Long-form thinking on evidence, access, and consequence.
Perspective for senior biopharma leaders on the decisions that determine whether a medicine reaches patients: health technology assessment (HTA) and Joint Clinical Assessment (JCA) readiness, United States pricing pressure, and the discipline of building evidence that earns access.
What I am writing toward
Three forces are acting on biopharma value and evidence strategy at once. Health technology assessment is expanding from single-product judgments toward system-level appraisal. Equity of access is moving from an aspiration to a formal assessment input, with distributional questions asked inside the evaluation itself. And every coverage decision now carries an explicit opportunity cost, with disinvestment from low-value care becoming an active policy lever rather than a theoretical one.
Each of these is manageable in isolation. What I call the three-front convergence is the harder fact: they are arriving simultaneously, and the simultaneity is the challenge. Evidence built to answer one front can fail another. The field is beginning to name these pressures now; I have been describing their convergence, in the language of value, for far longer than it has had a name. This series is where I work the convergence through, one front at a time, into something a leader can actually use.
When the Scope Outruns the Evidence: Europe's First Joint Clinical Assessment
The first place the convergence is already visible is the Innovation Pressure front, where Europe's Joint Clinical Assessment turns a system-level ambition into a live test of what an evidence base can produce.
The European Union published the first Joint Clinical Assessment in its history. Its scope set eight comparisons; the report answered one. That ratio is the clearest sign yet of the operationalization gap: the distance between what a Joint Clinical Assessment (JCA) scope demands and what an evidence base can actually produce. It is also why evidence packages now have to be built for several fronts at once.
What the first assessments are showing
When I wrote that a JCA scope is set by the questions member states pose, while the evidence is set by what a development program was built to produce years earlier, that was a structural claim. The assessments since have borne it out. Europe's first report could answer only one of the eight comparisons its scope demanded, because its pivotal trial was single-arm. The second and third answered in full, because they arrived with randomized evidence. Across every assessment so far, including the two the coordination
group discontinued before completion, the discriminator was never the strictness of the bar, or whether a medicine was orphan. It was whether the evidence base was built to feed the assessment. A documented absence of evidence is defensible; an undocumented one is not. I will not read more into a young system than it has shown. What it has shown, consistently, is a system learning in public, and there is real opportunity in treating it like one.
The Evidence Architecture series
A continuing series that takes the three-front convergence one front at a time and works it through to something usable: how evidence is built, sequenced, and defended across the moments that decide access.
It is written for the leaders who have to make those calls before the answer is obvious.
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If your evidence has to stand on several fronts at once, let us think it through together.
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Frequently Asked Questions
I write about evidence strategy for biopharma: how health economics and outcomes research (HEOR), real-world evidence, clinical, and patient-focused drug development come together into a value narrative that earns access. A smaller set of pieces addresses leading evidence: how the people who own evidence strategy actually lead the function and the decisions inside it. Pure leadership and coaching content lives on The Discernment Practice subpage.
I publish when a piece earns its place. That protects the depth that makes the writing worth reading, and new pieces are announced on LinkedIn.
Yes. These pieces are written to be referenced. Please cite them with a link and attribution to Schiffon Wong, Schiffon Wong Strategic Advisory. For republication or to quote at length, reach out and I will say yes wherever I reasonably can.
My published work is independent rather than commissioned. I am, however, open to collaboration and joint publication with researchers and peers whose work intersects mine; if you have a piece in mind, I would welcome the conversation. The contact page is the place to start.
