Something very wrong with the PBS

Cross posted from Begin Rant

The Pharmaceutical Benefits Scheme is a vital part of our nation’s health system and something all Australians should rightly be proud of. But there is something going very wrong in the process of getting new medicines on the PBS which all Australians should be concerned about.

While I am only new to understanding the opaque processes around PBAC and PBS listing, it does not take much investigation to ascertain that there is something going very wrong in this system. Since Greg Hunt entered the health portfolio he has made listing new medications an art form, delighting in the announcement of new medications on a regular basis. What is not evident to many in our community is that far too many of those medications are being listed solely because there was an agreement that the listing would be at no cost to the Government. Hunt has wired the system so that he can say “we will list everything the PBAC recommends”, while getting PBAC to deliver political advice in their recommendations that makes negotiations fraught, and in turn bullies the drug companies to withdraw their offerings.

Over the past two years, a new class of migraine prevention medications have come on to the market. These Calcitonin Gene Related Peptide (CGRP) antagonists are a game-changer in the management of migraine, both by being the first treatments specifically designed to break the migraine trigger sequence and effectively prevent migraine attack, and by enabling many to manage their condition for the first time. The new medications are the result of work led by eminent Australian neurologist Professor Peter Goadsby, and, as a result of that independent academic research, there are a number of treatments coming to market quickly and at a comparatively cheap price.

The first of the new medications, Aimovig, was heralded as one of Time’s Invention of the Year in 2018. Thousands of Australians have trialled this drug, provided for free by the drug company Novartis, and had their lives fundamentally changed for the better. I am one of those people, going from a completely debilitated life battling significant migraine symptoms every day for years, to relatively migraine free.

The Pharmaceutical Benefits Advisory Committee (PBAC) found that Aimovig works, and is cost-effective. But they rejected the drug twice because they did not like the size of the line item in the health budget. Forecast to cost the Government $200m over 6 years, they decided that was too much, and rejected the application. In short, they determined there were too many people living with migraine, and therefore we should not get subsidised medication. Facing a similar third rejection, Novartis withdrew the drug from the PBS process.

The second and third medications in this new class, Emaglity (made by Lilly) and Ajovy (made by Teva), did receive positive recommendations from the PBAC to be listed on the PBS. However, expressing similar concerns around the number of patients and the line item in the budget, the recommendations included advice that they should be provided under the existing cap of Botox for migraine – despite the fact that these are pharmacologically different, better medications, and Teva at least has already agreed to substantially discount their brand new product to an equivalent price being paid for Botox, which has been used to treat headache (not migraine) for 20 years. This cap limits the number of patients the Government will support to less than 10,000 per year, out of 400,000 chronic migraine patients. These two drugs are stalled in the PBS process, with the companies bearing the extended cost of providing their drugs to patients for free on compassionate and other access programs.

The PBAC advice is simply that: advice. The elected Government, accountable to the people, are the only ones who are responsible for determining if tax payer’s money should be spent. The advice to the Government to use the Botox money for the new medications is not advice PBAC should be giving, as which bucket of money pays for the drugs is a purely political decision, not a clinical one. But PBAC is free to make any advice they like. The Minister, however, is not obliged to take that advice.

Further, risk sharing agreements (RSAs) or caps were not designed nor intended to artificially limit PBS expenditure on a drug being used for what it is supposed to be used for. They were an appropriate and responsible mechanism to stop, say, a drug that was later found to have a recreational or cosmetic benefit being prescribed well beyond estimations and the purpose for which it was listed on the PBS. But over time, these mechanisms have morphed into an unofficial cap on PBS expenditure. Again, permitting Greg Hunt to say there is no cap on PBS spending, while PBAC does his dirty work and keeps the PBS budget under control.

Greg Hunt delivered an extraordinary attack on Lilly and, by inference, Migraine Australia, in the parliament on Wednesday 17 June. He accused Lilly of running an ‘astroturf’ campaign, or a fake grassroots campaign, funding patient groups to pressure the Government to list their drug. In that moment he claimed that the Botox cap – the only issue preventing the listing of these medications – “legal requirements… are mandatory because of efficacy, mandatory because of safety”.

