Submission to Health Select Committee on the Anne Hayden Herceptin Petition by the Breast Cancer Aotearoa Coalition (BCAC)

Summary of BCAC Submission to the Health Select Committee
Introduction
The Anne Hayden Herceptin Petition
Breast Cancer in New Zealand
HER2+ Breast Cancer
Trastuzumab (Herceptin)
Current Funding Status of Trastuzumab (Herceptin)
WHY WE ASK THE SELECT COMMITTEE TO ACT URGENTLY
References

Summary of BCAC Submission to the Health Select Committee

BCAC calls upon the Health Select Committee to champion and secure the immediate provision of funding for Herceptin to treat women with early HER2+ breast cancer.  The beneficial life-saving impacts of Herceptin in treating this aggressive disease are recognised as outstanding by oncologists and other cancer clinicians in New Zealand and worldwide.   International trials involving over 12,000 women have shown that when used in early breast cancer, Herceptin halves the likelihood of the cancer recurring as advanced, terminal disease (Piccart-Gebhart et al. 2005; Romond et al. 2005).

We ask this committee of our elected representatives to take up the challenge of saving New Zealand women’s lives today.  Urgency is needed because with every day that passes, one or two New Zealand women will fall beyond the limited “window of opportunity” for Herceptin administration (the post-chemotherapy period that will be defined as the acceptable delay following chemotherapy, perhaps to be 12 months, but as yet undefined).   These women who will miss out on funded provision will miss out on the opportunity of having their early breast cancer cured, and will know that their chance of dying of this disease is much greater than those who were able to access Herceptin.  PHARMAC representatives have noted that given the various steps remaining in the formal funding process, the earliest possible provision of Herceptin will be in September or October.  If we allow seven months to pass without provision of Herceptin to the women who need it, we will be standing back and silently accepting seven months of avoidable deaths of New Zealand women.  This delay would be inhumane, irresponsible and entirely unacceptable.

There is currently a situation of huge inequity within New Zealand, where women who are able to pay around $120,000 for Herceptin have a greater chance of living a long and healthy life than those who cannot.  Women recovering from breast cancer surgery and chemotherapy are currently faced with the prospect of selling or mortgaging their houses or organising fund-raising within their communities to access this drug.  They are forced to balance financial impacts on their families with the impacts of the loss of a mother, wife, partner, daughter, or family member.

Serious regional inequities also exist while Herceptin remains publicly unfunded.  Herceptin is being provided in private practice only in Auckland and Palmerston North, so women in other regions must travel long distances every three weeks over the course of a year to receive treatment.  We have been informed that no early HER2+ breast cancer patients based in the South Island are receiving Herceptin.  It is substantially more expensive to obtain Herceptin in Auckland’s private clinics than Palmerston North’s, with a 63kg woman needing to pay $28,000 more in Auckland for the same quantity of Herceptin.  The greater a woman’s weight the larger the quantity of Herceptin needed and the greater the price difference.

We urge the Health Select Committee to consider the plight of the women needing Herceptin now, and to act with compassion and responsibility towards these, their constituents.  We appeal to the members of the Committee to listen to the desperate pleas of those who met with them while presenting the Anne Hayden Herceptin Petition to Parliament on 16th March 2006.  We seek your support in securing immediate funded provision of this life-saving drug for those who came to the steps of Parliament and the many others they represent.  New Zealand women should not have to beg for access to a life-saving medicine. 

This submission is from the Breast Cancer Aotearoa Coalition (BCAC), PO Box 90224, Auckland Mail Centre, Auckland 1030.
We wish to appear before the committee by videoconference to speak to our submission.  Libby Burgess, chair BCAC and can be contacted at (09) 815 7730 (work), 021 990 244 or (09) 376 5941 (home).
The petitioner, Anne Hayden, will be making a submission and we wish that the following also appear (by teleconference or videoconference) in support of our submission: Mrs Belinda Scott, Medical Advisor to the NZ Breast Cancer Foundation and breast surgeon at Breast Associates Ltd; Dr Nicole McCarthy, medical oncologist at the Brisbane Hospital and former Senior Research Fellow of the Breast Cancer Research Trust at the Auckland Hospital; Dr Andrew Simpson, Secretary of the NZ Association of Cancer Specialists and medical oncologist at the Wellington Hospital.  These individuals may also prepare independent submissions on the abovementioned petition. 
The Breast Cancer Aotearoa Coalition (BCAC) is an umbrella group representing thirteen of New Zealand’s breast cancer organisations. BCAC provides a united consumer voice, advocating for improved detection and treatment of breast cancer in New Zealand.  Our member groups are The New Zealand Breast Cancer Foundation, The Breast Cancer Research Trust, The Breast Cancer Network, Breast Cancer Support Service, Te Ha o te Oranga o Ngati Whatua, Breast Cancer Action Trust, The Mamazon Club,     Breast Health NZ, Lymphoedema Support Network, Busting With Life, Look Good Feel Better, Age Concern, and Herceptin Heroes. 

