EXECUTIVE SUMMARY

‍The 2026 Medicare Part D redesign represents a fundamental shift in how prescription drug access economics are structured, with a $2,100 annual out-of-pocket cap and revised stakeholder liabilities reshaping payer incentives and manufacturer access strategies. Manufacturers that proactively adapt pricing, evidence, and commercial planning to these new dynamics will be better positioned to secure coverage and long-term access success.

---

As the industry gathers in San Francisco for J.P. Morgan week, one reality is clear: the 2026 Medicare Part D redesign is no longer a future policy exercise; it’s an imminent commercial reset. With a new annual out-of-pocket cap of $2,100 combined with rebalanced risk liability between CMS, payers, and manufacturers, the economics underlying access decisions are changing. For manufacturers planning launches or lifecycle strategy, the old assumptions about affordability, formulary leverage, and budget impact are increasingly unreliable.

‍

WHY IT MATTERS FOR PAYERS

From a payer perspective, Part D redesign alters both risk and incentives. Plans will shoulder greater responsibility earlier, sharpening sensitivity to utilization growth, adherence, and downstream costs. At the same time, reduced patient out of pocket exposure increases initiation and persistence. This will be good for outcomes but potentially destabilizing to budgets. The result is a payer mindset shift: less focus on blunt coverage decisions and more complex utilization management, real-world performance, and predictability of spend.

‍

IMPLICATIONS FOR MANUFACTURERS

For manufacturers, Part D redesign means launch access strategy must evolve beyond 'coverage secured at X rebate'. Budget impact models will be scrutinized more closely, comparators will be questioned more aggressively, and value narratives will have to align with plan-level economics, not just patient benefit design. In 2026, a compelling value story will connect clinical differentiation directly to utilization control, adherence dynamics, and total cost of care.

Forward-looking access teams are already recalibrating. They are forecasting net price under redesigned liability flows, validating value propositions and evidence against evolving payer perceptions, and preparing for tougher questions on long-term sustainability. Importantly, they are also aligning internal stakeholders; pricing, HEOR, and patient support around a shared view of how Part D redesign reshapes the “payer math.”

‍

‍5 ACTIONS TO TAKE NOW

1. Model redesigned liability impacts early:‍

Forecast net price and budget impact under the new stakeholder risk splits, not 2024–25 assumptions.

‍2. Strengthen RWE and outcomes insights:‍

Build capabilities to generate timely, payer-relevant evidence that aligns with utilization and cost-of-care metrics.

‍3. Revalidate value narratives for Part D economics:‍

Tailor evidence messages to plan-level incentives and value frameworks, beyond clinical endpoints alone.

4. Enhance cross-functional alignment:‍

Synchronize access, pricing, HEOR, and patient support services teams around Part D redesign implications.

5. Engage payers early and iteratively:‍

Initiate active dialogues to test assumptions, refine evidence tracking, and co-design utilization management approaches that reflect the new landscape.

‍

ALKEMI'S PERSPECTIVE

Part D redesign is more than a Medicare issue, it signals where access decision-making is heading more broadly. Manufacturers that treat 2026 as a compliance exercise will be reacting late. Those that adapt their access strategy today with consideration of payer economics, evidence credibility, and real-world outcomes will be better positioned to secure coverage in a more constrained environment tomorrow.

---

Max Klietmann is VP of Market Access Services at Alkemi, where he helps life sciences teams build payer-ready access strategies for launch and beyond.