Pricing & Reimbursement in France

Pricing & Reimbursement in France At a Glance Key Considerations France has a centralized pricing and reimbursement system, with a substantial amount of influence held by the Transparency Commission • The TC considers if a drug should be reimbursed, based on its • The TC does not publish guidance on trial endpoints, of the Haute Autorité de Santé, although public and private insurers are also involved in pricing decisions. medical benefit (SMR‡) and clinical added value, compared comparator or duration, however, it does prefer French with existing therapies (ASMR). patients to have been included in the study. Reimbursement of effective drugs is generous, however there are large patient copayments (often covered by complementary insurance) for ambulatory treatments that are less effective. • The CEESP reviews a manufacturer’s economic analysis to • The CEPS is made up of many stakeholders, including ensure compliance with HAS guidelines and evaluate the cost representatives of the MoH, MoF, MoR and insurers (public per QALY. and private). • Reimbursement is set by UNCAM using the SMR granted by the • The CEPS sets price/volume agreements, considering Pricing and Reimbursement Process TC—final listing is approved by the MoH. Hospital-only drugs comparator prices–as well as three-year sales forecasts, with SMR “important” and ASMR I–III ratings are placed on the likely real-world usage and target population size. “liste-en-sus,” (high-cost drugs reimbursed outside the hospital Submit dossier* and budget), which provides extra financial support by health set initial price request insurance, in addition to the standard hospitalization rates.

Manufacturer In Practice ** Submit Information Assessment of dossier Economic assessment TC of HAS 30 days 90 days 90 days CEESP Concerns cited by CEESP with manufacturer economic analyses submitted (2011-16)**1 CEPS Structural choices Measurement and Modeling Study objective Results presentation No concerns SMR Reimbursement UNCAM & MOH calculation of health and sensitivity analysis states and costs *** Patient Groups Important 65% to 100% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Possible step Moderate 30%

Mild 15% n=19 Insufficient None included at least one of dossiers were % important and/or major % completely invalidated 89 methodological concern 37 by major concerns

180 days ASMR Pricing rule Negotiated with CEPs, 1–3 considering EU5 prices SMRs and ASMRs granted in 20192

4 At comparator price 1% ASMR=Amélioration du Service Médical Rendu 5 Lower than comparator price 4% (improvement in medical 19% 11% I benefit); CEESP=Commission Important Évaluation Économique et de II Santé Publique; CEPS=Comité Moderate 6% III Économique des Produits de Santé; Possible price Price SMR Minor Oncologics negotiation negotiated or set HAS=Haute Autorité de Santé; 7% IV ICER=incremental cost-effectiveness 68% Insufficient ratio; MoF=Ministry of Finance; V 90 days MoH=Ministry of Health; MoR=Minstry of Research; 84% QALY=quality-adjusted life-year; SMR=Service Médical Rendu Agreement and Reimbursement set (medical benefit); TC=Transparency *Two-part submission: a technical file and an economic file, evaluated by the TC and CEESP/CEPS, respectively; **Economic assessment by CEESP if there is likely to be a significant contracting and price published Commission; UNCAM=Union spending impact, or if the manufacturer is seeking an ASMR of I–III; †Generally 65% for a typical ambulatory prescription and 100% for a hospital/specialist prescription; ‡Based on Nationale des Caisses efficacy, safety, the position of the medicine in the therapeutic strategy and the availability of therapeutic alternatives d’Assurance Maladie 1. Toumi M et al. J Mark Access Health Policy 2017; 5:1344088. 2. Haute Autorité de Santé Activity Report 2019. MARKET ACCESS & PHASE IV SOLUTIONS Experience Forward Thinking

Learn more at labcorp.com