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TFPA Discussion Paper

The Unmeasured Years

Why great launches still keep patients waiting, and the case for a common measure of Time to First Patient Access.

A considered, fully referenced look at the gap between approval and the first patient actually receiving a therapy, what that wait costs, why it persists, and what artificial intelligence is about to do to the whole picture.

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No form, no sign up. Nine pages. Every material figure referenced.

Cover of The Unmeasured Years discussion paper, click to download the PDF

What is inside

  • The paradox of the celebrated launch, told through Trikafta and its four very different market clocks.
  • The systemic evidence: the EFPIA access data, plus Zolgensma and CAR T as parallel cases.
  • What a day of delay actually costs, and why a shorter patent runway makes it cost more.
  • Why the delays persist: the expert view on pricing, assessment and launch sequencing.
  • What AI does to the picture, and the asymmetry it creates.
  • The case for a shared, forward looking measure of launch success.

A few of the numbers

532 days
Median wait from approval to patient access across Europe (EFPIA W.A.I.T. 2025).
~$500k
Peer reviewed estimate of the cost of a single day of launch delay (Tufts CSDD, 2024).
28%
Share of new medicines fully available on public reimbursement lists, down from 42% in 2019.
25% to 50%
Estimated AI time and cost savings in discovery to preclinical (BCG and Wellcome, 2023).
Download the paper (PDF)

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