“Once in a lifetime” restriction may be lifted for checkpoint inhibitors in NSCLC

Lung cancer

By Michael Woodhead

15 Apr 2019

Oncologists have had a sympathetic hearing from the Pharmaceutical Benefits Advisory Committee (PBAC) on their call to ease the “once in a lifetime” restriction on PD-L1 inhibitors for NSCLC.

In a February 2019 meeting to discuss a potential broad NSCLC listing for PD-L1 checkpoint inhibitors, representatives of MOGA said one of the biggest challenges they face is the restriction that prevents patients from receiving PBS-subsidised retreatment for recurrent disease.

The meeting heard that clinicians are currently unable to prescribe subsidised retreatment with a PD-L1 inhibitor when a patient has been successfully treated and has experienced an extended period without disease progression, or has been successfully treated for Stage III disease and then presents with Stage IV disease.

“Clinical and patient representative were particularly concerned that the ‘once in a lifetime’ restriction place significant barriers on the effective management of patients, including placing undue stress on the prescriber and the patient to optimally time the use of a PD-L1 inhibitors in the treatment regimen,” a meeting summary statement said.

Clinicians said the ‘once in a lifetime’ restriction was a particularly disadvantage for patients who responded well to immunotherapy  and were suitable candidates for a treatment break.

“This could lead to a situation where clinicians continue treating these patients to avoid the current prohibition on the re-initiation of treatment with a PD-(L)1 inhibitor,” the meeting summary noted.

MOGA representatives also said NSCLC stages III and IV should be considered as separate stages and not grouped together in any listing.

“If a broad listing encompassing both stages does proceed, the MOGA representatives were of the opinion that clinicians would be concerned if a limit on retreatment was applied (eg patients are only able to be retreated if they relapse beyond a certain timeframe),” the meeting summary said.

However, clinicians said they were not in favour of easing the restriction to allow sequential treatment with a PD-L1 inhibitors in patients unresponsive to a previous PD-L1 inhibitor, due to lack of evidence.

The PBAC members attending the meeting said they were sympathetic to the issues raised about the once in a lifetime restriction and the Committee made a commitment to look at mechanisms to deal with short treatment breaks.

The meeting was convened in response to health minister Greg Hunt’s  request for the PBAC to explore options for listing for PD-1 and PD-L1 inhibitors for the treatment of multiple cancer indications.

The PBAC considered it would be worthwhile to start with consideration of a broad PBS listing for checkpoint inhibitors such as nivolumab, pembrolizumab atezolizumab and durvalumab in NSCLC.

It said there was already considerable experience and evidence for the four drugs in this setting, and a broad listing had the potential had the potential to simplify the administrative burden and allow clinicians and patients to make their own decisions regarding the best treatment.

The next step in the process is for the PBAC to invite proposals for broad listings from interested sponsors of the checkpoint inhibitors.

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