EXPERT ANALYSIS FROM THE HFSA ANNUAL SCIENTIFIC MEETING

ORLANDO (FRONTLINE MEDICAL NEWS) – Use of sacubitril/valsartan to treat patients with heart failure with reduced ejection fraction (HFrEF) became a class I recommendation in both the U.S. and European heart failure guidelines in May 2016, but virtually all U.S. health insurers continue to regard the potent and effective sacubitril/valsartan formulation as a second-line treatment that needs special preauthorization before patients receive reimbursement for the prescription.

“What is really morally sad is that U.S. payers are requiring physicians to fill out extensive, patient-by-patient paperwork” to allow patients with HFrEF to receive health insurance coverage for sacubitril/valsartan (Entresto), Milton Packer, MD , said at the annual scientific meeting of the Heart Failure Society of America.

“It is very difficult to understand why third-party payers would intentionally try to slow adoption of this life-saving drug simply because it is considered expensive. It is much cheaper than many drugs they cover for patients with cancer that don’t work half as well,” said Dr. Packer, a cardiologist and heart failure specialist at Baylor University Medical Center in Dallas.

The “excessive paperwork” for insurers when starting patients on sacubitril/valsartan is a “new and unique phenomenon among the cardiovascular drugs I prescribe,” agreed Nancy K. Sweitzer, MD, PhD , professor and chief of cardiology at the University of Arizona in Tuscon. “This approach by insurers seems based on cost; they do not want to pay” for sacubitril/valsartan, and to successfully arrange for coverage patients need to exactly match the enrollment criteria used in the PARADIGM-HF (Prospective Comparison of ARNI [Angiotensin Receptor – Neprilysin Inhibitor] with ACEI [Angiotensin-Converting Enzyme Inhibitor] to Determine Impact on Global Mortality and Morbidity in Heart Failure Trial ), the pivotal study that supplied the evidence base for making sacubitril/valsartan a class I agent for treating HFrEF.

“I don’t put some HFrEF patients on sacubitil/valsartan just because they don’t meet the trial’s entry criteria,” Dr. Sweitzer said in an interview. “Insurers seem to scrutinize every single parameter to make sure patients match the PARADIGM-HF patients. Coverage is denied if their BNP [brain natriuretic peptide] level is too low.” Dr. Sweitzer added that in one instance she had to submit a second preauthorization to simply uptitrate the dosage of sacubitril/valsartan she wanted a patient to receive.

“Based on the data it seems like you could easily identify HFrEF patients who are good candidates for sacubitril/valsartan, but your hands are tied by payers because you can’t prescribe it until you’ve first tried something else, and even then you still need to deal with a lot of paperwork,” agreed Robert O. Bonow, MD , professor of medicine at Northwestern University in Chicago. “The paperwork burden is really cumbersome for physicians with busy practices; it impedes taking care of patients,” Dr. Bonow said in an interview.

Sales figures for sacubitril/valsartan that the drug’s manufacturer, Novartis, has reported since the agent received U.S. marketing approval a little over a year ago reflect these challenges in prescribing the compound to patients. During the first quarter of 2016, Novartis reported $17 million in worldwide sales of the agent, followed by $32 million in worldwide sales during the second quarter of 2016, through June 30. With a total of $49 million in sacubitril/valsartan sales during the first 6 months of 2016, it seems like Novartis may be challenged to meet its stated target of $200 million in total sales of the compound during 2016. In April, one commentator called the $17 million sales figure for first quarter 2016 “an astonishingly small amount for a drug that was widely expected to be a blockbuster.”

Dr. Packer has in the past been a consultant to Novartis and was one of the lead investigators for the PARADIGM-HF trial. He said that currently he has no financial relationship with Novartis but he does serve as a consultant to several other drug companies. Dr. Sweitzer has received research support from Novartis and was an investigator for PARADIGM-HF. Dr. Bonow has been a consultant to Gilead.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

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