One of the hottest topics for drug manufacturers today is the Centers for Medicare & Medicaid Services (CMS) price negotiations for Medicare Part D drugs. That’s because the implications for the new initiative go far beyond the 10 drugs CMS will select during the first round. It is expected to impact same-class competitors as well. The CMS list of selected drugs will be released on 1 September 2023.
ICON has used its healthcare intelligence capabilities, CMS published selection criteria, and data access to publish in advance the list information likely to come from CMS. Our list also includes next likely 40 and same-class competing drugs.*
The criteria specify Medicare Part D-covered drugs that are single-source, brand-name drugs or biologics with no generic equivalent or biosimilar alternatives. Small-molecule drugs must be at least 7 years past US Food and Drug Administration (FDA) approval or licensure; biologics must be 11 years past FDA approval or licensure, as of the list publishing date. CMS will use earliest approval date in cases where drugs have multiple FDA approvals. It will be based on data from 1 June 2022 to 30 May 2023.
Are you safe if your drug isn’t one of those on the primary list? In short, no. Here are the reasons why:
- CMS isn’t required to select from only the top-selling drugs. They can choose from any of the top 50 qualifying drugs.
- Same-class drugs are likely to be impacted. A substantial price cut by a key competitor may be very disruptive to an entire therapeutic class.
The bottom line is this: if a product in your class of drugs is selected, your pricing and profitability are likely to be impacted significantly. The inclusion of a listing of same-in-class competitors highlights other products that will be impacted.
What can you do about it?
Preparation is the key. The first round of Medicare Part D price cuts will go into effect on 1 January 2026. Now is the time to formulate your strategy for going forward.
Connect with ICON now. We want to help build evidence and prove value of your brand for all your audiences, including CMS pricing negotiations and communications with all those target audiences. ICON’s healthcare intelligence capabilities assist brands worldwide to maximize value in the payer, healthcare provider (HCP), and patient markets. To learn more or schedule a consultation, please contact us at MarketAccessStrategy@iconplc.com or visit www.ICON.com/contact.
Read the full brief: CMS Part D price negotiations: is your drug on the list?
*Uses best available data
Medicare Part D Top 50 Drugs
Download the list in a single quick-reference PDF