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Emerging diagnostics
Market Access, Commercial, Medical Affairs
PET diagnostic radiotracer
Cardiology / Rare Disease
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Emerging diagnostics
Market Access, Commercial, Medical Affairs
PET diagnostic radiotracer
Cardiology / Rare Disease
The client was preparing for a U.S. launch of a novel PET diagnostic radiotracer in a highly complex reimbursement environment. In hospital outpatient settings, reimbursement for diagnostic radiopharmaceuticals is bundled, creating uncertainty around provider economics and adoption following pass-through expiration.
At the same time, coverage pathways and timelines varied by site of care, and there was limited clarity on how decision-makers evaluate diagnostic radiotracers once reimbursement becomes less transparent. The client needed a clear understanding of access risk, stakeholder decision dynamics, and evidence requirements to inform launch planning.
1. Conducted primary market research with U.S. stakeholders to assess reimbursement sensitivity, buying dynamics, and decision-driver influence across sites of care.
2. Evaluated coding, coverage, and payment mechanics for diagnostic radiotracers in hospital outpatient departments and independent diagnostic testing facilities.
3. Assessed relevant analogue products and policy dynamics to inform access expectations and risk mitigation strategies.
4. Developed a phased, launch-ready market access roadmap spanning pre-launch through post-approval.
Translate complex reimbursement mechanics into clear, actionable guidance the client could use to make confident launch decisions.
"Honestly, this helped us finally make sense of a really messy reimbursement situation and figure out what to do next.” - Vice President, Market Access
Access risk was clarified by site of care, with near- and long-term reimbursement pathways defined.
Priority evidence generation and payer engagement activities were identified to mitigate coverage and reimbursement barriers.
The client entered late-stage development aligned around a realistic, defensible market access strategy and clear next steps.