KEY POINTS:
Advocates of the breast cancer drug Herceptin have responded angrily to today's decision from drug funding body Pharmac to fund nine-week courses of the medication, rather than the preferred 52-week option.
Pharmac announced today it would fund nine-week courses of Herceptin, in combination with a taxane drug, for women with early HER2-positive breast cancer.
A joint release from Pharmac and District Health Boards (DHBs) said 350 women each year would benefit, with funding available from July 1 in a move representing an investment of $6 million a year by DHBs.
The Herceptin Heroes, a group of women who are HER2+ breast cancer sufferers, mostly with early breast cancer, said they were "astounded" by what they described as Pharmac's misrepresentation of the efficacy of the nine-week course, while the Breast Cancer Aotearoa Coalition slammed the decision as "unintelligent" and showing a "reckless disregard" for the lives of New Zealand women.
And the drug's manufacturer, Roche Products (New Zealand) Ltd said tests had shown a nine-week course of the breast cancer drug Herceptin had no survival benefit.
Roche managing director Svend Petersen said by deciding to fund the nine-week course, Pharmac had ignored "significant" clinical evidence of the benefits of a 52-week course, which was "supported by both patients and oncologists across New Zealand and which has become international best practice".
He said the New Zealand public should not be surprised by this decision, given the financial constraints Pharmac operated under.
"Although the Government has significantly increased its investment into health over the last five years, the medicines budget has not kept pace."
Mr Petersen said Roche did not accept Pharmac's assertion that evidence for the efficacy of the nine-week course was comparable with that for 52 weeks.
"Four international clinical trials, involving more than 12,000 women have shown a clear survival benefit when treated with Herceptin for 52 weeks. Only 232 women took part in the nine week trial, which showed no survival benefit."
Herceptin Heroes chairwoman Anne Hayden said New Zealand women needed to be aware that unlike the 52-week course, the nine-week course did not have Medsafe approval.
"Pharmac are open about this, but perhaps are less so about its implications. Its FAQ sheet advises that women who are eligible for funded Herceptin will need to give informed consent to this treatment because it does not have Medsafe approval.
"Although patients routinely consent to medical and surgical treatment, does this disclaimer divorce Pharmac from any responsibility for the administration, success, side-effects or any thing else that might crop up relating to this treatment?" said Ms Hayden.
"It seems they are being very careful to cover their backs rather than care for women with an aggressive disease."
Breast Cancer Aotearoa Coalition chairwoman Libby Burgess said Pharmac's funding package was based "purely on cost, not evidence".
"This radical decision is way out of step with the rest of the world. Pharmac has ignored the recommendations of our oncologists and is forcing them to use an unproven treatment regimen designed by a Finnish researcher to test other chemotherapy agents.
"This is based on data from only 54 women in the entire world who have received this treatment whereas the international standard 12-month treatment is based on studies involving over 12,000 women and it has proven survival benefits," Ms Burgess said.
National Party associate health spokeswoman Jackie Blue said Pharmac's cancer experts were bullied into approving the nine-week programme.
Dr Blue released minutes from a November meeting of Pharmac's advisory committee which shows experts' preference was for a year-long course.
She said the Government had been claiming specialists had made the decision willingly when that was not the case.
New Zealand First leader Winston Peters said the decision to fund a larger nine-week trial of Herceptin was unethical and based on unsound research by Pharmac.
"A total of 23 first world countries have Herceptin available on the basis of 12 months' treatment and not some mythical nine-week treatment dreamt up by Pharmac."
Pharmac's deputy medical director, Dilky Rasiah, said a 52-week course could not be justified under Pharmac's funding criteria.
- NZPA