A newly FDA-approved drug to treat congestive heart failure is cost-effective, while a device to treat the same disease is priced 60 percent higher than it should be, according to an Institute for Clinical and Economic Review (ICER) analysis.

The researchers noted the two interventions could become the first breakthroughs in heart failure management in more than a decade.

For both analyses, the researchers developed a Markov model of the natural history of chronic heart failure using event rates from the published literature. They mentioned that nearly six million people in the U.S. have congestive heart failure, and the lifetime risk of developing the condition is approximately 20 percent.

In July, the FDA approved sacubitril/valsartan (Entresto, Novartis), a twice-daily oral medication to treat patients with heart failure and reduced ejection fraction. Valsartan is an ARB, while sacubitril is a neprilysin inhibitor.

With a wholesale acquisition cost of $4,560, sacubitril/valsartan will not save payers and patients money in the long-term, according to the ICER researchers. However, when considering that the medication increases the average life expectancy for patients and decreases the number of congestive heart failure hospitalizations, it is cost-effective based on accepted thresholds.

The researchers estimated that nearly two million patients could receive sacubitril/valsartan in the next five years, which could be costly. To meet ICER’s value-based price benchmark, the cost of the drug should be $3,779 per year, which is a discount that payers typically can achieve in negotiations with pharmaceutical companies. They compared sacubitril/valsartan with the current standard of care of an ARB or ACE inhibitor with co-administration of beta blockers.

The CardioMEMS device received FDA approval in May 2014, three years after the FDA rejected its application. The device includes a small wireless sensor and portable electronic transmitter, in which patients wirelessly transmit pulmonary artery pressure readings to an online database. Pulmonary artery pressure is an important indicator of worsening congestive heart failure.

The ICER researchers said the list price for the device is $17,750, which does not include the costs associated with surgical implantation or monitoring. Although they said there was insufficient evidence to determine if the CardioMEMS device improved patient outcomes, they noted that the value-based price benchmark should be $7,622, which is nearly 60 percent off the list price.

They mentioned that the costs associated with the device were incurred at the time of implantation and that ongoing monitoring and other costs were around $27 per month. They compared the device with usual congestive heart failure monitoring.

ICER, a nonprofit healthcare research organization, released the draft report on Sept. 11. The report is open to public comment until Sept. 25, and a revised report will be posted on Oct. 8. Members of the California Technology Assessment Forum will review and debate the revised report on Oct. 29 in Oakland, Calif. in a meeting that is free and open to the public.

“Figuring out the effectiveness and value of new drugs and devices is not merely an academic exercise,” Steven D. Pearson, MD, MSc, ICER’s founder and president, said in a news release. “The headlines are full of stories about rising health care costs and their impact on patients, families, and the budgets of states and the federal government.  A clear-eyed view of the evidence is critical to all members of the health care community as we try to figure out what should be used, which patients benefit most, and at what price innovative treatments represent a reasonable value.”