BCAC’s four current key objectives:

• 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 advocate for the prompt and effective implementation of the extended age breast-screening programme (45 to 69)
• To promote the roll-out of the National Breast Cancer Register
• To advocate for improved access to breast cancer treatment drugs.

The Anne Hayden Herceptin Petition

This petition, 2005/0030, asks "that Parliament note that 18,166 people signed the Breast Cancer Herceptin Appeal Petition, requesting that the New Zealand Government fully fund the pharmaceutical drug Herceptin immediately, and further, that Parliament support the progress of such funding as a matter of urgency"

• Cancer is the leading cause of death in NZ women aged 25-74 years.  Breast cancer is the most common cause of cancer death in women (Statistics New Zealand, 2005).
• 2500 New Zealand women are diagnosed with breast cancer each year (Ministry of Health, 2002).
• Over 700 NZ women are predicted to die as a result of breast cancer in 2006 (Ministry of Health, 2002).
• Despite having a lower risk profile for breast cancer, Maori women have a higher incidence of the disease than non-Maori women, particularly in the under 40 age group (McCredie et al., 1999).
• Maori women are more likely to die from breast cancer than non-Maori (Ministry of Health, 2002).
• This disease therefore touches many New Zealand families.
• Treatment for breast cancer usually involves surgery, radiotherapy, chemotherapy and/or hormonal therapy.  Treatment is determined by the characteristics of the tumour and how much the cancer has spread.  Breast cancer may be confined to the breast, may have spread to the lymph nodes near the breast or have spread to other parts of the body (e.g. to brain, bones, liver and/or lungs).
• Surgery involves removal of the tumour and usually removal and testing of lymph nodes in the region of the breast.  Based on the characteristics of the tumour (determined by examination by a pathologist) and the extent of spread of cancer, the most appropriate combination of treatments is chosen for an individual woman.  Over the last 30 years, scientific advances have provided a better understanding of breast cancer and have enabled much more targeted treatment to be given.
• The objective of treatment in women with early breast cancer (i.e. cancer that has not spread beyond the breast and lymph nodes to other parts of the body) is to kill all remaining cancer cells and prevent recurrence i.e. to cure the cancer.
• Once cancer has already spread to other parts of the body (either at diagnosis or as a recurrent cancer), chemotherapy, hormonal therapy and other targeted treatments such as Herceptin can extend life but cure is not possible.

• HER2 is a protein that exists on the surface of all normal cells sending messages telling the cell to grow and multiply (HER2 stands for ‘human epidermal growth factor receptor-type 2’) (Harries and Smith, 2002).
• In HER2+ breast cancer cells, the gene encoding the HER2 protein is either amplified (an excess number of copies of the gene) or overexpressed (excess production of protein), resulting in excessively high levels of the HER2 protein.  This causes these cells to behave aggressively: they grow and proliferate, they have increased invasive and metastatic capability, and they stimulate angiogenesis (growing a blood supply to a tumour) (Hortobagyi, 2005).
• HER2+ cancer is more aggressive & has a poorer prognosis (Harries and Smith, 2002; Slamon et al., 1987; 1989). The 10-year survival with HER2+ cancers is about 50%, i.e. half of all women with HER2+ cancer will be dead in 10 years (Ross and Fletcher, 1998). This contrasts with the current overall 10-year survival in breast cancer of about 80%.
• Around 25% of breast cancers express the HER2 protein (Harries and Smith, 2002).  Given the 2500 breast cancer diagnoses in NZ each year, around 7 NZ women receive a breast cancer diagnosis every day.  Of these one or two will be told they are Her2+ and need Herceptin (20-30% of BC is Her2+).
• Women diagnosed with breast cancer may have their tumours tested using an immunohistochemistry (IHC) test (available but not yet routinely undertaken in NZ) which measures the HER2 protein levels in breast cancer tissue (removed during a biopsy or surgery) using a scale from 0 through 1+, 2+ to 3+ (Bilous et al., 2003; Prati et al., 2005).   This test should be introduced as standard throughout New Zealand so all women newly diagnosed will be informed of the HER2 status of their tumour.
• If a breast cancer is scored as 0 or 1+, it is considered negative and people in that category do not benefit from Herceptin. Women whose breast cancer is scored as 3+ are the most likely to benefit from Herceptin.
• For women whose breast cancer is scored as 2+, a further test, the Fluorescence In Situ Hybridization test (FISH) should take place. This illuminates the HER2 genes in the tumour sample to see how many there are. If more than 2, the breast cancer is “FISH positive” and these women are also more likely to benefit from Herceptin. If “FISH negative”, then the women will not benefit from Herceptin.

