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CVS Concerned About Potential Impact of New Cholesterol Drugs on Health Care System

Company calls for cost-control measures

CVS Health has weighed in on the next chapter in the debate about the effect of expensive drugs on the health care system in a commentary published on the Health Affairs blog.

Currently in development, proprotein convertase subtilisin/kexin 9 (PCSK9) enzyme inhibitors could successfully treat millions of Americans with high cholesterol, but at great cost to the health care system, according to the authors. The real challenge is not the cost per dose, they say, but the large eligible patient population and the duration of chronic treatment, which could span decades.

“With the launch of Sovaldi [sofosbuvir, Gilead] to treat hepatitis C in 2013, we saw a first glimpse of the impact of high-priced specialty drugs that serve patient populations in the millions –– but that was just the tip of the iceberg,” said Troyen A. Brennan, MD, Chief Medical Officer at CVS Health. “Like the hepatitis C treatments, PCSK9 inhibitors represent a significant advance in treating intractable diseases. They are convenient and highly effective with few side effects, but they also pose a much more complex financial dilemma since, unlike the hepatitis C treatments, which offer a cure in as little as 12 weeks, PCSK9 inhibitors will be prescribed as ongoing maintenance therapy for the duration of patients’ lives.”

Several pharmaceutical manufacturers are currently developing PCSK9 inhibitors, which are projected to gain FDA approval by mid-2015. Injected once or twice a month, evidence from clinical trials suggests that they are well-tolerated and highly effective in reducing low-density lipoprotein cholesterol, or “bad” cholesterol.

Many experts believe these medications will first be indicated for familial hypercholesterolemia, a genetic form of high cholesterol affecting approximately 620,000 Americans. There is a growing interest, however, in additional patient subgroups for which PCSK9 inhibitors may be appropriate, including patients who are intolerant to statins, those who have more severe cases in which statins are not effective, and those with a history of coronary artery disease. As a result, as many as 15 million Americans could eventually be considered candidates for treatment with PCSK9 inhibitors once they have been approved, the authors say.

Estimates of annual pricing for these new drugs are in the range of $7,000 to $12,000. Even if PCSK9 inhibitors are indicated for a very narrow patient population, cost estimates show that this new drug class will eclipse the initial costs of Sovaldi seen at its launch. In addition, the authors point out that PCSK9 inhibitors are biologics, so there will not be a simple pathway to cheaper generics for at least a decade.

“High cholesterol is one of the most prevalent conditions in the developed world, and with primary prevention of high cholesterol as the eventual target for manufacturers, PCSK9 inhibitors will likely be the highest-selling class of medications in history,” added William Shrank, MD, Chief Scientific Officer at CVS Health and co-author of the blog post. “With a robust pipeline of expensive specialty drugs, this is just the beginning, and the resilience and ability of our health care system to absorb such high costs will be tested if rigid cost control mechanisms are not put in place.”

The authors suggest that careful managed-care oversight and compliance with clinical guidelines will be paramount to helping control health care costs once these drugs are approved. They also note that, ideally, this new class of drugs should spur discussion about the use of scarce resources on behalf of patients and should build consensus in the health care industry around how to approach the pricing of new specialty medicines that affect large patient populations.

Source: CVS Health; February 17, 2015.

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