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Smoking cessation drug varenicline will be made available again for NHS patients, three years after it was withdrawn owing to fears over a probable carcinogen, NHS England has announced.
In a statement published on 12 November 2024, NHS England said that generic varenicline will be available in England following a deal with Teva UK, its manufacturer.
The oral pill, which is taken once a day, was previously available in the UK under the brand name Champix.
The nicotine receptor partial agonist, which reduces nicotine cravings, was recommended as first-line treatment for smoking cessation until it was recalled in October 2021 by its manufacturer Pfizer, owing to the presence of unacceptable levels of nitrosamine compound N-nitroso-varenicline, a probable human carcinogen.
In May 2024, Pfizer told The Pharmaceutical Journal that its Champix product would be reintroduced for patients, but not planned for resupply before the end of 2024.
The generic version of the drug is nitrosamine-compliant.
NHS England said that the introduction of generic varenicline could help more than 85,000 people stop smoking each year and prevent up to 9,500 smoking-related deaths over the next five years.
Varenicline will provide an additional treatment option for patients through NHS stop smoking services. Existing treatment options include cytisine, which was only made available in the UK from January 2024, despite receiving authorisation by the Medicines and Healthcare products Regulatory Agency in 2019.
Commenting on the varenicline announcement, 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: “The relaunch of varenicline is welcome news after its withdrawal in 2021, as many have missed this effective smoking cessation option.
“In recent months, cytisine has been used as a substitute, though it remains limited in availability across various formularies.
“Both varenicline and cytisine are similar in their mechanisms but have slight differences in terms of patient eligibility. Varenicline maybe favoured due to its simpler dosing schedule, making it a popular first-line treatment option. However, cytisine should also be seen as an effective alternative.”
NHS England said that in the UK, an estimated 6 million of people smoke, equating to one in eight adults. In 2022/2023, there were more than 400,000 hospital admissions in England attributed to smoking.
It is estimated that the NHS spends around £2.5bn each year on treating health issues caused by smoking, with around 16% of all hospital admissions for respiratory diseases in 2022/2023 estimated to be related to smoking, as well as 8% of all admissions for cancers and 7% of admissions for cardiovascular diseases.
Varenicline will be offered in conjunction with pharmacy and council-led stop smoking services across the country, with ability for smokers to self-refer via the NHS Better Health website.
Commenting on the announcement, Amanda Pritchard, chief executive of NHS England, said: “This simple daily pill could be a game-changer for people who want to quit smoking and is another vital step in shifting our NHS further towards prevention.
“Smoking remains one of the biggest public health issues facing the NHS and has devastating impacts on the body.
“Alongside supporting the government’s ambition to create the first smoke-free generation, we are giving current smokers the tools they need to quit — with proven treatment options like this, alongside specialist care, helping to save thousands of lives and the NHS millions of pounds in treatment costs,” she added.
