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Good Advice – Taken as Directed

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The first clear evidence of how the incoming Health Minister, Peter Dutton, was going to settle into the role was seen last week with the announcement that 50 new and amended medicines have been added to the Pharmaceutical Benefits Scheme (PBS).

During the election campaign, the Coalition resolved to lift the Cabinet approval ceiling for the PBS to $20 million, restore efficiency to the listing process, and bring drugs to market more efficiently. All of these were supported by the AMA.

Among the approvals was Dabrafenib, which targets a genetic mutation present in about half of melanoma cases; Sunitinib, which targets pancreatic cancer; and Denosumab was extended to men suffering osteoporosis.  In total, around 230,000 people stand to benefit from these listings.

In relation to medicines for the Australian market, the AMA has been a long term supporter of the Therapeutic Goods Administration (TGA), which assesses therapeutic products for efficacy and safety before they are allowed to be registered and sold.

The AMA also believes there is merit in the addition of some “public” funding to the TGA so it can increase the activities that it carries out in the public interest. Our Therapeutics Committee is currently looking into this.

We also support the Pharmaceutical Benefits Advisory Committee (PBAC), which considers both the effectiveness and cost of the proposed drugs. I was a PBAC member in 2008 and 2009.

After extensive analysis, PBAC makes a recommendation to the Minister for Health about which drugs and medicinal preparations should be subsidised by the Australian Government under the PBS.

On many occasions in the past, we have seen delays in drugs getting subsidised by the PBS despite a positive recommendation from the PBAC. This was effectively shifting the decision about which drug to list from a group of highly trained medical and pharmaceutical professionals, supported by economists, to a group of Cabinet politicians who we would not expect to have the required professional expertise, but who should at least have the very best expert advice.

The most obvious example of a delayed listing was Pradaxa which, after an extended period of time, was finally listed for our patients with non-valvular atrial fibrillation.

The cost- effectiveness analysis carried out by PBAC, to which all drugs are subjected, helps to maximise the benefits of the particular drug when it is prescribed within the recommendations.

We currently spend over $8 billion a year on pharmaceuticals and, up until recently, the price was rising very fast.

The rigorous listing process ensures that when drugs become available we are paying the right price. But the PBS re-pricing process has meant long delays in realising the savings to the PBS when generics are introduced into the market at the end of patent protection of the parent drug.

As we know, this has resulted in Australia paying much more for some drugs than many countries around the world and, indeed, multiples of what is paid for drugs like statins in New Zealand.

What we need is a more efficient feedback loop to allow the price falls that are occurring due to increased competition to be passed on to the Australian community.

In fact, in these current economic times, it is really the cost savings from the introduction of generic statins and other drugs that have provided the fiscal headroom to be able to afford the listing and subsidisation of the drugs mentioned above.

We need to continue to improve the cost-saving efficiency if we are to be able to list new drugs for the use of the Australian population in a timely way.

In relation to pharmaceutical benefits and red tape, one of the biggest time wasters in medical practice is the long wait for phone authority prescriptions. It has been estimated that up to six million phone calls are made every year to the PBS authority line.

Waiting on the phone for someone to answer wastes an enormous amount of time. We don’t know of any evidence that suggests abolishing the authority approvals process would cause a blowout in costs.

It should be abolished immediately. This would free up the equivalent of up to 25,000 patient consultations while doctors wait for their calls to be answered.

AMA Secretary General, Anne Trimmer and I have already raised this issue with the Health Minister, who is intending to take a close look at this it. No more hanging on the telephone?  Let’s hope.