their recommendations dismissed.
So I would ask the Minister of Health and the HSE the following questions:-
Why did you not recommend a catch-up programme in the first place?
When do you plan on implementing the HPV vaccine programme?
How long will it be delayed?
Where do you plan on doing it? (I seriously doubt that there is sufficient doctor and nurse staffing in the school system to achieve a successful school-based vaccination programme.)
Have you met the stakeholders in the school system/public health system to see if vaccination in the school system is a feasible option?
I suggest a “modest proposal” for the Minister of Health and the HSE to entertain.
Please do your homework on HPV and consider both the medical and the political value of such a vaccine programme; there has been great criticisms of the handling of a number of different cancers within the HSE-supervised network in Ireland.
Implementing a timely HPV vaccine programme makes such good sense. Second, convene a group of experts from within Ireland who can provide you with guidance on planning for the implementation of a preventive HPV vaccine programme.
You need to start the process of evaluation of products, planning for tenders, and assessment of operational issues to ensure that a successful vaccination campaign can be achieved.
The abrupt cancellation of the programme is not an acceptable option; and the lack of communication of what alternative plans (if any) are under way is just not a good way of doing business.
- Dr Jack Lambert is a consultant in infectious diseases and genitourinary medicine at the Mater Hospital in Dublin