| Criteria | Evidence for criteria | Criteria grade |
|---|---|---|
| Minimum criteria | ||
| Included within statutory limits of Federal Coordinating Council’s definition of CER | Yes | High |
| Stakeholder/community interest | Yes | High |
| Feasibility | High incidence and mortality rate result in relatively large data sets available for analysis through insurance claims data linked to SEER. Initially, would be informative to look at claims data to get idea of variations in use of PET/CT for staging, restaging, and post-treatment surveillance of NSCLC patients in western Washington State | High |
| Evidence needed | Two RCTs performed outside the USA found fewer futile surgeries in the pre-operative PET/CT group, but no difference in survival. Studies looking at use of PET/CT in community (vs academic) setting needed | Medium |
| Primary criteria | ||
| Standards for modality and implementation of test results | NCCN guidelines recommend that PET/CT be used for pretreatment evaluation of NSCLC, but PET/CT is still not regarded as a standard of care for NSCLC staging. Controversy exists regarding PET/CT as an add-on or replacement test | High |
| Potential patient harm/safety concerns | Unnecessary radiation exposure in patients who receive PET/CT scans; potential unnecessary surgeries due to PET/CT false positives, or delayed treatment for false negatives; also potential for unnecessary surgeries in patients who do not receive PET/CT scans | High |
| Diagnostic accuracy and efficacy potential | Considerable evidence of PET/CT offering superior accuracy in NSCLC staging. RCTs and retrospective studies generally agree that PET/CT offers potential to change patient management, but there is little evidence for survival improvements | High |
| Economic impact | According to SEER–Medicare data, approximately 12% of lung cancer patients filed claims for PET/CT between 2005 and 2007. Cost of PET/CT is approximately US$2500–4000, but might reduce costs by eliminating unnecessary surgeries and by allowing surgeons to better target areas of resection | High |
| Secondary criteria | ||
| Severity of condition treated/diagnosed by modality | High incidence and low survival rates; accounts for the most cancer-related deaths. US incidence rate: 69.0/100,000; 5-year survival: 16%; US death rate: 53.4/100,000 | High |
| Pressure on payers | Anecdotal evidence suggests that use of PET/CT scans is increasing, with no evidence that the scans provide information that decreases morbidity, mortality, or recurrence rates | Medium |
| Potential or observed variation | No literature on this | No data |
| Diverse populations | Access to PET/CT machines is variable depending on patient location | Medium |
| Overlap/redundancy | Two RCTs looking at PET/CT for detecting recurrence in several cancers, including lung; none in western Washington State | Medium |
| Disease burden | Approximately 4000 incident cases in Washington State state per year; US prevalence: 370,617; aggregate 5-year Medicare cost (in 2004 dollars) of care for treatment of lung cancer was estimated to be US$4238 million | High |
CER: Comparative effectiveness research; CT: Computed tomography; NSCLC: Non-small-cell lung cancer; RCT: Randomized controlled trial; SEER: Surveillance, Epidemiology and End Results.