The JCA Early Birds: What we know and what to watch out for

Nick Stringfellow, Consultant at Lightning Health explores the key considerations that manufacturers should be aware of and the future lessons that will come following publication of the first JCAs, now that new oncology products and ATMPs are undergoing assessment.
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Abbreviations: AEMPS: Spanish Agency of Medicines and Medical Devices; AIHTA: Austrian Institute for Health Technology Assessment; AOTMiT: Agency for Health Technology Assessment and Tariff System ; ATMP: Advanced Therapy Medicinal Product; CHMP: Committee for Medicinal Products for Human Use; DMC: Danish Medicines Council; DVSV: Federation of Social Insurances; EMA: European Medicines Agency; EU: European Union; GVD: Global Value Dossier; HAS: National Authority for Health; HEOR: Health Economics and Outcomes Research; HTA: Health Technology Assessment; HTA: EU Health Technology Assessment Regulation; HTD: Health Technology Developer; INFARMED: National Authority of Medicines and Health Products; IQWiG: Institute for Quality and Efficiency in Health Care; ITC; Indirect Treatment Comparison; IZIV-INAMI: National Institute for Health and Disability; JAZMP: Public Agency for Quality in Healthcare; JCA: Joint Clinical Assessment; NCPE: National Centre for Pharmacoeconomics; NIHDI-INAMI-RIZIV: National Institute for Health and Disability Insurance; NIHO: National Institute for Value and Technology in Health; MA: Marketing Authorisation; MS: Member State; NNGYK: National Centre for Public Health and Pharmacy; NOMA: Norwegian Medical Products Agency; PICO: Population, Intervention, Comparator, Outcome; RCT: Randomised Controlled Trial; RWE: Real World Evidence; SMA: Spinal Muscular Atrophy; TLV: Dental and Pharmaceutical Benefits Agency; ZIN: Dutch National Health Care Institute