Over the next several months, biopharma companies and payers must decide whether to join the voluntary MFN model, shape the policy conversation to their advantage, and realign business and product portfolios to fit the new market landscape.
Losing the U.S premium starves the innovation capital that benefits tomorrow's therapies for all
On the right: Current U.S. revenue exposure to MFN requirement is significant especially in the biologics (blue) vs small molecules (orange).
There is no playbook for such a policy shift: We will learn as we go applying health economics concepts
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Lever
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Horizon
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Action plan
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Indicative EBIT protection
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1 |
Re-price corridors |
Immediate |
Cut U.S. list prices just enough to meet MFN and widen ex-U.S. discounts to keep reference baskets neutral. |
+5-7pp |
2 |
Launch resequencing |
Mid-term |
Flip launch order: EU → Japan → U.S. so MFN references lag 12-18m; delay U.S. exclusivity clock only where sales mix tolerates. |
+2-4pp |
3 |
Value-based contracts |
Immediate |
Use CMS “multiple best price” safe harbor to lock-in outcomes-tied net prices below MFN but keep list intact. |
+1-2pp |
4 |
Direct-to-consumer bypass |
Mid-term |
Stand-up limited DTC distribution (Section 804 import + cash-pay) to preserve margin and test demand outside PBM spread. |
+1-2pp |
5 |
Policy and legal defense |
Long-term |
Coalition litigation (APA, NFIB v. OSHA precedent) + trade-policy lobbying to slow or narrow a mandatory rule. |
"buys time" |
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Workstream
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Questions we will answer
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Work products
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1 |
Portfolio exposure mapping |
For your current and late-stage assets, how far is each U.S. net price from MFN parity? How much revenue, EBIT, and pipeline value is at stake brand by brand? |
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2 |
Scenario, sensitivity modeling |
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Monte-Carlo model (Excel) wired to your margin and tax assumptions + Three-scenario financial tables ready for earnings guidance |
3 |
Stakeholder behavior forecast |
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Stakeholder response matrix focused on your five largest payers + 10-interview voice-of-customer deck with verbatim quotes |
4 |
Strategic option testing |
Which levers — price-corridor redesign, launch resequencing, value-based contracts — protect the most EBIT for your portfolio in six months? |
Five-lever playbook deck showing EBIT saved per lever for your assets + 100-day action roadmap with owner, cost, timeline |
5 |
Policy and legal tracking |
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Live regulatory tracker filtered for your exposure + Investor talking points and FAQ tailored to your pipeline narrative |