CVS Health highlights potential impact of new class of cholesterol drugs

WOONSOCKET, R.I. — CVS Health weighs in on the next chapter in the debate about the impact of expensive drugs on the healthcare system in a commentary that appears today on the Health Affairs blog.



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



"With the launch of Sovaldi 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 Brennan, chief medical officer, CVS Health. "Like the hepatitis C treatments, PCSK9 inhibitors represent a significant advance in treating intractable diseases 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 they are well tolerated and highly effective in reducing low-density lipoprotein or bad cholesterol. Many believe these medicines will first be indicated for familial hypercholesterolemia, a genetic form of high cholesterol affecting approximately 620,000 Americans. Yet, there is a growing interest in additional patient subgroups where PCSK9 inhibitors may be appropriate, including for patients who are intolerant to statins, those who have more severe cases where 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 this new class of drugs once approved.



Estimates of annual pricing for PCSK9 inhibitors 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 class of drugs will eclipse initial costs of Sovaldi seen at its launch. In addition, PCSK9 inhibitors are biologics, so there will not be a simple pathway to cheaper generics for at least a decade, according to CVS Health.



"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, chief scientific officer, 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 the behalf of patients and build consensus in the health care industry around how to approach the pricing of new specialty medicines that impact large patient populations.



At CVS Health, the company approaches specialty drug cost management with a comprehensive offering of tools to manage and control rising trend while ensuring quality of care and access for patients. These include strategic price negotiations at an enterprise level combined with aggressive formulary management, exclusive networks, total patient care coordination and identifying the most effective site of care.