March 10, 2018 / 2:40 PM / 2 months ago

UPDATE 1-Regeneron/Sanofi offer new Praluent pricing to break reimbursement logjam

(Adds company comment, background)

By Bill Berkrot

March 10 (Reuters) - Regeneron Pharmaceuticals Inc and Sanofi SA said on Saturday they would be willing to charge less for their potent cholesterol drug, Praluent, if insurers agree to lessen onerous access barriers for high-risk patients.

Since the approvals in 2015 of Praluent and a similar rival biotech drug from Amgen Inc, insurers and pharmacy benefit managers have been rejecting some 70 percent of prescriptions written, severely holding back sales and frustrating doctors and at-risk heart patients.

Regeneron and Sanofi have decided to focus on patients at highest risk of a repeat heart attack or other major cardiovascular problems likely to derive the most benefit from significant lowering of “bad” LDL cholesterol in an attempt to break the reimbursement logjam.

“We commit to working with all health plans that agree to remove access barriers for high-risk patients to offer a more cost-effective net price for Praluent,” Regeneron Chief Executive Leonard Schleifer said in a statement.

“Inventing innovative medicines only matters if the people who need these products are able to access them, and that is unfortunately not the case with Praluent today,” he said.

Amgen has offered various strategies in an effort to loosen payer purse strings, such as a willingness to reimburse the drug’s cost if a Repatha patient has a heart attack. But prescription rejections remain high as insurers worry about the cost of long-term treatment for potentially millions of patients.

The new Praluent pricing would be tied to an independent review conducted by an organization that evaluates clinical and cost effectiveness of new medicines and be based on Praluent data unveiled on Saturday, the companies said.

That data, presented at the American College of Cardiology meeting in Orlando, Florida, showed that for patients who have acute coronary syndrome, meaning a recent heart attack or serious chest pain episode, and are unable to get their “bad” LDL cholesterol below 100 despite taking maximum doses of statins, adding Praluent reduced the risk of death.

Based on the new risk-reduction data seen in the huge, multi-year study, the Institute for Clinical and Economic Review (ICER) said an appropriate Praluent price for the highest risk patients would be $4,500 to $8,000 a year.

That is considerably less than the more than $14,000 a year list price and presumably below current net prices with discounts and rebates.

“We will begin working with payers to ensure that high-risk patients have appropriate access,” Sanofi CEO Olivier Brandicourt said in a statement. (Reporting by Bill Berkrot Editing by Bill Trott)

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