Sensitivity Specificity Positive Predictive Value Negative Predictive Value Receiver Operating Characteristic (ROC) Measures of comparative performance of PD-L1 testing methods: Concordance with other commercially available PD-L1 antibodies Comparison with other assays for determining response to treatment Rates of re-testing Measures of clinical utility Outcomes with pembrolizumab treatment with and without PD-L1 testing Other considerations Rates of re-biopsy Anticipated test turnaround time. The estimated number of patients being tested The number of patients tested per case of PD-L1 positive (≥50% and ≥1%) result detected The number of patients tested per case of PD-L1 positive (≥50% and ≥1%) result treated with pembrolizumab The cost of testing per case of PD-L1 positive(≥50% and ≥1%) NSCLC detected The cost of testing per case of PD-L1 positive (≥50% and ≥1%) NSCLC treated with pembrolizumab. Drug Outcomes Measures of clinical efficacy for pembrolizumab include: Primary outcome: Overall survival Progression free survival Secondary outcomes Objective tumour response rates (complete response or partial response according to RECIST and irRC criteria) Quality of life Disease control rate (response rate + rate of stable disease) Duration of response Rate of disease progression Time to progression Safety and tolerability. Table 9 For investigative services Prior tests Initial biopsy and tests to confirm diagnosis of NSCLC and EGFR/ALK testing if nonsquamous or NOS. Reference standard The evidentiary standard is the Market Ready Assay
Sensitivity Specificity Positive Predictive Value Negative Predictive Value Receiver Operating Characteristic (ROC) Measures of comparative performance of PD-L1 testing methods: Concordance with other commercially available PD-L1 antibodies Comparison with other assays for determining response to treatment Rates of re-testing Measures of clinical utility Outcomes with pembrolizumab treatment with and without PD-L1 testing Other considerations Rates of re-biopsy Anticipated test turnaround time. The estimated number of patients being tested The number of patients tested per case of PD-L1 positive (≥50% and ≥1%) result detected The number of patients tested per case of PD-L1 positive (≥50% and ≥1%) result treated with pembrolizumab The cost of testing per case of PD-L1 positive(≥50% and ≥1%) NSCLC detected The cost of testing per case of PD-L1 positive (≥50% and ≥1%) NSCLC treated with pembrolizumab. Drug Outcomes Measures of clinical efficacy for pembrolizumab include: Primary outcome: Overall survival Progression free survival Secondary outcomes Objective tumour response rates (complete response or partial response according to RECIST and irRC criteria) Quality of life Disease control rate (response rate + rate of stable disease) Duration of response Rate of disease progression Time to progression Safety and tolerability. Table 9 For investigative services Prior tests Initial biopsy and tests to confirm diagnosis of NSCLC and EGFR/ALK testing if nonsquamous or NOS. Reference standard The evidentiary standard is the Market Ready Assay
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