The evidence for a Notified Body is not the evidence for CNEDIMTS, G-BA, or NICE. Eclevar designs PMCF programs that satisfy both — from Day 1.
Only 43% of CE-marked TAVI devices achieve full EU-wide reimbursement.
Average monthly revenue lost for each month of HTA delay.
Average delay between CE Mark and first HTA decision without dual-strategy.
Notified Bodies assess safety vs state of the art. HTA bodies assess comparative effectiveness vs standard of care with health economic models.
Safety and performance. 12-month patency. Freedom from device-related AEs. Annex XIV hierarchy.
Comparative effectiveness. QALY quantification. ICER thresholds. 5-year budget impact. National cost data.
One protocol. Co-primary endpoints. Design once, get reimbursed everywhere.
Two-step process: ASA I-V grading then CEPS pricing. TLR preferred over patency.
Europe's largest market. Demands MALE composite endpoints. CEC adjudication is mandatory.
Strict ICER threshold (£20-30k/QALY). Pragmatic: accepts RCT-validated endpoints.
Mandatory from Jan 2025 for Class III and IIb implantables. One common clinical dossier.
Globally standardized. Accepted by all HTA bodies and Notified Bodies.
HAS · IQWiG · NICEPatient-centered outcome. Kaplan-Meier analysis. Explicitly preferred by HAS.
BIA-RelevantNon-negotiable for QALY. Recalculated for FR, DE, and UK value sets.
QALY CalculationBoth technical (duplex) and patient-outcome (TLR) endpoints required.
Annex XIV + HASAmputation-free survival. The MALE equivalent for IQWiG in BTK.
IQWiG MALEValidated for peripheral health utility. Essential for functional outcomes.
VascuQoL ValidatedThe ICER per QALY is the universal output. Eclevar builds the complete Markov model alongside your clinical program.
• 5-Year Budget Impact Analysis (BIA)
• Monte Carlo Simulations (min. 1,000 for HAS)
• Probabilistic Sensitivity Analysis (PSA)
Transition probabilities derived from PMCF dataset.
A manufacturer had CE Mark but 18 months of failed HAS submissions. Their PMCF used primary patency but lacked TLR data required for reimbursement.
Eclevar Solution: Redesigned protocol mid-program, added TLR co-primary, retrospective DCB comparator arm, and Markov model with French value set.
We review your current PMCF program against HAS, G-BA, and NICE requirements to identify exactly what needs to change to make your evidence reimbursement-ready.
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