• Trastuzumab (Herceptin) is an antibody that blocks the action of the HER2 protein, slowing the growth and spread of the cancer cells. 
• Herceptin was developed specifically for HER2+ breast cancer, based on the knowledge that in these cases the HER2/neu oncogene overexpresses the HER2 protein and a monoclonal antibody could be designed and produced to precisely target this molecule. This “molecular targeted therapy” represents a completely new type of breast cancer treatment, and the positive results of recent Herceptin trials have been heralded by some commentators as “not evolutionary but revolutionary” (Hortobagyi, 2005).
• Four independently run trials (NSAPB-B31, NCCTG- N983, HERA and BCIRG-006) involving more than 13,000 women with HER2-positive early breast cancer have each shown that trastuzumab (Herceptin) given with or after chemotherapy reduces the early risk of cancer recurrence by around 50% (Piccart-Gebhart et al. 2005; Romond et al. 2005).
• This 50% reduction in recurrence is a consistent finding.  Even at this early stage of follow up, the combined American analysis is already showing significant survival benefit (Romond et al. 2005). Such positive early results in breast cancer are unprecedented (Hortobagyi 2005).
• Based on what is seen for other breast cancer treatments, improvements in disease-free survival consistently improve over time and result in increased survival and cure rates (EBCTG, 2005). 
• The Herceptin results are therefore expected to be maintained or improved in the long term.  This means that the death rate from HER2+ cancer could be halved (from 50% survival at 10 years to 25% survival at 10 years).  This would represent an absolute risk reduction of 25%.  Therefore, for every 4 women treated with Herceptin, instead of 2 being alive at 10 years (the current situation), 3 would be alive, and 1 additional life would be saved for every 4 women treated.
• Most trials have used Herceptin for 1 year’s duration, added to current chemotherapy.  A small Finnish trial published recently showed that just 9 weeks of Herceptin improved disease-free survival at 2-year follow-up (Joensuu et al. 2005).  However, most of the evidence currently available supports the efficacy of 1 year’s treatment.
• Herceptin causes cardiotoxicity in a small percentage of patients and therefore cardiac function needs to be monitored in patients on this therapy (Tan-Chiu et al. 2005).  However this is usually minor and reversible (Ewer et al. 2005).

• Herceptin is currently funded for metastatic breast cancer strongly expressing HER-2.  The addition of Herceptin to chemotherapy increases average survival from 22.7 months to 31.2 months (an additional 8.5 months) compared to chemotherapy alone (Marty et al., 2005).
• MEDSAFE has recently approved Herceptin for early breast cancer and PTAC has already considered a submission for funding of Herceptin.
• Women with early breast cancer expressing HER2 and who currently wish to access Herceptin can do so only through private oncology clinics.
• Per patient cost of drug treatment for a full 1-year course is about $70,000 (ex manufacturer excluding GST).
• Patients are paying up to $150,000 (Dr V. Harvey was reported as providing a quote of $190,000, NZ Herald, 7 January 2006) for private treatment as there are additional mark-ups, administration fees and GST collected in the private sector.  The quantity required and thus the cost is weight-dependent.
• Herceptin is being provided in private practice only in Auckland and Palmerston North, so women in other regions must travel long distances every three weeks over the course of a year to receive treatment.  We have been informed that no early HER2+ breast cancer patients based in the South Island are receiving Herceptin. 
• It is substantially more expensive to obtain Herceptin in Auckland’s private clinics than Palmerston North’s, with a 63kg woman needing to pay $28,000 more in Auckland for the same quantity of Herceptin. 
• The total cost of Herceptin for New Zealand women with early breast cancer is estimated to be around $30M annually.
• Assuming that this would pay for 400 women to be treated, there would be 100 lives saved per year due to this treatment being available.  This means about $300,000 per life saved with this treatment.
• As HER2+ breast cancer tends to occur in young women (50% are in their thirties and forties), we can conservatively estimate a life expectancy of around 30 years for the average patient.  Thus the cost per life year saved would be around $10,000.  In cost-effectiveness terms, this is well within the range considered acceptable here and overseas as representing “value for money”.
• Therefore, it is not “cost-effectiveness” which represents a barrier to treatment acceptability but rather the overall cost of treatment.  This relates to the fact that breast cancer is all too common in this country.
• The amount of money allocated to the cancer treatments budgets available to District Health Boards should take into account long-term benefits to New Zealand society of short-term expenditure, and should accordingly be increased.

