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Insurers are slow to approve pricey new cholesterol drugs

Insurers are slow to approve pricey new cholesterol drugs
From Reuters - October 4, 2017

(Reuters Health) - During the first year an expensive class of new cholesterol-lowering drugs was on the market, only one in three patients with a prescription actually received the therapy due to lack of insurance approval and high copays, according to a study sponsored by a manufacturer of one such drug.

The drugs, known as PCSK9 inhibitors, are intended for use by adults whose bad low-density lipoprotein (LDL) cholesterol levels remain dangerously high even though theyre taking maximal doses of traditional cholesterol-lowering medications.

Because PCSK9 inhibitors can cost up to $14,000 per year, insurance companies usually require prior authorization and patient copays.

In the new study, the rate of insurance company approval of PCSK9 inhibitors was 47.2 percent. Ultimately, only 34.7 percent of patients prescribed the medicine ever picked it up due to its high out-of-pocket cost.

The higher the copay, the higher the rate of prescription abandonment, the study found. When the copay was more than $350, more than 75 percent of patients didnt pick up the medication.

For the analysis, published in JAMA Cardiology, researchers examined pharmacy claims data on 45,029 patients prescribed PCSK9 inhibitors in the U.S. in 2015 and 2016.

The two PCSK9 inhibitors approved in the U.S. are Praluent (alirocumab) marketed by Sanofi/Regeneron and Repatha (evolocumab) marketed by Amgen, the sponsor of the current study. Overall, this class of injectable drugs has been shown to lower LDL cholesterol levels by up to 60 percent.

Twenty percent of patients in the study received approval from their insurance provider on the first day. Of those whose prescriptions were rejected, 73.5 percent appealed or resubmitted, after which an additional 45.4 percent were approved to receive the medication.

Most of the time, PCSK9 inhibitors get denied the first time around, said lead study author Dr. Ann Marie Navar of the Duke Clinical Research Institute in Durham, North Carolina.

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