"PCSK9 Drugs' Hurdles Coming Down Slowly" - Crystal Phend
Many had hoped that positive findings from ODYSSEY Outcomes would build on the momentum for FOURIER the year before to bring down bureaucratic hurdles to reimbursement and boost use of PCSK9 inhibitors. Although the relative 15 percent reduction in major adverse cardiovascular event risk associated with alirocumab (Praluent) wasn't the home run that might have propelled the drugs into their once-expected blockbuster status, the manufacturers went to work with what they had. Despite all the purported progress in widening access to PCSK9 inhibitors, the bureaucratic burden often remains daunting. Roxana Mehran, MD, director of interventional cardiovascular research and clinical trials at the Zena and Michael A. Weiner Cardiovascular Institute at the Icahn School of Medicine at Mount Sinai, said she is still fighting for prescriptions when optimizing medical therapy upfront before coronary interventions. Recently, just one out of 15 of her patients was able to get the PCSK9 inhibitor, she said. As to the paperwork burden, "You need a full-time person just to be your scribe to do this work."
— Roxana Mehran, MD, Professor, Medicine, Cardiology, Population Health Science and Policy, Director, Interventional Cardiovascular Research and Clinical Trials, Zena and Michael A. Weiner Cardiovascular Institute, Icahn School of Medicine at Mount Sinai