Herceptin decision continues to disappoint

Herceptin decision continues to disappoint hundreds of New Zealand women

News release

Thursday, 7 August 2008

For immediate release

Roche Products (NZ) Ltd is very disappointed that New Zealand women with early HER2 positive breast cancer will continue to miss out on the internationally accepted 52 weeks' treatment with Herceptin(r) (trastuzumab).

Roche's managing director Svend Petersen says PHARMAC's decision comes despite the best efforts of Roche and many Herceptin supporters, including a large number of cancer specialists and patient advocates, to secure funding for 52 weeks of Herceptin.

"Roche has worked hard to reach an agreement with PHARMAC, offering all available clinical information and a price that means it is as cost effective and as affordable as possible".

Roche New Zealand does not accept PHARMAC's assertion that there is uncertainty in the evidence for giving Herceptin after (sequentially) or with (concurrently) chemotherapy.

"The published and independently peer reviewed studies clearly show that 52 weeks of Herceptin reduces the risk of death by 33 per cent whether it is given at the same time, or after, chemotherapy." 1,2

"PHARMAC is very critical of the clinical trial information supporting 52 weeks, yet seems quite accepting of the significant data gaps that exist with the 9 week regimen - such as a lack of survival benefit".

"32 countries have evaluated exactly the same evidence and come to the conclusion there are compelling reasons to fund Herceptin for 52 weeks now. New Zealand remains the only OECD nation not to fund Herceptin for 52 weeks."

Mr Petersen says PHARMAC's decision flies in the face of international best practice. It also fails to account for cancer specialists' support for 52 weeks' of Herceptin.

In 2007, the Karolinska Institute of Sweden assessed access to cancer medicines in 25 OECD countries and concluded that New Zealand's access was both "low and slow".3 Mr Petersen says PHARMAC's decision further confirms that finding.

Roche remains committed to working with all stakeholders in order to continue to best serve the needs of New Zealand women with early HER2 positive breast cancer.

As of March 2008, the following 32 countries fund Herceptin for 52 weeks for early HER2 positive breast cancer:

Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Italy, Japan, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Republic of Ireland, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Ukraine, United Kingdom, USA.

Ends

References:

1. Romond E, et al. Trastuzumab plus Adjuvant Chemotherapy for Operable HER-2 Positive Breast Cancer. N Eng J Med 2005; 353(16):1673-84. 2. Smith I, et al> 2-year follow-up of trastuzumab after adjuvant chemotherapy in HER-2 positive breast cancer: a randomized controlled trial. Lancet 2007; 369: 29-36. 3. B. Jonsson, N. Wilking. A global comparison regarding patient access to cancer drugs. Annals of Oncology 2007; 18 (Suppl 3): 1-78.

Roche Products (New Zealand) Limited is committed to providing innovative, high quality medicines for use in New Zealand. Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life.

Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 79,000 people. Additional information is available on the Internet at www.roche.co.nz

Consumer Information

Herceptin* (trastuzumab) is a Prescription Medicine used to treat patients with early breast cancer and metastatic (spreading) breast cancer who have tumours with a large amount of the HER2 protein.

Tell your doctor if you have coronary artery disease, high blood pressure, heart failure, lung tumours or disease, or if you are pregnant or breastfeeding.

Possible unwanted effects: Common: chills, shivering, fever, nausea, vomiting, pain, stiffness, shaking, headache, dizziness, cough, skin rash, itchy skin, weakness, fatigue, abnormal or fast heart beat, insomnia, anxiety, depression, runny or blocked nose, cold/flu-like symptoms, chest infection, worsening cough, pain on urination, diarrhoea, hair loss, muscle or joint soreness. Serious: shortness of breath or breathing difficulty, severe cough, severe swelling of feet or legs, chest pain, abnormal heart beat, severe diarrhoea, feeling faint.

Ask your oncologist if Herceptin is right for you. Use strictly as directed. If symptoms continue or if you experience side effects or would like further information, please talk to your oncologist or visit www.medsafe.govt.nz for Herceptin Consumer Medicine Information. Herceptin (150mg and 440mg vials) is a funded medicine only for patients with metastatic (spreading) breast cancer who meet pre-defined criteria. A prescription charge and normal oncologist fees may apply.

ENDS

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