Donald Trump Could Lower The Bar For FDA Drug Approvals, But Payers Will Limit Access

They were hailed as drugs that could change the treatment of heart disease by lowering harmful LDL cholesterol (LDL-c) to unprecedented levels for adults. Yet, the sales of Amgen’s Repatha and Sanofi/Regeneron’s Praluent, known as PCSK9 inhibitors, have been disappointing low. The reason isn’t due to lack of efficacy. Indeed, combining PCSK9 inhibitors with generic statins can drop LDL-c to below 40mg/dL, almost the levels of newborns, with no major safety issues. What has limited the uptake of these drugs has been the price – listed at $14,000 a year. As a result, payers have made access difficult, requiring extensive documentation showing that patients are truly in need of such potent therapy. In fact, 88% of first time prescriptions for patients with commercial insurance were denied access last year.

MORE ON THIS TOPIC