Since early 2005, BCAC has campaigned with many groups and individuals for a government funded 12 month course of Herceptin to be made available for NZ women diagnosed with early stage HER2 positive breast cancer.

In December 2008, the long campaign ended when the new National government agreed to fund 12 months of Herceptin for these women. New Zealand became the 35th country in the world to fund 12 months.

The following information provides some background to the campaign.

If you would like to know more, please make an enquiry to us - we welcome your questions, comments and opinions.

National delivers Herceptin Christmas gift for NZ women December 10 2008
National vows to honour Herceptin pledge November 10 2008
Read the BCAC Submission to PHARMAC (June 2008)
Latest BCAC press releases on Herceptin
Read our Herceptin Fact Sheet
Visit our pharmaceutical treatments page for more information
Some background on the Herceptin funding issue
33 countries now fund Herceptin for 12 months 
Is 12 months better than 9 weeks?
Risks vs benefits
Is Herceptin 'good value for money?'
The women who need Herceptin - read their stories
The Judicial Review and the Eight Herceptin Heroines
The Herceptin Fighting Fund
PHARMAC receives over 300 submissions on Herceptin
PHARMAC Press release announcing decision to decline 12 months Herceptin
PHARMAC outlines reasons for declining to fund 12 months Herceptin
PHARMAC's Shameful Decision on Herceptin - BCAC release 7 August
BCAC statement on current Herceptin issues - 11 August
Dr Richard Isaacs and Associate Professor Fran Boyle speak out - 12 August

Some background on the Herceptin funding issue …

In July 2006, PHARMAC declined Roche’s application for funding for 12 months treatment with Herceptin (administered following completion of chemotherapy – 12 months of ‘sequential’ treatment) for early stage HER2 positive breast cancer. PHARMAC announced at this time that it would fund only 9 weeks of Herceptin (administered at the same time as chemotherapy – 9 weeks of ‘concurrent’ treatment).

The eight Herceptin Heroines took PHARMAC to the High Court in February 2008 over its decisions (the Judicial Review, or ‘JR’) to decline 12 months of Herceptin and to only fund 9 weeks.

The High Court ruled on the Heroine’s Judicial Review and found that PHARMAC should have consulted prior to its decision to decline Roche’s application for 12 months funding. The Court has directed PHARMAC to make a new decision on Roche’s application for funding for 12 months treatment, following proper consultation with affected parties.

BCAC believes 12 months Herceptin should be funded and that the timing for each patient (i.e. sequential or concurrent) should be decided by the oncologist and patient, depending on the patient’s individual circumstances. Such medical decisions should not be dictated by PHARMAC, a government pharmaceutical funding agency.

PHARMAC has since issued a proposal on 5 May 2008 to decline funding for 12 months treatment with Herceptin for HER2 positive early stage breast cancer.  Their proposal can be viewed at http://www.pharmac.govt.nz/patients/consultation under the subheading ‘Proposal for 12 months trastuzumab (Herceptin) treatment 5 May 2008’.

The 9 weeks funded Herceptin treatment remains in place for New Zealand women and any new decision on 12 months Herceptin treatment will have no impact on this existing funding for 9 weeks treatment.

Members of the public and those affected by PHARMAC’s proposed decision to decline 12 months funding are invited to submit their views to PHARMAC, explaining what impact this proposed decision may have on them or others. Submitters are asked to provide reasons supporting their views, especially comments regarding the comparative risks and benefits between 9 weeks and 12 months.

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33 countries now fund Herceptin for 12 months

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Is 12 months better than 9 weeks?

1. Two NZ oncologists and a biostatistician wrote to the NZ Journal of Medicine in support of 12 months and explaining why providing only 9 weeks of treatment is risky. Read their article here.
2. International trials of 12 months Herceptin involving over 12,000 women have produced strong, reliable data showing increased survival rates and lower rates of recurrence. This is indisputable.
3. The 9 weeks PHARMAC currently funds is based on results from a single small Finnish trial involving 232 women. Only 116 women received Herceptin in this trial and only 54 of these received the 9 week treatment now funded in New Zealand. The data from this small trial suggests a possible benefit in disease recurrence but is too weak to show any survival benefit.  The findings from this trial are inconclusive.
4. 33 countries now fund 12 months of Herceptin. These countries reviewed the Herceptin trial data and based their decision to fund on the strongest information available – that from the 12 month trials.
5. New Zealand is the only country in the world to fund only 9 weeks.
6. New Zealand’s regulatory body Medsafe determines the safety and efficacy of medicines in New Zealand. Medsafe registered the 12 months Herceptin treatment as safe and effective in 2006. In 2007 PHARMAC applied to Medsafe to have the 9 weeks treatment registered. The application was rejected because of “insufficient evidence”. 

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Risks vs Benefits

• “Significant heart problems develop in a few women. Heart failure has occurred in 0.6% of patients when Herceptin is given following chemotherapy, and up to 4% when given at the same time as taxane-based chemotherapy. In some cases specific drug treatment was required but in most patients, heart function recovered after stopping Herceptin. The risk of heart failure is greater in women with previous heart problems. Patients must be checked for heart problems before receiving Herceptin and must have their heart function monitored during treatment.”

BCAC comment: Much has been made by PHARMAC of the cardiac (heart) risks associated with Herceptin for those women taking the drug for early stage HER2 positive breast cancer.
Indeed there is a proven risk but comment in The Lancet states: ‘While there is cause for concern, perspective is needed: over two years, the risk of cardiac damage seems trivial compared with that of breast cancer recurrence.’ (The Lancet, Volume 369, Jan 6 2007, Hind et al).  This known cardiac toxicity risk should not be used by PHARMAC as a reason to refuse funding for 12 months of treatment. Oncologists around the world are managing this risk with their patients through heart monitoring throughout treatment duration. In the rare cases where there is a problem, treatment is suspended, the issue is resolved and treatment is resumed. If the problem persists, treatment will stop.

