By Sarah-Jane Tasker 11 May 2019
The head of Australian drug company Specialised Therapeutics, Carlo Montagner, has warned that Bill Shorten’s cancer policy will not hit its target unless he overhauls the process to reimburse lifesaving treatments and puts a time frame on listing recommended drugs.
Mr Montagner said while it was a great “catch cry” to say all cancer drugs recommended for reimbursement would be approved by a Labor government, the approval process needed reviewing because it was delaying access to much-needed treatments.
“What would be more reassuring would be if Bill Shorten gave an actual time frame and said if the Pharmaceutical Benefits Advisory Committee recommended a drug, he would list it in six months,” he said.
Mr Montagner also said Labor had work to do to reassure the industry, given the last time it was in government it installed a new measure that meant any drug that cost the government $20 million or more a year had to be approved by cabinet, which he said delayed drug listings.
The Opposition Leader, in his $2.3 billion cancer care package, promised that every drug recommended by independent experts would be listed on the Pharmaceutical Benefits Scheme. That promise has also been given by the Liberal Party.
“I place little weight on either government saying that as soon as the PBAC recommends a drug we will list it,” Mr Montagner said. “The complexity of the processes that are required for drug approval need to be resolved first before any government can say they will list a drug as soon as it is recommended. The recommendation part is what is really delaying access to these new lifesaving therapies.”
Mr Montagner said both major parties had underestimated the complexity of first the drug approval process and then the price negotiations that took place once a drug was approved for reimbursement.
“It is clear that the process doesn’t work for complex drugs and most cancer drugs are complex,” he said. “It is rare that the PBAC will approve a cancer drug the first time around.”
Mr Montagner’s call for an overhaul of the drug approval system comes as he waits for the PBS to green light reimbursement for a new drug for multiple myeloma, which costs about $8000 a month.
The drug, Aplidin, has been approved by the Therapeutic Goods Administration, which is a world-first approval. The approval means Australian patients are the first globally to get access to this new therapy. Specialised Therapeutics is providing Aplidin to Australian patients via an exclusive licence arrangement with Spanish company PharmaMar. While the company awaits the outcome of its submission for a PBS listing, it is making the drug available in Australia through a compassionate access program.
Aplidin — which has been developed from “sea squirts” found 120m below the ocean's surface — is a new treatment option that can prolong the life of the patient. Mr Montagner said the drug was giving some patients an extra year of life. Since February, 60 Australian patients with multiple myeloma had been given the drug via the program.
“Myeloma is an aggressive disease and needs as many therapies as possible,” he said. “Because Aplidin is marine derived it has this mechanism of action that is unique to the currently available drugs for multiple myeloma.”