Herceptin not funded, under continuing review

Media release

Herceptin not funded, under continuing review

Funding has not yet been approved for breast cancer drug Herceptin, but will be kept under review by Government drug-funding agency PHARMAC as new information emerges.

The available clinical data is not sufficient to justify a positive funding decision, says spokeswoman Dr Dilky Rasiah. The data is unclear about Herceptin’s long-term benefit and its impact on life expectancy.

District Health Boards, who fund pharmaceutical cancer drugs used in hospitals, accepted PHARMAC’s recommendation to not fund Herceptin at this time.

The door remains open to funding Herceptin, but this would require better data, she says.

Dr Rasiah says PHARMAC is making every effort to obtain further information, including directly contacting clinical trial researchers in the United States and Finland. Two-year follow up data from the important HERA trial is also expected to be published in a peer reviewed journal by the end of this year.

In addition, discussions will be held with NZ oncologists on the possibility of New Zealand taking part in a further international trial on Herceptin.

Dr Rasiah says the first step in the ongoing review will occur in August when the clinical advisory committee PTAC will examine new information. PTAC’s role is to provide clinical advice to PHARMAC. When it examined Herceptin at its May meeting, PTAC identified key uncertainties in the data and sought further information, some of which has been received.

“We are continuing to examine the evidence that is emerging,” Dr Rasiah says. “At the moment the data is not strong enough to support a positive funding decision, although we are open to funding Herceptin if better quality evidence becomes available.”

“The available data is short-term and does not show the long-term benefit of Herceptin, particularly on life expectancy. We need sufficient data that shows an investment in Herceptin is justified, which is not currently the case.”

The high cost also remains a concern. Funding Herceptin for early breast cancer would cost DHBs $20-$25 million per year for up to 320 patients, compared to a current spend on all other hospital cancer drugs of about $35-40 million.

District Health Boards support the decision made by PHARMAC, says DHB CEOs spokesman David Meates.

“DHBs have to be mindful of Herceptin’s cost, and the impact funding would have on associated services such as echocardiograms, infusion and monitoring services,” David Meates says.

“Herceptin is a high cost drug, and in considering a $20-$25 million investment such as this, we need to be sure that Herceptin offers sufficient benefit for its considerable cost. We don’t have that confidence at the moment.”

Dr Rasiah says PHARMAC is keeping a close eye on international developments.

In Britain, the National Institute of Clinical Excellence (NICE) has issued draft guidance recommending funding for Herceptin, however this guidance has been appealed. It will be a number of weeks before a final recommendation is made.

In Australia, the Pharmaceutical Benefits Advisory Committee has provisionally recommended funding for Herceptin, although this recommendation remains subject to price negotiations with Roche and final approval by the Australian Federal Cabinet. If approved, funding could occur from 1 December 2006.

Other countries also noted similar concerns to those raised by PHARMAC’s clinical committee, says Dr Rasiah.

For example, the independent report commissioned by NICE noted:

“The benefits of trastuzumab (Herceptin) on rates of recurrence are unknown beyond three to four years; there is little evidence to date of the effects of trastuzumab on overall survival; and there is no evidence of the effects of trastuzumab upon long term cardiac dysfunction.”[1]

Dr Rasiah says in making a decision like Herceptin, PHARMAC and DHBs are aware that a $20-25 million investment will limit their ability to fund other pharmaceuticals or health services. Other countries do not necessarily take into account the impact of spending on wider health services.

Dr Rasiah says PHARMAC remains open to continuing negotiations with Roche and taking a further recommendation to District Health Boards. As Herceptin is a drug used in hospitals, funding must be approved by DHBs.

ENDS

[1] S. Ward et al. May 2006 "Trastuzumab for the Treatment of Primary Breast Cancer in Her2+ women". School of Health and Related Research, University of Sheffield.

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