Notified Bodies approve devices. HTA bodies decide whether they get paid for. Eclevar designs one protocol with co-primary endpoints that satisfies both — so you enter your first HTA submission with the evidence already built.
Notified Bodies assess safety versus state of the art. HTA bodies assess comparative effectiveness versus standard of care — with health economic models, QALY quantification and national cost data. These are two entirely different evidentiary standards — and most PMCF programmes are built for only one.
Safety and performance versus state of the art. 12-month patency. Freedom from device-related adverse events. Annex XIV evidence hierarchy. Clinical evaluation methodology.
Comparative effectiveness versus standard of care. QALY quantification. ICER thresholds per agency. 5-year budget impact model. National cost data and PRO instruments validated by country.
One protocol. Co-primary endpoints. We design the clinical programme so your CE Mark evidence is simultaneously your HTA dossier — built once, reimbursed everywhere.
Each HTA body has its own preferred endpoints, modelling standards and grading frameworks. A single submission strategy that ignores these differences costs you months and revenue.
Two-step process: ASA I–V grading then CEPS pricing negotiation. TLR preferred over patency. Markov model with French utility value set mandatory for Class III.
Europe's largest market. Demands MALE composite endpoints. CEC adjudication is mandatory. Monte Carlo PSA with 1,000 iterations minimum. Strong preference for RCT data.
Strict ICER threshold (£20–30k / QALY). Pragmatic: accepts observational data with strong bias control. EQ-5D-5L required for QALY. Budget impact for NHS commissioners.
Joint Clinical Assessment mandatory for Class III and IIb implantables from January 2025. One common clinical dossier. Early engagement recommended from protocol design phase.
The endpoint that gets you through a Notified Body review is often not the same one that gets you reimbursed. We design the co-primary endpoint hierarchy before protocol lock — so both are served by a single clinical programme.
Globally standardised. Accepted by all HTA bodies and Notified Bodies as the primary safety endpoint.
Patient-centred outcome. Kaplan-Meier analysis at 12 and 24 months. Explicitly preferred by HAS over technical patency.
Non-negotiable for QALY calculation. Recalculated for French, German and UK national value sets from the same dataset.
Both technical (duplex) and patient-outcome (clinically-driven TLR) endpoints required to satisfy NB and HAS simultaneously.
Amputation-free survival. The MALE composite equivalent for IQWiG in below-the-knee indications. Critical for German reimbursement pathway.
Validated disease-specific instrument for peripheral arterial disease. Essential for functional outcomes and health utility calculation in PAD programmes.
The ICER per QALY is the universal output that governs pricing negotiations with every HTA body in Europe. Eclevar builds the complete Markov model alongside your clinical programme — from the first protocol lock, not after the data is collected.
5-Year Budget Impact Analysis (BIA) — national cost data, admission rates, country-specific unit costs
Monte Carlo Simulations — minimum 1,000 iterations (HAS requirement), PSA with tornado diagrams
Probabilistic Sensitivity Analysis (PSA) — cost-effectiveness plane, CEAC, threshold analysis per country
Country value sets — EQ-5D utility recalculated for FR, DE, UK and EU JCA dossier in parallel
Transition probabilities derived directly from PMCF dataset. Model built in parallel with data collection — not retrospectively.
A manufacturer had CE Mark but 18 months of failed HAS submissions. Their PMCF used primary patency but lacked the TLR data required for reimbursement. Illustrative programme structure — not specific client data.
A Class III TAVI manufacturer had CE Mark but 18 months of failed HAS submissions. Their PMCF programme was built around primary patency — technically sound for the Notified Body, but inadequate for HAS which requires TLR data and a Markov model with the French utility value set.
Eclevar solution: Protocol redesigned mid-programme. TLR co-primary added with retrospective DCB comparator arm. Markov model built in parallel with French and German value sets. BIA constructed against the DRG reference tariff. ASA II grading achieved and CEPS pricing negotiation completed within 14 months of CE Mark.
We review your current PMCF programme against HAS, G-BA and NICE requirements to identify exactly what needs to change to make your evidence reimbursement-ready — free, 30 minutes, no obligation.
