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Pharmacoeconomic Review Report: Cyclosporine (Verkazia)

(Santen Canada Inc.)

Indication: Treatment of severe vernal keratoconjunctivitis in children from four years of age through adolescence

CADTH Common Drug Review

Cyclosporine (Verkazia) is a topical ophthalmic emulsion (0.1% weight by volume) indicated for the treatment of severe vernal keratoconjunctivitis (VKC) in children from four years of age through adolescence. Cyclosporine 0.1% is supplied as 30 single-use containers containing 0.3 mL unpreserved emulsion at a price of $110.1 The recommended dose is four drops daily in each affected eye. The dose can be reduced to one drop twice daily once adequate control of signs and symptoms is achieved. According to the clinical expert consulted by CADTH, the treatment is administered in response to VKC symptoms, which may be seasonal. At the submitted price, cyclosporine 0.1% would cost $14.68 daily assuming dosing at four separate times each day.

The manufacturer submitted a cost-utility analysis of cyclosporine 0.1% plus standard of care (SOC) compared with SOC in pediatric patients with VKC. SOC was defined as corticosteroid eye drop rescue medication and the use of over-the-counter lubricant eye drops. The analysis was conducted from the perspective of a Canadian publicly funded health care payer, with both costs and quality-adjusted life-years (QALYs) discounted at a rate of 1.5% per annum over a nine-year time horizon (i.e., until patients reached the end of adolescence, defined as 18 years of age). The model structure was a Markov state transition model with three health states: symptomatic, asymptomatic, and death. Among the modelled patients, 55.4% were assumed to have perennial VKC and remained in the symptomatic health state; the remaining patients (with seasonal VKC) alternated between the symptomatic and asymptomatic health states every six months.3 Patients had a monthly baseline risk of death. In the symptomatic health state, a constant proportion of patients were assumed to have treatment-emergent glaucoma. The key clinical outcome in the model was the Quality of Life in Children with Vernal Keratoconjunctivitis (QUICK) questionnaire score. Specifically, patients in the symptomatic health state accrued treatment-specific utility decrements based on mapping QUICK questionnaire VKC symptoms domain scores and daily activities domain scores as reported in the VErnal KeratoconjunctiviTIs Study (VEKTIS); a disutility was also associated with glaucoma. Direct medical costs were estimated from Canadian sources with the use of corticosteroids and eye drops based on the VEKTIS trial.

In the manufacturer’s base case, cyclosporine 0.1% plus SOC was associated with an incremental cost-utility ratio (ICUR) of $85,003 per QALY gained when compared with SOC alone. At a willingness-to-pay threshold of $50,000 per QALY, cyclosporine 0.1% plus SOC had a 0.03% probability of being cost-effective compared with SOC alone.

Version: Final

Funding: CADTH receives funding from Canada’s federal, provincial, and territorial governments, with the exception of Quebec.

Disclaimer: The information in this document is intended to help Canadian health care decision-makers, health care professionals, health systems leaders, and policy-makers make well-informed decisions and thereby improve the quality of health care services. While patients and others may access this document, the document is made available for informational purposes only and no representations or warranties are made with respect to its fitness for any particular purpose. The information in this document should not be used as a substitute for professional medical advice or as a substitute for the application of clinical judgment in respect of the care of a particular patient or other professional judgment in any decision-making process. The Canadian Agency for Drugs and Technologies in Health (CADTH) does not endorse any information, drugs, therapies, treatments, products, processes, or services.

While care has been taken to ensure that the information prepared by CADTH in this document is accurate, complete, and up-to-date as at the applicable date the material was first published by CADTH, CADTH does not make any guarantees to that effect. CADTH does not guarantee and is not responsible for the quality, currency, propriety, accuracy, or reasonableness of any statements, information, or conclusions contained in any third-party materials used in preparing this document. The views and opinions of third parties published in this document do not necessarily state or reflect those of CADTH.

CADTH is not responsible for any errors, omissions, injury, loss, or damage arising from or relating to the use (or misuse) of any information, statements, or conclusions contained in or implied by the contents of this document or any of the source materials.

This document may contain links to third-party websites. CADTH does not have control over the content of such sites. Use of third-party sites is governed by the third-party website owners’ own terms and conditions set out for such sites. CADTH does not make any guarantee with respect to any information contained on such third-party sites and CADTH is not responsible for any injury, loss, or damage suffered as a result of using such third-party sites. CADTH has no responsibility for the collection, use, and disclosure of personal information by third-party sites.

Subject to the aforementioned limitations, the views expressed herein are those of CADTH and do not necessarily represent the views of Canada’s federal, provincial, or territorial governments or any third party supplier of information.

This document is prepared and intended for use in the context of the Canadian health care system. The use of this document outside of Canada is done so at the user’s own risk.

This disclaimer and any questions or matters of any nature arising from or relating to the content or use (or misuse) of this document will be governed by and interpreted in accordance with the laws of the Province of Ontario and the laws of Canada applicable therein, and all proceedings shall be subject to the exclusive jurisdiction of the courts of the Province of Ontario, Canada.

Copyright © 2020 Canadian Agency for Drugs and Technologies in Health.

The copyright and other intellectual property rights in this document are owned by CADTH and its licensors. These rights are protected by the Canadian Copyright Act and other national and international laws and agreements. Users are permitted to make copies of this document for non-commercial purposes only, provided it is not modified when reproduced and appropriate credit is given to CADTH and its licensors.

Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at http://creativecommons.org/licenses/by-nc-nd/4.0/

Bookshelf ID: NBK558372PMID: 32579317

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