Patient, Consumer, and Public Health Coalition Public Comment to CMS on Transcatheter Tricuspid Valve Replacement Coverage
July 19, 2024
Dear Administrator Brooks-LaSure:
As nonprofit organizations that are members of the Patient, Consumer, and Public Health Coalition, we appreciate the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) National Coverage Analysis on Transcatheter Tricuspid Valve Replacement (TTVR).
Our coalition includes nonprofit organizations representing millions of patients, consumers, researchers, and doctors united to ensure that medical treatments are safe and effective. None of the organizations that have signed this comment have financial conflicts of interest on this topic.
The Evoque system designed by Edwards for transcatheter tricuspid valve replacement (TTVR) was recently approved by the Food and Drug Administration (FDA) based on 6-month findings from their TRICSEND II trial. As CMS considers coverage for TTVR, we share the concerns of many experts that the FDA approval was premature and the data are inadequate to support the safety and effectiveness of TTVR for the Medicare population. Our major concerns are as follows:
- Poor research design:
The trial was unblinded, and therefore all subjective outcomes are vulnerable to bias. Moreover, severe, irreversible conditions lead to severe tricuspid regurgitation, usually either end-stage congestive heart failure or pulmonary hypertension. Neither of these is reversed or reduced by TTVR or the other surgical procedure used as a safety comparison group, and we question the appropriateness of the effectiveness outcome measures that were used instead. In addition, all the comparison safety data (including MAEs) should be based on data for patients receiving the current standard of care — a medical control group, not a surgical one.
- Incomplete data:
Complete data is only available at 30 days and 6 months, which is much too short a time to provide reasonable assurance of safety or effectiveness for Medicare beneficiaries. Fewer than half the participants in the TTVR group and control group completed the 12-month follow-up visit. 12 months should be the minimum required for all or nearly all of the participants, to avoid a biased assessment.
- High rate of Major Adverse Events (MAE):
The 30-day rate of Major Adverse Events (MAE) was notably high at 27.4%, and the MAE rate for the control group wasn’t reported. Instead, the TTVR MAE rate was compared to a performance goal of 70% based on isolated tricuspid valve replacement surgery outcomes. However, as the control group for TRISCEND II is medical therapy, and that is the standard of care alternative to TTVR, the MAE rates should be from the medical therapy control group, not surgical patients. It is misleading to use a surgical control group, which of course will have higher MAE rates in the first 6 months. Additionally, almost one fourth (22.6%) of participating TTVR patients who did not previously have pacemakers or ICDs required permanent pacemakers after the procedure, and 10% of TTVR patients experienced severe bleeding.
- Mortality rates:
The 30-day MAE rate is misleading because of the large number of deaths between 30 days and 1 year: By 12 months, 12 out of 96 (12.5%) patients in the TTVR group were reported to have died, compared to 4 out of 54 (7.4%) in the control group. This indicates a need to complete the 12-month data collection on all patients and suggests that longer follow up would be even more meaningful.
The FDA made its approval decision without convening an FDA Advisory Committee panel to review the data, none of which have been published in a peer-reviewed journal. Given the flaws of the study, the problem with missing data, and of the lack of vetting by the FDA Advisory Committee, we strongly urge a thorough MEDCAC review to determine if the evidence is robust and persuasive enough to support Medicare coverage for TTVR.
Sincerely,
AMSA Wisconsin
Doctors for America
Jacobs Institute of Women’s Health
MedShadow Foundation
Mothers Against Medical Error
National Center for Health Research
National Women’s Health Network
Patient Safety Action Network
SCAD Alliance
TMJ Association
Washington Advocates for Patient Safety
Woody Matters
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