Shutterstock.com
Cytisinicline, a prescription-only medicine to support smoking cessation, could be added to the National Institute for Health and Care Excellence (NICE) stop-smoking guideline.
NICE has opened a consultation on adding the medicine to its existing guideline — ‘Tobacco: preventing uptake, promoting quitting and treating dependence‘ — which was published in 2021, before cytisinicline (also known as cytisine) was available.
The medicine was approved by the Medicines and Healthcare Regulatory Agency (MHRA) in 2019, but was not made available in the UK until January 2024.
Announcing the proposed update in its ‘2024 exceptional surveillance of tobacco: preventing uptake, promoting quitting and treating dependence’, NICE said: “The change in the availability of cytisine in the UK means that it should be considered alongside other interventions for smoking cessation.
“Given the evidence provided in the Cochrane review [of nicotine receptor partial agonists for smoking cessation, published in May 2023] and more recently published trials, it is apparent that cytisine should be listed in the medicinally licensed product recommendations as an option for people who smoke.
“There is evidence that the level of adverse events is less than those reported for varenicline and the costs of cytisine do not appear to be prohibitive to the recommendation.”
In a phase III trial, 33% of participants using cytisinicline for 12 weeks abstained from smoking during weeks 9 to 12 of the trial, compared with 7% of people taking a placebo.
Cytisinicline is a plant alkaloid, which acts in a similar way to varenicline: it selectively binds to the nicotinic receptors in the brain that regulate nicotine dependence.
The cytisinicline consultation comes shortly after it was announced that varenicline would be made available again for NHS patients as a generic — three years after batches of the branded medicine were withdrawn owing to levels of N-nitroso-varenicline, a probable carcinogen.
Commenting on the NICE consultation, Darush Attar-Zadeh, clinical fellow respiratory pharmacist at North West London Integrated Care Board and co-chair of the Taskforce for Lung Health medicines optimisation working group, said: “I certainly think cytisinicline will be an excellent addition to the NICE guidelines.
“According to [the] Cochrane [review] data, varenicline, cytisine and vaping show similar efficacy in helping patients quit smoking, though each comes with its own set of pros and cons. Selecting the most suitable option depends on individual patient needs.
“As I commented previously, both varenicline and cytisine are similar in their mechanisms but have slight differences in terms of patient eligibility. Varenicline has a simpler dosing schedule, making it a popular first-line treatment option. But cytisine should also be considered as an effective alternative. Patients may find they tolerate some of the side effects better, and the course of tablets — under the UK license — is only 25 days.”
The consultation on cytisinicline will close on 29 November 2024, with the final update scheduled to be published on 4 February 2025.
