Health Economics Model Shows Cervarix(R) Cross-Protective Efficacy Could Provide Greater Cost Reductions Than Protection Against Genital Warts

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Cancer / Oncology;  Sexual Health / STDs
Article Date: 13 Oct 2009 - 4:00 PDT

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Results from a modelling study have showed that cross-protective efficacy of GlaxoSmithKline's Cervarix® against cervical cancer-causing human papillomavirus (HPV) types1,2 could provide greater public health cost reductions than the cost reductions potentially offered by Gardasil® due to its efficacy against genital warts.3

The study presented at the16th International Meeting of the European Society of Gynaecological Oncology (ESGO), evaluated the potential cost consequences of cervical cancer vaccination for the healthcare system in Italy. In the modelling exercise, it was shown that the substantial reduction in the incidence of cervical cancer and precancerous lesions due to the cross-protective efficacy of Cervarix® observed in clinical trials1,2 could avert €2.7 million more in costs annually than the costs potentially averted by Gardasil® due to its efficacy against genital warts.3

The cross-protective efficacy of Cervarix® has been observed in the largest efficacy trial of a licensed cervical cancer vaccine to date, the results of which were also presented at the ESGO conference.2,4

The study (HPV-008) showed that in women previously not infected with HPV and who received at least one vaccine dose (TVC-naïve cohort), Cervarix® provided significant protection against pre-cancerous lesions (CIN 2+) associated with the five most common cancer-causing HPV types.2,4

Other data presented at ESGO include data from the first, large-scale comparative trial of immunogenicity (HPV-010), which showed that Cervarix® generated a significantly higher immune response compared to Gardasil®.5 Also presented at the congress, were findings from the HPV-023 study which showed that Cervarix® induced high levels of antibodies for up to 7.3 years, indicating the longest period of immune response observed for any licensed cervical cancer vaccine to date.6

Hugues Bogaerts, Vice President and Senior Medical Director of GSK commented: "The burden of cervical cancer continues to rise globally and it is therefore important that healthcare professionals are able to provide women with effective protection against the disease. While studies like HPV-008 and HPV-023 further support the efficacy and immunogenicity profile of Cervarix®, results from the economic models illustrate the value that the vaccine could offer in terms of cost-effectiveness in some countries like Italy."

About HPV and cervical cancer

Women are at risk of HPV infection throughout their sexually active lives.4 Approximately 100 types of HPV have been identified to date9 and, of these, approximately 15 virus types are known to cause cervical cancer.10 HPV types 16 and 18 are responsible for approximately 70 percent of cervical cancers globally, with types 45, 31 and 33 the next three most common cervical cancer causing virus types after 16 and 18.11,12 Persistent infection with cancer-causing HPV types can lead to abnormal Pap smears, cervical pre-cancer and cervical cancer. Cervical intraepithelial neoplasia (CIN), graded as CIN 1, 2 and 3, refers to pre-cancerous cells found on the surface of the cervix. The higher the grading number, the higher the probability the abnormal cells will become cancer cells.13 CIN 1, 2 and 3 refers to mild, moderate or severe cell changes respectively. Worldwide, more than 500,000 women will be newly diagnosed with cervical cancer and 280,000 women will die from it each year.14

HPV types 16, 18 and 45 are particularly important because these types are associated with nearly 90 percent of adenocarcinoma cases11 a very aggressive type of cervical cancer more common in younger women and more difficult to detect through screening.15,16

References

1. Tjalma W et al. Efficacy of the HPV-16/18 AS04-Adjuvanted vaccine against abnormal cytology and low-grade histopathological lesions in an oncogenic HPV-naïve population. Abstract presented at the 16th International Meeting of the European Society of Gynaecological Oncology (ESGO), Belgrade, Serbia

2. Kitchener H et al. Cross-protective efficacy of the AS04-Adjuvanted HPV16/18 vaccine in oncogenic HPV infection-naïve women: Results from a double blind, randomised, Phase III trial (PATRICIA) Abstract presented at the 16th International Meeting of the European Society of Gynaecological Oncology (ESGO), Belgrade, Serbia

3. Capri S et al. Differences in cross-protection between bivalent and quadrivalent vaccines: cost-consequences evaluation in the Italian setting. Abstract presented at the 16th International Meeting of the European Society of Gynaecological Oncology (ESGO), Belgrade, Serbia

4. Paavonen J et al. Efficacy of the HPV-16/18 AS04-adjuvanted vaccine against cervical infection and pre-cancer caused by oncogenic HPV types: final event-driven analysis in young women (the PATRICIA trial). 2009. Published online, The Lancet July 7 2009.

5. Einstein M et al. Comparative evaluation of immunogenicity of two prophylactic human papillomavirus cervical cancer vaccines. Abstract presented at the 16th International Meeting of the European Society of Gynaecological Oncology (ESGO), Belgrade, Serbia

6. De Carvalho N et al. Sustained immunogenicity and efficacy of the HPV-16/18 AS04-Adjuvanted vaccine (Cervarix™) : Follow-up to 7.3 years. Abstract presented at the 16th International Meeting of the European Society of Gynaecological Oncology (ESGO), Belgrade, Serbia

7. Aguilar JC. Vaccine adjuvants revisited. Vaccine 2007; 25: 3752-3762.

8. Descamps D, Hardt K, Spiessens B et al. Safety of human papillomavirus (HPV)-16/18 AS04 adjuvanted vaccine for cervical cancer prevention: a pooled analysis of 11 clinical trials. Human Vaccine, 2009; 55: 1-9.

9. WHO. Expert Committee on Biological Standardization. Guidelines to assure the quality, safety and efficacy of recombinant Human Papillomavirus virus-like particle vaccines, accessed on 27/3/2009 at http://screening.iarc.fr/doc/WHO_vaccine_guidelines_2006.pdf

10. Muñoz N, Bosch FX, de Sanjose S, et al. Epidemiologic classification of human papillomavirus types associated with cervical cancer. N Engl J Med 2003; 348: 518-527.

11. Bosch X, Burchell A, Schiffmann M et al. Epidemiology and Natural History of Human Papillomavirus Infections and Type-Specific Implications in Cervical Neoplasia. Vaccine 26S (2008) K1-K16.

12. Cohen J. High Hopes and Dilemmas for a Cervical Cancer Vaccine. Science 2005; 308: 618-621

13. Cancer Research UK accessed on 11 June 2009 at http://www.cancerhelp.org.uk/help/default.asp?page=1673.

14. World Health Organization. Initiative for Vaccine Research. http://www.who.int/vaccine_research/diseases/hpv/en/ Accessed on February 13, 2009.

15. Garland S et al. Cross-protective efficacy of Cervarix against HPV-45 in a double blind randomised controlled Phase III efficacy trial. Abstract presented at the 19th FIGO World Congress of Gynaecology and Obstetrics 4-10 October 2009; Cape Town, South Africa

16. Castellsagué X et al. Worldwide Human Papillomavirus Etiology of Cervical Adenocarcinoma and Its Cofactors: Implications for Screening and Prevention. Journal of the National Cancer Institute 2006; 98 (5): 303-315.

Source
GlaxoSmithKline