• “Recent studies have shown that Herceptin is also beneficial in patients with early-stage HER2-positive cancer, where the cancer is limited to the breast and underarm lymph nodes. Treatment of patients with early stage breast cancer aims not only to extend life, as in advanced cancer, but to cure the disease. Trials involving over 11,000 (now over 12,000) women with early-stage HER2-positive breast cancer show that Herceptin given with or after post-operative chemotherapy reduced the risk of the cancer recurring by up to half, compared with chemotherapy alone. After 2-4 years, more patients were free of disease and fewer had died among those who had received 1 year of Herceptin treatment than among those who had not.”

BCAC comment: If breast cancer is caught early the aim of treatment is to cure. If it is allowed to progress, cure is not possible. Herceptin is fully funded in New Zealand for advanced HER2 positive breast cancer (where cancer has progressed to other parts of the body and cannot be cured) but not for early stage when a woman has the best chance of beating her cancer and living a full and long life.
 

• “A study in early-stage HER2-positive cancer found that 1 year of Herceptin reduced the likelihood of the cancer returning by 52% and the risk of death by 34% at 2 years after completing treatment.  Recent results showed that after 4 years of follow-up in this trial, Herceptin-treated patients still had a 52% lower rate of cancer recurrence and a 35% lower risk of death.  Because the follow up of patients on this trial has been relatively short, the effects over the longer term, including increases in total duration of life, are not yet known.”

• “In a small trial known as the FinHer (Finland Herceptin) study, 232 patients with early-stage HER2-positive breast cancer received either 9 weeks of Herceptin with chemotherapy or chemotherapy without Herceptin as post-surgical treatment. This trial used an unconventional chemotherapy regimen. After 3 years, more patients were free of disease in the group that received Herceptin but the trial was too small to allow detection of a statistically significant difference in survival between treatments.  The small number of patients treated in this trial and serious imbalances between the Herceptin and no Herceptin treatment groups, means the results must be interpreted with great caution and are less certain than for the multiple larger studies involving 12 months of Herceptin treatment.”

BCAC comment: Funding a 9 week regimen (with weak data) for a population is, in itself, a risk because it may not work. Although the study was interesting it is too small to convince medical experts in New Zealand and around the world that it will be effective.

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Is Herceptin ‘good value for money?’

When faced with the fortunate reality that lives can be saved, enhanced or prolonged by appropriate and medically proven administration of a drug, why would we not choose to make this drug available to those who need it?

2400 women are diagnosed with breast cancer in New Zealand every year. Approximately 25% of these women are HER2 positive (about 600). Some of these 600 women have advanced HER2 positive cancers for which Herceptin is already fully funded. Others may choose not to have chemotherapy. About 300-400 women are diagnosed with early stage HER2 positive and could benefit from 12 months treatment with Herceptin.
 
HER2 positive cancer tends to occur in younger women and many of these women are mothers with small children, or women wishing to start families or embark on productive careers. Irrespective of age and family circumstances, all of these women have much to contribute to their families, communities, workplaces and to society through their roles as mothers, partners and as productive citizens within the workforce. Giving these women the proven 12 months course of Herceptin when their disease is in the early stage offers the potential for a cure and minimizes the likelihood of the cancer progressing. These women would then have the best chance of seeing their children grow up and enjoying a full and productive life.

Herceptin is fully funded in NZ for advanced (metastatic) HER2 positive breast cancer. This is where the cancer has progressed from the original tumour site to other parts of the body such as the liver, lungs, bones and brain. Given at this stage, Herceptin cannot cure. It can only prolong life by, in most cases, a matter of months.

PHARMAC prides itself on providing the taxpayer with ‘value for money’ when it comes to funding pharmaceutical treatments. It was very pleased to announce a record budget under spend of $19.4 million for the year 2006. This continued a five year trend of budgetary under spending by PHARMAC that National MP Jackie Blue estimated at the time totaled $73 million. Matthew Brougham, now PHARMAC’s CEO, described the under spend as ‘excellent’ and BCAC replied: “It is simply unbelievable that the Acting CEO of PHARMAC can call that ‘excellent’ when people are crying out for medicines. It’s enough to make you weep.” (BCAC Press Release Nov. 12 2006).

Since PHARMAC’s formation in 1993, the pharmaceutical spend under its management has decreased from 11% of the health budget to less than 6% in 2006. The OECD average is currently 18%.

In New Zealand the funding of pharmaceuticals per person is only 76% that of Australia.  In Australia public expenditure on prescription medicines is 14% of the total health budget compared with only 6% in New Zealand (supplied by RMIA). New Zealand women with breast cancer are 33% more likely to die from the disease than Australian women (Australian Institute of Health and Welfare and the National Breast Cancer Centre 2006. Breast Cancer in Australia: an overview 2006. Cancer Series no. 34, cat. No. CAN29. Canberra:AIHW).

An international survey published in the Annals of Oncology in 2007 showed that of 25 countries surveyed, only Poland invested less per capita than New Zealand on cancer medicines (Jönson, B. and Wilking, N. 2007. A global comparison regarding patient access to cancer drugs. Annals of Oncology 18, Supplement 3, 77pp. www.annonc.oxfordjournals.org)

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