Sanofi and Regeneron spent months waiting for cardiovascular outcomes data on their PCSK9 drug Praluent as they watched Amgen tout its rival drug's CV benefits. But they won't have to wait too much longer to hear the FDA's word on their own CV approval.
Sanofi and Regeneron have their application in, and if they get the green light by April as scheduled (PDF), the companies are ready to wheel and deal to get payers on board.
The application is based on data from the Odyssey Outcomes trial, which made its debut at the American College of Cardiology meeting in March. Praluent cut the risk of a composite measure of CV risks—comprising heart attack, stroke, death from heart disease and serious unstable angina, known as MACE—by 15%, while cutting the risk of death by an equal percentage.
In high-risk patients, the benefit was much bigger: a 29% cut to the risk of death from any cause and 24% to the risk of a MACE event. That's key to marketing Praluent if it wins the sought-after FDA approval, because high-risk patients are essentially Praluent's target market.
The benefit in high-risk patients fits what "clinicians would want to do in real practice," Odyssey Outcomes' lead investigator told FiercePharma at ACC. Plus, payers get the biggest "bang for the buck" by using Praluent in patients most likely to suffer a heart attack or stroke, he said, thanks to the hefty expense of treating patients who do.
And the proof that Praluent cuts the risk of death is something Amgen's Repatha doesn't have—a miss that analysts pounced upon last year when its outcomes data hit. After this year's ACC and the Odyssey release, SunTrust analyst Yatin Suneja wrote that Praluent's mortality benefit in that trial will likely be seen as a "key differentiator" between the PCSK9 outcomes trial results.
Of course, if Sanofi and Regeneron win the new approval, they'll have to persuade payers to act, and in the past, they've been notoriously recalcitrant about covering the expensive cholesterol meds. Despite big discounts off the $14,000 list price—up to half in some cases—both PCSK9 developers have still struggled to get their meds to patients without prior authorization hurdles.
But the Praluent partners have already signaled they'll lower Praluent's price further to win obstacle-free coverage, to a range of $4,460 to $7,975, using a "precision medicine" approach to identify high-risk patients. The companies struck a deal in May with pharmacy benefits manager Express Scripts that does just that, in return for a exclusive berth on the PBM's national preferred formulary.