Out-of-Pocket Costs May Curb ARNI Use Among Medicare Recipients

By Marilynn Larkin

July 22, 2019

NEW YORK (Reuters Health) - High out-of-pocket costs may be hindering the use of sacubitril/valsartin, an angiotensin receptor-neprilysin inhibitor (ARNI) with a known mortality benefit for those with heart failure with reduced ejection fraction, researchers say.

"It's important to realize that being able to afford medications is no longer just an issue of having health insurance or whether a drug is covered by a health plan," Dr. Chien-Wen Tseng of the University of Hawaii told Reuters Health by email. "When a drug has a $5,000 price tag, even when patients pay only 5% of the cost, it's still hundreds of dollars out-of-pocket each year for one drug."

Coauthor Dr. Collette DeJong of the University of California, San Francisco, noted in a separate email, "Clinicians should be aware that many Part D patients receiving sacubitril/valsartan (in January) will enter the Part D coverage gap, or 'donut hole' by July, after which their monthly copay could skyrocket. Frequent conversations about cost may be needed to assess whether sacubitril/valsartan is an affordable option for patients."

"Federal laws currently prohibit the Department of Health and Human Services (HHS) from negotiating drug prices on behalf of Medicare Part D patients," she told Reuters Health. "Strengthening Medicare's ability to negotiate prices may be one step towards curbing the cost of sacubitril/valsartan and other novel therapies."

Drs. Tseng, DeJong and colleagues analyzed all Medicare Part D formulary and pricing for sacubitril/valsartan for the first quarter of 2018, including 30-day cost-sharing requirements.

As reported online July 10 in JAMA Cardiology, a total of 2,818 Part D plans across the U.S. were included in the analysis. In early 2018, 100% of plans covered sacubitril/valsartan (with 38% requiring prior authorization).

Mean cost-sharing for a 30-day supply of an ARNI during the coverage period was $57, compared with a range of $2 to $5 for other examined drugs, including beta blockers, diuretics, and HFrEF regimens.

Overall, under a standard 2018 plan, beneficiaries receiving an ARNI, carvedilol, and furosemide would pay their full $405 deductible in January and hit the Part D coverage gap in July, after which their monthly cost would increase on average to $163. Their projected annual out-of-pocket costs would be $1,685, of which 97% would be attributable to the ARNI.

By contrast, beneficiaries receiving an angiotensin II receptor blocker, carvedilol, and furosemide would have projected annual costs of $291 and would not meet their deductible or fall into the donut hole before the end of the year.

JAMA Cardiology Associate Editor Dr. Gregg Fonarow of the University of California Los Angeles Medical Center, coauthor of a related editorial, told Reuters Health that in addition to facing the donut hole, "by law, Medicare beneficiaries cannot receive prescription copayment discounts. These are critical barriers to access that are unique to Medicare beneficiaries in the United States."

"HHS could readily address this by eliminating the Part D coverage gap, allowing use of prescription copayment discounts, or both," he said by email. "This change could be limited to only those select medications that have been proven to reduce all-cause mortality. That way, patients who otherwise have prescription drug coverage would not be forced to forego medications that are truly life-saving just because they reach an arbitrary and ill-conceived coverage gap."

"The American College of Cardiology, American Heart Association, and Heart Failure Society of America are all working to help address this important issue of access to beneficial therapies," he said. "Yet, ultimately this will require HHS to decide it will meaningfully address this critical issue rather than taking very small and incomplete steps in the right direction."

SOURCE: http://bit.ly/2SpSL5e and http://bit.ly/2Sv7PP5

JAMA Cardiol 2019.