5/8/2018 VERANTWOORD GEBRUIK VAN HOOGRISICO MEDISCHE HULPMIDDELEN: HET VOORBEELD VAN 3D GEPRINTE MEDISCHE HULPMIDDELEN 15 mei 2018 KCE, Belgian Health Care Knowledge Centre www.kce.fgov.be Semi-governmental institution Operational 2004 50 researchers medicine economics statistics, sociology, law Studies (n>300) Good clinical practice (GCP) guidelines Health services research (HSR) Health technology assessment (HTA) Methods Publieke financiering klinische studies 2 1
Onze missie 3 Achtergrond 3D-project Pact Medical Technologies (2016): Om de kwaliteits- en veiligheidsnormen van 3Dprinting van medische hulpmiddelen zo correct mogelijk te definiëren is aan het KCE gevraagd een studie uit te voeren naar de omkadering van de 3D-geprinte medische hulpmiddelen. 4 2
Typologie 3D geprinte medische hulpmiddelen Naar maat gemaakt MH (Custom-made) Uniek product productieproces werd specifiek voor het unieke hulpmiddel ontwikkeld. Op maat gemaakt/aangepast MH (Customisable) Op een gestandaardiseerde wijze geproduceerd. Aangepast via aantal parameters aan de patiënt. Standaard medische hulpmiddelen (Mogelijk) geproduceerd op grote schaal via 3D printing technologie omwille van complexiteit of prijs. 5 Scope Focus= Hoog-risico invasieve medische hulpmiddelen en implantaten Buiten scope: Printen van geneesmiddelen, weefsel, Veiligheid processen na het printen (polishing, sterilisatie) Veiligheid van de materialen op zich 6 3
Onderzoeksvragen 1. Wat is de evidentie over de veiligheid (voor de patiënt), werkzaamheid/doeltreffendheid & doelmatigheid (kosteneffectiviteit) van 3D geprinte medische hulpmiddelen? 2. Wat is het juridisch-beleidsmatige kader van 3D printen? 7 Legal qualification and classification Requirements for marketing and market entry Liability Insurance law issues Data protection Reimbursement Traceability Patients rights IPR Veiligheid & (kosten-) effectiviteit Vooraleer we dit kort toelichten, eerst wat achtergrondinformatie 8 4
Ontwikkelingssucces van nieuwe interventies? Opmerking: registratie/ce-label versus terugbetaling 9 Bron: kmrgroup.com FYI: Nieuwe regelgeving devices Nadruk nog steed op Safety & Performance 10 Compared to? 5
Klinische ontwikkeling en HTA voor innovatieve hoog-risico medische hulpmiddelen 11 Bron: KCE rapport 246 (publieke financiering van trials) Klinische ontwikkeling en HTA voor geneesmiddelen 12 Bron: KCE rapport 246 6
Wat zit er achter het CE-label??? Pre-market clinical trials in Europe are not made public BE UK NL 13 Bron: KCE reports 158 Veiligheid & (kosten-)effectiviteit - toegepast op 3D Methodologie Systematische review Focus op SR & RCTs Quality appraisal + evidence tables Descriptive presentation (No GRADE) 35 RCTs geïdentificeerd 14 7
Resultaten N Operative time Function Custom implants: Orthopaedics shoulder: 1 RCT 13 Surgical guides: Orthopaedics knee: 23 RCTs 1690 Orthopaedics hip: 2 RCTs 58 Orthopaedics shoulder: 1 RCT 31? Maxillofacial surgery: 2 RCTs 30 Model for surgery planning: Orthopaedics shoulder: 1 RCT 46? Orthopaedics ankle: 1 RCT 30? Maxillofacial surgery: 1 RCT 37? Model for implant shaping: Maxillofacial surgery: 1 RCT 57? Cranial surgery: 1 RCT 39? 15 Conclusies (cost-)effectiveness In general no conclusions on (long-term) patient-relevant outcomes (e.g. rehospitalisation, QoL, LT safety) Patient-specific surgical guides for orthopaedic surgery, and total knee arthroplasty no effect on mechanical axis malalignment only limited decrease in operative time For most other indications Small trials and/or no significant effects Cost-effectiveness? 16 8
Legal issue: Requirements for placing custom-made and customisable 3D printed MD on the market Current no CE marking / no quality system req. / no conformity assessment req. only Annex VIII statement req. + essential req. Future Customisable standard MD... 17 Traceability PIP scandal additional rules UDI (not for CM devices and hospital-produced MD) Registration UDI-DI and other core elements in UDI database; Registration manufacturers and importers in database of the European Commission; EUDAMED-database; Class III implants: economic operators and healthcare institutions store and save UDIs of the MDs they delivered or have been supplied with. Implant card for patients 18 9
Reimbursement Reimbursement request but refused because no/little evidence, too expensive or no budget Now: can be charged to the patient (~hospital), even if equivalent alternative exist (Logic?) Proposal: if safety sufficiently guaranteed Reimbursement level of the alternative Firm/patient: innovation is not blocked RIZIV: possibility to control budget Patient information is needed! 19 Reimbursement No reimbursement request introduced Can be charged to patient Inform patient that he/she pays for possibly innovative device for which a reimbursed alternative exists. Enforceability? No/little evidence and no appropriate (reimbursed) alternative? case-by-case evaluation Separate reimbursement for services linked to 3D printed devices? Added value is priority Decrease operation time no impact for payer 20 10
VOORSTEL: Introduction high-risk (3D) medical devices FYI: CE label Dev.1 Dev.2 I D E A L Reference centres Optimal use existing databases Reimbursement (level alternative) RCT (relevant >price? comp., endpoints) High potential of optimal use existing data Positive for manufacturer, physician, patients & government Independent analysis based on complete info from existing databases (incomplete) reporting of 3rd party Prospective/proactive No extra effort from physicians Use UDI Also applicable for non-reimbursed med. dev. Suggestion: start with high-risk implants Collaboration - working group! 22 11
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