Are PCSK9 inhibitors too pricey?

PCSK9 inhibitors such as alirocumab (Praluent, Sanofi) and evolocumab (Repatha, Amgen) are priced too high to benefit the US healthcare system, according to a new study.

Published in the August 16 JAMA, the study found that the drugs would need to be reduced by up to 70% to be cost-effective in the US using commonly accepted standards.

“If all eligible US adults were put on PCSK9 inhibitors we’d face an unsustainable increase in healthcare spending,” said Dhruv Kazi, MD, assistant professor of medicine at the University of California-San Francisco and lead author of the new study.

Related: Move over Sovaldi: Could PCSK9 inhibitors be a bigger cost challenge?

\While Praluent and Repatha dramatically reduce levels of low-density lipoprotein (LDL) cholesterol, they must be injected every 2 to 4 weeks and cost around $14,000 per patient annually. “Although they are highly efficient in lowering blood LDL levels, and far more effective than statins alone, PCSK9 inhibitors cost nearly 18 times more than generic statins such as atorvastatin,” UCSF said.

To determine the cost-effectiveness of PCSK9 inhibitors, researchers used the Cardiovascular Disease Policy Model, collaboratively developed by UCSF and other institutions, to simulate the cardiovascular health of all US adults by drawing on demographic and health data from public records and other sources. Treatment costs were evaluated for two high-risk populations: those with a family history of high cholesterol and individuals with pre-existing cardiovascular disease.

They found that prescribing PCSK9 inhibitors to all eligible adults would increase US drug spending by 38%, or a 4% increase in overall healthcare spending, even after accounting for cost savings from prevented cardiovascular events.

Related: FDA panel recommends approving Repatha, Praluent to lower cholesterol

While there is no nationally-mandated cost threshold for drug treatments, consensus in the medical community suggests that treatments should cost roughly $100,000 per life-year gained or less, Kazi said. However, the model estimated it would cost $423,000 for PCSK9 inhibitors to gain one quality-adjusted life-year.

The model also shows, however, that considerable healthcare savings could be realized if statins were more consistently prescribed for patients who could benefit from them. Not all patients who should take statins currently do, for reasons ranging from inadequate medical follow-up to poor health literacy.

According to the model, prescribing statins-which cost around $810 annually-for these patients, would prevent more than 200,000 major cardiovascular events. This would result in a staggering savings of $12 billion over 5 years.

Read more: The first PCSK9 inhibitor approval: 5 lessons