Appendix E- Review Tracking Tool 10-12-22.xlsx
XLSX spreadsheet 13 KB Posted
- Solicitation number
- 75FCMC23R0006
About this file
This document contains an environmental scan review tracking tool and details of a related federal contract opportunity. The tracking tool includes templates for collecting data on medical device technologies, such as unique identifiers, sponsors, device descriptions, FDA authorizations and review dates. Data fields also capture study details on unpublished and published research, including numbers of randomized controlled trials and observational studies, as well as patient demographics and follow-up durations. Outcome tracking includes primary and secondary health outcomes as well as patient-reported outcomes. The related federal contract opportunity is a solicitation from the Centers for Medicare and Medicaid Services to establish external contractor support to complete up to 30 high-priority environmental scans over the period of performance, in order to efficiently inform timely policymaking by the Coverage and Analysis Group.
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ES Evaluation Master
| Technology Descriptors | FDA / Review Timing | Unpublished Studies | Published Studies | Generalizability | Duration | Outcome Variables | |||||||||||||||||||||
| Review Type | Unique ID | Sponsor | Breakthrough Device | Description | FDA Pathway | Authorization Date | Review Date | RCT | Observational | Case | Control | RCT | Observational | Case | Control | % Female | % > 65 | % ESRD | % Disabled | Short | Average | Median | Long | Primary HO | Secondary HO | PRO | Guideline |
| Evidence Preview | 100001 | Edwards | Leaknomore | Transcatheter tricuspid valve replacement. | PMA | 3/22/22 | 7/1/22 | 0 | 3 | 300 | 360 | 1 | 0 | 150 | 150 | 43 | 62 | 0 | 0 | 1 | 14 | 12 | 24 | 4 | 4 | 2 | None |
| Evidence Preview | 2304055 | Abbott | Bettervalve | Transcatheter tricuspid valve replacement. | PMA | 5/15/22 | 8/1/22 | 1 | 2 | 250 | 250 | 1 | 1 | 200 | 200 | 47 | 55 | 20 | 0 | 1 | 14 | 12 | 26 | 5 | 3 | 2 | None |
| Definitions: | |||||||||||||||||||||||||||
| Technology Descriptors | |||||||||||||||||||||||||||
| Unique ID: Will most likely be a billing code and will be added by CAG staff (TBD) | |||||||||||||||||||||||||||
| Sponsor: Submitter / Manufacturer / Sponsor | |||||||||||||||||||||||||||
| Device: Name of Technology | |||||||||||||||||||||||||||
| Description: One sentence description of the device. | |||||||||||||||||||||||||||
| FDA Pathway: PMA, DeNovo, 510k (if applicable) | |||||||||||||||||||||||||||
| FDA / Review Timing | |||||||||||||||||||||||||||
| Authorization Date: Date the device was FDA market authorized. | |||||||||||||||||||||||||||
| Review Start Date: Date that review was completed. | |||||||||||||||||||||||||||
| Unpublished Studies | |||||||||||||||||||||||||||
| RCT: Number of unpublished RCTs reviewed (including in SSED). | |||||||||||||||||||||||||||
| Observational: Number of unpublished observational studies reviewed (including in SSED). | |||||||||||||||||||||||||||
| Case: Total number of treated patients (All studies). | |||||||||||||||||||||||||||
| Control: Total number of control patients (All studies). | |||||||||||||||||||||||||||
| Published Studies | |||||||||||||||||||||||||||
| RCT: Number of published RCTs identified in environmental scan. | |||||||||||||||||||||||||||
| Observational: Number of published observational studies identified in environmental scan. | |||||||||||||||||||||||||||
| Case: Total number of treated patients (All studies). | |||||||||||||||||||||||||||
| Control: Total number of control patients (All studies). | |||||||||||||||||||||||||||
| Generalizability (All Studies) | |||||||||||||||||||||||||||
| % female: Percent of patients studied who are were women at the time of FDA market authorization. | |||||||||||||||||||||||||||
| % > 65: Percent of patients studied who are were > 65 years old at the time of FDA market authorization. | |||||||||||||||||||||||||||
| % ESRD: Percent of patients studied who are had ESRD at the time of FDA market authorization. | |||||||||||||||||||||||||||
| % disabled: Percent of patients studied who are were disabled at the time of FDA market authorization. | |||||||||||||||||||||||||||
| Duration (All Studies) | |||||||||||||||||||||||||||
| Short: Shortest duration of follow-up (months). | |||||||||||||||||||||||||||
| Average: Average duration of follow-up (months). | |||||||||||||||||||||||||||
| Median: Median duration of follow-up (months). | |||||||||||||||||||||||||||
| Long: Longest duration of follow-up (months). | |||||||||||||||||||||||||||
| Outcomes | |||||||||||||||||||||||||||
| Primary Health Outcomes: Number of unpublished or published studies with primary health outcomes. | |||||||||||||||||||||||||||
| Secondary Health Outcomes: Number of unpublished or published studies with secondary health outcomes. | |||||||||||||||||||||||||||
| PRO: Number of unpublished or published studies with patient reported outcomes. | |||||||||||||||||||||||||||
| Guideline: Is the device featutured in any guidelines or consensus statemetns at the time of review. |
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