№ lp_2_1_12882
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Health technology assessment summary outlining the proposed PBS listing, clinical criteria, economic evaluation, and regulatory considerations for ciclosporin 0.1% eye drops in severe keratitis associated with dry eye disease.
Medicine: Ciclosporin 1 mg/mL (0.1%) eye drops
Brand name: Ikervis®
Sponsor: Seqirus (Australia) Pty Ltd
Regulatory authority: Therapeutic Goods Administration (TGA)
Registration date: 11 December 2020
Program: Pharmaceutical Benefits Scheme (PBS)
Restriction type: Authority Required (Streamlined)
Schedule category: GENERAL – General Schedule (Code GE)
Indication: Treatment of severe keratitis in adult patients with dry eye disease not improved despite tear substitutes
Population: Patients aged 18 years or older with severe keratitis and dry eye disease
Comparators: Best supportive care including preservative free artificial tears
Clinical criteria (initiation): Corneal fluorescein staining grade 4 (modified Oxford scale or equivalent) and OSDI ≥ 23; failure of optimised preservative free tear substitutes
Clinical criteria (continuation): Demonstrated adequate response at 6 months
Definition of adequate response: Improvement in CFS ≥ 3 grades and ≥ 30% improvement in OSDI from baseline
Prescriber restrictions: Ophthalmologist or optometrist
Economic basis: Cost-utility analysis versus best supportive care
Proposed treatment phases: Initiation; continuation; continuation after assessment of response
Price: 8 / 10 USD
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Guidelines for Management of HSV Keratitis
Year: 2014
Region / city: Tucson, Arizona
Topic: HSV Keratitis Management
Document Type: Medical Guidelines
Organization / Institution: University of Arizona
Author: Kristina Voss M.D., Todd Altenbernd M.D.
Target Audience: Healthcare providers, ophthalmologists
Period of validity: Not specified
Approval Date: May 2014
Date of Changes: Not specified
Topics: Ciclosporin Ikervis Keratitis