Judge orders review of Herceptin decision

Judge orders review of Herceptin decision

Thursday, 3rd April 2008

Roche Products (New Zealand) Limited welcomes Justice Gendall’s directive to set aside PHARMAC’s decision not to fund 52 weeks of Herceptin® for the treatment of early HER2 positive breast cancer. Svend Petersen, managing director of Roche, says Roche remains committed to working productively with PHARMAC and other relevant parties in order to meet the needs of NZ women with early HER2 positive breast cancer.

“We are pleased PHARMAC will have an opportunity to review their decision and Roche looks forward to being part of the consultation process.” Mr Petersen says 32 countries now fund Herceptin for the treatment of early HER2 positive breast cancer, but New Zealand remains unique in being the only developed country to have declined funding for 52 weeks of Herceptin.

“PHARMAC reviewed the same clinical evidence as 32 other countries but came to a different conclusion. Internationally, the standard of care is 52 weeks and we have always believed that PHARMAC’s decision was unduly affected by its requirement to stay within its allocated drugs budget.” “We remain concerned that funding decisions on innovative new medicines like Herceptin may be unfairly biased by their budget impact.” In countries with similar health systems such as the United Kingdom and Australia, the clinical and cost effectiveness review of medicines is conducted separately to the assessment of budget impact.

“The challenge of funding significant new advances like Herceptin in New Zealand under the current system is not going to disappear.” In addition, Mr Petersen says that New Zealand needs to increase its medicines budget. Decades of investment in biotechnology are now producing major advances in a wide variety of diseases. Whilst this innovation does come at a financial cost, he says innovations such as Herceptin can provide real value in return for the investment made.

“Through using Herceptin in early breast cancer we will save lives and, significantly reduce the number of women who will require extensive and costly treatment for relapsed (advanced) disease.” Page 2 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

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/flulike symptoms, chest infection, worsening cough, pain on urination, diarrhoea, hair loss, Page 3 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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