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
Table 10 List of resources to be considered in the economic analysis Provider of resource Setting in which resource is provided Proportion of patients receiving resource Number of units of resource per relevant time horizon per patient receiving resource Disaggregated unit cost MBS Safety nets* Other government budget Private health insurer Patient Total cost Resources provided to identify eligible population Equivalent to current practice To be provided in submission To be provided in submission Resources provided to deliver proposed intervention (PD-L1 IHC test and pembrolizumab) PD-L1 IHC testing MBS Pathology lab To be provided in submission To be provided in submission Additional biopsy (if required) MBS Public or private hospital To be provided in submission To be provided in submission Resources provided in association with proposed intervention Pembrolizumab for patients deemed eligible based on PBS criteria PBS Outpatient To be provided in submission To be provided in submission Administration cost for pembrolizumab Hospitals/MBS Inpatient/outpatient and public and private hospitals To be provided in submission To be provided in submission Physician visits (Oncologist or respiratory physician) MBS Outpatient To be provided in submission To be provided in submission Clinical monitoring (radiological or other imaging, blood counts) MBS Outpatient To be provided in submission To be provided in submission Treatment of adverse events PBS Outpatient To be provided in submission To be provided in submission
Resources provided in association with comparator 1 (no testing followed by docetaxel) (e.g., pre-treatments, co-administered interventions, resources used to monitor or in follow-up, resources used in management of adverse events, resources used for treatment of down-stream conditions) Pharmaceuticals (relevant carboplatin/cisplatin+gemcitabine) followed by pemetrexed maintenance if appropriate PBS Outpatient To be provided in submission To be provided in submission Administration cost for carboplatin/cisplatin+gemcitabine followed by pemetrexed maintenance if appropriate Hospitals/MBS Inpatient/outpatient and public and private hospitals To be provided in submission To be provided in submission Physician visits (Oncologist or respiratory physician) MBS Outpatient To be provided in submission To be provided in submission Clinical monitoring (radiological or other imaging, blood counts) MBS Outpatient To be provided in submission To be provided in submission Treatment of adverse events PBS Outpatient To be provided in submission To be provided in submission * Include costs relating to both the standard and extended safety net.