The National Pharmaceutical Council (NPC) on Friday, Jan. 25, submitted comments to the Centers for Medicare and Medicaid Services regarding the agency’s recent notice of proposed rulemaking, “Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses.”
In its comments, NPC says the proposed rule includes three exceptions to the protected class policy which “focus on costs without careful consideration of the clinical benefits or harms.” One such exception would preclude a protected class drug from a formulary if the wholesale cost of the therapy ever exceeds inflation.
Regarding CMS’ proposal to implement step therapy for Part B medications, NPC states that while step therapy protocols were at first focused on delivering drugs with better efficacy and fewer safety concerns, they recently have been geared more toward cost.
“The National Pharmaceutical Council shares CMS’ goal to provide patients and health care providers with safe and effective therapies that will best serve the needs of patients and the health care system,” NPC states in its letter. “Meeting that goal will require strategies based on sound evidence and strategies that reflect patient-centered principles which include clinically nuanced approaches to care, rather than blunt policy solutions.”