Breast Cancer Aotearoa Coalition (BCAC)
Media Statement
Auckland, 11 August 2008
The Breast Cancer Aotearoa Coalition responds to issues raised in the Herceptin debate
Nine weeks was refused approval for use by New Zealand’s expert medicines safety agency:
In 2007 PHARMAC applied to MedSafe, the government’s expert medicines safety and regulatory body, to have nine weeks of
Herceptin approved for use in New Zealand. MedSafe refused to give approval, citing the lack of clinical evidence
supporting nine weeks and the overwhelming amount of evidence in favour of 52 weeks. In making its decision, MedSafe
stated there was “insufficient data of a regulatory quantity and quality” to justify approving PHARMAC’s application to
register nine weeks of Herceptin for use.
Alarming inconsistencies in PHARMAC’s decision making process:
In 2006 PHARMAC declined Herceptin funding due to a lack of clinical evidence supporting its safety and efficacy. Four
independent international trials, including the largest ever breast cancer trial, involving more than 12,000 women have
proven the efficacy of 52 weeks to the satisfaction of 33 other developed nations.
Yet, PHARMAC continues to hold up a single nine week trial, conducted in one country and involving only 232 women as
sufficient reason to fund for nine weeks.
If these four trials provided insufficient evidence to fund 52 weeks in 2006, how can one trial involving only 232 women
provide sufficient evidence to fund for nine weeks in 2008?
Cancer specialists do not support nine weeks:
PHARMAC does not have the support of the majority of New Zealand’s cancer specialists.
During the recent consultation 33 of New Zealand’s cancer specialists made a submission to PHARMAC showing their support
for 52 weeks funding. This submission highlighted their confidence in 52 weeks treatment with Herceptin and their
concern about the lack of evidence for nine weeks.
PHARMAC letter published in the Lancet:
A great amount has been made of an article supposedly authored by the editors of the Lancet regarding concerns over 52
weeks. This article was in fact an opinion piece, authored by PHARMAC itself and published in the Lancet – as such it is
misleading to hold this up as representative of the views of the Lancet or its editors.
SOLD clinical trial:
PHARMAC is funding a clinical trial to retrospectively discover the efficacy of nine weeks Herceptin treatment as
opposed to the now international standard 52 weeks. The results of this trial will not be known for at least 7 years.
Over that period, around 2000 New Zealand women will have been exposed to a treatment that remains unproven and
unregistered for use in this country. This has the potential to be another ‘unfortunate experiment’ but this time on a
massive scale.
Cardiac toxicity:
PHARMAC’s comments regarding Herceptin’s cardiac toxicity are misleading. All pharmaceutical treatments, particularly
cancer treatments have side effects, many of which are significantly worse than Herceptin.
In their submission to PHARMAC, 33 New Zealand cancer experts commented that “the risks of significant cardiac toxicity
are low and usually reversible”. They conclude that for the majority of patients cardiac concerns should not stand in
the way of 12 months’ Herceptin therapy. This is because the consequences of the cancer returning are far worse than
those of a cardiac event.
Funding:
The cost of Herceptin has recently been quoted at up to $35 million dollars annually, when PHARMAC's own documentation
(distributed with the notification of their decision not to fund on 7th August) refers to a maximum of $17-19 million.
This is only $9 million more than what PHARMAC is currently spending on the SOLD trial.
About the Breast Cancer Aotearoa Coalition
www.breastcancer.org.nz
The Breast Cancer Aotearoa Coalition (BCAC) is an Incorporated Society with charitable status, presenting a unified
voice to call for change, improvement and innovation on behalf of all New Zealand women experiencing breast cancer.
BCAC was formed in November, 2004 when twelve New Zealand breast cancer organisations came together at a forum to create
one group. BCAC now has twenty-four member organisations and is currently working on five major initiatives:
to ensure consistent, high quality detection and treatment of breast cancer throughout New Zealand by promoting the
development and implementation of evidence-based best practice guidelines;
to support the prompt and effective implementation of the extended age breast-screening programme (45 to 69);
to inform and advocate for improved access to breast cancer treatment medicines;
to research and promote the provision of professional psychosocial services for breast cancer patients and their whanau,
family and friends;
to identify and promote breast cancer issues for Māori and Pacific Island women
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