Advocacy Group Disappointed by PTAC Decision
Breast Cancer Advocacy Coalition (BCAC)
Auckland, 17 February 2006
For Immediate Release
Breast Cancer Consumer Advocacy Group Disappointed by PTAC Decision
The Breast Cancer Advocacy Coalition (BCAC) is disappointed at the decision made by the Pharmacology and Therapeutics Advisory Committee (PTAC) today regarding the funding of trastuzumab (Herceptin) for early breast cancer. PTAC provides clinical advice to PHARMAC on pharmaceuticals being considered for subsidy.
Clinical trials show that Herceptin reduces the rate of recurrence of the aggressive HER2 positive form of breast cancer by up to 52%. PTAC has indicated that ‘interim and incomplete data … looks promising’ but has concerns over the drug’s safety profile and will await approval from Medsafe, the regulatory group that will make a decision regarding the safety and efficacy of the use of Herceptin for early HER2 positive breast cancer.
BCAC Chairperson Libby Burgess notes that Herceptin has a low rate of cardiac toxicity (around 1% of treated patients if given after a taxane or 4% if given concurrently). Of the 13,000 women who participated in clinical trials, 2 died of cardiac complications (1 in the untreated group and one in the group that received Herceptin) However, some chemotherapy drugs widely used and funded in cancer treatments also have a known and much higher rate of cardiac toxicity (e.g. Adriamycin). Ms Burgess says “it has always been up to the individual patient to discuss the risks for their particular circumstances with their oncologist and so make a decision appropriate for their care.
Data from 5 large international trials involving 13,000 women show the risks of recurrence of this aggressive form of breast cancer far outweigh any side-effects for the vast majority of patients. Clinicians in New Zealand and around the world are already prescribing the drug because of its life-saving properties. Funded access is already being provided prior to registration by health authorities in parts of the UK, Canada, Italy and France. Herceptin has been widely used in New Zealand since 2001 for advanced metastatic HER2 positive breast cancers so the risk has already been considered and managed by many patients and their oncologists.”
“This is not a new drug . The evaluation of its cardiac toxicity is not new. What is new is the need to extend the use of Herceptin to a wider group of women. Clearly the drug is already considered safe enough to prescribe to people with advanced breast cancer and to those who can pay to use it. There is plenty of data both from the widespread use of Herceptin for advanced breast cancer and from the more recent clinical trials for PTAC to consider”.
‘We acknowledge that Medsafe is the appropriate government body to evaluate the safety and efficacy of Herceptin for use in early breast cancer treatment,’ says Ms Burgess, but PTAC should not wait until then to seek further information. We urge PTAC to seek further advice from the experts on its cancer treatments subcommittee (CaTSOP) before the Medsafe meeting on March 7. We look forward to PHARMAC funding the drug promptly once Medsafe has approved it because time is of the essence for those women and their families who desperately need Herceptin. Every delay brings fresh heartbreak.’
‘Every day in New Zealand 7 women are diagnosed with breast cancer and of those, up to 2 will be told they could benefit from Herceptin. Without funded access, women with early stage Her2+ cancer may be faced with the choice of having to raise around $100,000 or live with the knowledge that their chance of recurrence of this aggressive cancer is twice as high as someone who has access to Herceptin. This is inhumane. We call on the Minister of Health to ensure the necessary funds are provided immediately upon registration by Medsafe.’
About the Breast Cancer Advocacy
BCAC was formed in November, 2004. Twelve New Zealand breast cancer organisations came together at a forum to create one group, presenting a unified voice to advocate and lobby for change, improvement and innovation on behalf of all New Zealand women suffering from breast cancer. The group is currently working on four major initiatives – advocating for nationwide adoption of the National Breast Cancer Register of data, supporting the Breast Screen Aotearoa programme in reaching its screening targets, improving access to pharmaceutical treatments for breast cancer and advocating for a consistency of high quality care throughout the country by the establishment of best practice clinical guidelines.