Heart failure drug poised for new pricing model

On July 7, FDA approved sacubitril/valsartan (Entresto, Novartis) orally administered tablets for the treatment of Class II to Class IV chronic heart failure with reduced ejection fraction. The drug has been shown to reduce the rate of cardiovascular death and hospitalization related to heart failure in a study with more than 8,000 patients. Entresto was reviewed under FDA’s priority review program; it was also granted fast-track designation.

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“Ejection fraction is a measurement for how well the heart is pumping blood, and is also used in diagnosis and ongoing tracking of heart failure,” explains April Kunze, PharmD, director, formulary development & pipeline, at Prime Therapeutics. “Heart failure is a chronic and progressive disease that prevents the heart from pumping enough blood to meet the body’s needs.”

Impact

Approximately 5.1 million Americans have heart failure, according to the Centers for Disease Control and Prevention.

Sax

This drug is intended to replace ACE inhibitors and physicians will need to be educated on the appropriate use, says Michael J. Sax, PharmD, president, The Pharmacy Group LLC.

“The drug has been touted as a potential blockbuster by the manufacturer with estimated sales of $5 billion,” Sax says.

While Entresto may be a valuable treatment for some members suffering with heart failure, Prime predicts minimal impact on Prime’s commercial business, according to Kunze. Prime estimates 40% of commercial members eligible for Entresto therapy will be utilizing it in August 2016 for an expected use rate of 41 per 100,000 members.

“A more significant impact will be felt on the Medicare business due to the higher prevalence of heart failure among the elderly,” she says. “Prime estimates 40% of eligible Medicare recipients with heart failure will be utilizing Entresto in August 2016 for an expected use rate of approximately 1,138 per 100,000 Medicare recipients.”

Evidence

In clinical trials, Entresto reduced the risk of cardiovascular death or heart failure hospitalization by 20%. Although the difference from enalapril was a 20% change, the absolute difference in death rate between patients treated with Entresto compared with those treated with enalapril was 2.8% over 2.5 years.

Cost implications

The cost of the drug will be an important issue and a greater expense than what patients pay for ACE inhibitors, according to Sax.

The treatment of heart failure by Entresto has been quoted as $12.50 per day, or approximately $4,500 per year versus $10 for three months or $40 per year for ACE inhibitors.

“We have reached out to a few U.S. payers to discuss potential pricing models linked to clinical outcomes, including a reduction in heart failure hospitalizations,” says Eric Althoff, Novartis head, global media relations. “While discussions have been encouraging, we’re in the early stages and it is too early to share specifics.”

Using Prime’s forecasted potential use, the estimated cost to health plans would be $0.15 per member per month (PMPM) for commercially insured members and $4.27 PMPM for Medicare members at one-year post launch.

Tracey Walker is content manager for Managed Healthcare Executive.