Payer issues with new heart failure drug

Entresto is the first in a new class of drugs, valsartan combined with sacubitril, a pro-drug of a compound that is a receptor‐neprilysin inhibitor (ARNI).  It is taken orally twice daily. It was approved for heart failure patients with reduced ejection fraction based on the PARADIGM-HF trial.

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Since the majority of the angiotensin-converting enzyme (ACE) inhibitors are off patent, the payer will want to promote the appropriate use of this agent, according to says Michael J. Sax, PharmD, president, The Pharmacy Group LLC.

“I believe the payer will require prior authorization of Entresto and request that the patient fulfill all the criteria of the clinical trial,” Sax says. “The trial included a population that was tolerant of full doses of ACE inhibitors, there were not a lot of participants with comorbidities or renal insufficiency, very little data on patients older than 75, and they were not on a number of drugs. Essentially, the patients had stable heart failure. Also, the payer will be looking for discounts on the drug as well as outcomes based contracting in terms of reductions in hospitalizations.”

Payers may face a bit of an issue managing drug trend in cardiovascular drugs with these new treatments and what they cost, Shehata says. 

“Drug makers will have to provide evidence to payers and providers to build that momentum for market acceptance to show greater value than inexpensive generic drugs, which are widely available to treat blood pressure and high cholesterol,” Little says.   

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The drugs are already approved, so the biggest regulatory challenge for drug makers is expanding indications for these new medicines to generate more sales, Little adds.

Prime will work with its health plan clients to develop utilization management programs to help ensure appropriate use of Entresto, according to Kunze.

For commercially insured members, prior authorization will help ensure the drugs are available to the right members, those with reduced ejection fraction, and we’ll follow the FDA label for indication and quantity limits,” she says. “For government program clients, Entresto will be managed by excluding it from formulary. Upon thorough research and discussion, it may be added to the formulary at a later date. Even without this management approach, we anticipate a slow uptake because congestive heart failure can be difficult to treat and, once a patient is stable, physicians are not likely to switch treatments.”