Government gives thumbs up to wider use of Herceptin

The Government this afternoon provisionally approved use of the costly drug Herceptin for certain women in the early stages of breast cancer.

Medsafe, the Ministry of Health's medicines safety unit, announced its long-awaited decision to extend the licence for the drug for early breast cancer.

But patients with early breast cancer must now wait for a separate ruling on whether state funding will be extended to them for Herceptin, a drug hailed as a breakthrough by some cancer experts.

Some women in this patient group are already receiving the drug, paying for it themselves, at an average cost of about $110,000 in Auckland. Women are running fundraising drives or extending their house mortgages to pay for it.

Herceptin is already taxpayer-funded for women with so-called HER2-positive breast cancer in whom tumours have spread to other parts of the body.

More than 2000 women are diagnosed with breast cancer in New Zealand each year and around 600 die from the disease. HER2-positive breast cancer produces large amounts of a protein called HER2 and the disease accounts for around a quarter of all breast cancer. It is an aggressive form of cancer that responds poorly to chemotherapy and most cases are aged under 50.

International trials have shown that women with early HER2-positive breast cancer who are treated with Herceptin are about 40-50 per cent less likely to suffer a cancer recurrence and possibly 30 per cent less likely to die in the next few years than those who receive standard treatment.

Herceptin has been the subject of a lobbying campaign by patients, doctors, Opposition MPs and the drug's supplier for expanded state funding.

If drug buying agency Pharmac and the 21 district health boards agree to fund Herceptin for patients with early breast cancer, the $47 million a year state cancer drugs budget could increase by $30 million.

An 18,000-signature petition was presented to Parliament last week seeking an extension of funding for Herceptin to early breast cancer.

Medsafe said today the provisional consent limits the use of Herceptin to treat women with early breast cancer who test positive for the HER2 gene once they have had surgery and completed their adjuvant (additional) chemotherapy.

Due to concerns that use of Herceptin may be associated with heart damage, the provisional consent also limits the treatment to those women who have a normal heart function before treatment starts and requires women using Herceptin to have their heart function checked by echocardiogram every three months during treatment.

Medsafe's principal technical specialist, Dr Stewart Jessamine, says Medsafe is the first medicines regulatory authority to assess and approve Herceptin as a treatment for primary breast cancer.