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Appeal to PM on Cervical Cancer Vaccination

MEDIA RELEASE: 23 May, 2007

Appeal to PM on Cervical Cancer Vaccination


CSL Biotherapies (NZ) Ltd is seeking an urgent meeting with the Prime Minister, Helen Clark, to discuss how the cervical cancer vaccine, Gardasil, can be funded in the 2008 immunisation schedule.

Dave Bowler, General Manager of CSL Biotherapies (NZ) Ltd., said he wanted to ensure that the Prime Minister and Cabinet were aware of the full range of funding options available to them.

“It is hard to see how funding of Gardasil as early as possible could not be an imperative considering the lives that will be saved and improved,” he said.

“We feel an obligation to the estimated 150,000 young woman who are now going to be at risk of infection with human papillomavirus (HPV) and exposed unnecessarily to the risk of pre cancers and cervical cancer because of the delay in making this vaccine freely available to them from 2008.

“The strength of support from Health Professionals, who deal daily with HPV related disease and who will have to deal with the medical consequences of any delay in the funding of this vaccine, means we feel a duty to explore all possibilities in order to get it on the schedule as soon as possible” Mr Bowler said.

To date the Government had not entered into any direct negotiations with CSL on price and supply of GARDASIL.

“CSL Biotherapies would like to work with the Government to ensure that NZ girls and young women have access to a funded cervical cancer vaccine as soon as possible,” he said.

Dr Ai Ling Tan, Gynaecology Oncologist Auckland Hospital said “Cancer specialists see this vaccine as an essential vaccine to be publicly funded for girls and young women at a relatively low cost. Gardasil is an extremely effective vaccine reducing cervical cancer by 70% and high grade abnormalities by 50%. I can’t help but think of the girl’s who will not be vaccinated, and will go on to develop pre-cancers and cancer later in life requiring extensive treatment and potential loss of life. It’s a tragedy.”

Mr Bowler said an enormous amount of work by medical advisory groups and health professionals in NZ, including the Ministry of Health, had gone into evaluating and recommending cervical cancer prevention via vaccination to the Government.

The Government had also outlined in the Cancer Control Strategy and Sexual Health Strategy the importance of a HPV vaccine such as Gardasil in disease prevention.

Gardasil had undergone extensive clinical and economic evaluation both internationally and here in New Zealand. Gardasil was registered last year following a priority review process due to its clinical importance. A New Zealand specific health economic evaluation has been completed that clearly demonstrates Gardasil in conjunction with the current cervical screening programme, is very cost effective in preventing cervical cancer and HPV related disease.

It would cost the Government around $10 million per year to vaccinate all girls in a single age group.

As the immunisation schedule is only reviewed once every two years - if the vaccine is not made available in June 2008, a publicly funded cervical cancer vaccine could not be implemented until June 2010 at the earliest. This means as many as 150,000 school girls will have moved off a potential school based vaccination programme and into the high risk age group for exposure to the HPV virus.

Australia has seen the importance of this vaccine and last month marked the start of a Government immunisation programme in schools throughout Australia.

Background

Every year there are 30,000 abnormal cervical smears in New Zealand with approx 4,200 being high grade requiring extensive follow-up and treatment. Each year 180 New Zealand women are diagnosed with cervical cancer and 60 women die from cervical cancer. Gardasil could drastically reduce the incidence of the above life changing events straight away and reduce significantly the unacceptably high level of preventable deaths in the long-term.

The cervical cancer screening programme has significantly reduced cervical cancer deaths in New Zealand. Gardasil will not replace the cervical cancer screening programme as approx. 30% of cervical cancers are caused by HPV types not in the vaccine. However in a vaccinated population there will be significantly less abnormal smears and cervical cancer cases detected. It is important that women receive the message that even if you have received vaccination you still need to get regular smears.

One of the limitations with the cervical cancer screening programme, as in all screening programmes, is enrolment. Only two thirds of those eligible for the cervical cancer screening programme are enrolled. Participation by Maori, Pacific Island and low income women is even lower. An adolescent school based vaccination programme has a high uptake thereby significantly reducing the cervical cancer rates in a non screened group.

In worldwide clinical trials, published this month in New England Journal of Medicine (NEJM), involving over 20,000 women, Gardasil was proven to be 100% effective against HPV types 16, 18, 6 and 11. Together HPV types 16, 18, 6 and 11 cause approximately 70% of cervical cancer cases, 50% of high grade abnormal smears, 35% low grade abnormal smears and 90% of genital warts along with a significant number of vulvar and vaginal pre-cancers and cancers.

In addition data submitted to Medsafe this month outlines that Gardasil is even more effective than previously reported, providing protection against additional HPV types potentially increasing Gardasil’s total prevention against cervical cancer to greater than 80%.

Gardasil has been approved in more than 70 countries including the United States, the 27 countries of the European Union, Mexico, Australia, Taiwan, Canada and Brazil. Additional applications for Gardasil are currently under review with regulatory agencies in more than 50 countries around the world.

Gardasil is currently funded in the US, Australia, Germany, Italy and Sweden with France commencing a Government programme in July 2007. Many other countries are in the process of determining a Government Funded programme.

ENDS

About CSL Biotherapies Limited
CSL Biotherapies Limited is a global, specialty biopharmaceutical company that develops, manufactures and markets products to treat and prevent serious human medical conditions. Innovation and new product development for unmet medical needs continue to drive CSL Biotherapies growth. CSL Biotherapies (NZ) Limited was set up in New Zealand in 1992 to provide a range of vaccines and medications to the New Zealand population. Over the past 14 years CSL Biotherapies has also held contracts with the NZ Government to supply vaccines ranging from influenza, tetanus, diphtheria and combination vaccines.


CSL Biotherapies and Merck & Co
Fundamental technology, contributing to the development of GARDASIL, was discovered in 1991 at the University of Queensland by Professor Ian Frazer and Dr Zhou in collaboration with CSL Biotherapies Limited. In 1995 CSL Biotherapies licensed this technology to Merck & Co., Inc. - parent company of Merck Sharp & Dohme New Zealand (MSD NZ). Merck then undertook an extensive clinical trial programme leading to the development of GARDASIL. CSL Biotherapies will market GARDASIL in New Zealand and Australia. Merck & Co., Inc. will market the vaccine in the rest of the world. MSD NZ has also contributed to the international research efforts for the vaccine by co-ordinating a Phase III clinical trial, with sites in Auckland and Christchurch.

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