Medicines

Over a dozen cancer drugs in PBS ‘limbo’ due to listing delays


The average wait for patients to receive subsidised access to new cancer medicines remains above a year in Australia, far longer than in many comparable countries.

There are calls for more to be done to fast-track the process for PBS approvals amid claims patients are being forced to dip into superannuation to access treatment.

Analysis by industry group Medicines Australia shows it takes an average of 496 days for a cancer drug and 528 days for a cardiology drug to get on the PBS after being registered with the TGA.

Other therapy areas where drugs face prolonged average wait times for PBS listing include arthritis, Asthma/COPD and mental health, while vaccines typically take over three years to get the nod.

Therapy area Average wait for PBS listing Number of registered products
Arthritis 227 days 12
Asthma/COPD 219 days 8
Cancer 496 days 56
Cardiovascular 528 days 8
Diabetes 376 days 9
Hep C 295 days 11
Mental health 361 days 5
Others 376 days 80

It says in other developed countries, 60% of medicines are reimbursed within six months of registration, compared with only 22% in Australia.

The lobby group pointed to figures showing 80 medicines registered in Australia between 2015 and 2020 still had not received PBS listings.

All up, there were currently 21 cancer drugs and seven other medicines being reimbursed in other OECD nations but not in Australia, Medicines Australia said.

Among them were the cancer drugs Cyramza (ramucirumab) and Ninlaro (ixazomib) which had been subsidised in 17 and 14 OECD countries respectively.

Notably, Cyramza remained off the PBS despite having been recommended by the Pharmaceutcal Benefits Advisory Committee (PBAC) in March 2018.

AMA vice president Dr Chris Moy said that although the Federal Government had promised to subsidise every medicine recommended by the committee, there were still major delays while bureaucrats haggled with drug companies over price.

“The delays come from a combination of things and to be fair to the government, it’s ultimately a matter of resources,” he said.

“Nevertheless, the process can take an inordinately long time.”

Clinical Oncology Society of Australia president Professor Fran Boyle said that with cost a major factor in government decision making, many medicines faced an uphill battle to gain funding.

“Drugs for early disease tend to struggle, as do those with co-dependent assessments to have a test approved as well,” she said.

“The third group are drugs that have not been trialled in Australia and are not owned by one of the usual local big pharma companies with the experience to take it through the system.”

“We see that with quite a few of the drugs coming out of Japan and China at the moment.”

Professor Boyle, the medical oncology chair at the University of Sydney’s Northern Clinical School, stressed there were sometimes workarounds for clinicians able to sign patients up for drug trials or other access schemes.

But this was not always possible, particularly for patients in rural areas and those with diseases that lacked active consumer organisations, she said.

“Things have improved though compared to what they were 20 years ago and we’re far better now than New Zealand for example,” she added.

“We have seen increasing transparency and public reporting of the deliberations of the Pharmaceutical Benefits Advisory Committee as well as the development of a rapid re-entry process for drugs with data that is not controversial but have previously been rejected on cost grounds.”

Medicines approved for use in Australia but yet to receive PBS listing* 

Product Molecule Therapy area Number of other OECD countries reimbursed Launched in Australia Registration Year
PIQRAY ALPELISIB Cancer 7 No 2020
ERLEADA APALUTAMIDE Cancer 13 Yes 2018
SUNVEPRA ASUNAPREVIR Hepatitis C 2 Yes 2015
CABLIVI CAPLACIZUMAB Cardiovascular 10 No 2020
VRAYLAR CARIPRAZINE Mental health 13 No 2020
LIBTAYO CEMIPLIMAB Cancer 8 No 2020
NORAVID DEFIBROTIDE Cardiovascular 10 No 2020
UNITUXIN DINUTUXIMAB Cancer 9 No 2020
EMPLICITI ELOTUZUMAB Cancer 13 No 2016
IDHIFA ENASIDENIB Cancer 1 No 2020
BRAFTOVI ENCORAFENIB Cancer 15 Yes 2019
XOSPATA GILTERITINIB Cancer 9 No 2020
TRESIBA INSULIN DEGLUDEC Diabetes 10 No 2017
SARCLISA ISATUXIMAB Cancer 9 No 2020
NINLARO IXAZOMIB Cancer 14 No 2016
VITRAKVI LAROTRECTINIB Cancer 8 No 2020
NERLYNX NERATINIB Cancer 7 No 2019
ZEJULA NIRAPARIB Cancer 14 No 2019
FARYDAK PANOBINOSTAT Cancer 11 No 2016
POLIVY POLATUZUMAB VEDOTIN Cancer 8 No 2019
CYRAMZA RAMUCIRUMAB Cancer 17 Yes 2015
ULTOMIRIS RAVULIZUMAB Cancer 6 No 2019
CINGAIR RESLIZUMAB Asthma/COPD 12 No 2017
QINLOCK RIPRETINIB Cancer 1 No 2020
KEVZARA SARILUMAB Arthritis & Psoriasis 14 No 2018
TALZENNA TALAZOPARIB Cancer 9 No 2019
IMLYGIC TALIMOGENE LAHERPAREPVEC Cancer 8 No 2015
TUKYSA TUCATINIB Cancer 1 No 2020

(*source: Medicines Australia)

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