KEY POINTS:
Hand on heart, if any of the women in my family were diagnosed with breast cancer that could be treated with Herceptin, I would advise them to take the nine-week option funded in New Zealand.
The nine-week treatment is administered with other chemotherapy drugs and all the evidence points to it providing a similar benefit to a 12-month course of the drug, but with less impact on the women taking it and possibly fewer side-effects.
This is a bold statement to make, but I truly believe we have made the correct decision in reaffirming our confidence in the nine-week Herceptin treatment and not funding an extended 12-month treatment.
The bottom line is that the jury is out on the evidence that extending the treatment time brings extra benefit for the women taking it.
And that's the issue for us.
When we took a fresh look at all the information, we just did not have confidence that it would bring extra health benefits over the full and effective concurrent nine-week treatment already funded.
Pharmac is the guardian of the taxpayers' money, making decisions all the time on which drugs New Zealand will fund. Our decisions must be based on getting the best health outcomes for New Zealand because any money spent in any one area of health may mean other New Zealanders needing other treatments will miss out.
It's an international problem - some medicines cost a lot of money and no country can afford to keep giving drug companies a blank cheque.
Irrespective of what the exact additional cost would have been, why would we spend significant extra money on something we weren't confident gave extra benefits? To do so would be irresponsible as a guardian of taxpayer money.
Before we made this latest decision we consulted very widely. We went back to the drawing board with our work, with our independent clinical advisers looking at the clinical evidence, and we very carefully considered all the submissions we received.
What we found was a lot of uncertainty about the best way to use Herceptin - which is even acknowledged by Herceptin's supplier, Roche, who said to us that "the issues of optimal duration and sequence of Herceptin treatment remain unanswered at this time".
Some people argue that in that case we should fund 12 months anyway - but when no one can say hand on heart that 12 months works better or worse than nine weeks, we just can't justify that approach.
Advocates of the 12-month treatment course say the evidence is stronger for that treatment. It is not hard for most medicines to find some evidence that supports one side of an argument. But Pharmac's job is to look across all the evidence and make considered judgments using our decision criteria. Based on our assessment, we simply don't agree with those who believe 12 months is better than nine weeks.
We do agree, though, that we need more evidence and that is why we are supporting a clinical study that will look at the best way to use Herceptin.
It is important to emphasise that it would not be possible to get an ethics committee's permission to run this trial if there was compelling evidence that 12 months' treatment was better than nine weeks'. The fact that the trial is up and running overseas, and has been granted ethics approval here in New Zealand, reinforces the uncertainty that exists.
What we are also calling for is complete transparency from researchers and drug companies in publishing data from trials. There is information from Herceptin research that has not yet been published and that is worrying to us.
It is an issue that has been recently raised in the medical journal, the The Lancet. Non-publication of results subverts science by denying access to peer reviewed data.
It means that decision-makers like Pharmac don't always have all desired information to make decisions, and for consumers and doctors it means drug benefits can be overstated and risks understated.
We think the public has the right to know the results of all trials whether they show positive or negative results.
We have given an undertaking to review our position on Herceptin if new information emerges. We will do just that.
In the meantime, New Zealand women will continue to receive funding for the full and effective concurrent nine-week treatment with Herceptin.
We understand that some people will be disappointed with our decision. They need to know that Pharmac has approached this responsibly and with an open mind.
Like the vast majority of New Zealanders, people working at Pharmac are touched by cancer affecting family and friends. It is only human to sympathise with people coping with serious illnesses like this.
In the end, though, we have the difficult job of putting our feelings aside and making decisions based on robust assessment of the merit of treatments. We have done just that.
Even though I've worked at Pharmac for 11 years, I have personally found this process very hard - it is complicated and full of emotion. But in the end the decision was simple.
We don't have confidence that 12-month treatments are any better than the nine-week treatment that is already available free of charge.
