Lung cancer

PD-L1 testing for access to pembrolizumab gets MBS approval

The Medical Services Advisory Committee (MSAC) has ‘foreshadowed its support’ for a new MBS item for PD-L1 testing to help determine eligibility for PBS-subsidised pembrolizumab as a first line treatment in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).

The application was part of a co-dependent resubmission from MSD Australia and progression of the MBS item depends upon PBAC recommending the PBS listing of pembrolizumab.

MSAC had previously rejected an application to list PD-L1 immunohistochemistry (IHC) testing – considering it ‘an imperfect biomarker’ that could exclude some patients who might otherwise benefit from treatment with pembrolizumab.

However some quality assurance promises around testing and the subsequent PBS listing of nivolumab have lead to a different decision this time around.

“This changed the clinical utility consequences of poor PD-L1 IHC test performance, because most patients with advanced NSCLC who test negative (correctly or not) for treatment with pembrolizumab would now have access to nivolumab in due course,” MSAC said in the Public Summary Document from their 71st meeting.

“In the clinical management algorithm, all patients suspected of having NSCLC will undergo a biopsy at initial diagnosis to determine histology. For patients with NSCLC of squamous histology, assessment of PD-L1 status through IHC will be the only biomarker test undertaken at diagnosis. For patients who have non-squamous or not otherwise specified NSCLC, PD-L1 IHC testing will be performed at initial diagnosis, along with EGFR and ALK testing.”

MSD Australia was understandably pleased with MSAC’s support for PD-L1 biomarker testing.

“In their latest public summary document responding to MSD’s codependent resubmission for an MBS number for PD-L1 testing and KEYTRUDA PBS listing for first line non-small cell lung cancer, MSAC have recommended an MBS item number for PD-L1 testing for any PD-L1 antibody. This is a critical step to enable appropriate non-small cell lung cancer patients access to KEYTRUDA as a first line cancer treatment,” they said in a statement.

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