№ lp_1_2_34255
File format: docx Character count: 124649 File size: 1398 KB
Year: 2023
Region / Country: Australia
Drug: Edaravone (Radicava®)
Type of Document: Pharmaceutical Benefits Submission
Regulatory Body: Therapeutic Goods Administration (TGA)
Submission Purpose: PBS Section 100 Highly Specialised Drugs Listing
Indication: Amyotrophic lateral sclerosis (ALS)
Treatment Phase: Initial and Continuing treatment
Prescriber Type: Medical Practitioners, Nurse Practitioners (continuing therapy only)
Clinical Criteria: Diagnosis by neurologist, disease duration ≤ 2 years, FVC or SVC ≥ 80% predicted, ambulatory or upper limb/swallowing ability, ALSFRS-R ≥ 2 on each item, no tracheostomy or respiratory failure
Population: Adult patients (≥18 years)
Pricing: Special Pricing Arrangements apply
Regulatory Dates: Orphan designation 17 August 2021, TGA registration 15 February 2023
Comparator: Standard of care with or without riluzole
Outcomes Measured: ALS Functional Rating Scale – Revised (ALSFRS-R) after 6 months
Price: 8 / 10 USD
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Amyotrophic Lateral Sclerosis Overview and History
Year of Discovery: 1870s
Location of Discovery: Paris, France
Medical Field: Neurology
Document Type: Informational article
Author: Samantha Budge
Target Audience: General public, students of human biology
Affected Population: Mostly active adults
Symptoms: Muscle weakness, poor balance, speech and swallowing difficulties, fatigue
Progression: Loss of mobility, respiratory support needed, dietary adjustments
Life Expectancy: Typically 2–8 years, occasionally over 10 years
Treatment Approaches: Medications for spasms and cramps, physical therapy, rest, dietary management
Topics: EDARAVONE mg20 Amyotrophic