Study: Members not following updated statin therapy guidelines

Prime Therapeutics conducted a study to estimate how many commercial members have ASCVD, but are not being treated with high-intensity statin therapy, as recommended in the 2013 ACC/AHA cholesterol guidelines. View the results.

The American College of Cardiology (ACC) and American Heart Association (AHA) updated guidelines for treatment of blood cholesterol in 2013. The updated guidelines recommend treating most patients younger than 75 years old with established atherosclerotic cardiovascular disease (ASCVD) with a high-intensity statin.

Prime Therapeutics conducted a study to estimate how many commercial members have ASCVD, but are not being treated with high-intensity statin therapy, as recommended in the 2013 ACC/AHA cholesterol guidelines. The results will be presented in a poster session at the Academy of Managed Care Pharmacy (AMCP) in Orlando.


Two drugs were recently approved from a new class of drugs, PCSK9 inhibitors, which decrease low-density lipoprotein cholesterol (LDL-C). As the FDA label indicates, they are approved to use in addition to statins to treat adults with ASCVD as who require additional lowering of LDL-C. These new drugs are priced at more than $14,000 a year and people would need to take them for the rest of their life.

The study findings

The Prime Therapeutics study looked at statin use among more than 3 million commercially insured members aged 18 to 74 years who were continuously enrolled from January 2011 through December 2014 and had claims that indicated that they had established ASCVD.

Related:High cost of new PCSK9 inhibitors could plague payers

Prime assigned intensity of therapy based on statin, dose, days supply and quantity dispensed by determining when a member’s last statin claim occurred each calendar year. Statin therapy intensity was categorized in the 2013 ACC/AHA cholesterol guidelines. Adherence to therapy was defined as the proportion of days covered greater than or equal to 80%.

Prime found that both the use of any high-intensity therapy and the fraction of members adhering to statin therapy increased a small amount after the new guidelines were released. However, in 2014:

  • Only about 30% of these members with ASCVD had filled a prescription for high intensity statin therapy and of these, only 66% were adherent to their statin therapy (adherent is defined as proportion of days covered being 80% or more).

  • Approximately 40% of members with ASCVD filled a prescription for moderate or low-intensity statin therapy, and almost 30% had no pharmacy claims for a statin.


Following the old guidelines of treating to LDL-C goals, some members with ASCVD may not have received a statin because they met the LDL-C goal, according to Kevin Bowen, MD, MBA, senior health outcomes researcher, at Prime, who will be presenting the study at the AMCP conference. “Whereas, the updated guidelines recommend most individuals with ASCVD should be receiving high-intensity statin treatment,” he says.


NEXT: Three takaways on PCSK9 inhibitors


“PSCK9 inhibitors’ long-term health outcomes and effectiveness of lowering cardiac events have yet to be shown,” says Bowen, adjunct assistant professor, College of Pharmacy, University of Minnesota. “However, statins have known long-term safety and efficacy. We recommend health plans encourage maximizing statin therapy prior to PCSK9 inhibitor use to help the right people get on the right medicines and save money.”

Related:New cholesterol-lowering drugs draw attention

Consistent with national trends, Prime saw gaps in care and/or poor statin medication adherence. To help improve statin adherence, Prime recommends developing care management programs that specifically address ASCVD members that are non-adherent to high-intensity statin therapy.

Bowen offers three takeways:

  • PCSK9 inhibitors are a very expensive, new category of drugs that provide a way to treat individuals with, genetic abnormalities (homozygous or heterozygous familial hypercholesterolemia) that prevent sufficient cholesterol lowering by statin therapy.

  • With further study, PCSK9 inhibitors may prove to be a safe and effective addition to statin therapy for individuals at very high cardiovascular risk.

  • Optimizing statin therapy for members who can be identified as having diagnosed ASCVD should be a very high priority goal for managed care plans.