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A money-back deal for cholesterol-lowering PCSK9 inhibitors doesn’t cut costs enough, claims a new analysis from a University of Pittsburgh researcher.  The drug’s manufacturer says the numbers used to calculate her cost figures don’t reflect reality.  But the voice that’s missing from this public debate is the one that arguably has the most to lose – patients, who already struggle to access breakthrough cardiovascular therapies.

Access to PCSK9 Inhibitors

Approved by the FDA to treat patients with genetic high cholesterol and those who have already experienced a cardiac event, PCSK9 inhibitors can lower stubborn “bad” cholesterol for patients who’ve found few results with existing treatments.  But the drugs’ price point has led health plans to establish extensive prior authorization processes to limit costs.  A national IfPA health plan report card found that 43 percent of patients are denied access to the PCSK9 inhibitor their doctor prescribes.

To reduce health plans’ risk in allowing patients to take PCSK9 inhibitor, one manufacturer introduced a value-based pricing offer.  Patients who experienced a heart attack or stroke despite taking their PCSK9 inhibitor, the manufacturer agreed, would receive a rebate.  The arrangement reflects a growing interest in innovative ways to reduce health plans’ risk in allowing patients to take innovative but costly drugs.

Professor Inmaculada Hernandez, PharmD, PhD, however, argues that even with the money-back rebate in play, health plans would pay too much for the drugs.  One PCSK9 inhibitor manufacturer notes that Hernandez’s analysis cobbles together data from disparate sources and relies upon an estimated figure for the actual negotiated cost of the drug, as the exact sum is not publicly available.  Another issue is the calculated figure for cardiac events such as stroke and heart attack; Dr. Hernandez’s data point comes from clinical trials, yet the rate of cardiac events observed in the real world may be higher.

Impact on Patients

Beyond who’s right and who’s wrong is the question of who feels the impact of this analysis.  Some patients and physicians have described PCSK9 inhibitors as game-changing, even life-saving drugs.  But according to Partnership to Advance Cardiovascular Health Director Ryan Gough, blanket statements about the value of a drug don’t just make headlines – they can hurt patients by giving health plans justification to further restrict access.

“At town hall events, we hear patients describe watching family members struggle and even die from cardiac events related to high cholesterol.  Some of these patients have inherited this predisposition; they see themselves as ticking time bombs,” Gough explained.  “Yet health plans can easily seize upon data interpretations like Dr. Hernandez’s and push advanced medicine such as PCSK9 inhibitors even further from patients’ grasp.”

For more on patient access to PCSK9 inhibitors, see the Institute for Patient Access’ 2017 health plan report card series.

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