As Abbott seeks an expanded indication for its CardioMEMS device for patients with heart failure, the company also hopes to win a national coverage decision from the Centers for Medicare and Medicaid Services.
The implantable device was first approved in 2014 to prevent hospitalization for patients with heart failure. Abbott is now seeking the blessings of the Food and Drug Administration to use it on a wider range of patients, including those in the early stages of heart failure and more severe stages of the disease.
The company has filed a pre-approval addendum with the FDA and is also on the national waiting list to determine CMS coverage.
Abbott’s CardioMEMS device measures pressure on the patient’s pulmonary artery, and if he’s out of range, his doctor can adjust his medication. Although this method is more invasive, it is a more accurate way of detecting progression than weighing patients, said Dr. Philip Adamson, Abbott’s heart failure chief medical officer.
The intent is to keep people out of the hospital by preventing decompensation when fluid builds up in the lungs. Often times, patients don’t notice symptoms until they’re well into the decompensation process, he said.
“It’s a terrible feeling. … Just preventing this from happening is a fantastic opportunity, ”he said.
Abbott recently tested the device on a wider range of patients, including those with Class II to IV heart failure. While CardioMEMS is currently approved for use in Class III patients who were previously hospitalized, the study also included patients who who have not yet been hospitalized with the condition but had blood test results that suggest they have heart failure. Like many studies last year, the study was canceled because of the Covid-19 pandemic.
The year-long study enrolled 1,000 patients implanted with the device, half of whom received heart failure treatment based on pulmonary artery pressure and the other half received standard treatment. It failed to prove that the patients cared for with the device had fewer heart failure events or lower death rates, according to results published in the Lancet.
However, Covid-19 could have influenced these results. Analysis of the pre-pandemic data found a 19% reduction in hospital admissions with heart failure, emergency rooms and death, and a 34% reduction especially in patients with early-stage heart failure.
Analysts believe this should be enough evidence to support an expansion of the device for patients with early-stage heart failure (Class II). However, in patients with severe (Class IV) heart failure, patient recruitment has been too low to draw any conclusions about clinical benefit, Robbie Marcus, a senior analyst at JPMorgan, wrote in an Aug. 27 research report.
“Although the study showed no mortality benefit, this was not surprising given the smaller pre-Covid-19 population and the short timeframe of just one year,” he wrote. “While there has been some criticism of the use of pre-Covid-19 analysis, the fact that the sensitivity analysis (p = 0.11) hit the FDA agreed pre-determined benchmark of 0.15 leads us to believe that If this is not the case, you are not an obstacle to admission. “
Abbott hopes to have the device covered by the CMS for both the original and expanded indications.
“We don’t want to work with them for the incomplete indication and have to go back and change them,” said Adamson. “We want to get clarity about the indication and work with you on a national coverage decision based on this indication.”
If the FDA takes a full six months to make its decision, it expects a response from the agency in January. Then Abbott could begin the nine-month process with CMS.
Abbott faced reimbursement issues a few years ago because some insurers raised concerns about the pivotal CHAMPION study. In 2016, Medicare administration contractor Novitas declined coverage of the device because more evidence was needed. Novitas discontinued non-coverage insurance last year.
Abbott CEO Robert Ford acknowledged these challenges on a conference call on July 22nd, adding that he hoped the new results would allay concerns about the previous study.
“We believe that monitoring pulmonary arterial pressure is a good indicator of preventing acute heart failure and decided to invest in a larger study to either address the perceived deficiencies of CHAMPION and / or expand the data set” , he said.