Analysis concludes PCSK9 inhibitors from Sanofi, Regeneron, Amgen are too expensive

An analysis released by the Institute for Clinical and Economic Review (ICER) suggests that the cost of recently approved PCSK9 inhibitors, which include Sanofi and Regeneron Pharmaceuticals' Praluent (alirocumab) and Amgen's Repatha (evolocumab), are too high. The independent non-profit organisation said its analyses indicated "that the price that best represents the overall benefits" the drugs may provide would be between $3615 and $4811 a year, a 67 percent discount to their list prices.

Amgen has disclosed that Repatha, which was approved by the FDA last month, will have a US wholesale price of $14 100 a year for bi-weekly administration. Meanwhile, Sanofi and Regeneron's Praluent, which was cleared by the FDA in July, is priced at around $14 600 a year.

The injectable therapies have been shown in clinical trials to lower LDL cholesterol by between 55 percent and 60 percent in patients who could not reduce their levels enough with statins or those who could not tolerate statins. Studies are also ongoing to determine if they actually cut heart attacks. ICER noted that depending on how Praluent and Repatha are used in practice, it has been estimated that between 3.5 million and 15 million Americans could be eligible for treatment.

ICER president Steven D. Pearson remarked "even if these drugs were used in just over 25 percent of eligible patients, then employers, insurers, and patients would need to spend on average more than $20 billion a year for these drugs, a cost that would continue on into the future." The analysis concluded that further price reductions to an annual cost of $2177 would be needed for the total costs of PCSK9 inhibitors to come down to a level at which doctors and insurers would not have to try to limit patient use in some way in order to keep overall healthcare costs under control.

In response to the findings, Amgen said that while it welcomed a "balanced discussion of value," the company disagreed with ICER's methodology, assumptions and preliminary conclusions. "We are concerned that ICER's review does not place value on addressing a significant unmet medical need and its short-term budgetary focus will be used to create access barriers to innovative medicines like Repatha for appropriate patients," Amgen added.

Last month, the CVS Health Research Institute urged that current guidelines for the management of high cholesterol be reconsidered in light of the introduction of PCSK9 inhibitors, which "could complicate treatment choices and inhibit utilisation management tools to manage costs." Commenting on the ICER analysis, CVS Health chief medical officer Troyen Brennan suggested that the conclusions were "basically right in line with our view of the medications — that they have some value, but at their current prices they are way overpriced." Meanwhile, pharmaceutical benefit manager Express Scripts indicated that it plans to use findings from the ICER report in its negotiations with the drugmakers.

For related analysis, see ViewPoints: Payers, PBMs begin marshalling forces to kerb PCSK9 spending.

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