June 22, 2015 – Curant Health COO, Marc O’Connor, in MedCity News  $1,000 per month for life cholesterol drugs brings immense pressure on prescribers to ensure outstanding medication adherence by patients.

The pharmaceutical industry is about to wade into a new battlefield with payers and prescribers. A new class of drugs known as PCSK9 inhibitors restricts a protein that impedes the liver’s ability to get rid of bad cholesterol. FDA approval of the first in this new class of drugs is expected within months if not sooner. The implications for improving the lives of the millions of Americans affected by heart disease is significant. And the prospective cost to payers and plan sponsors could be astronomical.

Cholesterol issues in the United States are widespread, as the prevalence of familial hypercholesterolemia is 1 in 500 according to the latest NIH data. Moreover, there are 71 million people with high cholesterol and heart disease is still a leading killer.

PCSK9s could become the industry’s biggest-selling new drug by a staggering amount. As many as 3.5 million Americans may qualify for the drugs carrying annual treatment costs between $7,000 and $12,000 per patient. PCSK9 inhibitors could place an unprecedented burden of around $150 billion on the health system, according to an article published inHealth Affairs earlier this year.

PCSK9 products are self-injectable biologics intended for patients with serious cholesterol control issues for whom statins are intolerable or ineffective. With prospective $1,000 per-month for the rest of your life price tags, and a more difficult path to generic as a biologic, payer pressure on clinicians to have their patients exhibit outstanding adherence to realize the drugs’ full value will be immense.

Medication nonadherence is already a massive cause of wasted healthcare spending. The World Health Organization estimates medication nonadherence among chronically ill patients is 50 percent. And a recent IMS Health report estimates $105 billion in avoidable healthcare expenditures is directly attributable to nonadherence.

Understandably, payers are highly concerned about growth in development, cost, prescription of and adherence to new specialty therapies. In 2014, sales of Gilead’s curative Hepatitis C drug Sovaldi totalled $10.3 billion according to the manufacturer. But unlike Sovaldi and its more recently approved ‘cousin’ Harvoni, PCSK9 therapies are not curative. They do not have a 12 week course that ends with a cure. Patients could require them for decades. Moreover, there are approximately 1.5 million Americans with Hepatitis C. More than double that number (3.5 million) may qualify for PCSK9 drugs.

As I wrote previously for Medcity News, medication therapy management has the ability to reduce U.S. prescription drug spending keeping the patient front and center. And in the ongoing shift towards value-based care, we must all endeavor to positively affect both sides of the value equation: outcomes and costs. These, combined with candid discussions about pricing among all concerned prior to FDA approval can make every looming battle over new, high cost pharmaceutical therapies less painful, and less costly.

Marc O’Connor

Marc O’Connor is chief operating officer of Curant Health, a medication therapy management firm focused on improving outcomes for people living with chronic diseases including HIV, Hepatitis C, rheumatoid arthritis, diabetes and more. He is a member of the board of directors of Team Type 1 Foundation which is focused on increasing awareness and support for Type 1 diabetic patients around the world. On LinkedIn

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