A Closer Look at Patient Support: Upcoming Legislative and Regulatory Changes

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Avalere experts explore how potential implications of the Inflation Reduction Act (IRA)’s out-of-pocket cap, in addition to other key regulatory and policy activities shaping benefit design and patient cost-share (e.g., EHB), could impact patient commercial and foundation assistance.

The IRA added increasing complexity to drug pricing, stakeholder liability, and patient affordability. While the introduction of an out-of-pocket cap and the Medicare Prescription Payment Plan in Part D may allow for greater affordability for some enrollees, new liabilities for plans may create additional pressures for patients accessing and adhering to their treatments.  

Coupled with vagueness in the commercially insured definition of cost sharing assistance as defined by HHS as well as the essential health benefit (EHB) loophole and the rising use of alternative funding programs, there is more uncertainty than ever for stakeholders and patients. 

In this webinar, our experts will delve into the impact of the Inflation Reduction Act and other relevant policies on patient access and affordability efforts from manufacturers, foundations, and patient advocacy organizations. Panelists will discuss topics including: 

  • Changes of the IRA’s Medicare Part D benefit redesign that will be effective in PY 2025 impacting patient access  
  • Proliferation of affordability challenges in the commercial market (e.g., due to increase of copay maximizers, alternative funding programs) 
  • Regulatory and legislative impacts to patient OOP expected for 2024 and 2025 
  • Critical questions or solutions that stakeholders may adopt in response to policy changes 


Ayesha Azam , Associate Principal, Client Solutions

Ayesha Azam advises life sciences clients on policy, commercialization, and patient access strategies in response to a complex, evolving healthcare landscape.


Mark Gooding Managing Director
Market Access & Reimbursement
Lisa Joldersma Strategic Advisor
Brigit Kyei-Baffour Principal
Market Access & Reimbursement
Kylie Stengel Associate Principal
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