New Cholesterol Drugs Vastly Overpriced, Study Contends

From Drugs.com - August 22, 2017

New Cholesterol Drugs Vastly Overpriced, Study Contends

TUESDAY, Aug. 22, 2017 -- Are new medicines for people with out-of-control cholesterol wildly overpriced? It's a question that's sparking debate among consumers and providers of care.

Now, researchers at the University of California, San Francisco (UCSF) report that the price of these drugs -- called PCSK9 inhibitors -- would have to be slashed by a whopping 71 percent to be deemed cost-effective.

PCSK9 inhibitors are a relatively new class of medicines for treating patients whose LDL (bad) cholesterol is not well-controlled on statins or who cannot tolerate statins. Lipitor (atorvastatin) and Crestor (rosuvastatin) are examples of first-line statins doctors typically prescribe to patients with high cholesterol.

The UCSF team did not question whether these new medicines are effective in reducing heart attacks and strokes.

"These are super awesome drugs, they really work," said study co-author Dr. Kirsten Bibbins-Domingo.

But the price is "far in excess" of what would be considered a reasonable cost for the clinical benefit they provide, added Bibbins-Domingo, a UCSF professor of medicine, epidemiology and biostatistics.

The list price of these newer PCSK9 drugs is upwards of $14,000 a year per patient.

Dr. Kim Allan Williams, who was not involved in the study, is past president of the American College of Cardiology. He said some doctors have a difficult time with such studies because they compare patients' lives and "events" -- such as heart attack and stroke -- versus dollars spent on these medicines.

The new study does not change his view of the value of the PCSK9 inhibitor class.

"No one's giving those drugs unless the patient is incapable of getting to the target [level of LDL cholesterol]," said Williams, who is chief of cardiology at Rush University Medical Center in Chicago. "You are only going to use it for a situation where you have no choice."

Because the study is based on list prices, not what patients actually pay, it's also "difficult to analyze the cost-effectiveness when [you] do not know exactly what the cost is," Williams added.

He said he's had patients with copays of $380 a month and others who had zero copays because the cost was completely covered by insurance. He worries, though, that poor patients may not be offered the same access to these medicines.

The CSF researchers designed the study to find out how much bang for the buck these drugs actually provide.

Their study updates a prior cost-effectiveness analysis using current list prices as well as results of a recent clinical trial. That trial demonstrated the clinical effectiveness of Repatha (evolocumab), one of two PCSK9 inhibitors approved by the U.S. Food and Drug Administration, in reducing the risk of heart attack and stroke.

Based on a simulation involving 8.9 million adults who would meet trial criteria, adding PCSK9 inhibitors to statins would prevent 2.9 million more heart attacks and strokes compared with adding Zetia (ezetimibe), another type of medication that blocks the production of cholesterol by the liver.


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