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.