Herceptin fears baffle doctor

A Pharmac committee has expressed concerns about the safety of the costly breast cancer drug Herceptin - mystifying a cancer doctor and lobby group.

Breast cancer lobbyists are pushing for the Government to buy Herceptin for women in the early stages of a certain type of breast cancer.

It costs on average $110,000 for the 12-month course, a price which has forced some to sell or mortgage their houses.

It is already funded for women with so-called HER2-positive breast cancer that has spread and become incurable.

Trials have shown that women in the early stages of the disease who are treated with the drug are about 50 per cent less likely to die or suffer a cancer recurrence than those who receive standard treatment.

Around a quarter of all breast cancers are HER2-positive, an aggressive form of the disease which responds poorly to chemotherapy.

Pharmac's Pharmacology and Therapeutics Advisory Committee (PTAC), which compares the effectiveness of new drugs with existing medicines before Pharmac checks on value for money, looked at Herceptin data yesterday.

The drug is yet to be licensed by the medicines regulator Medsafe, which must consider safety issues, for use in early breast cancer.

Pharmac medical director Dr Peter Moodie said the committee's view was that the "interim and incomplete" data it had been supplied appeared promising, but it was concerned about the drug's safety profile.

"The committee will not pre-empt any decision of Medsafe, but PTAC does note that there are a number of safety issues that need to be addressed.

"PTAC recommends that at present for early breast cancer, this is a drug that should only be administered as part of a clinical trial."

Breast Cancer Advocacy Coalition chairwoman Libby Burgess said the safety concerns were ridiculous.

And Auckland City Hospital cancer specialist Associate Professor Vernon Harvey, a member of PTAC's cancer treatments subcommittee, said he found the decision strange.

A number of privately paying women were being treated with Herceptin infusions for early breast cancer, in line with overseas use and a large international trial he took part in which showed the drug to be very safe and effective in this patient group.

Doctors can treat patients "off label" with a drug that has not been registered for certain groups, in this case early breast cancer patients.

Medsafe spokesman Dr Stewart Jessamine said off-label use was permitted based on the doctor and patient making an informed choice that the drug was the best treatment.

Herceptin trials found that 0.5 per cent of patients developed heart failure if given the drug separately from chemotherapy; the rate was higher if taken with chemotherapy.

"There is a small cardiac risk, but it is significantly less than with some chemotherapies," said Professor Harvey.

"Withdrawal of Herceptin will nearly always be followed by rapid improvement. Sometimes the improvement will occur if you continue with Herceptin."

Widening access to Herceptin could add $30 million a year to the Government's $47 million cancer drugs budget.

Breast Cancer Foundation spokeswoman Dr Belinda Scott said she was disappointed by Pharmac's comments on Herceptin.

"Clinicians want it. Women want it. It is safe and it works. For Pharmac to suggest it isn't safe is rubbish. This is just an excuse not to fund it."

Pharmac said its committee would look at the drug again once Medsafe had made its licensing decision.