Posted 13 August 2019
Oncologists are urging the PBAC to allow non-small cell lung cancer patients to use PD-(L)1 drugs more than once, providing they show an adequate response the first time.
The Medical Oncology Group of Australia (MOGA) would like clinicians to be able to use PBS-listed immuno-oncology drugs twice for some lung cancer patients, and potentially also for patients with melanoma.
The issue is one of three on a 'wish list' for which the group is urging the PBAC to consider greater access. Use of the IO class in first-line BRAF melanoma and adjuvant access to zoledronic acid in breast cancer are also on the clinicians' wish list.
MOGA Oncology Drugs Working Group chair Dr Demi Karikios says the NSCLC issue has come to the fore with AstraZeneca's PD-(L)1 Imfinzi going to the July PBAC meeting seeking access to NSCLC patients with unresectable stage three lung cancer, while MSD's Keytruda is looking for reimbursement in stage four.
If recommended, current restrictions mean patients who received Imfinzi would be prevented from later accessing Keytruda.
Dr Karikios says while there is no evidence to say a second round will work, neither is there evidence to say it will not.
"We should have the chance to use it again," Dr Karikios said, as tumour progression a year after the original treatment meant its biology had changed.
"We don't restrict chemotherapy in that sense so why restrict access to immuno-oncology? We would like the PBAC to leave it to clinicians and patients to decide."
Recognising the second-chance option represents a big expense and uncertain benefit for government, Dr Karikios said he was hopeful drug companies would agree to a lower price in this setting.
The MOGA working group meets with the PBAC three times a year and Dr Karikios is also a member of PBAC's Economic Sub Committee (ESC), so very aware of the need to contain PBS costs.
But he says clinicians want to give patients the best possible chance of survival.
He says the issue is one of three on MOGA's PBS wish list, with the use of the powerful IO class in first-line BRAF-mutated melanoma also a key issue.
In most other jurisdictions, the therapies are not restricted in this indication and MOGA wants similar access in Australia.
However, while both Opdivo and Keytruda are listed in second line, he says both sponsors are reluctant to resubmit to PBAC in first line, potentially for fear of being knocked down on price.
Also on MOGA's wish list is access to zoledronic acid as an adjuvant therapy in breast cancer.
Originally marketed by Novartis as Zometa, the genericised drug treats bone metastases in patients with multiple myeloma and other conditions, but not breast cancer.