Facts and figures about first year PCKS9 use

PCKS9 utilization cost, utilization management impact and discontinuation rate among 13 million commercially insured Americans

What kind of impact did PCSK9 drugs make the first year after launch? What was the study about?

PCSK9 inhibitor drugs received a lot of press before launching in late 2015. The market expected broad uptake. The cholesterol-lowering drugs were priced at $14,000/year. However, impact on drug spend was low. Most plan sponsors used prior authorizations (PA) to help ensure use was directed to those most likely to benefit.

PCSK9 inhibitor drugs are a new class of cholesterol-lowering drugs. They help people improve their low-density lipoprotein (LDL), or “bad” cholesterol”. Praluent® (alirocumab) and Repatha® (evolocumab), the first two PCKS9s, launched in July and August 2015 respectively. Pre-launch, these drugs got a lot of press for their cholesterol-lowering ability.

More than 35 million Americans have cholesterol levels of 240 mg/dL or higher.¹ This puts them at higher risk for heart disease. PCKS9s were priced at about $14,000 per person per year, giving this drug class a huge potential market. Cost impact was expected to be very high, even though long-term data was not available. Statins have been treating high cholesterol successfully for decades with a long safety and outcomes history; statins cost just pennies a day.

The PCKS9 drugs were approved to treat patients with:

• Two rare genetic anomalies:
  • Heterozygous familial hypercholesterolemia (HeFH)
  • Homozygous familial hypercholesterolemia (HoFH)
• Atherosclerotic cardiovascular disease (ASVCD) who need their LDL lowered further after a statin therapy trial

This study looked at claims results from drugs’ launch through the end of February 2016.

What did we learn?

Uptake for the two new drugs was slower than expected. It started at 0.02 members per 100,000 in August 2015 and ended at 1.6 members per 100,000 in February 2016. More than 86 percent of members submitting a PCKS9 claim had a clinical prior authorization (PA) rejection.

Methods

We looked at claims from an average of 13.1 million commercial members at Blue Plans across the country. Health plan sponsors implemented PA requiring diagnosis confirmation and statin prior use or intolerance with continued elevated LDL cholesterol.

Results

2,143 (16 per 100,000) members submitted a PCKS9 claim during the study period. Of those, 296 members had 771 final paid PCKS9 claims during the study period. Two thirds of the final paid claims were written by cardiologists and endocrinologists. This means that one third of the paid claims came from members that had not seen a cardiologist before being prescribed this specialty medication.

The high percentage of members with rejected PCKS9 claims may not have had adequate trials of more cost-effective statin therapies.

When we followed members on PCKS9 treatment over a 90-day period, 21 percent of them discontinued the drug. This is twice the discontinuation rate reported in the manufacturer prescribing information.

Conclusions

PCKS9 utilization was predicted to be 112 commercial members per 100,000 one year post launch with UM. As of Jan. 1, 2016, the actual rate was 1.2 members per 100,000. This looks to be trending up, but is much lower than projected.

What does this mean for you?

A high rate of claim rejections of PCKS9 drugs may point to an opportunity for both member and prescriber education. Previous research has shown that 80 percent of people with established cardiovascular disease significantly underuse statins:²

• Only 1 in 5 were using a high dose statin and taking it regularly.
• Only 1 in 4 had tried a second statin in the past 4 years.
• 1 in 4 had no statin claim at all in the last year.²

Prime’s analysis shows that optimizing the use of statins before adding PCKS9s is the right thing to do.

GuidedHealth® has targeted, outreach and adherence programs to improve statin use. Prime can work with a plan sponsor’s provider relations group to support broader use of ePrescribe and ePA. These tools speed up turnaround of UM review, and are designed to improve safety and accuracy.

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References

1. American Heart Association. Heart Disease and Stroke Statistics—2010 Update. Available on the American Heart Association Web site.
2. Bowen, KL, Gleason, PP, Statin therapy, intensity, adherence and number of distinct statins tried among commercially insured adults with atherosclerotic cardiovascular disease continuously enrolled before and after 2013 ACC/AHA cholesterol guideline. October 2015. AMCP Orlando, FL. Accessed at: https://www.primetherapeutics.com/content/dam/corporate/Documents/Newsroom/PrimeInsights/2015/posters/1015fall-statin-therapy.pdf

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