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Denial rates for PCSK9 inhibitor prescriptions high
WASHINGTON — Two studies presented at the American College of Cardiology Scientific Session found that an overwhelmingly high number of prescriptions for PCSK9 inhibitors have been initially rejected by payers.
Both studies found that approximately half of PCSK9 inhibitor prescriptions are ultimately rejected, and one study found that many of those ultimately approved are never filled by the patient.
Symphony Health data
Ann Marie Navar, MD, PhD, assistant professor of medicine at Duke University Medical Center and Duke Clinical Research Institute, and colleagues used data from Symphony Health Solutions, covering approximately 85% of U.S. ambulatory prescriptions, to assess new PCSK9 inhibitor prescription claims between July 2015 and August 2016.
Navar and colleagues stratified claims by approval status (approved/dispensed, approved/unfilled or rejected), compared data by patient, provider and payer characteristics, and evaluated the time between initial filing and ultimate claim status.
Of the 51,422 claims filed during the study period, 80% were initially rejected and 54.8% were ultimately rejected, Navar said during a presentation.
Among the claims approved, 36% were never filled by the patient, she said.
Median time between filing and ultimate decision was 21 days for rejected prescriptions, 24 days for approved and filled prescriptions, and 32 days for approved but unfilled prescriptions.
Rejection rates were higher for adults with LDL 190 mg/dL than for those with LDL < 190 mg/dL (58% vs. 48%; P = .02), according to the researchers.
Rejection rates varied by prescriber and provider (P < .0001), Navar said. Rejection rates were 50% for cardiologists vs. 58% for endocrinologists and 62% for primary care doctors; they were 69% for those with commercial insurance vs. 46% for those with Medicare. They did not differ by sex (55% for both men and women).
“This is the experience in the first year of PCSK9 [inhibitor] availability,” Navar said during the presentation. “It may not reflect today’s experience. We also suspect these trends are going to change now that we have [CV] outcomes data. But it’s important ... that we recognize that the complex interactions patients, pharmacies, payers and [pharmacy benefit managers] can dramatically affect patient access. When we see that two-thirds of patients whom doctors have tried to put on therapy never receive therapy, there’s a disconnect between what providers are trying to do and what’s actually happening to the patients.”
Quintiles IMS data
Seth J. Baum, MD, FACC, FACPM, FAHA, FNLA, FASPC, chief medical officer at Excel Medical Clinical Trials, clinical affiliate professor of biomedical science at Florida Atlantic University, Boca Raton, and president of the American Society for Preventive Cardiology, and colleagues analyzed the Quintiles IMS Formulary Information Analyzer database to determine payment status for PCSK9 inhibitor prescriptions between July 29, 2015, and July 15, 2016.
Baum and colleagues linked those data to the Quintiles IMS Longitudinal Prescription and Ambulatory Electronic Medical Record databases to determine characteristics of patients seeking the therapy.
Outcomes of interest were approval and rejection rates by payer type and demographic and clinical characteristics of patients by approval/rejection status.
There were no significant differences in approval/rejection rates by baseline statin use, statin intensity, ezetimibe (Zetia, Merck) use or co-medication use, including antiplatelet therapy, according to the researchers.
Of the 44,234 claims filed during the study period, 83% were initially rejected, Baum and colleagues found.
The ultimate approval rate was 43% — 57% for those on Medicare and 30% for those with commercial insurance.
Approval rates were similar between alirocumab (Praluent, Sanofi/Regeneron) and evolocumab (Repatha, Amgen) among those with commercial insurance, but were higher for alirocumab than evolocumab among those on Medicare, “potentially due to differences in formularies,” Baum and colleagues wrote on a poster.
“The high rejection rates for [PCSK9 inhibitor] therapies are unprecedented and this study suggests a serious flaw in the utilization management process,” Baum and colleagues wrote. “The impact of these high denial rates on patients’ outcomes needs to be explored.” – by Erik Swain
References:
Baum SJ, et al. Abstract 1258-435.
Navar AM, et al. Featured Clinical Research III. Both presented at: American College of Cardiology Scientific Session; March 17-19, 2017; Washington, D.C.
Disclosure: Both studies were sponsored by Amgen. Baum reports speaking for Merck and receiving consultant fees/honoraria from Aegerion, Amgen, AstraZeneca, Genzyme, New Haven Pharmaceuticals and Sanofi Aventis. Navar reports no relevant financial disclosures.