№ files_lp_3_process_9_70822
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Systematic review addendum presenting the handling of company submissions, appraisal of clinical and economic evidence, and modelling assumptions for natalizumab and its biosimilar in highly active relapsing-remitting multiple sclerosis.
Producing organisation: Bristol Technology Assessment Group
Document type: Addendum to systematic review and economic model
Subject: Clinical and cost effectiveness of natalizumab and its biosimilar in highly active relapsing-remitting multiple sclerosis
Interventions assessed: Natalizumab (intravenous and subcutaneous) and natalizumab biosimilar (Tyruko)
Population: Adults with highly active relapsing-remitting multiple sclerosis after at least one disease-modifying therapy
Study inclusion criteria: Randomised controlled trials comparing eligible interventions or placebo
Comparators considered: Alemtuzumab, cladribine tablets, fingolimod, ocrelizumab, ofatumumab, ponesimod, interferon beta formulations, peginterferon beta 1a, glatiramer acetate
Manufacturers involved: Biogen and Sandoz
Assessment components: Clinical effectiveness review, network meta-analysis, cost-effectiveness modelling
Data sources: Company submissions, published literature, previous technology appraisals
Economic perspective: Cost-comparison submissions and EAG base case model
Geographical context: United Kingdom
Regulatory context: NICE technology appraisal process
Price: 8 / 10 USD
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Topics: Tyruko Relapsing-Remitting Disease-Modifying