ibusinesslines.com September 18, 2018

New cholesterol drug lowers heart attack, death risk in study

14 March 2018, 12:55 | Melissa Porter

New cholesterol drug lowers heart attack, death risk in study

New cholesterol drug lowers heart attack, death risk in study

Regeneron and Sanofi's move to adopt ICER's recommended price range reflects the growing scrutiny of drug costs, and calls for pharmaceutical companies to price their products according to their value to patients, rather than what the market will bear, ICER President Steven D. Pearson said in an interview. Doctors say this finding, though not statistically clear-cut (more on that below), could still drive greater adoption of the expensive cholesterol drug.

The companies will meet with USA healthcare providers to to discuss potential net pricing adjustments for those that agree to provide straightforward access for high-risk patients, while working with healthcare professionals to define best practices.

Regeneron and Sanofi have offered insurers a roughly 50 percent price cut on their PCSK9 inhibitor alirocumab (Praluent) for patients with the highest cholesterol levels, according to Forbes. Sanofi, Regeneron and Amgen initially rolled their drugs out with prices of more than $14,000 per year before rebates and discounts. The trial was created to maintain patients' LDL-C levels between 25-50 mg/dL, using two different doses of Praluent (75 mg and 150 mg). Months can go by before a patient gets them. The study is the second of its kind-following a similar, 27,564-patient trial from Amgen a year ago. Praluent slashed bad cholesterol by more than half after four years.

The trial succeeded on its primary goal - reducing the combined risk of heart attack, stroke, heart disease-related death and chest pain requiring hospitalization - by 15 percent.

A highly anticipated study of the injected drug found it reduces complications including heart attacks and strokes by 15 percent, less than the 20% benefit analysts say would be needed to force insurers to loosen their stranglehold.

"We need to reset our expectations" and realize that benefits for any new drug are going to be fairly small when added to already good treatments such as statins, said Dr Jeffrey Kuvin, conference leader and cardiology chief at Dartmouth-Hitchcock Medical Centre.

For high-risk patients with LDL levels of 100 mg/dL or higher, the benefit was larger: a 24% reduction in risk of MACE and a 29% drop in all-cause mortality. "With almost 90 percent of the patients in this trial on high-intensity statins, the data demonstrate that a precision-medicine approach in the field of cardiovascular disease may further advance how we better treat high-risk patients". But preventing fewer than one heart problem a year at the drug's current price is not cost-effective, he said. A price of $4,500 to $8,000 per year would be justified for patients with LDL over 100, the group said.

An independent group, the Institute for Clinical and Economic Review, on Saturday released a new range for what Praluent should cost, based on the new results - $2,300 to $3,400 per year for people like those in the study.

From 300,000 to 400,000 people in the U.S. each year fall in that second category.

Yancopoulos said the changes will result in a trifecta for patients: data that proves Praluent's benefit, a lower price that makes it undeniably cost effective, and a requirement that payers break the gridlock and allow its use.

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