The FDA appears to be in an uncharacteristically benevolent mood, waving through Abbott Laboratories' (ABT) mitral valve repair device MitraClip despite a barely positive panel vote back in March. Coming just ahead of the Transcatheter Cardiovascular Therapeutics meeting in San Francisco this weekend, which will see several presentations on MitraClip, the approval is perfectly timed to gain cardiologists' attention and kick-start sales.
Unfortunately, for Abbott, the Centers for Medicare and Medicaid Services (CMS) does not seem so generous. Analysts from Deutsche Bank (DB) say that the limited reimbursement the CMS is likely to grant MitraClip will not be enough to cover the cost of the device, and it will be nearly a year before Abbott can do anything about it.
MitraClip is used to pin the mitral valve's two leaflets together, partially closing them, to prevent valvular regurgitation - the backflow of blood from the left ventricle into the left atrium. The FDA has approved its use in patients with significant symptomatic degenerative mitral regurgitation who are too sick to undergo surgery. This population has no treatment options, which explains how the device was approved despite the panel's ambivalence about its efficacy (Shock adcom endorsement for MitraClip but U.S. approval still a long shot, March 21, 2013).
Reimbursement, however, looks set to limit sales in the short term. According to Deutsche Bank's Kristen Stewart, MitraClip is most likely to fall under the CMS category DRG 250, which covers percutaneous cardiovascular procedures without stent placement but with major complications or comorbidities (MCC), or DRG 251, which is the same but without MCC.
The average Medicare payments under 250 and 251 are $17,330 and $11,447 respectively - MitraClip costs around $30,000. Abbott had applied for a new technology add-on payment, but was denied. The company can try again but, if the add-on granted, it will not come into effect before October 1, 2014.
MitraClip has been approved in Europe since 2008 and sales should approach $140-$150m this year, Ms. Stewart said. U.S. sales in the first year - it will be launched immediately - could be even lower, thanks to the reimbursement situation.
Down the line, Abbott is also seeking to expand the indications for which MitraClip may be used. The Coapt trial in the U.S. and the European Reshape-HF study are trialing the device in heart failure, which can be a consequence of mitral valve disease. Both trials have all-cause death and repeat hospitalizations due to heart failure as their primary endpoints. The completion dates are August 2016 for Reshape-HF and January 2017 for Coapt.
Heart failure is a hard condition to treat and has many aetiologies, and medtech companies are attempting to tackle it through widely varying strategies. MitraClip's success in mitral regurgitation is rather a surprise; an approval in heart failure would be impressive indeed.