Table 2.
Payers’ concerns about MCED testing and which concerns would preclude coverage if unaddressed.
| Concern | Percent (n/N) of payers expressing this concern (N = 19) | Percent (n/N) of payers for whom this concern would preclude coverage if unaddressed (N = 19) |
|---|---|---|
| Test performance | ||
| Rate of false-negatives is too high | 74 (14/19) | 53 (10/19) |
| Rate of false-positives is too high | 32 (6/19) | 26 (5/19) |
| Inclusion of cancers | ||
| Inclusion of indolent cancers will lead to overtreatment | 47 (9/19) | 47 (9/19) |
| Inclusion of cancers where early diagnosis does not lead to improved outcomes | 74 (14/19) | 74 (14/19) |
| Clinical integration | ||
| No protocols for uncertain scenarios where cancer is not confirmed | 79 (15/19) | 53 (10/19) |
| No protocol for testing frequency | 21 (4/19) | 11 (2/19) |
| Difficulty implementing in clinical care | 47 (9/19) | 0 |
| Costs | ||
| Costs of test | 26 (5/19) | 11 (2/19) |
| Cost of downstream diagnostics and care | 63 (12/19) | 26 (5/19) |
| Other concerns | ||
| Lack of FDA approval | 11 (2/19) | 11 (2/19) |
| Lack of coverage recommendation from BlueCross/Blue Shield Association | 11 (2/19) | 11 (2/19) |
Note: Numbers in cells do not amount to 100% as some payers expressed multiple concerns. FDA = Food and Drug Administration; MCED = multicancer early-detection.