UPDATE 1-Regeneron/Sanofi heart drug succeeds in major trial; Will insurers pay?

From Reuters - March 10, 2018

(Reuters) - A potent, expensive cholesterol drug sold by Regeneron Pharmaceuticals and Sanofi significantly reduced major adverse heart events in a huge study presented on Saturday but it remains to be seen whether the new data willprompt insurers to pay for increased use of the medicine.

The drug, Praluent, also led to fewer deaths among high-risk patients, which could be the strongest argument for insurers to finally remove barriers that have severely constrained sales and frustrated physicians trying to get the medicine to patients.

Insurers have balked at paying for Praluent and a rival Amgen (AMGN.O) drug, which dramatically lower bad LDL cholesterol but carry list prices of more than $14,000 a year before discounts, over fear of the cost of use over many years by millions of patients. They have routinely rejected about 70 percent of prescriptions written, the companies have said.

Regeneron and Sanofi said on Saturday they would lower the net price of Praluent if onerous barriers to its access are removed for the highest-risk patients. That price would be tied to an independent review of Praluents value based on the new risk reduction data from the multi-year study called Odyssey Outcomes.

The hard data from the Odyssey Outcomes trial confirms ... that treatment with Praluent does lead to a reduction of both cardiovascular and all-cause deaths, particularly for the higher-risk patient population, said David Whitrap, a spokesman for ICER, which conducted the review. The organization recommended a price range of $4,500 to $8,000 for those high-risk patients likely to gain the most benefit from Praluent therapy.

The study tested the injected biotech drug versus placebo in nearly 19,000 patients who had a recent heart attack or severe chest pain episode and were already on maximum doses of cholesterol-lowering statins, such as Pfizers Lipitor.

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.

While fewer heart-related deaths with Praluent did not reach statistical significance, there was a nominally significant reduction in all-cause deaths - 334 versus 392 for placebo, researchers reported.

In a subgroup analysis of highest-risk patients - those with bad LDL cholesterol of 100 or above despite maximum statin therapy - Praluent significantly reduced all-cause death risk by 29 percent and risk of the adverse event composite by 24 percent.



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