Varenicline tablets (ChampixÒ) - smoking cessation in adults

SMC recommendation
Advice:
following a full submission
Varenicline (ChampixÒ) is accepted for use within NHS Scotland for smoking cessation in adults.  It should be used only as a component of a smoking cessation support programme.  The benefits of an additional treatment course in those who have stopped smoking after the initial 12 weeks of therapy appear modest.  Efficacy and safety in patients with significant co-morbidity are uncertain.
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Tayside recommendation
Recommended in Smoking Cessation guideline
Points for consideration:
  • Varenicline is a new medicine introduced as an aid to smoking cessation in adults (18 years and above).
  • Approximately half of the benefit demonstrated in clinical trials for the medicine was delivered from the intensive system of support and advice offered to patients.
  • There are no data comparing varenicline with NRT or in combination with other smoking cessation therapies.
  • Smoking cessation, with or without pharmacotherapy, has been associated with the exacerbation of underlying psychiatric illness.  Care should be taken with patients with a history of psychiatric illness and patients should be advised accordingly.
  • Depression has been reported in patients taking varenicline and symptoms may include suicidal thoughts and behaviour.  Patients should be advised to stop their treatment immediately and contact their doctor if these symptoms occur. See MHRA advice
  • Discontinuation of varenicline at the end of treatment is associated with an increase in irritability, urge to smoke, depression and insomnia in up to 3% of patients.  Dose tapering may need to be considered.
  • A 12-week course of varenicline is more expensive than NRT (£164 versus £109 - £120).
  • Prescribers are directed to the revised algorithm for smoking cessation in the TAPG.
  • Locally, varenicline is reserved for patients who have attempted to stop smoking unsuccessfully with the assistance of nicotine replacement therapy (in combination with support and counselling) on one or more previous occasions.  Prescribers should be assured that patients are thoroughly engaged with a formal smoking cessation service to provide structured support over the 12-week course of the medicine.