FDA advisory panels this week recommended approving two drugs that may significantly lower cholesterol. But experts warn the potential high cost for these blockbuster drugs could limit their access and once again raise concerns about skyrocketing prescription costs.
An advisory committee Wednesday voted 11-4 to recommend approval for drugmaker Amgen's injectable drug Repatha. It treats high-risk patients. On Tuesday, an advisory panel voted 13-3 to recommend approval for Praluent, an injectable medication produced by Sanofi and Regeneron Pharmaceuticals.
Both Praluent and Repatha are PCSK9 inhibitors, a new class of biologic medications experts say lowers levels of low-density lipoprotein cholesterol by as much as 60% when used alongside older statins. The drugs are injected about twice a month.
But a new report released Tuesday projects PCSK9 inhibitors could cost the U.S. health system up to $23 billion annually. An analysis conducted by pharmacy benefits manager Prime Therapeutics stated initial estimates of the cost for PCSK9 inhibitors are between $7,000 and $12,000 a year.
Both drugs received limited approval by the advisory committees for treatment of familial hypercholesterolemia, where cholesterol forms in the blood. The genetic disorder affects around 600,000 people in the U.S.
“While these new drugs offer hope to those who aren't able to effectively manage their cholesterol with existing therapy, they need to be affordable,” said Patrick Gleason, director of health outcomes for Prime. “Contributing to the high cost is the fact that these drugs are considered maintenance medicines, so people would expect to take them for many years.”
A similar view was shared in a February article in Health Affairs, where authors estimated the long-term use of PCSK9 inhibitors could set the price for treatment with such drugs significantly higher than that of Gilead Sciences' $84,000 hepatitis C drug Sovaldi. That drug's cost has raised eyebrows and ire.
The article calculated that at a cost of $10,000 a year, the cost of PCSK9 inhibitors for the treatment of familial hypercholesterolemia alone would be around $16 billion. As a chronic therapy, the author projected it could add up to $200 billion a year to the country's healthcare system.
“Managed pharmacy care, indeed the healthcare system, has never seen a challenge like this to our resilience in absorbing costs,” the article stated. “Payers, the employers and health insurers, will first be shocked, then expect action. Action will take the form of compliance with clinical guidelines, and careful managed care oversight.”
The FDA is expected make a decision on Praluent in July, with a decision on the approval of Repatha in August.