As the only patient body in migraine in Australia, there was no other organised group the Minister could have been referring to with his claim of ‘astroturf’. (We’ll just ignore for the moment that Hunt clearly doesn’t know what astroturf means.) Worse than that, given he cleared Migraine Australia of wrongdoing three hours later (see next video), the smear extends to the many thousands of citizens who have made representations to their local MPs about the new medications.

Chris Bowen (does understand what astroturfing means, and) asked the speaker if we had the right of reply to Hunt’s bizarre accusations. Migraine Australia does not, as the company is not a natural person, but individuals do and apparently have taken up the option.

“I didn’t name any group” is an utterly pathetic attempt by Hunt to weasel out of what he did. And saying “that group hasn’t done anything wrong” is not an apology to our hard working volunteers, nor the individual citizens who have written or called their MPs. The ‘there you go’ followed by a smirk right at the end there also indicates he’s pretty pleased with himself.

For a Health Minister to attack a patient group, or indeed individual citizens, for making representations on a matter that is central to their lives, beggars belief. To claim in that attack that there was an issue with safety or efficacy of the medications, which have been found by the TGA and PBAC to be safe and effective, was similarly dumbfounding. And in claiming the Botox cap restriction was a legal requirement, or mandatory, or anything else other than just advice, was misleading and disingenuous.

And, while I concede the smirk could mean nothing at all, if Hunt is proud of himself for making such a baseless attack to the detriment of seriously ill people, that, in my personal opinion, is a sackable offence.

The emails from individuals to MPs have ratcheted up a notch since Hunt called us astroturf, and the form letter responses from MPs to their constituents are just adding to the frustration and infuriation. (For clarity, we have never done a form letter email to MPs.) I even took the step of emailing Hunt’s staff and asking them to stop sending the form letters, as they were being badly received and we were concerned about migraine attacks being triggered by outrage. For example, $36m a year spent on migraine medication was being read as ‘we spend $7 each per year on you annoying migraine people, piss off’. The repeated attempts to blame drug companies for the standoff over PBS listing is being thoroughly rejected as lies. Even the repeated reference to ‘chronic migraines’ – which doesn’t exist by the way, the illness is migraine, a sub-type diagnosis is ‘chronic migraine’ (no s) – is raising people’s hackles. The form letters are still being sent.

It may be politically easy to blame big bad pharma, but they are not the ones behaving improperly here. It is PBAC and the Minister playing games with the health and wellbeing of Australians. To date, there are more people with migraine who have tried the new CGRP medications than the PBAC thinks should receive subsidised treatment via the PBS. And it is a very sad day for our democracy when business is doing more to help people than our Government.

Raised in a politically involved family that has devoted much of their lives to the Liberal and National parties for generations, and having worked on my first campaign when I was 10, I know Liberal and National party ideology better than I know the back of my own hand. And it defies my understanding why a conservative government would not leap at the opportunity to list these drugs. Migraine costs the economy $36b a year, most of that being borne by business in lost productivity and absenteeism. Listing these comparatively cheap drugs will save the government money, get people off welfare and back to work, and help many thousands of Australian businesses be more productive and profitable.

This is the kind of message that could have been lifted straight from Liberal Party campaign material. And yet, instead of embracing this opportunity to help people, business and the economy, and reaping the benefits of billions saved by an outlay of less than a $100m, the Government seems to want business to continue to bear the heavy burden of migraine, and for people living with significant migraine to continue to suffer.

All Australians should be concerned that the Government are not willing to act when it is in the interests of people, business and the economy for them to do so.

All Australians should be concerned that the listing of drugs has become a political play thing, rather than the independent clinically driven process that it was designed to be.

The PBAC is compromised, and the rhetoric has descended to outright lies.

Something is very wrong.