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A recent Trump administration decision nudges health plans to do right by patients who struggle with high LDL, or “bad,” cholesterol.  

Beginning in 2020, cholesterol-lowering PCSK9 inhibitors will no longer qualify as specialty tier drugs, according to the Centers for Medicare and Medicaid Services.  The announcement could reduce what patients pay out of pocket for the medication, making treatment more accessible for those at risk for heart attack, stroke or cardiovascular-related death.

The specialty tier is the highest category a health plan uses in organizing prescription drug coverage.  The tier is often reserved for highly specialized drugs that serve a small patient population, and it typically asks a significant out-of-pocket payment from patients.  Instead of the flat co-pay required for insurer-preferred or generic medications on the lower tiers, specialty tier drugs require co-insurance – a portion of the drug’s list price.  Co-insurance on specialty tier medications can be upward of 30% of a drug’s price – more than many seniors on fixed, modest incomes can pay.  

The high cost sharing denies access to the potentially lifesaving treatment for these patients.  With CMS’ announcement, however, Medicare patients could soon have access to the drugs at “lower cost tiers,” CMS Administrator Seema Verma explained.

Patient advocacy organizations like the Partnership to Advance Cardiovascular Health have urged CMS to see the effort through.  “We are concerned that though PCSK9i therapy may be placed on a lower tier, out-of-pocket costs to the patient will remain high, or possibly, even higher than they were when the therapy was placed on specialty tier,” the organization’s executive director noted in a letter to CMS, adding, “. ..Tiering of a medication is of little consequence to America’s seniors if they aren’t realizing a lower out-of-pocket cost for these heart attack and stroke-preventing medications.”

Accessible PCSK9 inhibitors have been a long time coming.  Since the drugs debuted, insurers have restricted access through prior authorization and specialty tier placement.  Last year, manufacturers slashed their prices by 60%, a move hailed for expanding access.  Now, CMS’ announcement presents an opportunity for health plans to do their part by covering the life-saving drugs on a tier that’s affordable for more patients.

The stakes are high.  PCSK9 inhibitors can reduce the risk of heart attack, stroke and cardiovascular disease by lowering stubborn LDL cholesterol by up approximately 60%.  This is especially important for people with familial hypercholesterolemia, or FH, who struggle to control their genetically high cholesterol.  Recent research shows that high-risk patients who cannot access prescribed PCSK9 inhibitors have a 16-21% increased risk of a cardiovascular event such as a heart attack or stroke.

*Blog post updated on October 10, 2019

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