UnitedHealth's Oxford Group Picks Praluent As First-Line PCSK9
This article was originally published in Scrip
The battle for US health insurance reimbursement of the roughly $14,000 annual cost of PCSK9 inhibitors continues with Oxford Health Plans, a UnitedHealthcare company, making Praluent (alirocumab) from Regeneron Pharmaceuticals and Sanofi its first choice for lowering LDL cholesterol beyond what's possible with generic statins.
While the pharmacy benefit manager (PBM) Express Scripts chose to cover Praluent as well as Amgen's competing therapy Repatha (evolocumab), the PBM CVS/Caremark chose Repatha over the Regeneron/Sanofi monoclonal antibody. While UnitedHealthcare, like Express Scripts and CVS/Caremark, is one of the largest private payers covering pharma products in the US, the Oxford decision this month favoring Praluent applies only to patients in New York, New Jersey and Connecticut with atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH).
The US FDA approved Praluent in July and Repatha in August to treat ASCVD patients who cannot tolerate statins or who cannot meet cholesterol-lowering goals on statins alone, or for the treatment of patients with HeFH, a rare genetic condition that causes extremely high LDL levels. Express Scripts and CVS/Caremark revealed their reimbursement decisions for the biologics in October and November, respectively.
Oxford will reimburse the cost of Praluent to the exclusion of Repatha, unless patients cannot tolerate Praluent or they do not respond to the Regeneron and Sanofi therapy after 12 weeks. The coverage decision will be implemented on Jan. 1.
Regeneron/Sanofi and Amgen – as well their investors – have blockbuster hopes for the first two PCSK9 inhibitors on the market, since several million people cannot achieve recommended LDL cholesterol levels by taking mainstay drugs like statins and Merck & Co. Inc.'s cholesterol absorption inhibitor Zetia (ezetimibe).
But while Praluent and Repatha have shown greater cholesterol-lowering effects than their oral predecessors for several thousand patients who participated in large Phase II and III clinical trial programs, analysts covering Regeneron, Sanofi and Amgen – and the companies themselves – have warned that it will take a while for PCSK9 inhibitors to build momentum in the absence of cardiovascular outcomes data that are expected in the second half of 2016 for Repatha and in 2017 for Praluent. The data could support approvals of broader labels for the therapies and better reimbursement from US payers.
Datamonitor Healthcare noted in an October analysis of Praluent's potential that reimbursement of the Regeneron and Sanofi therapy will be limited to high-risk patients due to the high $14,600 annual cost.
"Insurance companies are expected to enforce strict protocols to ensure that patients have tried every other option available to them before moving on to this type of therapy," Datamonitor's analysis said, noting that uptake should be strong in the high-risk population due to Praluent's high efficacy and relative safety in the Phase III ODYSSEY clinical trial program.
"Positive [cardiovascular] outcomes data will therefore be central to Praluent's commercial and clinical success in the wider, more commercially lucrative, dyslipidemia population," according to Datamonitor.
Repatha was approved in the EU in July, followed by Praluent in September.