ST. PAUL, Minn., July 21, 2015 /PRNewswire/ -- The first of two cholesterol-lowering PCSK9 inhibitors (Proprotein Convertase Subtilisin/Kexin type 9) is expected to be approved by the U.S. Food and Drug Administration (FDA) as early as this week. To guide its utilization management approach of these new drugs, Prime Therapeutics LLC (Prime) analyzed its claims data and confirmed current statin treatments were not being used or adhered to as guidelines** recommend. Adherence to statins is a long-standing national problem which is well studied and documented. Not surprisingly, Prime's analysis validates there is a significant opportunity to optimize statin use even for members who may be eligible for PCSK9s.
Prime analyzed more than 3.0 million members who were commercially insured and enrolled in benefits through a Prime client continuously for four years through 2014. Of those, 1.8% had established cardiovascular disease. Prime found that only 1 in 5 of these members were using a high dose statin and were taking it regularly in 2014*, which is the recommendation of the American College of Cardiology and the American Heart Association**. In other words, 80% of people with established cardiovascular disease significantly underuse statins. Additionally, Prime found:
- 27% had no statin claim in 2014
- Of those without a statin claim or not adherent*, only 1 in 4 had tried a second statin during the 4 years
- 45% either had no statin claim or were not adherent to their prescribed statin therapy* in 2014
"PCSK9s may be an appropriate solution for our members with a rare genetic condition who are unable to lower their LDL cholesterol levels," said David Lassen, chief clinical officer at Prime. "However, for the majority of others struggling to lower their bad cholesterol levels, the best and most affordable therapy is treatment with statins, which have a long track record of safety and effectiveness. Because PCSK9s have not been proven to prevent heart attacks and their long-term safety has not yet been established, we feel compelled to help our clients optimize statin therapy prior to the initiation of PCSK9s. We believe this is the right thing to do clinically for our members and the responsible thing to do as we manage the total cost of care."
It has been widely reported that PCSK9 drugs could be priced between $7,000 and $12,000 per year. At this price point, Prime previously estimated PCSK9s could cost the U.S. health system $23.3 billion per year if broadly used by as many as 2.3 million Americans. If used by only 40 percent of the more than 600,000 Americans with a rare genetic condition leading to abnormally high cholesterol levels for which statins aren't always effective, they could still add an additional $2.1 billion per year in new costs.
When new drugs come to market, especially high-cost specialty drugs without long-term safety data, it's important that the health care industry evaluate the clinical merit, long-term safety profile and cost of the drug as part of the overall drug management strategy. With the objective of helping improve health outcomes and managing total cost of care, Prime recommends conducting a thorough review of claims history for high-risk members requesting PCSK9s to ensure every attempt has been made to optimize the use of statins before adding PCSK9s.
"At Prime, our goal is to help our members get the medicine they need to feel better and live well, while also helping keep prescriptions more affordable. Carefully reviewing prior statin use and then implementing utilization management strategies will be necessary so the appropriate high-risk patients are prescribed PCSK9s. Doing so will help keep costs for all our members within reach," said Lassen.
Prime developed a drug cost calculator that helps insurance companies and other large plan sponsors estimate how PCSK9s may affect overall costs. Visit it here.
*adherence, also known as taking medication regularly, is defined using the proportion of days covered (PDC) >/= 80%
** Stone NJ, et al. 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults. https://circ.ahajournals.org/content/early/2013/11/11/01.cir.0000437738.63853.7a.full.pdf. Accessed July 17, 2015.
About Prime Therapeutics
Prime Therapeutics LLC (Prime) helps people get the medicine they need to feel better and live well. Prime manages pharmacy benefits for health plans, employers, and government programs including Medicare and Medicaid. The company processes claims and delivers medicine to members, offering clinical services for people with complex medical conditions. Headquartered in St. Paul, Minn., Prime serves more than 26 million people. It is collectively owned by 13 Blue Cross and Blue Shield Plans, subsidiaries or affiliates of those plans. Prime has been recognized as one of the fastest-growing private companies in the nation.
For more information, visit www.primetherapeutics.com or follow @Prime_PBM on Twitter.
Contact: Karen Lyons, APR
SOURCE Prime Therapeutics