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Support builds for potential smoking cessation aid
With some existing nicotine replacement therapies marked for PBS removal, the RACGP has backed a new scheduling application for cytisine.
GPs may soon have another way to help patients quit smoking, with the Advisory Committee on Medicines Scheduling (ACMS) set to consider a new private application to make cytisine available in Australia.
According to an RACGP submission supporting the application, there has been little prior interest in registering the drug for use up until now, due to a perceived lack of return on investment for pharmaceutical companies.
However, cytisine has long been used for smoking cessation in herbal form and is already marketed in 18 countries throughout eastern and central Europe and Central Asia.
More recently, its availability as an over-the-counter product for smoking cessation has extended to Canada, Portugal, Spain, Italy and the UK, and RACGP President Dr Nicole Higgins believes it could make a big difference in Australia, should the application prove successful.
‘There has never been a more important time to help people quit nicotine products, including cigarettes and nicotine vaping products,’ she said.
‘Unfortunately, some of the approved medications for smoking cessation, including nicotine replacement therapy options like patches, are set to be removed from the Pharmaceutical Benefits Scheme [PBS] in a few months’ time.
‘We have asked Federal Health and Aged Care Minister Mark Butler to step in to prevent the possible removal of nicotine patches from the public scheme. Otherwise, we will regress in our fight against nicotine use in Australia.
‘In the meantime, approving this new medicine cytisine, will also play a key role in helping patients quit nicotine.’
The applicant has proposed to create new Schedule 2 and 4 entries for cytisine oral tablets, which would be used for a 25-day treatment course. The proposed amendment would include divided preparations containing 1.5 mg or less of cytisine per dosage unit in Schedule 2, and all other preparations containing in Schedule 4.
The college submission pointed out there is moderately certain evidence supporting the efficacy of cytisine for smoking cessation, and while it can cause some mild gastrointestinal symptoms, there is only a very low risk of serious adverse effects.
‘This medicine has a proven track record in smoking cessation, it has minimal side effects, and it is sorely needed to tackle the ongoing battle of nicotine addiction, particularly among our youth,’ Dr Higgins said.
‘It has been safely used in eastern Europe for smoking cessation since the 1960s. So, we support the application for this medicine to be scheduled as a smoking cessation aid and continue to urge the Government to step in and prevent the removal of nicotine patches from the PBS.’
The ACMS will consider the application next month.
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