Dive Brief:

• The Centers for Medicare and Medicaid Services has proposed expanding coverage of transcatheter mitral valve repair (TMVR) to take in additional populations of mitral regurgitation (MR) patients.

• The proposal, which CMS published Tuesday, could help Abbott significantly increase sales of its MitraClip device. Analysts at Cowen estimate the proposal could double or triple the number of U.S. patients eligible for TMVR.

• Companies including Edwards Lifesciences and Medtronic want to challenge Abbott for those patients but are yet to bring rival devices to market in the U.S.

Dive Insight:

Abbott has spent the six years since CMS backed the use of TMVR in the treatment of significant symptomatic degenerative MR working to expand into additional patient populations. Those efforts began to come to fruition last year when FDA approved MitraClip for use in patients with secondary MR and CMS agreed to reconsider its 2014 TMVR national coverage determination. 

Now, CMS has proposed expanding coverage to include patients with secondary MR, also known as functional MR. CMS Administrator Seema Verma said the change will enable patients with “limited treatment options beyond medical therapy” to access an intervention “that may lead to improved health outcomes.” MitraClip cut mortality in the population in an Abbott-funded trial. 

Under the existing determination, analysts at Cowen estimate 60,000 to 70,000 patients are eligible for the procedure. The analysts predict the expanded coverage will make an additional 60,000 to 140,000 patients eligible for the treatment.

Despite big rivals looking into the market, Abbott stands to be the big beneficiary of the expansion of the patient population. In August, Cowen analysts said they do not expect Abbott to face “meaningful competition” in the U.S. for three years, enabling MitraClip to add 1% annually to organic growth at the company’s medtech unit over that period. Sales of MitraClip grew around 30% last year to reach almost $700 million. 

The CMS proposal could also lead to increased use of MitraClip in patients with degenerative MR. CMS is planning to drop the “coverage with evidence” designation it applied to the MR indication in 2014. In doing so, the agency will enable healthcare providers to use MitraClip in Medicare patients without first enrolling them in a registry or clinical trial. 

CMS is also planning to stop referring to the procedure as TMVR. Instead, the agency will use the term mitral valve transcatheter edge-to-edge repair (TEER). CMS said the use of TEER will “more precisely define the treatment.”

The proposal is now out for a second public comment period, after which CMS will issue a final decision. The initial phase elicited 26 comments, all of which backed expansion and which included device makers, physicians and patient groups.