PhRMA balks at CMS’ proposed changes to protected drug classes

BY Sandra Levy

The Pharmaceutical Research and Manufacturers of America has expressed strong opposition in its comments to the proposed changes of the Center for Medicare and Medicaid Services proposed rule, “Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses.”

PhRMA voiced strong opposition to the proposed changes to the six protected classes policy. “The protected class policy affords access to vital and lifesaving medicines for patients with serious and debilitating conditions. The administration is proposing to weaken the current six protected class policy in several ways, notably by allowing health plans to force patients who are stable on a medicine to go through prior authorization or step therapy. We have several concerns with these proposed changes. The proposed changes could have serious health consequences for patients and are unnecessary given that plans already have tools to manage utilization in these classes and significant savings from the proposed changes are unlikely. We also have legal concerns with the proposed changes, which are inconsistent with Part D’s non-discrimination protections,” PhRMA said.

PhRMA also stressed that weakening the six protected classes unlikely will result in significant savings because Part D plans already have tools to manage utilization, and that CMS’ proposed exceptions based on cost considerations are a significant, unexplained departure from current policy and would harm patients.

Finally PhRMA said, “Alternative policies could achieve the administration’s goals without putting patients at risk. If CMS wishes to address patient affordability challenges caused by rising list prices, there are more appropriate policy solutions that would not put patients’ health at risk. The changes to six protected classes being proposed by the administration are unlikely to lower patients’ out-of-pocket costs for brand medicines and could harm patients by introducing access barriers.”

The proposed rule also contains potential changes to how direct and indirect remuneration, or DIR, fees work — something the National Association of Chain Drug Stores weighed in on last week.


Leave a Reply

No comments found



What area is your company focused most on in 2019?
  • Add your answer