E-drug: Australian PBS recommends listing Sildenafil citrate
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[Although this is long message, it has been broadcast because of the
importance of the debate over the PBS - TD]
Debate over subsidising Viagra
ABC-TV 7:30 Report, Transcript, 16/01/2002
http://www.abc.net.au/7.30/s460043.htm
MAXINE McKEW: If at first you don't succeed, try, try and try again.
That's the tactic that looks like working for the pharmaceuticals giant
Pfizer, makers of the sex drug Viagra.
Twice the Federal Government's Pharmaceutical Benefits Advisory
Committee [PBAC] has decided that taxpayers should not help pay
for even a limited number of patients to overcome erectile
dysfunction.
Now the committee has changed its mind. Why?
Did a change in personnel on the committee have anything to do
with its change of heart? And will the new minister of health accept
the committee's advice?
Given that the cost of subsidised drugs blew out by $700 million last
year, it's a recommendation with implications for the long-term
health of Australia's unique Pharmaceutical Benefits Scheme [PBS].
Mark Bannerman reports.
ALAN EVANS, AUST. PHARMACEUTICAL MANUFACTURING
ASSOCIATION: Well, I think that's an appropriate outcome given
that's all gone before.
MARTIN GODDARD, FMR MEMBER, PBAC: This Minister now is
in a no win situation. She's damned if she doesn't, she's damned if
she doesn't.
MARK BANNERMAN: Sex, money and power, that is the story of
the drug Viagra in Australia. Three times the trans-national
company Pfizer has applied to have Viagra subsidised by the
taxpayer. Now it seems the Federal Government's Pharmaceutical
Benefits Advisory Board agrees, recommending subsidies for
selected patients.
LLOYD SANSOM, PBAC: When companies submit data what
PBAC has to do, is compare it with existing therapies, in terms of
efficacy, toxicity and cost. When you examine the submission for
Viagra, in that context, what you find is a product which is
apparently equally effective to the injectable form that's currently
listed, that it is apparently safer and of similar cost.
MARK BANNERMAN: This is a decision that will delight many
patients with spinal injuries or advanced diabetes. Until now, the
only subsidised drug they could use had to be injected into the
penis, but that may change.
LLOYD SANSOM: In this new submission from the company they've
actually identified 10 disease states where erectile dysfunction is a
secondary outcome. This differs from previous submissions for this
drug, where the population was not as clearly defined.
MARK BANNERMAN: But there is another side to this story -- cost.
The committee advising the Government has warned it will not be
cheap. Try up to $100 million a year.
LLOYD SANSOM: Because it will have a greater acceptability, it will
have a much higher uptake and there the total cost to Government
will be much, much higher and we predict in the order of $30 to 50
million in the early stages, possibly increasing to excess of $100
million in a relatively short period of time.
MARK BANNERMAN: The drug industry though, rejects these
figures.
ALAN EVANS: Well, I'm very disappointed in Lloyd Sansom saying
that. Firstly, it doesn't match the evidence. The actual cost in the
first year will be $13 million, if everyone who could take it up, took it
up. And that's the reality. For Lloyd to suggest it's going to be $100
million is a bit of a mischievous exercise. The reality is, if you look
at this, it's been on the Repatriation Pharmaceutical Benefits
Scheme for some time. The actual take-up rate was one quarter of
that projected. So only a quarter of the people who were eligible to
take it, took it up.
MARK BANNERMAN: Little wonder there's concern. In 1998, when
the Government put the anticholesterol drug Atorvastatin on the
PBS screen, it costs taxpayers $126 million. The next year it
jumped alarmingly to 226. How did this happen? Well, the industry
calls it leakage. That means doctors prescribe the subsidised drug
to people even though they don't quite fit the guidelines.
MARTIN GODDARD: The integrity in the system is based on the
Australian public through the PBS. Being able to set the price which
is objectively cost-effective for a drug.
MARK BANNERMAN: Martin Goddard should know, for some years
he sat on the Pharmaceutical Benefits Advisory Committee and was
alarmed at what he saw. Although he concedes it is doctors who
prescribe the drugs, he alleges that some companies encourage
doctors to bend the law.
MARTIN GODDARD: What companies have learnt, is that they put
in for the indication, for the use, which, no matter how narrow, gets
the drug on to the list at the highest possible price. And then there's
nothing to prevent them promoting to doctors, right around the
country, all sorts of other uses. And waiting for the doctors to break
the law is what they're doing, and they do it constantly.
MARK BANNERMAN: Martin Goddard's concerns are echoed by
the Australian Medical Association who warn that in the case of
Viagra, doctors could come under pressure to break prescription
guidelines.
MUKESH HALKERWAL, AUSTRALIAN MEDICAL ASSOCIATION:
If you think that around 40 per cent of 40-year-olds and 50 per cent
of 50-year-olds and 60 per cent of 60-year-olds may have an
erectile problem, then you've got quite a big pent-up demand there.
MARK BANNERMAN: So will the costs of subsidising Viagra blow
out? Well, the industry says no.
ALAN EVANS: Firstly, the price that the Government's been able to
negotiate for this product to be able to go on the PBS is the lowest
in the world, the lowest in the world. Secondly, it's on a very tight
and very restricted authority. So they're not going to be making a
fortune. And thirdly, it's going to people in need.
MARK BANNERMAN: Of course, there is another reason why this is
all being so hotly debated. Twelve months ago, the Federal
Government under Health Minister Michael Wooldridge, changed
the make up of its Pharmaceutical Benefits Advisory Committee.
Amongst other changes, it added a former drug industry lobbyist Pat
Clear to its number. And that decision now seems to overshadow
almost any decision that the committee is likely to make.
MARTIN GODDARD: I think that the new and aggressive approach
taken by the industry and particularly taken by this company, Pfizer,
has put them in this position and any positive decision for this drug
is going to look as if it was made under duress, even if it wasn't.
LLOYD SANSOM: I absolutely reject that. This committee agrees
with the previous committee's rejection of the two prior applications.
The company addressed the issues that were raised in those two
prior submissions and I totally and absolutely reject any influence
that this decision was made as a result of a changing of the
committee of PBAC.
MARTIN GODDARD: I've got no reason to doubt the new chair
when he says that it wasn't made under duress and made on
evidence. I've got no reason to doubt that, I don't. But my concern
is that the message now going out to many people in the industry,
many down the more aggressive end, is that these aggressive
tactics work. They've worked before, frankly, and they're worth,
they've been shown to be worth, maybe hundreds of millions of
dollars a year.
MARK BANNERMAN: In the ends it is the new Health Minister,
Senator Kay Patterson who, must make a decision on Viagra.
To list or not to list? For her, this is now a $100 million question
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Reprinted under the fair use doctrine of international copyright law:
http://www4.law.cornell.edu/uscode/17/107.html
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Dr. Ken Harvey
Board Member, Therapeutic Guidelines Ltd. (http://www.tg.com.au)
Council Member, Australian Consumers Association
(http://www.choice.com.au)
Senior Lecturer, School of Public Health
Room 221, Building HS1 (NW9),
La Trobe University, Bundoora, 3086, Australia,
Telephone +61 3 9479 5773, Facsimile +61 3 9479 1783, Personal mobile
0419 181910,
Internet: http://www-sph.health.latrobe.edu.au/kharvey/
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