Table 5: Summary of extended PICO to define research question that assessment will investigate Population Prior tests Intervention Comparator Reference standard Outcomes to be assessed by MSAC Patients with testing in order of treated with advanced to inform comparative crizotinib eligibility to performance - The cost of (Stage IIIB) or second line of ALK gene testing per case of metastatic (Stage IV), non- treatment ALK +ve NSCLC squamous or options that testing detected does not methods: - The cost of otherwise not include classified testing per NSCLC at the crizotinib. - case of ALK time of +ve NSCLC with treated with diagnosis. FISH is to be evidentiary considered as crizotinib. AND the evidentiary standard (FISH) standard. - Receiver Patients diagnosed with The Operating early stage non- performance of Characteristic (ROC) squamous or other test - otherwise not methodologies classified is to be NSCLC that compared index against have progress against the evidentiary to advanced evidentiary disease and standard. standard have failed at (potential alternative to first-line therapy. Safety: Safety of ROC). Tests required to performing confirm diagnosis the ALK relating of advanced gene to clinical NSCLC. . testing (including - Rates of safety Testing for ALK gene outcomes - Rates of rearrangement to associated with determine if the re-biopsy). - Anticipated test proposed PBS turnaround time. requirements relating access to ALK testing crizotinib are Measures of uptake: fulfilled. Primary metrics analytic on testing use Testing options performance and costs: of ALK gene include: - Estimated FISH number of CISH patients testing IHC being tested including: RT-PCR - The number of - Sensitivity Current practice patients - Specificity whereby following - Positive tested per treatment failure case of ALK Predictive with first line +ve result Value therapy, patients detected - Negative may access - The number of molecular profiling Predictive patients tested Value that does not per case of ALK include ALK gene +ve result Measures rearrangement
Table 5: Summary of extended PICO to define research question that assessment will investigate Population Prior tests Intervention Comparator Reference standard Outcomes to be assessed by MSAC Patients with advanced (Stage IIIB) or metastatic (Stage IV), non- squamous or otherwise not classified NSCLC at the time of diagnosis. AND Patients diagnosed with early stage non- squamous or otherwise not classified NSCLC that have progress to advanced disease and have failed at first-line therapy. Tests required to confirm diagnosis of advanced NSCLC. . Testing for ALK gene rearrangement to determine if the proposed PBS requirements relating access to crizotinib are fulfilled. Testing options include: FISH CISH IHC RT-PCR Current practice whereby following treatment failure with first line therapy, patients may access molecular profiling that does not include ALK gene rearrangement testing in order to inform eligibility to second line treatment options that does not include crizotinib. FISH is to be considered as the evidentiary standard. The performance of other test methodologies is to be compared against the evidentiary standard. Safety: Safety of performing the ALK gene testing (including safety outcomes associated with re-biopsy). Measures of analytic performance of ALK gene testing including: - Sensitivity - Specificity - Positive Predictive Value - Negative Predictive Value Measures of comparative performance of ALK gene testing methods: - with evidentiary standard (FISH) - Receiver Operating Characteristic (ROC) - index against evidentiary standard (potential alternative to ROC). relating to clinical - Rates of - Rates of - Anticipated test turnaround time. ALK testing uptake: Primary metrics on testing use and costs: - Estimated number of patients being tested - The number of patients tested per case of ALK +ve result detected - The number of patients tested per case of ALK +ve result treated with crizotinib - The cost of testing per case of ALK +ve NSCLC detected - The cost of testing per case of ALK +ve NSCLC treated with crizotinib.
1250-ALK-Final%20DAP-accessible.docx