Six barriers to prescribing PCSK9 inhibitors


A National Lipid Association survey has interesting findings on the prescription approval process for PCSK9 inhibitors.

When it comes to proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor therapy, providers are following the appropriate clinical steps before they prescribe a PCSK9 inhibitor, but patients still are denied this treatment, according to results of a survey published in the Journal of Clinical Lipidology.

Recent findings from clinical trials have shown PCSK9 therapy lowers LDL-cholesterol in addition to lowering atherosclerotic cardiovascular disease (ASCVD) events. In 2016, the NLA conducted an online survey to assess the barriers and challenges experienced in the PCSK9 inhibitor prescription approval process.

The survey and the analysis of the findings sought to identify barriers facing providers and practice personnel in prescribing PCSK9 inhibitor therapy. Between August 26 and October 14, 2016, the National Lipid Association (NLA) conducted a 170-question online survey among experienced healthcare workers who provide care to high-risk patients with ASCVD or familial hypercholesterolemia (FH). The NLA had full control and input in the creation of the survey. The survey was sent to all NLA members, and included the opportunity to refer other colleagues to the survey. The survey was distributed to other relevant medical societies, including the American College of Cardiology, Preventive Cardiovascular Nurses Association, and American Society for Preventive Cardiology. All respondents participated on a voluntary basis. The survey received a response from 434 healthcare workers, a high percentage of which were certified in clinical lipidology.

The results of the survey show several important barriers to PCSK9 inhibitor prescription approval. These barriers include:

  • Formulary or plan exclusion 

  • Inadequate documentation of maximally tolerated statin dose,

  • Inconsistent applicability of diagnostic criteria for familial hypercholesterolemia

  • Unclear requirement of number of statins failed if statin intolerant,

  • Current LDL-C levels, and

  • Administrative burden (time, staff, paperwork, and appeals)

“Barriers more difficult to overcome include perceived higher LDL-C threshold requirements by payers, and drug costs,” says Peter Jones, MD, NLA chief science officer.

Among the providers with good approval rates, results showed the best solutions include (1) improved documentation, which is aided by checklists before submitting prior authorizations, (2) increased staff support and training in the approval process and (3) overall experience with the process.

The study also helps to identify multiple tools that enable enhanced efficiency in the approval process, according to the study authors. These include improved documentation of the underlying disease (ASCVD or familial hypercholesterolemia); maintenance of documentation of recent lipid levels; and adequate documentation of patients’ statin prescription history (if statin intolerant).


“Additional analysis of the survey data shows that practitioners spend on average two hours on approval processes due to frequent initial denials, paperwork as well as extra phone calls to insurers, all for patients that clearly meet appropriate use criteria,” says Jerome Cohen, MD, the study’s corresponding author and chair of the NLA Health Quality and Research Committee.

This study findings are both pertinent and relevant to managed care executives, according to James Underberg, MD, NLA president. “The survey sampled experienced providers struggling to get appropriate patients access to a new therapy,” Underberg says. “Analysis of the data demonstrates that providers are following the appropriate clinical steps before prescribing a PCSK9 inhibitor, yet patients are still being denied access.”

Furthermore, the study showed that there is a difference in lipid thresholds utilized by providers when initiating PCSK9 inhibitor therapy versus what the respondent experienced during the approval process, according to Alan Brown, MD, NLA president-elect.

“This difference in low-density lipoprotein cholesterol [LDL-C] threshold indicates a possible disconnect between clinical criteria utilized by providers and payers,” Brown says.





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