HTA Bridge is building an AI-enabled evidence strategy and market access service for health technology developers. We help teams identify the right access route, strengthen evidence before submission, and plan recovery or reassessment when decisions are at risk.
Evidence Strategy for Health Innovation
HTA Bridge helps pharma, biotech, medtech, and digital health teams prepare for EU HTA and French market access. We combine route clarification, evidence strategy, and writing services so teams know what to do, what to produce, and what to strengthen before high-stakes decisions are made.
Not every product needs every committee, analysis, or evidence package. One of the first strategic decisions is to separate what is in scope from what is not, so time and budget go into the work that can actually change the decision.
For in-scope medicines, we review likely PICO exposure, comparator logic, endpoint relevance, subgroup credibility, and evidence vulnerabilities before national access decisions start to crystallise.
For medicines, we localise global evidence for French decision logic, including SMR/ASMR positioning, reimbursement implications, and CEESP scoping where an economic evaluation may be required.
For medical devices and digital health, we help determine whether CNEDiMTS, LPPR, or a transitional or anticipatory access route is likely to be relevant—and what evidence that route is expected to need.
After a negative or restrictive outcome, we help define whether the next step is reanalysis, supplementary evidence, real-world data, indication reframing, or a planned reassessment strategy.
Timing varies by product type, regulatory status, and data maturity, but access work usually clusters into four windows. The earlier the issue is identified, the more options are still open.
Stress-test comparator choice, endpoint hierarchy, subgroup strategy, and the evidence gaps most likely to create downstream friction.
Use this window to map the relevant access pathway, define the value story, and decide whether additional analyses are worth doing.
Focus on claims discipline, committee-facing narrative, final risk review, and go / no-go decisions on NMA or RWE work.
Use follow-up evidence, real-world data, or focused reanalysis to support recovery, re-entry, price discussions, or reassessment.
Each engagement is modular. We recommend only the packages that match your product, route, and timing, rather than forcing every programme through the same workstream.
Rapid scoping of the relevant EU and France route for your product type, stage, and claims. Deliverable: a concise pathway memo covering likely committees, required evidence types, decision dependencies, and near-term priorities.
Best first engagementStructured review of likely PICO exposure, comparator alignment, endpoints, subgroup plan, and clinical defensibility for products likely to face joint clinical assessment. Deliverable: a prioritised risk map and action plan before submission.
EU HTA · pre-submissionIdentification of the gaps most likely to weaken access or reimbursement decisions, with practical recommendations on comparator justification, endpoint hierarchy, indirect comparison options, and additional evidence priorities.
Upstream evidence planningMethodological go / no-go review before investing in an indirect comparison. We assess network geometry, transitivity, data consistency, and likely committee credibility so weak analyses are avoided early.
Evidence synthesis scopingFor single-arm, rare disease, or high-uncertainty programmes, we assess data-source fit, external control design options, operational feasibility, and likely HTA acceptability before study design is locked.
RWE · external controlsLocalisation of a global evidence package for the relevant French route. That can include SMR/ASMR framing for medicines, CEESP-oriented inputs where relevant, or CNEDiMTS / LPPR positioning for devices and digital health—plus a coherent dossier structure and defensibility map.
France localisationRoot-cause review after a negative, delayed, or commercially weak outcome. Deliverable: a pragmatic recovery plan covering reanalysis, new evidence, RWE support, pathway repositioning, or reassessment preparation.
Post-opinion action planScientific and strategic writing support across the access journey, including dossier sections, evidence summaries, review-ready narratives, and structured documents that connect claims, evidence, and committee expectations.
Core writing supportSupport for statistical analysis plans, study design choices, protocol production, and evidence-generation logic so the study is more likely to answer the questions that matter for HTA and reimbursement later.
Study planningFocused literature synthesis, ongoing evidence-gap monitoring, and comparator landscape tracking to identify where the value story is strong, where the evidence is thin, and what is changing in the published record.
Monitoring and synthesisStructured evidence reviews, systematic reviews, pairwise meta-analyses, and related synthesis work designed for decision use, with methods matched to the question, the data, and the expected level of scrutiny.
Evidence synthesis deliveryWe make access strategy clearer by separating route, timing, and evidence requirements before teams invest in the wrong work.
HTA Bridge · Access and reimbursement strategy
Reach out if you need to clarify the relevant route, pressure-test a dossier before submission, or define the next step after a negative or restrictive outcome. The fastest way to scope a discussion is to share product type, indication, geography, development stage, and next access milestone.