June 19, 2017 – Big Pharma, insurers, and doctors engage debate over efficacy and cost; meanwhile, patients struggle to access to an expensive new class of cholesterol drugs.

Sumathi Reddy writing in the The Wall Street Journal offers a fascinating look at the tangled moral issues involved in securing patient access to ever more expensive drugs. The drugs in question—Praluent and Repatha—are the only two PCSK9 inhibitors on the market. Introduced in 2015 to reduce levels of LDL (bad) cholesterol, the drugs each cost over $14,000 a year.

Some doctors believe PCSK9 inhibitors could be a lifesaving solution for millions of heart-disease patients, especially those with a genetic disorder known as familial hypercholesterolemia (FH). In patients with FH, the liver is unable to remove excess LDL. The WSJ article details some of the difficulties these patients face in trying to gain access to the drugs,

According to the author, “Doctors and patients say getting insurance to pay for the drugs is a battle that requires countless hours, applications and appeals. Even then, the battle for insurance approval of PCSK9 inhibitors is successful less than half the time, according to several recent studies.” Of course, high copays can pose an additional barrier for those who are approved.

Health insurers, for their part, point out that there are less-expensive alternatives for most patients and that doctors are somewhat divided on the efficacy of these new drugs. Indeed, according to Sanjay Kaul, a cardiologist at Cedars-Sinai Medical Center in Los Angeles, a clinical trial of Amgen’s Repatha shows that the lower LDL “didn’t translate into a mortality benefit.”

(The author also spoke to a Dr. Baum, a big believer in PCSK9 inhibitors, who happens to have been paid as a consultant and board member for both Amgen and Sanofi/Regeneron.)

As the article notes, some health plans have entered into “value-based” contracts with drug companies, in which the drug company gives the insurer discounts on the drugs if the medicines don’t help patients lower their cholesterol levels as much as expected. We are waiting to see how those deals work out (for patients and for their self-funded employers). Click here to read more on that subject. 

Scripta recommends that our clients require pre-authorization for both Repatha and Praluent.

Read Sumathi Reddy’s piece in the Wall Street Journal: 

When Cholesterol Drugs Cost $14,000, an Insurance Tug-of-War