Overcoming Barriers to PCSK9 Prescriptions and Initial Denials


Although providers might turn to PCSK9 inhibitors to treat patients at risk for atherosclerotic cardiovascular disease or familial hypercholesterolemia for whom statins do not work, the initial denial rate for this therapy can be very high.

Statin therapy is typically prescribed to lower the risk of atherosclerotic cardiovascular disease (ASCVD), but some patients have an insufficient clinical response or statin intolerance. That’s where PCSK9 therapy comes in handy: in addition to lowering low-density lipoprotein cholesterol (LDL-C), PCSK9s have been shown to reduce ASCVD events.

However, a 2016 survey by the National Lipid Association found that 434 respondent healthcare workers faced a rate of initial denial of PCSK9 inhibitors above 85%. Of the respondents, 70% said that up to one-fourth of their high-risk patients have an intolerance to statins and they were unable to reach their LDL-C goals.

“The survey results confirm there is a common problem with denials of PCSK9 inhibitors,” author Jerome Cohen, MD, professor emeritus at St. Louis University, said in a statement. “There are opportunities for providers to improve the initial denial rate. We’ve created a checklist based on results of the survey for healthcare providers to follow when seeking approval.”

Currently, providers are not quick to prescribe PCKS9s, the survey found. The results showed that 71.4% opted for a PCSK9 as a third line of action following statins and adjunctive therapies. Providers are more likely to attempt to prescribe a PCSK9 inhibitor for a patient with familial hypercholesterolemia (FH) than for patients with ASCVD. Providers prescribing PCSK9s for FH had a lower denial rate. About one-fourth reported denial rates of more than 75% for patients with FH, while one-third reported the same denial rate for patients with ASCVD.

The barriers to PCSK9 inhibitor prescription approval can be overcome with “adequate documentation and persistence,” according to the authors. Documentation is one of the biggest barriers, as respondents said deficient documentation was often associated with the PCSK9 prescription being denied. However, a reapplication with adequate documentation usually results in approval, the authors wrote.

They included a checklist for PCSK9 inhibitor approval applications:

  • Indication or documentation of medical conditions (ASCVD or FH)
  • Statin use history
  • Failure to achieve LDL-C goal despite maximally tolerated statin therapy
  • Documentation of adjunctive lipid-lowering therapy
  • A recent lipid panel (less than 30 days old)

“The findings of this survey will help healthcare providers who take care of high-risk lipid patients gain approval for this new effective PCSK9 inhibitor drug class,” Cohen said. “Our findings are significant in that they showed us there are a number things that healthcare providers can do (to get PCSK9 inhibitor prescriptions approved), which is really paying close attention to documentation of the patient’s clinical history. That includes documentation of the underlying disease, ASCVD or FH, documentation of recent lipid levels and documentation of the trial of statin therapy.”

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