The human papillomavirus (HPV) is the most common viral infection of the reproductive system and the second viral agent responsible for cancer. About 5% of cancers can be attributed to HPV; the most common is cervical cancer, but also other cancers are due to HPV. Five-years survival rates are very low except for cervical cancer thanks to the screening. Genotypes 16 and 18 are responsible of around 70% of cervical cancers, but considering also 45, 31, 33, 52, 58 and 35, the proportion reaches 90%. Most of them are preventable through vaccination. The objective of this report is to assess the impact of the implementation of a universal HPV vaccination campaign with a nine-valent vaccine in Italy using the rigorous methodology of the Health Technology Assessment (HTA).
A HTA has been developed considering all the available evidence on epidemiological, clinical effectiveness, safety, cost-effectiveness, organizational, social and ethical aspects with a focus on Italian population.
A great amount of evidence is available regarding HPV epidemiology, vaccine efficacy and safety and the economic impact of a national vaccination program, but this is the first attempt to collect them together using HTA. The report highlights that a nine-valent universal vaccination is cost-effective in reducing the risk of HPV-related cancers and diseases. The introduction of a nine-valent vaccine extends the protection to an increasing number of genotype and, consequently, can avoid a huge amount of neoplastic lesions in different sites and reduce the burden of disease. In fact, around 88% of anal, 70% of vaginal, 50% of penile and 43% of vulvar cancers are due to HPV. The nine-valent vaccine represents an investment for public heath as demonstrated by the favorable cost-effectiveness profile under the perspectives of both the National Health Service and the society. This is strictly related to a reduction of healthcare costs to manage HPV-related diseases and to an increasing patients’ quality of life. From an organizational point of view, schools have been identified as one of the most effective setting for immunization campaigns. Additionally, amelioration in the invitation letters, communication strategies and/or activities aimed at strengthening the involvement of health care workers emerged as possible determinants of a higher vaccination coverage and a reduction of access inequality. A universal vaccination with nine-valent vaccine is an ethical choice for the society due to the higher clinical benefit-non-maleficence ratio than available alternatives for both the single vaccinee and the entire society considering also the incremental benefit due to the herd immunity.
1. De Martel et al., Global burden of cancers attributable to infections in 2008: a review and synthetic analysis, The Lancet, Vol. 13, 2012, p. 607-15
2. 13th Edition Epidemiology and Prevention of Vaccine-Preventable Diseases CDC. Epidemiology and Prevention of Vaccine – Preventable Diseases – Human Papillomavirus. Available from: http://www.cdc.gov/vaccines/pubs/pinkbook/hpv.html
3. Serrano et al., Potential impact of a nine-valent vaccine in human papillomavirus related cervical disease, Infectious Agents and cancer 7:38, 2012