How IRA, MFN, and HTA are rewriting oncology launch strategy

For years, oncology launch planning followed a relatively familiar playbook. Companies prioritized indication sequencing, evaluated market opportunities, and built evidence strategies around anticipated pricing and reimbursement requirements.

Today, that’s all changing.

New policies, evolving Health Technology Assessment (HTA) requirements, and growing scrutiny around pricing are forcing pharmaceutical companies to rethink how and where they launch oncology assets. What was once primarily a commercialization decision is increasingly becoming a complex exercise in pricing, access, evidence generation, and lifecycle value optimization.

Alan Crowther, General Manager, Global Pricing & Access, and Paolo Correale, Senior Vice President, Global Pricing & Access Consulting, shared their perspectives on how the Inflation Reduction Act (IRA), Most Favored Nation (MFN) policies, and HTA evolution are reshaping oncology launch strategy in the 2026 pharmaphorum Oncology Deep Dive.

Launch Sequencing Has Become More Important Than Ever For Oncology

Launch order has always influenced pricing and access. However, new market dynamics are increasing the stakes.

According to Correale, launch sequencing now plays a direct role in both pricing outcomes and HTA success. For oncology markets in particular, reaching key markets ahead of competitors can reduce evidentiary pressure and improve the likelihood of favorable access decisions.

MFN Is Reshaping Global Launch Priorities

One of the most significant shifts is the impact of MFN policies on global launch planning.

Rather than simply changing launch timing, MFN is prompting some organizations to reconsider where they launch altogether. Markets that have historically played an important role in early commercialization strategies are now being reevaluated as companies assess the potential impact on broader pricing objectives.

As a result, launch sequencing discussions are becoming more sophisticated, requiring organizations to balance market opportunity, pricing exposure, and long-term asset value.

The IRA Is Adding New Layers of Complexity

In the United States, the IRA is creating additional considerations for oncology manufacturers.

Decisions around indication sequencing, orphan designations, competitive timelines, and lifecycle planning now require a more comprehensive evaluation of future pricing implications.

Rather than evaluating each indication independently, companies need to assess how cumulative revenue, future launches, and long-term market dynamics may influence the value of an asset over its lifecycle.

Evidence Planning Is Evolving

The growing complexity of oncology markets is also influencing clinical and evidence strategies.

Competitive landscapes can shift rapidly, creating new expectations from payers and HTA bodies. In response, organizations are placing greater emphasis on market intelligence, competitive monitoring, and scenario planning to ensure evidence packages can support future access objectives.

What Will Define Successful Oncology Launches Going Forward?

One theme emerged consistently throughout the discussion: proactive planning matters more than ever.

Organizations can no longer rely on historical launch models alone. Success now depends on understanding how pricing policies, reimbursement requirements, competitive dynamics, and global access considerations interact throughout the product lifecycle.

For oncology companies, launch sequencing is now about maximizing value, supporting patient access, and building a strategy capable of adapting to an increasingly complex global environment.