New Data Spark Debate on Cost and Value of Breakthrough Cholesterol Meds

August 30, 2016

A new analysis calls for drastic price reductions for PCSK9 inhibitors, breakthrough lipid-lowering medications. Data published in the Journal of the American Medical Association suggest that the treatments would need to be reduced to two-thirds their current price to meet analysts’ cost-effectiveness thresholds.

But critics say the analysis drastically overestimates the number of patients who receive the treatment – and overlooks the individual value of these treatments for patients whose high cholesterol is not adequately controlled by traditional statins.

Cost-effectiveness Data

Researchers at the University of California, San Francisco found that adding PCSK9 inhibitors to statin regimens for certain patients could prevent roughly 4.6 million major cardiovascular adverse events.   But the price per quality-adjusted life year – and the overall impact on health care spending – led analysts to declare that the medication is not cost-effective. The opinion echoes an analysis of PCSK9 inhibitors earlier this year by the Institute for Clinical and Economic Review, which recommended reducing the medications’ prices by 67 percent.

Analysis Shortcomings

Some stakeholders points out, however, that analysts’ number don’t reflect reality. Estimates of PCSK9 inhibitors’ impact on health care spending assume that all patients eligible under the Food and Drug Administration’s indications would actually take the treatments. In reality, about two-thirds of patients are denied access to PCSK9 inhibitors – due largely to health plans’ aggressive prior authorization processes. Thus, while researchers estimate that use of PCSK9 inhibitors could cost $120 billion over five years, projected sales of the medications by 2020 are $4.5 billion.

Impact on Patient Access

The study’s senior author, Kristen Bibbins-Domingo, MD, explained to Medscape that, “Our study does not address whether one should prescribe these medications. The evidence suggests these drugs are highly effective at lowering LDL cholesterol and thus are potentially very important therapeutics for many people.” Yet cost-effectiveness data may well exacerbate the access barriersthat already plague patients.

Several health plans have implemented extensive prior authorization and re-authorization processes for PCSK9 inhibitors, some of which include step therapy or “fail first” requirements. Express Scripts, for example, introduced last year its Cholesterol Care Value Program, which requires extensive documentation to make sure that only the “right patients” receive the breakthrough treatments. The company’s vice president later reported that the company and insurers had rejected “a surprisingly high number of prescriptions” for PCSK9 inhibitors.

As a preventive cardiologist and cholesterol expert, Seth Baum, MD, explained, “Inaccurate and misleading data are shaping a false narrative about PCSK9 inhibitors’ impact on health care spending.  The real story is this: Patients who need these treatments and who qualify for them under the FDA’s indication are being inappropriately denied coverage by health plans that prioritize budget goals over patient health. The patient-doctor relationship is being undermined by those who care more about the bottom line than our patients’ well-being.”

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