Study models way to optimize cholesterol drug value

With the introduction of cholesterol-lowering PCSK9 inhibitors, health plans are looking for ways to best lower the incidence of atherosclerotic cardiovascular disease (ASCVD) in their insured population, as well as strategies for optimizing use of statins, including the PCSK9 drug therapies.

Prime Therapeutics conducted a study to help inform modeling around the value of using the new PCSK9 drug therapies. The data will be presented at a poster session at the Academy of Managed Care Pharmacy (AMCP) conference.

Bowen

Kevin Bowen, MD, MBA, senior health outcomes researcher at Prime, and other researchers followed a cohort of 5,713,158 commercially insured members ages 18 to 74 years who were continuously enrolled from January 1, 2012 through December 31, 2014 to identify the incidence of coronary heart disease (CHD) events.

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These members were assigned to one of three categories based on their 2011 claims: 1) ASCVD, 2) diabetic and ages 40 to 74 years without ASCVD, and 3) all others. Members in each of these three categories were further divided into two subcategories: 1) those with a statin claim in 2011, and 2) those without a statin claim in 2011. According to the researchers, using statin therapy as an indicator of cardiovascular risk is a more complete way to assess than basing on a claim alone.

For each of the six categories, Prime studied the occurrence of CHD events during, and up to, three years of follow-up. The incremental medical plus pharmacy claims cost associated with a member’s first CHD event during follow-up was estimated as the difference between the member’s baseline claims expense and expense in the 60 days before and 120 days after their CHD event.

“Members who can be identified from claims data as having ASCVD, including those not receiving statin therapy, have a much higher risk of experiencing CHD events than those who do not have claims indicating an established diagnosis of ASCVD,” according to Bowen, adjunct assistant professor, College of Pharmacy, University of Minnesota.

Approximately 10% of the analyzed commercially-insured member population with ASCVD had a CHD event over the three-year time period from January 1, 2012 to December 31, 2014. This compares to:

• Approximately 2.5% of members with diabetes but without ASCVD;

• Approximately 1.4% of members on a statin but without diabetes or ASCVD; and

• Approximately 0.4% of all other members.

Members with ASCVD made up 2% of the adults in the study sample but accounted for almost 30% of all CHD events and 29.5% of members with ASCVD had no statin therapy during 2011.

The medical and pharmacy cost associated with a CHD event was $56,233 (includes 30 to 60 days before and up to 180 days after the event).

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“There is significant cost is associated with having a CHD event. The frequency of these events may be reduced with appropriate prescription of and adherence to statin therapy,” says Bowen. “This estimated frequency and cost of CHD events can be used to model the value of new cholesterol-lowering drugs known as PCSK9 inhibitors as compared to other established treatments. These new PCSK9 inhibitors are priced at more than $14,000 per year, whereas statins are available at generic prices of less than $250 a year.”

The results of this type of value modeling can help health plans determine how to get members the most appropriate medicines as well as decide what care management programs are needed to help members who are not receiving appropriate statin therapy, according to Bowen.

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“This study can help inform decisions about utilization management of these very expensive new drugs, as well as investments in care management programs,” he says. “The goal of the study was to address gaps in care or medication adherence problems that result in members not receiving the cholesterol lowering therapy recommended by the 2013 American College of Cardiology [ACC] and American Heart Association [AHA] cholesterol guidelines.”

Based on this study, Bowen offers five takeaways:

• 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.

• Statins are known to work, known to prevent heart attacks and cost less than PCSK9 inhibitors, yet four out of five members studied don’t adhere to their prescribed statins, which is consistent with national trends.

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

• Improving use of statin therapy by members who do not have diagnosed ASCVD but who have high cholesterol should also be a high priority goal for managed care plans.