Cancer lobbyists plead for funding after drug approved

Cancer lobbyists say Medsafe's regulatory decision to provisionally approve the use of Herceptin in early-stage breast cancer is a significant gain.

"This is a huge relief for women needing Herceptin," Libby Burgess, chairwoman of the Breast Cancer Advocacy Coalition (BCAC), said.

But she said that even if the government funding agency, Pharmac, and district health boards were able to justify spending up to $30 million on the drug, and were able to find the money, the earliest possible wider access to Herceptin would be in September or October.

"This is not acceptable," she said. Women who could benefit from the drug were not able to wait months as they need Herceptin now.

New Zealand is the first country to formally register Herceptin for use in early-stage breast cancer, but Pharmac and district health board representatives told a press conference in Wellington yesterday they could not guarantee it would be subsidised.

Herceptin will now be referred directly to Pharmac's cancer sub-committee, scheduled to meet in April, and then back to Pharmac's advisory board for a final recommendation when it meets in May.

In the meantime, Pharmac will try to negotiate down the asking price for the drug, and the 21 district health boards will try to find a way to fund the new drug by the time their chief executives discuss it in June.

At current market prices, funding Herceptin for the 400-odd early-stage breast cancer patients each year who have the HER2 form of the disease, could cost $30 million a year.

That is nearly as much as the board presently spend on all their other anti-cancer drugs.

"Spending $30 million on Herceptin would constrain our ability to fund other drugs we are currently considering," said Pharmac spokeswoman Dr Dilky Rasiah.

"At this stage we can't guarantee that Herceptin will be funded."

The clinical data and cost-effectiveness would have to stack up, and a deal done with drug supplier Roche, before health boards could decide if it was affordable.

Medsafe's principal technical specialist, Dr Stewart Jessamine, said it had given the world's first regulatory approval of Herceptin as a treatment for primary breast cancer despite concerns that its side effects can include heart damage in 3 per cent of patients.

Women who qualify for the drug will have to be regularly screened for normal heart function.

The biggest overseas clinical trial so far has shown Herceptin can reduce the recurrence of HER2 breast cancer by about 9 per cent after one year, and a small study showed an 18 per cent advantage after four years -- but this involved only a 4 per cent increase in survival rates at four years.

The actual range of survival rates in this study could be as low as a 0.6 per cent increase in survival or as high as 9 per cent.

And the big study, in which NZ women participated, showed no significant difference after two years in the survival rates for those treated with Herceptin.

- NZPA