worth watching.., page-12

a few good points made here very relevant for CVac:

"Government seeks evidence on PBS-listed cancer drug Yervoy"
Four Corners 26/08/13


The subsidy of an expensive new cancer drug has prompted the Federal Government to seek its own evidence that the drug works in real patients the way it did in clinical field trials.

This is the first time this has happened in Australia.
In August Health Minister Tanya Plibersek announced that three new drugs for terminal cancer, including an immunotherapy drug for end-stage melanoma called Yervoy, will be subsidised on the Pharmaceutical Benefits Scheme (PBS) at a cost of $430 million over the next four years.
Yervoy, the most expensive of these new drugs, offers on average a 3.9 month extension on life.

One in 10 patients will get a survival benefit of four or more years, but it is not possible to predict which patients will get this lifeline.
Before it was subsidised, four injections of Yervoy cost patients $110,000.
While the PBS costs over $9 billion a year to fund, to date there has been no attempt to systematically follow up with patients to see if the drugs do indeed deliver the benefits claimed by pharmaceutical companies.

Dr Suzanne Hill is the chair of the Pharmaceutical Benefits Advisory Committee (PBAC), the expert group that advises on which drugs to subsidise.
She has told Four Corners that the smaller evidence base used to establish if a drug works is one of the reasons behind the Government's decision to seek its own evidence.
"If we are going to look at new products and try to judge them on the basis of smaller clinical trials - which is what is happening - then we are going to be less confident about the clinical trial data when we see them for making recommendations," she said.

For the first time the PBAC will gather data on who gets prescribed Yervoy and what happens to them.

"For Yervoy, what we want to look at is who gets prescribed it, what happens to them, how long do they get treatment for, how is the treatment with Yervoy put in the context of other treatments that they have and what happens to the outcome?" Dr Hill said.

"Do we get the survival benefit in the community that we saw in the trials?"

The decision to gather evidence comes in the context of what is expected to be an avalanche of expensive end-stage cancer drugs that the pharmaceutical industry will seek to list on the PBS in coming years.

"I think there's no reason to assume that the expectations of the pharmaceutical industry are going to change over the next two years and that seems to be the pattern at the moment, that new products for cancer are coming through with pretty heft price tags," Dr Hill said.

According to PBS data, expenditure on cancer medicines has grown by more 60 per cent in the last five years.
In the five years to 2011 they were the fastest growing group of drugs on the PBS.

The listing of Yervoy coincides with concern in the US about the high costs pharmaceutical companies are charging for new end-stage cancer drugs.
A report from the UK medical journal Lancet observed: "we are at the crossroads of affordable cancer care, where our choices, or refusal to make choices, will affect the lives of millions of people."
Concerns over 'horrendous' costs
Dr Ian Haines, a Melbourne-based oncologist, says with an aging population more baby boomers will get cancer and they will want the best treatment.
"Someone has to pay for it, and until we work out how to do that, I fear for the future of all these drugs of incremental benefit," he said.
"They'll all be claiming on average a benefit in survival of one, two or three months.
"I don't think it's going to be a lot longer than that and they're going to be horrendously expensive."
Professor Jonathon Cebon, a leading investigator in the Australian clinical trials for Yervoy, says there is "absolutely no question it's costly".
"If you talk to a patient or to their family there's no question in their mind that it's worthwhile," he said.
"And if you ask the community at large how many millions or billions they want to spend on healthcare, there's a discussion. There are priorities out there."

The listing of Yervoy coincided with the release of a pharmaceutical industry report claiming Australians were missing out on new cancer treatments, and that the Government ought consider subsidising new drugs based on less evidence.

Ms Plibersek rejected concerns about the affordability of subsidising expensive end-stage cancer treatments.
She said the cost was covered by savings that are made when patients stop using older drugs.

By Wendy Carlisle