Klisyri (tirbanibulin) SMC card - digital

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Tirbanibulin 10mg/g ointment (Klisyri®) SMC23951

The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and, following review by the SMC executive, advises NHS Boards and Area Drug and Therapeutics Committees (ADTCs) on its use in NHSScotland. The advice is summarised as follows:

Advice: following a full submission

Tirbanibulin (Klisyri®) is accepted for use within NHSScotland.

Indication under review: field treatment of non‑hyperkeratotic, non‑hypertrophic actinic keratosis (Olsen grade 1) of the face or scalp in adults.

In two phase III studies, a greater proportion of adults with actinic keratosis affecting an area of 25cm2 on the face or scalp achieved complete clearance when treated with tirbanibulin ointment 1% compared with vehicle.

About the SMC

The Scottish Medicines Consortium (SMC) is part of Healthcare Improvement Scotland, the national healthcare improvement organisation for Scotland. SMC reviews new medicines that have received a licence from the Medicines and Healthcare products Regulatory Agency (MHRA – the licensing body for the UK). SMC also reviews new formulations of, and new ways to use, established medicines. Before a medicine can be prescribed routinely in Scotland, it has to be accepted for use by SMC. SMC advice helps the health service plan for the quick, uniform introduction of beneficial treatments across NHSScotland.

Reference

  1. Scottish Medicines Consortium. tirbanibulin 10mg/g ointment (Klisyri®) SMC2395. SMC, December 2021. https://www.scottishmedicines.org.uk/medicines-advice/tirbanibulin-klisyri-full-smc2395/

The production of this Guidelines summary card has been commissioned by Almirall Ltd. Almirall Ltd has reviewed the card for technical accuracy and regulatory compliance and supplied the prescribing information. This summary card only displays the concise guidance; readers are strongly advised to refer to the full guidance at: https://www.scottishmedicines.org.uk/medicines-advice/tirbanibulin-klisyri-full-smc2395/

The guidance is reproduced with permission of the Scottish Medicines Consortium (SMC). Copyright of the guidance rests with the SMC, and it may be freely reproduced for educational and not-for-profit purposes. No reproduction by, or for, commercial organisations, or for commercial purposes, is allowed without the express written permission of the SMC.

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IE-KLI-2100010

Date of preparation: December 2021