UK School Girls Will Not Benefit From The World's Leading Four-type Human Papillomavirus (HPV) Vaccine, Gardasil(R) - Sanofi Pasteur MSD Statement

The tender decision made by the UK authorities choosing a two-type (16/18) HPV vaccine for their immunisation campaign means that the girls in this campaign will not benefit from the world's leading four-type (6,11,16,18) HPV vaccine, Gardasil®.


"We regret that school girls in the UK, unlike most of their peers in Western Europe, the USA, Australia, New Zealand and Canada, will not benefit from the unmatched cervical cancer protection and additional benefits provided by the world's leading HPV vaccine, Gardasil®", comments Dr Nicholas Kitchin, UK Medical Director, Sanofi Pasteur MSD.


Two years after its first launch in June 2006, Gardasil® is today the HPV vaccine of choice across the world with more than 26 million doses distributed* and 95% global market share. Countries like Australia, New Zealand, Canada, France and Switzerland have chosen Gardasil® preferentially or exclusively for their vaccination campaigns or recommendations.


In addition to protection from cervical cancer, Gardasil® provides protection from precancerous cervical, vulval and vaginal lesions (an extension to the licence following a recent CHMP positive opinion) and from genital warts caused by virus types targeted by the vaccine. The four HPV types 6, 11, 16 and 18 together cause the vast majority of cervical cancer and other HPV-related genital diseases. 1,2,3


Patrick Poirot, Vice President for Medical and Scientific Affairs at Sanofi Pasteur MSD concludes: "With strong global endorsement from regulators, health authorities and physicians and with a very favourable cost-benefit profile, Gardasil® will continue to be the HPV vaccine of choice for girls and women worldwide".


The leading HPV vaccine


In all other tenders awarded to date in Western Europe†, health authorities have chosen Gardasil® for about 80% of the population covered. Gardasil® is, or will be, used exclusively for campaigns in the USA, Australia, New Zealand, Canada and Switzerland‡. The French authorities recommend the preferential use of Gardasil®.4 Where doctors can choose between the two vaccinesВ§, more than 9 out 10 doctors worldwide choose Gardasil®.


Cost-effectiveness, early benefits and quick return on investment


The cost-effectiveness ratio (CER) of routine vaccination with Gardasil® at 12 years of age is estimated to be ВЈ5,890 per Quality Adjusted Life Year (QALY**); the CER including a catch-up programme to 17 years of age is ВЈ5,971/QALY gained. This is within the lower part of the range typically regarded as cost-effective in the United Kingdom (QALY







* By the end of March 2008; including almost 16 million doses in the USA and more than 5 million doses in Western Europe.


† Regional tenders in Italy, Spain, and Sweden; a national tender in Switzerland.


‡ The two-type vaccine has not yet been approved in Canada and Switzerland to the best of our knowledge.


В§ Germany, France and Belgium in Western Europe.


** Cost per QALY is a measure of the efficiency of a new health intervention, which compares its costs and health benefits with those of an alternative strategy and combine both quantity of life (mortality) and in quality of life (morbidity).


†† Routine vaccination of girls at age 12 along with a temporary catch-up programme of two years for girls aged 12-17 years.



Preventing genital warts


The UK Joint Committee on Vaccination and Immunisation (JCVI)'s recommendation for an HPV immunisation programme was supported by an analysis presented by the Health Protection Agency (HPA)'s that showed that that a four-type (6,11,16,18) vaccine would prevent up to 70% of cervical cancer and 95% of genital warts.6 The HPA reports that the number of first attack cases of genital warts has increased by 22% in the past 10 years, to reach 83,745 diagnoses made in genito-urinary medicine (GUM) clinics in 2006.7 The treatment of genital warts can be difficult and painful, and recurrence rates can be high, as only the visible lesion is treated while the infection persists.8,9,10 Genital warts management is a significant burden on National Health Service (NHS) resources. A survey of GUM clinicians in 2003 found that annual costs of managing genital warts in GUM clinics alone to be ВЈ22.4 million.11 Additional costs for the 20.9% of female and 16.5% of male genital warts cases that are managed outside GUM clinics, add to the total burden of disease.12


Essentials of the EU indication for Gardasil®


Gardasil® is indicated for the prevention of cervical cancer, precancerous cervical lesions (CIN2/3), precancerous vulvar lesions (VIN 2/3) and external genital warts caused by HPV types 6, 11, 16 and 18. The Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for a licence extension to include the prevention of precancerous vaginal lesions (VaIN 2/3); approval by the European Commission can be expected in the coming weeks.


About Sanofi Pasteur MSD


Sanofi Pasteur MSD is the only company in Europe dedicated exclusively to vaccines and a major supplier to the National Health Service in the UK, supporting immunisation campaigns that protect health at all stages of life. The company is committed to bringing innovative vaccines to the market to improve public health in the UK.
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Sanofi Pasteur MSD is a joint venture between sanofi pasteur, the vaccine division of sanofi-aventis, and Merck & Co., Inc., able to draw on the research expertise of sanofi pasteur and Merck & Co., Inc., together with their teams throughout the world, to focus on the development of new vaccines for Europe, which aim to extend protection to other diseases and perfect existing vaccines in order to improve the acceptability, efficacy and tolerability of vaccination. spmsd


References


1. Smith JS et al. Int J Cancer 2007; 121:621-632


2. Gardasil®, Summary of Product Characteristics, 2007


3. Gardasil®, European Product Assessment Report (EPAR),
Scientific Discussion


4. hcsp.fr/hcspi/docspdf/avisrapports/hcspa20071214_Papillomavirus.pdf


5. Dasbach E, Insinga R, Elbasha E. The epidemiological and economic impact of a quadrivalent human papillomavirus vaccine (6/11/16/18) in the UK. BJOG. 2008


6. hpa/hpa/news/articles/press_releases/2007/070919_hpv_cost.htm


7. Testing times - HIV and other sexually transmitted infections in the UK: 2007. Health Protection Agency 2007.


8. Beutner KR and Wiley DR. Recurrent external genital warts: A literature review. Papillomavirus Rep 1997;8:69-74


9. Clinical Effectiveness Group (Association for Genitourinary Medicine and the Medical Society for the Study of Venereal Diseases. National guideline for the management of anogenital warts. (last visit 18.08.06)


10. McMillan A. The management of difficult anogenital warts. Sex Transm Dis 1999;75:192-194


11. Brown RE, Breugelmans JG, Theodoratou D et al. Costs of detection and treatment of cervical cancer, cervical dysplasia and genital warts in the UK. Curr Med Res Opin 2006;22:663-670


12. Cassell JA et al. Trends in sexually transmitted infections in general practice 1990-2000: population based study using data from the UK general practice research database. BMJ 2006;332-4

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