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New rules allowing optometrists to prescribe lifitegrast dry eye therapy

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Australian optometrists will be able to prescribe dry eye therapy lifitegrast (Xiidra) from next month without the involvement of a medical practitioner, under updated Optometry Board of Australia (OBA) rules.

The therapy – marketed by Novartis under the brand Xiidra – was approved in January 2019 and is indicated for moderate to severe dry eye disease in adults for whom prior use of artificial tears has not been sufficient.

On 11 November, the OBA updated its Guidelines for use of scheduled medicines to include lifitegrast, which it described as a new topical schedule 4 (prescription only) medicine.

Luke Arundel.

The dry eye medicine has been added to the approved list of medicines in Appendix B of the guidelines, when it becomes available on the market. The update will come into effect 10 December 2021.

Under current arrangements, access to lifitegrast has be arranged through a medical practitioner.

“Allowing optometrists to prescribe lifitegrast will ensure thousands of Australians receive the medication they need without spending additional time and money seeking the treatment from a GP or ophthalmologist,” Optometry Australia chief clinical officer Mr Luke Arundel told Insight.

Optometrist Ms Margaret Lam, national president of the Cornea & Contact Lens Society of Australia and head of professional services at George & Matilda Eyecare, said the performance of lifitegrast had been promising based on feedback from overseas colleagues.

Margaret Lam.

“And this change in Australian prescribing will allow our patients with severe dry eye much better access to the medications they desperately need. We have so many severe dry eye sufferers in Australia that could benefit from an expansion in their dry eye treatment that this is a welcome addition for us as practitioners,” she said.

The OBA stated that while it considered endorsed optometrists qualified to prescribe topical lifitegrast, the authorisation remains subject to state and territory drugs and poisons legislation.

It also noted lifitegrast – the active ingredient in Xiidra – is subject to additional monitoring through the Therapeutic Goods of Australia’s (TGA) Black Triangle Scheme for adverse events in new medications.

The scheme provides a simple means for practitioners and patients to report adverse events associated with new prescription drugs or those being used in new ways.

The Black Triangle does not necessarily mean there are known safety problems, but the TGA is seeking to build a fuller picture of the medicine’s safety profile. This is because clinical trials generally have strict inclusion criteria and limited participants, and it is common for new adverse events to be identified after new medicines are used more broadly, or when existing medicines are used in a significantly different way.

“All medicines that enter the market have undergone clinical trials to ensure appropriate safety and efficacy, but it is important that they continue to be monitored for adverse effects as they become more widely used,” Arundel added.

The proposal to update the guidelines was supported by the majority of the OBA’s stakeholders, including key professional bodies, safety and community groups and government health departments.

An advance copy of the guidelines is available here, including the revised OBA-approved scheduled medicines list.

Arundel said there were no other therapies of interest listed on the OBA’s Guidelines for the Use of Scheduled Medicines, however “Optometry Australia is continually monitoring this space and has forwarded other new drugs to the OBA for consideration for future updates to the guidelines”.

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