№ files_lp_4_process_2_81105
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Summary of regulatory submission for a protein-based enteral nutrition formula detailing proposed usage, pricing, comparators, and considerations for public health subsidy in Crohn disease management.
Year: 2023
Region / Country: Australia
Document type: Regulatory submission
Organization: Nestle Health Science
Product: Modulen® IBD
Formulation: Powder for oral liquid, 400 g
Intended use: Dietary management of Crohn disease in adults and children over 5 years
Requested quantity: 12 x 400g cans per prescription, 5 repeats
Price: AEMP $361.56, DPMQ $407.59
Place in therapy: First-line enteral nutrition for paediatric Crohn disease, alternative to corticosteroids
Clinical guidelines referenced: Gastroenterological Society of Australia (GESA) inflammatory bowel disease 2018 update
Comparator products: Peptamen Junior® for paediatric population, Fortisip® for adults
PBS listing request: Restricted Benefit
Access considerations: Rural and remote patient access, hospital-based programs
Regulatory standard: Australia New Zealand Food Standards Code — Standard 2.9.5
Price: 8 / 10 USD
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HIGH FAT FORMULA WITH VITAMINS, MINERALS AND TRACE ELEMENTS AND LOW IN PROTEIN AND CARBOHYDRATE, Oral liquid, 250 mL, 30, KetoVie 4:1, KetoVie 3:1, KetoVie Peptide 4:1, Cortex Health Pty Ltd
Year: 2023
Region / city: Australia
Topic: Medical foods
Document type: Application submission
Organ / institution: PBAC (Pharmaceutical Benefits Advisory Committee)
Author: Cortex Health Pty Ltd
Target audience: Medical practitioners, healthcare professionals
Period of validity: Not specified
Approval date: Not specified
Date of changes: Not specified
Supplementary Table 1. Search Strategy for Crohn Disease and Pharmacological Interventions (2020–Current)
Document type: Supplementary table
Subject: Crohn disease pharmacological treatment search strategy
Topic: Literature search methodology for inflammatory bowel disease therapies
Disease focus: Crohn disease
Interventions: Tumor necrosis factor inhibitors, monoclonal antibodies, JAK inhibitors, cytokine inhibitors, immunomodulators, aminosalicylates, methotrexate, azathioprine, mercaptopurine
Data sources: MEDLINE, Cochrane Central Register of Controlled Trials (CCTR), Embase
Search fields: Title, abstract, keywords, registry numbers
Search period: 2020–Current
Methodology: Structured database search strategy using controlled vocabulary and keyword combinations
Research context: Identification of studies on pharmacological treatments for Crohn disease
Topics: BETA-2 CARBOHYDRATE CROHN