6 April 2019 - While the pledge may be well intentioned, it reveals the Leader of the Opposition's poor understanding of the PBS listing process.

In his budget reply speech, the leader of the Opposition Bill Shorten stated that "every drug recommended by the independent expert also be listed on the Pharmaceutical Benefit Scheme, not just cutting the cost of treatment but cancer medication, too."

One is left to assume that his definition of 'independent expert' is the PBAC.

The Leader of the Opposition has assumed that every recommendation made by the PBAC is a favourable one and will be readily embraced and accepted by the applicant/sponsor company.

The role of the PBAC is to provide advice to the Minister/Government on the listing of new medicines on the PBS. A new medicine cannot be listed on the PBS unless recommended by the PBAC. 

While it is common practice for the Minister/Government to accept such advice, those with long memories will recall in 2002, the then Minister of Health in the Howard Government Senator Kay Patterson, chose not to accept the PBAC's recommendation to list sildenafil citrate (Viagra) for certain patients with erectile dysfunction. Sildenafil citrate (Revatio) has since been listed on the PBS for patients with pulmonary arterial hypertension.  This is the last known time a Minister of Health or the Government has rejected PBAC advice.

The Leader of the Opposition seems to be unaware that from time to time the PBAC makes recommendations with one or more conditions (so called 'conditional recommendation') that are unacceptable to the applicant/sponsor.

Furthermore, the PBAC has in recent times, recommended some medicines on the basis of a cost-minimisation basis against a lowest/least cost alternative. These recommendations are unlikely to be accepted by their respective sponsors.

As part of the PBS process improvements, sponsors will be required to complete and submit a Notice of Intent for Pricing. The lodgement of a notice will be associated with a fee.

How can a PBAC recommended medicine be listed on the PBS if the sponsor company does not:

• Submit a Notice of Intent for Pricing
• Submit a pricing proposal (including a PB11 form)
• Agree to the terms of a risk share agreement
• Sign a Deed of Agreement
• Give an undertaking regarding supply

In such circumstances, it is hard to fathom how the Department of Health would determine an acceptable ex-manufacturer price. One would assume that the medicine would be listed at the price 'accepted' by the PBAC.  It would not be possible for the medicine to be listed with a special pricing arrangement.

If the Opposition is committed to list every new medicine recommended by the PBAC, then it should make a public commitment to list the following PBAC recommended new medicines on the PBS without delay if it is elected next month:

• Tenofovir alafenamide fumarate (Vemlidy)
• Canakinumab (Ilaris)
• Radium Ra 223 dichloride (Xofigo)
• Ranolazine (Ranexa)
• Ramucirumab (Cyramza)
• Sarilumab (Kevzara)
• Encorafenib (Braftovi)
• Binimetinib (Mektovi)

This list gets larger if one includes medicines recommended by the PBAC before 2017.

Whilst it is unreasonable to expect a politician to be across every minute detail of every Government program, one would expect the Leader of the Opposition to be sure of his facts when giving a budget reply speech in parliament a month before a Federal election. It shows poor preparation for an important speech; perhaps he devoted as much time to this as it takes him to fully recharge the battery in his electric car (apparently just 8-10 minutes).