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Biopharma · HTA & evidence strategy

A citation-verified evidence synthesis and interactive executive briefing that benchmarks HTA precedent across roughly 20 HTA bodies to shape the Phase III design and global launch strategy of a late-stage biologic.

Client
DreamBig Health, for a global biopharmaceutical company
Role
Fractional Director, HTA & Evidence Generation Policy
Period
2025 – present
Practices
HTA & market access strategy, Clinical evidence & endpoint strategy, Pricing & health policy analysis, Economic evaluation & modeling

~20

HTA bodies benchmarked

6

regulators advised on

9

markets in the policy synthesis

The challenge

A trial can win approval and still stall at reimbursement. The sponsor needed endpoint, comparator and evidence choices that would hold up under HTA scrutiny in every launch market, while U.S. and global pricing policy shifted underneath the plan.

What we did

  1. 01Benchmarked regulatory approvals and first-wave HTA and reimbursement outcomes for the established therapies in the category.
  2. 02Mapped cost-effectiveness requirements, preferred analysis types and threshold conventions across roughly 20 HTA bodies, including NICE, HAS, G-BA/IQWiG, CADTH, ICER and PBAC.
  3. 03Designed the Phase III endpoint hierarchy. The anchoring patient-reported outcome was chosen after weighing the candidate instruments on content validity, responsiveness and meaningful within-patient change, grounded in systematic review and meta-analysis.
  4. 04Compared trial designs, endpoint structures and comparator options, and assessed the feasibility and limits of indirect comparison.
  5. 05Kept regulatory status, HTA conclusions and confirmatory-evidence strategy as separate lenses. Every claim is footnoted, labeled with its confidence, and bounded by an explicit evidence-gap log.
  6. 06Modeled exposure to IRA price negotiation and most-favored-nation pricing, then re-sequenced the evidence plan around 2026 policy shifts using a likelihood-by-impact risk matrix.

Four questions the synthesis answers

  1. 1

    Where is the access signal strong, and where is it weak, in each launch market?

  2. 2

    Which regulatory facts must be kept apart from HTA conclusions?

  3. 3

    Which endpoint and instrument differences matter for comparator anchoring and payer acceptance?

  4. 4

    Which evidence gaps still block a stronger value story, and what should not be claimed?

The outcome

  • An interactive executive briefing app covering the market-access landscape, comparator strength, evidence-gap priorities, the regulatory picture and global HTA requirements.
  • Advice on Phase III design, endpoints and confirmatory evidence for FDA, EMA, MHRA, Health Canada, TGA and PMDA.
  • EU Joint Clinical Assessment readiness planning alongside the NICE, IQWiG, HAS, CADTH and PBAC frameworks.
  • Delivered by a cross-functional team of health economists, software engineers and reimbursement specialists, supervised end to end.

The client, asset and indication are confidential.

Next engagement

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