Boston Scientific (NYSE:BSX) said late yesterday it won coverage from the Centers for Medicare and Medicaid Services for left atrial appendage closure therapies using its Watchman device.
The device and LAAC procedure will be available to patients who meet certain criteria, outlined in the CMS final National Coverage Determination, Marlborough, Mass.-based Boston Scientific said.
“We are very pleased CMS has established national coverage for this life-changing therapy for Medicare beneficiaries who have a reason to seek an alternative to long-term anticoagulation. The final decision reflects more than a decade of robust clinical evidence and will facilitate additional data collection via a prospective national registry,” CEO Mike Mahoney said in a press release.
Patients will not need to be contraindicated for warfarin to receive the treatment and procedure, but rather “deemed unacceptable for long term use, as arrived at via a conversation/agreement btween physician and patient,” according to Leerink Partner analyst Danielle Antalffy.
The company will no longer require randomization of warfarin or novel anticoagulants for its registry, which makes the process less prohibitive and gives Boston Scientific a higher potential success rate.
“Given this positive coverage decision, we believe that Watchman is on the path to meet or exceed the estimated addressable market opportunity laid out by BSX – $500M by 2019 – and could exceed our and Street estimates of ~$300M by 2020. Longterm, with building clinical evidence via the registry under the NCD, Watchman could ultimately ramp to a $1B+ addressable market opportunity if it eventually does move to first line therapy as a number of our MEDACorp physician conversations have suggested is possible,” Antalffy wrote in a letter to investors.
The guidelines adopted by the CMS were based on physician and professional medical society feedback during a 30-day public comment period, Boston Scientific said.
The company said Medicare beneficiaries account for “the overwhelming majority of patients deemed candidates for the Watchman Device.”