CVS Health Corp., one of the most popular pharmaceutical distributors that cater to both employers and insurers in the US, wants experts to rewrite the current guideline for the treatment of cardiovascular and cholesterol-related conditions. The said move was made following the approval of new and costly drugs for the treatment of high cholesterol.
The US Food and Drug Administration (FDA) approved alirocumab (Praluent) on July 25, 2015. The said drug is a proprotein convertase subtilisin/kexin type 9 (PCSK-9) inhibitor, which is a highly-effective drug that can decrease the levels of low-density lipoprotein cholesterol (LDL-C) as per initial clinical findings. Another drug called Repatha, which may be prescribed together with Praluent for enhanced efficacy, is expected to be approved in the near future. Both drugs come in injectable forms and are said to be more effective than the widely-used statins. More data about these drugs are expected from studies, but at present, it has already exhibited an innovation in the treatment of hyperlipidemia or increased cholesterol.
With the seemingly potent features of the drug class, the medications carry with it a higher price tag. This creates a new dilemma for health care payers as approximately 32 percent or more than 73 million individuals in the US have elevated LDL-C. CVS says the drug is a new class of expensive medication that targets a very common medical condition.
Praluent and Repatha are expected to retail at around $15,000 per year. This is way more expensive than statins, which may be availed in generic form that costs about $50 per month. If the three medications would be administered to patients, cholesterol levels may decrease by up to 60 percent compared to a treatment regimen that involves statins alone.
With this, CVS says that the best treatment option is to give low-cost statins instead of PCSK-9 inhibitors to patients. However, this may not be possible with the latest alterations made in the guidelines of hyperlipidemia treatment. In 2013, the American College of Cardiology and American Heart Association (ACC/AHA) released the modified guideline for cholesterol management, which basically changed the standards involved in prescribing medications and in the process, inhibits the consumers from using the fundamental measures. According to the letter of CVS regarding the said appeal, published in the Journal of the American Medical Association, the authors may not have foreseen the present challenge while they were making the guideline in 2013.
"The current cholesterol management guidelines do not provide clarity as to how these expensive new medications could fit in the treatment paradigm, potentially resulting in some scenarios where a prescriber could consider a PCSK9 inhibitor for a low-risk patient," says Dr. William Shrank, chief scientific officer at CVS.
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