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.
To be provided in submission in submission Administration cost for pemetrexed or docetaxel Hospitals / MBS Blend of inpatient/ outpatient and public and private hospitals To be provided in in submission Physician visits MBS Outpatient To be To be
Setting in Proportion Number of units of resource per unit cost (Oncologist, Respiratory Physician) Provider of resource which resource is provided of patients receiving provided in relevant time horizon per patient receiving resource provided in submission MBS Safety nets* Other govt budget Private health insurer cost Clinical monitoring (radiological or other imaging, blood counts etc) To be provided in submission in submission Treatment of adverse events Hospitals / MBS / PBS Blend of inpatient/ outpatient and public and private hospitals To be provided in submission in submission Pharmaceuticals (crizotinib, pemetrexed or docetaxel, relevant pre-medications/ concomitant therapies) To be provided in submission in submission Resources used to manage patients successfully treated with the proposed intervention As above (with the exception of crizotinib costs) above See above See above As above (with the exception of crizotinib costs)