MFN & Global Pricing: what's your real exposure?

Before you delay your European launch to protect your US price, put a number on what you're actually protecting — and what you're giving up.


The fear


Since the US Most-Favored-Nation (MFN) pricing push, biotechs have been postponing European launches to shield their US price. The instinct is understandable: launch in Europe at a lower price and it could travel back to the much larger US market. Reuters, citing GlobalData, reported EU drug launches fell by about 35% in the ten months after the executive order — though a direct causal link remains unproven.

But the fear is usually bigger than the exposure.


The reality: the finalised rules are narrow


GLOBE brings international reference pricing into Medicare Part B — but only for a product that:


  • is a single-source drug or biologic under Original Medicare Part B;
  • falls within one of seven therapeutic categories;
  • exceeds $100 million in Part B spend over 12 months; and
  • isn't otherwise excluded or waived.


Excluded: orphan-only drugs, cell & gene therapies, plasma-derived products, IRA-negotiated drugs, and originators once a biosimilar is listed. GLOBE applies only in areas covering about 25% of Part B beneficiaries, its performance period begins 1 April 2027, and it faces a PhRMA legal challenge.


GUARD (Part D) remains only a proposed model — its final scope is uncertain.


And the reference basket is 19 countries. Delaying Europe alone doesn't remove exposure — only staying out of all 19 would, a far bigger decision than postponing Europe.


For many biotechs, the direct exposure is small.


The real question is a pricing question


Before postponing an EMA submission, you should be able to answer four things:


  • Scope — is your product even within GLOBE's scope, or potentially GUARD's?
  • Exposure — which reference countries matter, and what benchmark could they set?
  • Cost of waiting — a therapy worth $50M/year in Europe gives up ~$100M over a two-year delay, plus ground ceded to competitors who launch first.
  • US strategy — the real effect on net revenue, rebates and payer contracting.


For orphan drugs, cell & gene therapies, and assets below the threshold or outside the seven categories, delaying Europe offers little MFN protection — while the opportunity cost is substantial.


Most companies can't put a number on this. That's exactly what I do.


What I do — the MFN Exposure & rNPV Check


For your asset, I tell you:


  • whether you're genuinely in scope for GLOBE or GUARD;
  • which reference countries and benchmarks actually matter;
  • the European revenue and competitive position you'd forgo by delaying; and
  • the net effect on your risk-adjusted value (rNPV) under today's US–EU price convergence.


The deliverable is a defensible answer in plain terms: the specific US mechanism you're protecting against, and the number attached to it.


Who it's for


US and Chinese biotechs weighing a European launch, and biotech teams approaching EMA submission, partnering or launch decisions without a large internal pricing function.

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