• Time is of the essence for the many women who have completed or are completing their standard chemotherapy and have a limited 'window of opportunity' to begin Herceptin. 
• Every week that goes by sees 50 New Zealand women receiving a breast cancer diagnosis and 12 of these women will have Her2+ cancer. 
• Many will learn that they need Herceptin and that they will need to find around $120,000 or more (depending on body weight and oncologist fees) to pay for it. 
• The current situation is creating a lot of despair for many New Zealand families. Currently women who cannot pay or cannot attend a private oncology clinic in Palmerston North or Auckland have a greater chance of dying from advanced (metastatic) breast cancer.
• Women are desperately fund-raising around NZ to obtain Herceptin in order to have a chance at life.  They are selling and mortgaging their houses, they are being supported in fund-raising efforts by their friends and communities.  This is creating huge stress for these women who are coping with a cancer diagnosis, surgery and chemotherapy, and for their families.  Many of these women have young families to look after, and the social impacts of allowing them to die avoidable deaths are immense.
• Many are simply unable to raise this sort of money and have to live with the fact that they have a very poor chance of living a long and healthy life.
• Ironically, Herceptin is funded for women whose cancer has advanced to become terminal.  At this stage Herceptin will extend life but not save it. Provision of Herceptin in early breast cancer aims to cure the disease.
• Provincial governments in Canada as well as Health Authorities in parts of the UK, France and Italy are providing funding for this life-saving drug NOW, prior to Herceptin being registered for use in early breast cancer in those countries.
• Time is critically important here because following chemotherapy, there is a limited "window of opportunity" for Herceptin to be effective.  Every day that goes by one or two women will fall beyond this limited "window of opportunity" and will be deemed ineligible for funding because of this.  These women's lives are at stake, and we must not consign them to likely death from recurrent cancer by delaying any further. 
• While PHARMAC and the DHBs may complete their deliberations in June or July, they have stated that the earliest possible provision date would be September or October.  This delay will cost many NZ women their lives. 

• We do not have faith that the current system will deliver timely funding for Herceptin as is demonstrated by the current example of taxanes for early breast cancer.  Taxanes are a type of chemotherapy agent administered intravenously along with other chemotherapy.  Two taxanes are available in New Zealand; paclitaxel (Taxol®) and docetaxel (Taxotere®).  Taxanes are currently subsidised only for metastatic breast cancer.  A submission for funding of taxanes to be extended to patients with early breast cancer was considered by the Cancer Treatments Subcommittee of PTAC in December 2004.  This was recommended for funding with a high priority.  Nearly 18 months on, this decision has yet to be implemented.  (In Australia, a taxane has been fully subsidised as adjuvant therapy in conjunction with AC (doxorubicin & cyclophosphamide) since February 2001).  This level of bureaucratic delay is totally unacceptable, particularly for a drug with the remarkable life-saving qualities of Herceptin.
• New Zealand cannot afford to stand back and allow early curable breast cancer to progress to advanced terminal disease.  We must provide this life-saving treatment to the women who stood on the steps of Parliament urging our elected representatives to intervene to save their lives, and those of all the other Herceptin Heroes they represent.

• We call on our Health Select Committee to urgently access the funds needed to enable all NZ women with early Her2+ breast cancer to provide treatment for all who need it now.

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