Case Studies / Type 1 Diabetes clinical guidelines: international guid…
Market Access Access & Localization Endocrinology

Type 1 Diabetes clinical guidelines: international endocrinology guidance adapted to local market access realities

Challenge
International T1D clinical guidelines were scientifically strong but too globally framed to serve as practical tools for local market access teams navigating distinct reimbursement environments.
Approach
Mapped each priority market's access landscape, identified the gaps between international guidance and local reimbursement reality, and produced adapted reference documents for each market.
Result
Adapted guidelines adopted as the primary internal reference tool by Market Access teams across all priority markets.
The challenge

International guidelines do not speak the language of local payers

A leading endocrinology brand held rights to an advanced insulin delivery system for Type 1 Diabetes. The global medical team had produced a comprehensive clinical guidelines summary based on the latest international standards — ADA, EASD, and ISPAD recommendations.

The problem was translation. Not linguistic translation, but contextual translation. Each priority market had its own reimbursement criteria for T1D technologies: different definitions of 'inadequately controlled diabetes', different thresholds for device eligibility, different comparator technologies currently reimbursed.

Market Access teams in each country were using the international guidelines document as a scientific reference — but they found it difficult to directly deploy in payer meetings because the framing did not match their local HTA body's terminology or decision criteria.

International clinical guidelines are built for global scientific consensus, not for local reimbursement committees. The gap between the two is where access decisions are won or lost.

Our approach

What we did

1
Local access landscape mapping
Documented the reimbursement criteria, comparator technologies, and eligibility thresholds for T1D devices across 6 priority markets. Identified the specific points where international guidance diverged from local payer logic.
2
Gap analysis
For each market, produced a structured gap analysis: where does international guidance support the brand's access argument, where does it need supplementation, and where does local data take precedence?
3
Adapted reference document design
For each market, developed a concise adapted reference document: international guidance as foundation, with market-specific annotations, local data insertions, and payer-facing framing.
4
Medical and Market Access alignment
Cross-referenced all adapted documents with the global Medical Affairs team to ensure scientific accuracy was maintained throughout. Resolved 6 instances where local and global positions required careful alignment.
5
Training delivery
Delivered a 2-hour briefing for each market's Access team on how to use the adapted documents in payer dialogues, formulary submissions, and HCP education contexts.
Result

Measurable impact

All priority markets received adapted clinical reference documents aligned to their specific access environment. Market Access teams adopted the adapted guidelines as their primary internal reference tool, replacing the generic international document. Several markets subsequently used the adapted framework as a supporting annex in HTA submissions, with all receiving favourable assessments.

Locally adapted
clinical references
Delivered across all priority markets
Adopted as primary
internal reference
Replacing the generic international document across markets
2
HTA submissions supported by adapted framework — both favourable
Facing a similar challenge?

Tell us what you’re working on — we’ll show you relevant cases and suggest the fastest path forward.

Evidence Scanner
Evidence ScannerTM
AI infrastructure

AI-powered.
Expert-validated.

We built AI workflows into our daily practice — not as a marketing claim, but as the infrastructure that lets our medical experts deliver faster without cutting corners.

Research
Structured PubMed queries with narrative or table outputs
Monitoring
Weekly literature digests by drug, target, or topic
AI-Enhanced EDC
Electronic data capture with AI-assisted structuring of unstructured records
Fact-Checker
Claim verification against your source documents
AI accelerates. Our experts validate.
Every output goes through expert medical review before it reaches your team. AI handles structure and speed — we handle scientific judgement and MLR readiness.
Evidence Scanner · Research module
// Query: ribociclib OS data MONALEESA 2023–24
search("ribociclib overall survival", {
  years: [2023, 2024],
  output: "structured_table"
})
// 847 records → 23 relevant
Processing 847 records...
Evidence Summary
MONALEESA-2 updated OS (NEJM 2023): median OS 63.9 mo vs 51.4 mo (HR 0.76, 95% CI 0.63–0.93). Benefit maintained across all pre-specified subgroups...