By Rebecca Leemputte
The Inflation Reduction Act (IRA) has triggered significant shifts in the healthcare landscape, with profound implications for patient access and affordability. Earlier this month, I discussed how life sciences organizations can address these challenges as a panelist on AssistRx’s webinar, Ahead of the Curve: Considerations for Your 2025 Patient Support Program.
As we approach 2025, it’s crucial for manufacturers to stay ahead of access and affordability changes by proactively updating patient support programs (PSPs) to address shifting patient and provider needs. While changes driven by the Inflation Reduction Act (IRA) hold the potential to enhance drug affordability for many patients, there may be unintended consequences as plans adjust their access strategies in response to increased cost-sharing responsibilities.
To navigate this period of transformation effectively, life sciences organizations, healthcare providers, and pharmacies must collaborate closely. A multi-stakeholder approach to education will be essential to ensure that patients receive the support they need in a changing environment.
IRA’s Impact on Patient Access and Affordability
The IRA has introduced several key provisions aimed at controlling drug prices, with wide-reaching effects on patients and treatment access. A central pillar of the legislation is the introduction of price negotiations, which will reshape drug cost and access dynamics for select high-cost drugs starting in 2026. The IRA also imposes inflationary caps on drug prices, limiting the extent of annual price hikes. Both policies aim to improve long-term drug affordability for patients.
Importantly, changes to Medicare Part D benefit design will have significant patient affordability implications. The removal of patient cost-sharing during the catastrophic coverage phase, effective in 2024, marked a monumental shift. This policy eliminates cost liability for patients during this phase, improving access to high-cost therapies that many patients previously struggled to afford.
Looking ahead, 2025 promises further improvements in affordability. The introduction of an out-of-pocket maximum of $2,000 annually will further lower the financial burden on patients. Patients will also benefit from the launch of the Medicare Prescription Payment Plan (M3P), which allows them to pay their out-of-pocket drug costs in monthly installments rather than in a lump sum at the pharmacy if they choose to opt in. This payment “smoothing” has important implications for patients prescribed high-cost therapies.
Medicare Prescription Payment Plan (M3P): Improved Affordability for Patients Who Opt-In
M3P represents a significant shift in how patients pay for prescription drug costs. Under this program, all Medicare Part D enrollees will have the option to pay for their out-of-pocket drug expenses in monthly increments. By offering payment flexibility, this approach alleviates the financial burden of large upfront payments, especially for patients prescribed high-cost therapies and low- or fixed-income patients. By reducing the likelihood of missed doses or discontinued treatments due to cost, M3P aims to improve access, adherence and outcomes.
To fully realize the benefits of M3P, it is crucial that patients and providers are well-informed about the program, as opt-in is required. Although some providers are enthusiastic about the potential advantages of M3P, there are gaps in widespread understanding of its benefits and operations. As the program is rolled out, ensuring providers, pharmacies, and industry partners have the knowledge to support patients through the opt in process will be key to the program’s success.
Access Risks with Cost Share Shifts: Why Patient Support Programs Must Adapt
While the changes to Medicare Part D benefit design are set to enhance patient affordability, the increased share of drug costs covered by Medicare Part D may lead to unintended consequences for overall patient access. As Medicare Part D absorbs a greater share of drug costs, payers may respond by tightening their formularies, imposing additional prior authorization requirements, or instituting step therapy protocols. These adjustments may affect not only Medicare but also the commercial plans, as payers seek to offset greater financial liability on the Medicare side. These changes may increase barriers to access for many patients, particularly in high-cost therapeutic areas like oncology, immunology, and cardiovascular disease.
As patient access and affordability continue to evolve, manufacturers must ensure their PSPs adapt accordingly. It will become increasingly important that PSPs are flexible and responsive to changing payer criteria to support uninterrupted access to treatments. Additionally, it is essential for PSPs to proactively educate patients and providers on the advantages of new affordability options, such as the M3P program, to maximize overall patient benefits. A well-crafted engagement strategy will help providers and patients effectively navigate this changing landscape.
Collaboration & Proactive Patient Support Program Engagement: Keys to Success
Amid these complex changes, manufacturers must embrace a multi-stakeholder approach to education. Many providers are still working to understand and communicate the IRA’s implications to their patients. By partnering with providers and pharmacies to deliver clear, concise messaging, manufacturers can help bridge the knowledge gap and ensure that patients don’t fall through the cracks. Ongoing education efforts will be essential to keep all stakeholders informed and engaged as the landscape evolves.
As the IRA reshapes the healthcare environment, manufacturers and life sciences organizations have a unique opportunity to be at the forefront of patient support. By developing proactive strategies that address both affordability and access issues, they can help ensure patients receive the therapies they need without undue financial burden.
Navigating the complexities of IRA-driven access & affordability changes requires a nimble and forward-thinking approach. Through collaboration, innovation, and a deep commitment to patient care, manufacturers can position themselves as invaluable partners in this new landscape.
Want to learn more about how The Dedham Group can help you navigate your IRA and patient support program strategies? Contact us.
