Statement from BCAC on Herceptin Issues

11 August 2008

The Breast Cancer Aotearoa Coalition (BCAC) issued the following statement in response to issues raised in the current 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.

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.

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