The data exists. The argument doesn’t.
Real-world evidence has been collected in-market, but never synthesized into a usable HTA dossier or payer value story. The data exists — the argument doesn’t.
Why this happens
Collecting data is not the same as building an argument
Many pharmaceutical companies invest heavily in real-world evidence collection — registries, observational studies, post-marketing surveillance. But the resulting datasets often sit in databases, unanalyzed or under-utilized.
The gap is between data and narrative. Payers don’t read raw datasets. They need structured dossiers with clear clinical and economic arguments, adapted to local HTA frameworks.
Without this translation layer, strong real-world data never reaches the people who make reimbursement decisions. The investment in evidence generation is wasted.
“We had three years of registry data. But when the HTA body asked for our local value dossier, we had nothing formatted for their process.”
— VP Market Access, MENA, Cardiovascular
Sound familiar?
Typical situations we hear
01
RWE collected but never synthesized
A post-marketing registry has been running for 3 years. The data is rich, but nobody has written the HTA-ready analysis.
02
Clinical data strong, value story weak
Phase III results are excellent. But the dossier lacks real-world context — local treatment patterns, comparator effectiveness, budget impact.
03
Multiple data sources, no integration
Claims data, registry data, and published evidence exist separately. No integrated evidence package connects them.
04
HTA submission deadline approaching
A reimbursement decision window is opening. The evidence hasn’t been compiled into the required format.
What breaks without intervention
The cost of doing nothing
Reimbursement decision delayed
Without a properly formatted dossier, HTA submissions are returned for revision. Timelines slip by 6–12 months.
Suboptimal pricing negotiation
Weak evidence presentation leads to lower negotiated prices. The gap between clinical value and reimbursed value widens.
Evidence investment wasted
Years of data collection produce no strategic return. Registry data becomes outdated before reaching decision-makers.
How MAG solves it
From raw data to payer-ready argument
1
Evidence inventory & gap analysis
We audit your existing data assets — clinical trials, registries, RWE, published literature — and identify what’s missing.
2
Data synthesis & analysis
Our biostatistics team analyzes the available data, runs the required comparisons, and produces statistical outputs HTA bodies expect.
3
Value dossier construction
We structure evidence into a formal HTA dossier — clinical benefit, safety, comparator analysis, budget impact, patient outcomes.
4
Payer messaging & objection handling
We develop payer-facing summaries, objection-response matrices, and budget impact scenarios tailored to each market.
5
Submission support
We prepare the complete submission package, including reference annotations, appendices, and reviewer-ready formatting.
Services we use to solve this
What you get
Typical deliverables
HTA value dossier
Budget impact analysis
Payer objection matrix
Evidence gap analysis report
Statistical analysis plan
Registry data synthesis
Reimbursement submission package
Real work. Measurable outcomes.
Related case studies
Global value dossier localized for 5 MENA markets: SGLT2 inhibitor in heart failure
✓ HTA-ready dossiers submitted in all 5 markets within same quarter
Read case study →
Payer objection handling matrix for CDK4/6 inhibitor: country-specific HTA responses across CEE
✓ Objection-response pairs used in 4 successful reimbursement submissions
Read case study →
Frequently asked
Common questions
What types of real-world data can you work with?
We work with all standard RWE sources: disease registries, claims databases, EHR, post-marketing surveillance, and patient-reported outcomes.
Do you handle the biostatistics?
Yes. Our team handles everything from statistical analysis plans to survival analyses, indirect comparisons, propensity score matching, and budget impact modeling.
How do you adapt dossiers for different HTA bodies?
We build modular dossiers adaptable for NICE, G-BA, HAS, TLV, AIFA, and other European HTA frameworks.
Can you help if we don’t have enough data?
Yes. We conduct evidence gap analyses and recommend pragmatic strategies — targeted literature reviews, published RWE synthesis, or focused data collection.
Still have questions about payer evidence?
Book a 20-minute scoping call. We’ll review your situation and suggest the fastest path forward.
Book a scoping call →
Browse all services
Have data that needs
a payer argument?
a payer argument?
Share your data situation — we’ll tell you what’s possible and propose a realistic path to HTA submission.
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
Advisory board transcription + structured AI summary
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.
// Query: SGLT2 real-world outcomes heart failure 2023–24
search("SGLT2 inhibitor heart failure RWE", {
years: [2023, 2024],
output: "structured_table"
})
// 2,140 records → 47 relevant
Processing 2,140 records...
RWE Evidence Map
DELIVER (Registry, 2024): dapagliflozin RWE in HFpEF — 28% reduction in HF hospitalization vs matched controls (HR 0.72, 95% CI 0.61–0.85)...