Market access strategy, HAS/CEESP health economics files, CEPS negotiation and post-listing studies. Our models are grounded in French real-world data from the SNDS and our specialised EDS.
From burden of disease to post-listing studies, we produce the evidence that supports your market access strategy with HAS and CEPS.
Estimation of prevalence, incidence, mortality, direct costs (hospitalisations, treatments, chronic conditions) and indirect costs (sick leave, productivity loss). Basis for quantifying unmet medical need and the target population.
3 to 5-year projection of the financial impact on the French National Health Insurance of introducing your product. Modelling of market shares, penetration rates, therapeutic switches and generated savings. Key deliverable for the CEPS.
Markov models, microsimulations, decision trees. Calculation of the incremental cost-effectiveness ratio (ICER) and QALYs. CEESP deliverables compliant with the HAS methodological guide.
Drafting of reimbursement applications (SMR/ASMR for the CT, health economics section for the CEESP), CNEDIMTS files for medical devices, renewal applications and post-listing studies.
Each file meets the specific requirements of the authority evaluating it. Our in-depth knowledge of their assessment frameworks maximises your chances of success.
The CT assesses the Medical Benefit (SMR) and the improvement in SMR (ASMR) of your product. It takes into account disease severity, efficacy, adverse effects, place in the therapeutic strategy and public health interest.
The Commission for Economic Evaluation and Public Health delivers an efficiency opinion on products claiming an ASMR I, II or III. It assesses the methodological quality of the health economic model and the robustness of the parameters.
The Economic Committee for Health Products sets the drug price and negotiates volumes, rebates and performance clauses. Budget impact analysis and international price benchmarks are its preferred arbitration tools.
CNEDiMTS evaluates the Expected Benefit (SA) and ASA of medical devices. The ANSM is involved in post-marketing safety studies, risk management plans (PGR) and risk minimisation measures.
From early access to post-listing studies, we intervene at every critical phase of your product's journey in France.
Strategy preparation ahead of marketing authorisation. Target population estimation, burden of disease, unmet medical need. Price positioning framework and competitive landscape analysis.
Preparation of the transparency file for the CT (SMR/ASMR) and the health economics section for the CEESP (if ASMR I-III). Modelling, sensitivity analyses, systematic literature review.
Preparation of the price rationale, budget impact and economic file for negotiation with the CEPS. Support for rebate strategy and performance-based contracts.
Post-listing studies (HAS or ANSM request), appropriate use studies, 5-year reimbursement renewal. RWE data from the SNDS and our EDS to confirm commitments made at first listing.
Models fed by French real-world data, compliant with the CEESP and HAS methodological requirements.
Top-down approach (SNDS target population) and bottom-up (per-patient costs). Penetration scenarios based on real prescription data (THIN, SOG Health). Sensitivity analyses on main drivers.
Validated Excel model, BIA report compliant with ISPOR standards, CEPS summary note, negotiation scenarios.
Markov models, microsimulations, decision trees adapted to the pathology. Cost parameters from the SNDS (no theoretical GHS tariffs). EQ-5D utilities from the literature or surveys. Adapted time horizon (lifetime if necessary).
Validated model, CEESP technical report, deterministic and probabilistic sensitivity analyses, acceptability curves.
Phenotyping algorithms on the SNDS to identify patients. Analysis of care pathways, average per-patient costs (hospitalisations, pharmacy, procedures), mortality and comorbidities. Case-control comparison if necessary.
Epidemiological report, target population estimate for the CT file, unit costs to feed BIA and cost-effectiveness models.
Our HEOR models draw on the richness of SNDS data and our specialised EDS to produce parameters grounded in the reality of care delivery in France.
National medico-administrative data. 65M beneficiaries, prescriptions, medical consumption, hospitalisations.
CardioHub, UroCCR, Colibri, DataMesh. Detailed clinical data by therapeutic area.
Electronic medical records from primary care. 3,050 GPs, 3.1M active patients per year, 15 years of history.
Pharmacy dispensing data. 85% of French pharmacies, real prescription patterns.
Our analyses rely on the best French health data sources, CNIL-authorised, HDS-certified and compliant with regulatory standards.
Strengthen your market access file with robust French data. Our HAS/CEPS analyses help pharma companies achieve favourable decisions.