Roche committed to securing Herceptin funding

Roche committed to securing Herceptin funding

Friday, 28 July 2006, 3:34 pm

Roche remains steadfast in its commitment to secure funding for Herceptin®

Auckland, 28 July 2006

Roche Products (New Zealand) Ltd is disappointed by PHARMAC’s decision to decline funding of Herceptin (trastuzumab) for HER2-positive early breast cancer, but the company is committed to keeping its chair at the negotiating table until a positive outcome for patients is reached.

Svend Petersen, Roche Products (NZ) Ltd Managing Director, says: “This is a watershed decision for New Zealand. It will affect the lives of approximately 400 New Zealand women and their families today and many more women in the future.

“Roche firmly believes Herceptin is a cost effective treatment for early stage breast cancer and the cost to benefit threshold is below that of other drugs PHARMAC has funded. Herceptin represents one of the biggest breakthroughs in breast cancer research in the last 20 years and we will continue to work constructively with PHARMAC to make it available to New Zealand women as soon as possible.

“We have supplied PHARMAC with the same extensive clinical and cost effectiveness data that has convinced Australia and the UK to provisionally recommend funding for this patient group.

“Additional information has recently become available including further international clinical data. The next step is to await PHARMAC’s assessment of this data and continue to work collaboratively until we find a solution to the funding challenges,” he says.

Herceptin is a new generation, targeted type of cancer therapy that offers a new approach by specifically targeting the HER2 protein on the surface of the cancer cell, inhibiting cell growth and division.

Herceptin was given to women after their surgery and chemotherapy in one of the largest breast cancer studies ever carried out. The study found that giving Herceptin for one year significantly reduced the risk of breast cancer coming back by 36 per cent and reduced the risk of death by one-third compared to surgery and chemotherapy alone. 1,2

In New Zealand there are approximately 400 women diagnosed with the HER2-positive form of early breast cancer each year. These patients could potentially receive the benefit of Herceptin treatment, provided their heart function is normal, after completion of chemotherapy.

Roche Products (New Zealand) Ltd received Medsafe regulatory approval in March this year to extend the use of Herceptin treatment to HER2-positive early breast cancer patients with normal heart function. 3

In New Zealand there are over 2500 new registrations for breast cancer annually. One third of these patients will develop advanced or metastatic cancer (when cancerous cells from the original tumour travel to another part of the body) and approximately one in four patients will have HER2-positive disease, a particularly aggressive type of breast cancer that progresses rapidly, responds poorly to some chemotherapy and is often associated with a poor prognosis (shortened survival).

A funding application for Herceptin use in HER2-positive early breast cancer setting was submitted by Roche in December 2005 and formal negotiations with PHARMAC commenced in May. PHARMAC announced its decision earlier today to defer making a decision on funding, following a recommendation by its Pharmacology and Therapeutics Advisory Committee (PTAC) and feedback from its Cancer Advisory Treatment Sub-Committee (CaTSoP).

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About Roche
Roche Products (New Zealand) Ltd is committed to providing innovative products for cancer care in New Zealand. Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-orientated health groups in the fields of pharmaceuticals and diagnostics. Roche’s products and services address prevention, diagnosis and treatment of disease, enhancing well-being and quality of life. Roche employs some 62 000 people in more than 150 countries around the world. The company has business alliances and R&D relationships with numerous partners, including majority ownership interests in Genentech and Chugai, which are both members of the Roche Group.

References:
1. Piccart-Gebhart MJ, et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med 2005; 353:1659-1672
2. Smith IE, et al. Trastuzumab following adjuvant chemotherapy in HER2-positive early breast cancer (HERA Trial): Disease-free and overall survival after 2 year median follow-up. Presented at the American Society of Clinical Oncology 2006, Atlanta, Georgia.
3. Herceptin® (trastuzumab) Data Sheet, 15th March 2006.

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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