HEALTH TECHNOLOGY ASSESSMENT

Transcription

1 LIQUEZ POUR LIQUEZ HEALTH TEHNOLOGY POUR MODIFIER ASSESSMENT LES STYLES DU AESS TO MARKET HEALTH TEHNOLOGY ASSESSMENT omparative Effectiveness Research EMEA FDA PMDA (ER) NIE, IQWIG LAURENT DEGOS President HAS DEISION REIMBURSEMENT PRIING MOH LIQUEZ POUR INNOVATION ASSESSMENT LIQUEZ POUR MEDIAL ASSESSMENT To compare the effectiveness of innovation with existing care Fromefficacy to effectiveness (real life in the national context) To combine medical and economical assessments Is it good enough to be reimbursed? (national priorities) To make the choice of the best cost benefits ratio Is it better than any other treatment? (national availabilities) LIQUEZ PRINIPLES POUR LIQUEZ POUR FOUR PRINIPLES FOR 4 Scientific assessment independent of PAYERS (National Health Insurance) & DEISION MAKERS (MOH) Immediate single for a positive list of reimbursement and for pricing Separationof medical and economical assessments Delayed multiple full (class of products) according to multiple criteria and alternative care HAS (F) NIE (UK) IQWIG (G) Independent body/decision makers ( ) Immediate assessment for each product ( ) Separation medical and economical assessment Delayed multiple full

2 LIQUEZ IMMEDIATE POUR SINGLE MODIFIER LES STYLES DU LIQUEZ RULES POUR DRUG EXAMPLE IIII Effectiveness Actual linical Benefit Reimbursement «Is it good enough to be reimbursed Product : expected» effectiveness Disease : severity, alternative treatment RITERIA Patient population: specific clinical indication Public health interest Expected Effectiveness Expected Relative Effectiveness Expected Volume (Indication + Epidemiology) PRO Immediate positive list Price negotiation (pricexvolume) OVERAGE PRIING NEGOTIATIONS ON Uncertainties (need evidence development) Relative Effectiveness Improved Actual linical Benefit Pricing «Is it better than any treatment» 5 categories from «Major innovation» to «No improved linical Benefit» LINK WITH DEISION Actual Benefit rating: ratio NHI/ co pay settings ( rates) Insufficient no reimbursement Improved Actual Benefit ategory 5: lower price than competitors LIQUEZ OVERAGE POUR OF TEHNOLOGIES LIQUEZ OVERAGE POUR OF TEHNOLOGIES Single Early assessment of clinical benefit POSITIVE LIST lass INSUFFIIENT EVIDENE Reimbursement Pricing Appropriate use Delayed assessment of clinical & collective benefit AEPTABILITY? NEGATIVE LIST LIQUEZ OVERAGE POUR OF TEHNOLOGIES LIQUEZ POUR MEDIO EONOMIAL TEXTE DU EONOMIAL MASQUE APPROAH lass Single Delayed assessment of clinical & collective benefit SAFE & EFFIIENT Early assessment of clinical benefit INSUFFIIENT EVIDENE POSITIVE LIST Reimbursement Pricing Appropriate use Patients vs itizen Philosophy Types ost Benefit GOOD PRATIE REASSESSMENT

