Just prior to an election season, it is not surprising to see a few bills emerge as potential silver bullets to solve pressing policy issues. One issue that has consumed the public for several years is drug prices. This article examines two Congressional bills aimed at increasing biosimilar utilization in an effort to lower drug costs.
On Feb. 6, 2019 the Department of Health and Human Services (HHS) officially proposed the rebate rule known as the “Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees.”
With the list price of newer drugs rising, policy makers are continuing to debate the cost savings biosimilar medications may offer. To date there are 17 FDA-approved biosimilars targeting various disease states. While biosimilars could slow the dramatic rise in the overall drug spend, many questions about them remain such as litigation, interchangeability, and how they will be integrated into the market. The last question is the most intriguing, and it is heavily dependent on the decision of pharmacy benefit managers (PBMs) about their formularies.
Sen. Bernie Sanders has introduced three bills aimed at reducing prescription drug prices, two of potential importance to biosimilar developers. This article discusses these cost-containment policies, as well as two other congressional initiatives to watch.
CMS has announced a new payment model that seeks to reduce out-of-pocket costs for patients. This payment model arises out of the Trump administration’s American Patients First Blueprint that was released earlier this spring. CMS is providing this notice of its proposed payment model via an Advance Notice of Proposed Rulemaking (ANPRM), meaning a formal proposed rule will be introduced in the near future. Comments close on this ANPRM on Dec. 31, 2018.
With the continued policy dialogue on how rising drug costs impact patient access, the theoretical cost savings that biosimilars may offer is intriguing to many policymakers as well as those in the industry.