Trials Data Strengthens Patients’ Demands for Breakthrough Cholesterol Meds

New data on PCSK9 inhibitors is in – and it may bolster patients’ demands for the breakthrough cholesterol drugs in the face of health plan coverage barriers.

In clinical trials of more than 27,000 patients, treatment with a PCSK9 inhibitor lowered cardiovascular risks such as heart attack and stroke.  Outcomes materialized even in patients who were taking the optimal level of statins, traditional cholesterol medications.  Patients in the clinical trials used the PCSK9 inhibitor evolocumab.

Up until now, studies have shown that the treatments lowered LDL cholesterol levels more than traditional statins do. But only these newest results have definitively linked the drugs to improved outcomes such as lowered stroke risk.  In a public statement, the drug’s manufacturer reported that the results “show unequivocally the connection between lowering LDL cholesterol with [evolocumab] and cardiovascular risk reduction.”

The results could lead the Food and Drug Administration to expand the approved uses of the drug, according to Politico PRO.

The therapy’s impact comes at a cost. PCSK9 inhibitors’ price before discounts and rebates is significantly more than the price of statins, which exist in generic form.  Thus, health insurers have blocked patients’ access to PCSK9 inhibitors through prior authorization requirements – or by excluding the treatments from their formularies.  As reported by The New York Times, insurers reject 80-90 percent of claims for PCSK9 inhibitors.

Cost-driven coverage denials frustrate physicians and patients alike.  For patients who are genetically predisposed and have extremely high LDL cholesterol, statins alone may not adequately shield them from heart attack or stroke.  Thus, PCSK9 inhibitor coverage denials may well stand between them and the promise of a safer, healthier life.

As cardiologist Seth Baum, MD, explained in a guest blog post for the Institute for Patient Access, “…the PCSK9 inhibitor conundrum demands that we consider a cost factor that analysts and researchers often overlook: What is the cost, and the value, of a life? How do we measure this intangible and all-important metric?”

Advocates hope that new data can help drive this point home – and reduce the barriers between patients and significantly reduced cardiovascular risks.

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