Cancer clinician slams ‘arrogant’ PBAC

By Megan Brodie 3 years ago | In Products, Regulatory
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23 April 2021

Australia multiple myeloma patients are dying up to two years faster than in comparable jurisdictions because the PBAC is “run by accountants” and does not allow clinicians to use PBS listed drugs in combination, a Monash University blood cancer expert has told the Zimmerman Inquiry.

Professor Andrew Spencer, who heads up the Myeloma and Related Diseases Registry in Australia and New Zealand, appeared before the Parliamentary inquiry into approval processes for new medicines and medical technologies in Melbourne on Thursday and described his 20 years experience in dealing with the PBAC as “adversarial” and “unrealistic”.

He said the PBAC was “kidding themselves” in trying to tell global pharma companies how to price their drugs given Australia is not even the size of an Asian city and resulting in pharma companies “not bothering” to bring new therapies to Australia.

“There are a number of drugs where the pharma companies don’t even bother trying to get reimbursed in Australia. It’s a waste of their time.”

Prof Spencer said the average survival for newly diagnosed myeloma patients in Australia is now seven years but for those aged over 70, the average survival is 44 months – up to two years less than in overseas jurisdictions and “that gap is getting bigger and bigger and bigger”.

“The outcomes in our jurisdiction compare very poorly to other world countries in terms of survival, and one of the major reasons I believe is that we have limited access to therapeutics,” Prof Spencer said. “We consider ourselves a first-world nation but we are a second world nation in access to drugs.”

Professor Andrew Spencer

Cancer combinations not funded

Prof Spencer said for the past 14 years, only two classes of drugs were available in Australia to treat multiple myeloma but the PBAC would not allow for them to be combined.

“We can’t combine drug A and drug B, which is a standard of care in Europe, for example, and which scientifically makes so much sense,” he said. “They work by different mechanisms. We’re not allowed to do that. So we’re paying for a drug, but we’re not being allowed to use it.

“They had to be used in isolation, which beggars belief scientifically, but that’s how it was.”

He said while “half a dozen other drugs have been approved in other first-world countries with different mechanisms of action to treat myeloma”, they were not in Australia.

He cited BMS’ EMPLICITI (elotuzumab) and Janssen’s DARZALEX (daratumumab) as examples of drugs that are used in combination and which struggled to get reimbursement in Australia, leaving clinicians with cheaper and significantly more toxic combinations.

He described PBAC’s economic modelling as being “30 or 40 years out of date”, saying Janssen went “back and forth” trying to meet PBAC requirements for its daratumumab before finally gaining listing, while BMS was rejected by the PBAC in November and has resubmitted Empliciti to the July PBAC meeting.

Prof Spencer also referred to Novartis FARYDAK (panobinostat), saying it was ” particularly effective in people with very advanced myeloma” but that the company never pursued PBS listing.

“It seems to me that this approach from the PBC is being driven by accountants. It’s not being driven by people that actually are looking at the evidence and saying, well, what is the best option for these patients? That clearly is not what happens in Australia.”

“The process is failing on so many levels and unless we change it, we are going to fall further and further behind in terms of drug delivery… because the process here does not work”.

“There’s a high level of arrogance in the PBAC towards clinicians and pharma,” he told the committee, adding “the modelling they use, in my experience, I don’t know where they get their information from. [It’s] quite odd.”

Genomic testing ‘a shemozzle’

Prof Spencer said Australia was also lagging the world in genomic testing, with less than half of multiple myeloma patients having access to a genomic test according to the Myeloma and Related Diseases Registry and, for those that do, the results not being available in time for clinicians to prescribe the appropriate PBS-listed therapy available only to subsets identified by testing.

“It’s like a disaster waiting to happen, and it’s not just in myeloma,” he said. “Knowing about the disease is so important in making decisions about the outcome for these people… The variability in how you can manage people is driven by understanding the biology and we don’t have access in this country.”

He described access to testing as “a shemozzle”.

“We have this tidal wave of new therapies coming and we are not in a position to start to understand how to use them in this jurisdiction, never mind pay for them. We are so far behind it’s unbelievable.”

He was also critical of the PBAC and MSAC not talking to each other, and their reliance on genomic experts who did not have an understanding of the use of therapies in clinical practice.

“They’re smart people but they don’t understand that translation and how you can utilise these things in clinical practice, and that wouldn’t be just in myeloma. There’s a range of cancers where that’s applicable.”

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