The smoking cessation drug cytisine will be available in the UK from January 2024 as a prescription-only medicine (POM), Consilient Health, the distributor of cytisine in the UK, has confirmed.
Cytisine (Tactizen; Aflofarm) is a partial agonist of the α4β2 nicotinic acetylcholine receptor, used for smoking cessation in Central and Eastern Europe since the 1960s.
It was licensed in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA) in March 2019; however, no supplies have been made available until now.
A spokesperson from Consilient Health told The Pharmaceutical Journal on 13 December 2023 that cytisine will be available via three mainline wholesalers: AAH, Alliance and Phoenix, from the “mid to end of January 2024”.
A single pack of 100 tablets will cost £115, which is “sufficient for a complete treatment course” of 25 days.
Commenting on the announcement, Robert West, professor emeritus of health psychology at University College London, said: “Cytisine appears to be at least as effective as varenicline when taken for 12 weeks but the standard course is 25 days.
“Even at that dose it is probably more effective than nicotine replacement therapy and could give a real boost to smoking cessation.
“While the company who is marketing it in the UK has to charge £115 per 25-day course to recoup a substantial expense in getting MHRA approvals and setting up the distribution etc., the drug itself is extremely cheap to produce and the hope is that in time the cost will come down substantially.
“It is also likely that other suppliers will come on the market in time as it is generic,” added West.
Also commenting on the announcement, Darush Attar-Zadeh, an independent prescriber and clinical fellow respiratory pharmacist at North West London Integrated Care Board, said: “It’s great news a well-established medicine [cytisine] will be available in the UK in the new year.
“Varenicline (when it was available) was under-utilised by NHS services and I am hoping this won’t be the case with cytisine.
“As cytisine is a POM with quite a complicated dosing schedule thorough training will be needed by clinicians and stop smoking advisors,” said Attar-Zadeh.
There has been a shortage of smoking cessation drugs since 2021 in the UK owing to concerns over unacceptable levels of nitrosamine, a probable human carcinogen.
Champix (varenicline; Pfizer) was recalled in October 2021 following the detection of N-nitroso-varenicline, a probable human carcinogen, at levels that breach acceptable limits set by the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA).
Then, in November 2022, GSK placed an immediate hold on batch release and distribution of bupropion (Zyban) 150mg tablets, having found the potential for the presence of nitrosamine N-nitroso-bupropion at levels above the EMA’s temporary acceptable intake limit.
In September 2023 GSK told The Pharmaceutical Journal that it had set a target for December 2023 for the reintroduction of Zyban after the EMA updated its guidance on nitrosamines.
On 5 December 2023, a spokesperson for GSK confirmed to The Pharmaceutical Journal that Zyban had in fact been resupplied to the UK from October 2023.
A spokesperson for Pfizer, told The Pharmaceutical Journal that they were unable to provide any “updates on the availability of Champix in the UK”.
In April 2023, then pharmacy minister, Neil O’Brien, said that the government was working with manufacturers to restore the availability of varenicline.
In November 2023, the Department of Health and Social Care announced that the government will invest an additional £70m per year, to a total of £138m from 2024 to 2024, to support smoking cessation services.