Strategic Outlook: IRA 2024 Negotiation Milestones and their Impact on Stakeholders

Chad Patel

As we step into 2024, a transformative landscape unfolds in the healthcare realm with key provisions reshaping the dynamics. The centers for Medicare and Medicaid Services (CMS), by February 1, is set to send initial maximum fair price (MFP) offers to the pioneering 10 drug manufacturers, marking the commencement of a negotiation period. By September 1, CMS will unveil MFPs for 10 Medicare Part D drugs, slated to take effect in 2026. 

Anticipate limited additional savings for patients, given the substantial rebates on the first ten drugs. CMS negotiations will likely aim to mirror these rebates, aligning the negotiated prices with existing net price points. 

Key negotiation timelines:

Here’s a snapshot of the implications for various stakeholders this year:

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Payers:

Brace for Part D benefit redesign and financial pressures with IRA capping patient average premium growth. Expect aggressive utilization management strategies and tighter formularies, potentially driving an uptick in Medicare Advantage plan enrollment. 

Patients:

A ray of affordability shines as insulin becomes available at $35/month per covered prescription for Part D patients. A $2,000 out-of-pocket cap promises enhanced adherence and affordability. Additionally, more uninsured patients may qualify for the low-income subsidy program (LIS), expanding access to care.

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Providers:

Will have to navigate potential challenges with lower reimbursement and payments for negotiated drugs which will likely lead to the introduction of practice administrative complexities potentially impact care delivery. 

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Manufacturers:

Conducting scenario analyses becomes imperative, necessitating portfolio prioritization, supply chain considerations, and real-world evidence (RWE) generation.

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Proactively crafting high-quality and comparative RWE studies in the Medicare population emerges as a strategic move for future price negotiations, grounded in robust evidence.

In this post-IRA environment, AESARA invites you to delve deeper into these implications. We’re eager to discuss our framework for both long-term and near-term needs, ensuring seamless preparation for IRA readiness & execution. Let’s navigate this transformative terrain together!  

References:  

  1. Centers for Medicare and Medicaid Services. Accessed online January 22, 2024:
    https://www.cms.gov/inflation-reduction-act-and-medicare  

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