Medicandus

Medicandus

Will a desperate Federal Government drag the integrity of the PBS down the plughole with it?

A Senate Committee report released nearly a year ago which recommended that the Federal Government stop using the PBS for political grandstanding has finally had a response from the Health Minister Tanya Plibersek.

Her response was deeply disappointing. It hints at a Cabinet willing to sacrifice the highest principles for short-term expediency.

Under the guise of ‘fiscal responsibility’ the Minister rejected all the recommendations of the Committee, preferring to continue the current policy of reserving the right to delay the listing of even low-cost PBS additions until the economic and political priorities of the moment seem favourable. It is worth remembering that this tactic was introduced last year by the Gillard Government, who insisted on deferring the addition of 7 new drugs until it suited them to put them on. This broke a bipartisan convention of pollies butting out of of the PBS approval process which had lasted since 1948. Through the tumultuous 1970s, the recession-hit 1980s, the economic rationalism of the 1990s and even the GFC of the last decade successive Governments followed the compassionate and humane course. All sides agreed that as soon as practicable after a drug was recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) it should be available for subsidised use. Following the unprecedented cost blowout when Celebrex was introduced in August 2000, decisions regarding listing of a drug with an estimated cost of more than $10 million in any of the first four years on the scheme have been taken by Cabinet since 2001.

In the 20 years prior to February 2012, only 2 PBAC recommendations were rejected or indefinitely deferred by the Health Minister of the day. There was Nicotine patches in 1994 and Viagra in 2002. Both indefinite deferrals were because of very high expected cost, despite recommendations of cost-effectiveness to the the contrary by PBAC. In February last year, with the political imperative of a Budget surplus to produce, no fewer than 7 drugs were indefinitely deferred by then Health Minister Nicola Roxon. In the face of community, industry and political outcry, 2 of them were added to the PBS during last year, but the Committee could find no explanation as to why these were chosen and the others weren’t. Nary a soul from the Department of Health and Ageing could outline to the Committee a process by which the other drugs in limbo could progress their listing. A worrying precedent has been set.

The Senate Committee found that the antics of last year constituted a significant and concerning departure from usual policy. Claims by the Gillard administration at the time that it was a temporary change to the process were about as convincing as promises of imminent free elections by a Central American junta which has declared a state of emergency. And now Minister Plibersek has announced formally that this supposedly temporary enlistment of the PBS process to help with a short-term political goal is here to stay. As the submission from the Council of Social Service Networks put it

The PBAC is an independent statutory body established to provide expert advice to the Minister. Its advice is based on independent assessment made in the best interests of the community in terms of health, safety and cost…The Commonwealth Government is now politicising a process that used to have expertise, integrity and independence

The end result may well be that Australian patients will miss out on the best available medicines, as has begun to happen already in New Zealand. Mr Brendan Shaw from Medicines Australia testified to the Committee that

When you look at what has happened in New Zealand over the last 20 years, the industry has basically abandoned New Zealand. There are medicines available there. Some of the medicines available in New Zealand are forty years old and have become lesser used in Australia. Basically, a lot of the New Zealand market is now run out of Australia because of the commercial environment in New Zealand. Patients in New Zealand have to wait much longer for medicines than patients in Australia. There is various data that we are happy to provide you with that shows that New Zealand, in terms of access to medicines, is one of the worst countries in the OECD

Several other witnesses expressed grave concerns that the expertise of Cabinet was simply not sufficient to make the type of complex clinical and cost-effectiveness judgements that are the bread and butter of the PBAC. I can think of one very smart play which Cabinet will undoubtedly miss. They are currently waiting to consider a recommendation for a nerve pain drug called pregabalin. It must be listed as a matter of urgency because there is no comparable drug for a fairly common and severe problem. It will be expensive because there is no other PBS listed treatment for the same condition. There is an older drug in the same class called gabapentin which is only marginally less effective, better tolerated at low dose, will work in some patients where pregabalin doesn’t and is already off patent. Listing both drugs will work out cheaper than listing just pregabalin, and will arguably benefit more people with nerve pain. It will also spread the profit among several companies, including generic manufacturers, rather than just being a bonanza for Pfizer, which owns pregabalin. Of course, only someone like me who has been prescribing them both for the last 5 years week in, week out would realise this. That’s kinda the point of having ‘experts’ to advise you.

The availability of affordable, effective and safe medications has been a cornerstone of Australian life for more than 60 years. The PBS is a justly revered institution which has always been considered to be above the political turmoil of the times. I call on Minister Plibersek to look at the history and principles of the national monument her Government is threatening to deface, and stand up to her colleagues in defence of it. By the time she’s old enough to benefit from a strong PBS, it may have gone….