Many prescription claims for proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, including evolocumab and alirocumab, that are rejected can be appealed and approved by a collaborated physician team working on behalf of patients with hypercholesterolemia or heart disease, according to study results published in the Journal of Clinical Lipidology.

A team-based approach composed of a preventive team of cardiologists, nurse practitioner, physician assistant, care coordinator, pharmacist, and pharmacy technician was implemented at the Minneapolis Heart Institute. This team compiled documents required to support approvals for PCSK9 inhibitors and collaborated with an in-house pharmacy to complete both prior authorization and appeals processes.

Patients included in the study were age ≥18 years, had familial hypercholesterolemia (20.9%) and/or very high risk atherosclerotic cardiovascular disease (54.1%), had submitted ≥1 claim for a PCSK9 inhibitor, and had ≥1 direct provider visit to either a preventive cardiologist or nurse practitioner/physician assistant. The patients included in the study were also required to have had ≥1 complete lipid profile within 1 month of the visit.

The researchers stratified patients according to initial approval of pharmacy claims that were paid by the payer (71.9%) or rejection of pharmacy claims by the payer (28.1%). In addition, patients who did not purchase or retrieve their medication after approval (7.4%), who appealed after rejection (85.7%), and who were approved after appeal (100.0%) were identified.

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Of the 196 patients included in the analysis, a total of 64 were prescribed alirocumab and 132 were prescribed evolocumab. According to the final coverage decision, the majority of patients’ claims were approved (96.4%) vs rejected (3.6%). At 12 weeks, reductions were observed in low-density lipoprotein cholesterol (alirocumab, −53%; evolocumab, −65%) and total cholesterol (alirocumab, −35%; evolocumab, −44%). Four of 5 patients with existing apheresis halted apheresis therapy and relied solely on PCSK9 inhibitor treatment.

Limitations of the retrospective analysis include the small sample size as well as the inclusion of patients from a single center.

Researchers would write and submit appeals letters on behalf of patients whose claims were rejected, emulating the language of the denial letters and including relevant clinical references to promote a shared understanding.

“Given the fact that 100% of patients who appealed were ultimately approved, an initial denial should not be regarded as an absolute denial,” the researchers wrote. “Rather, patients and their health care teams should persist in seeking approval, as denials may be the result of errors in [physician assistant] review rather than an ineligible patient.”

Reference

Knickelbine T, Jia L, White SK, et al. A systematic approach for successful PCSK9 inhibitor prescribing in clinical practice. J Clin Lipidol. 2019;13(2):265-271.