Value of Praluent, Repatha Differs by Patient Population

A new systematic review comparing the strength of evidence for the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors alirocumab and evolocumab shows stronger evidence for alirocumab for patients at high cardiovascular risk who have not reached low-density lipoprotein cholesterol (LDL-C) target goals with statin therapy. Evidence for evolocumab, however, is stronger for patients with heterogeneous familial hypercholesterolemia and patients with varied cardiovascular risk not at LDL-C target goals.

Researchers published their findings in the Journal of Managed Care & Specialty Pharmacy.

“Alirocumab (Praluent) and evolocumab (Repatha) have shown striking LDL-C reductions over 10 to 78 weeks (26% - 67%). But, as with many novel specialty drugs, the promise of better results with PCSK9 inhibitors comes with a high price tag—in this case, the cost is estimated at more than $14,000 per patient per year,” wrote researchers from Oregon Health & Science University. “In this cost-conscious era of health care, clinicians, payers, and the public are already questioning how to best manage this costly new drug class.”

The review included 17 trials, although none directly compared the 2 PCSK9 inhibitors.

Researchers reported strong evidence that alirocumab lowers lipids significantly but identified no evidence of a benefit in cardiovascular outcomes when looking at adjudicated cardiovascular events and a priori analyses. Evolocumab’s evidence regarding cardiovascular events was insufficient to draw conclusions, according to the review.

In addition to patients with heterogeneous familial hypercholesterolemia and patients with varied cardiovascular risk, evolocumab showed evidence for patients with homozygous familial hypercholesterolemia, populations of patients with varied cardiovascular risk, and follow-up studies of varied populations, researchers wrote.

“Unfortunately, the evidence for the long-term health benefits and harms of the PCSK9 inhibitors alirocumab and evolocumab is insufficient to draw conclusions at this time, mainly because of limited or no information on the long-term impact of the large reductions in LDL-C,” researchers wrote. “The current evidence on health outcomes such as cardiovascular events is limited because these studies reported them as secondary outcomes and were not designed to assess cardiovascular events.”

The study concluded with a call for more research to assess cardiovascular and potential harm outcomes.—Jolynn Tumolo

Reference

McDonagh M, Peterson K, Holzhammer B, Fazio S. A systematic review of PCSK9 inhibitors alirocumab and evolocumab. Journal of Managed Care & Specialty Pharmacy. 2016;22:641-653q.