3 HIGH LIQUEZ OSTPOUR TEHNOLOGY O PIB LIQUEZ POUR QUESTION OF USTOMERS: PATIENTS AND ITIZEN New Strategy of ompanies Small population (Targeted Therapy / personalized Therapy) Price not related to ost (Discovery, Development, Production) but related to ratio expected incom / targeted population oncept of progressive Blockbuster First on small population (high degree of Efficacy) Extended to other patient population LIQUEZ OST PERFORMANE POUR LIQUEZ MEDIO EONOMIAL POUR EONOMIAL MODIFIER STUDIES LES STYLES : WHEN DU? OST-QALY threshold I Positive list and pricing immediately after market approval (actual clinical benefit and improved actual benefit) OST-EFFIAY (Willingness to pay) eiling II Delayed class full for good practice OST-BENEFIT Multi-parameters good practice III 5 years reviews and disinvestments LIQUEZ DELAYED ASSESSMENT POUR MODIFIER / MULTIPLE LES STYLES (FULL DU ) LIQUEZ MEDIO EONOMIAL POUR EONOMIAL MODIFIER STUDIES LES STYLES : DU TYPES MEDIAL BENEFIT REASSESSMENT Actual Effectiveness Actual Relative Effectiveness Actual Volume OLLETIVE BENEFIT Economics Organization Ethics Social Values I II SIMILAR EFFETIVENESS and TOLERANE = the less expensive Technology (ex. IE vs Sartans) DIFFERENES in EFFETIVENESS/TOLERANE and OST ost effectiveness ( medical indications: ex. Stents) Transparency ommittee Executive BOARD «OLLEGE» Recommendation based on matters (Disinvestment, revised Pricing) orrect Use - Good Practice Economic & Public Health ommittees ATIONS III INIDENE in OLLETIVE BENEFITS Full (ex. screenings)

4 LIQUEZ POUR DISSEMINATION LIQUEZ QUESTIONS POUR (ER) Pharmaceutical Devices Procedures OLLETIVE BENEFIT & PUBLI HEALTH Economy Social Value Organisational Ethics GUIDELINES Good Practice Patient Safety Public Health ATIONS HO Accreditation i PD ertification Information ertification hronic Disease Management Whyvarious«relative effectiveness» opinions? How to combine drug device procedure assessments? How to manage UNERTAINTIES (conditional requirements)? LIQUEZ POUR WHY RELATIVE EFFETIVENESS OPINION? LIQUEZ POUR OORDINATION AT EUROPEAN LEVEL. hoice Scientific set of data The best comparator Statistical methods for indirect comparisons. oncept. National Rule Reference to a scale from a group of experts or from citizen preference Rapid access of innovative technology National priorities, organization, ethical issues and social values Taxsystem and social insurance models LIQUEZ POUR OORDINATION AT EUROPEAN LEVEL Relative effectiveness LIQUEZ POUR OORDINATION AT EUROPEAN LEVEL A European dimension would help harmonize assessment tools and methods and define high performance instruments for data collection (evidence tables) help identify truly innovative technologies encourage the use of as a basis for national decisions enhance experience sharing among Member States to avoid wasting time and resources when performing assessments

5 LIQUEZ POUR OMBINATIONS OF TEHNOLOGIES LIQUEZ PROMISING POUR HEALTH MODIFIER TEHNOLOGIES LES STYLES DU TEXTE AND UNERTAINTY DU MASQUE Device + procedures Drug + procedure Drug + device + procedure Drugs + device Percutaneous valve replacement Drug limited to a genetic marker oated stents Patch Risks of making inappropriate decisions for access Delay potential benefits to patients by waiting for stronger evidence Introduce technologies with a weak assessment on effectiveness, efficiency and safety LIQUEZ POUR ONDITIONAL REQUIREMENTS LIQUEZ ONLUSIONS POUR MODIFIER : LES IN STYLES FRANE DU onditional APPROVAL onditional OVERAGE onditional PRIING Post listing STUDIES For more AESS Temporary use approval (F) Off label use (F) Innovation pass (UK) Fixed budget (price x volume) (F) For more EVIDENE Still in research (UK, G, F) One year (EMEA, E, I) Temporary reimbursement (USA, E, a, Australia) Risk sharing (UK) Post listing studies (F ) LIQUEZ POUR REOMMANDATIONS LIQUEZ POUR Technology assessment (comparative effectiveness research) independant of decision makers and payers Market approval at the level of common markets (FDA,EMEA,PMDA) HEALTH TEHNOLOGY ASSESSMENT Health technology assessment for reimbursement and good use at national level TEXT ONTEXT

6 LIQUEZ POUR THANK YOU