ATC codes: N07BA03
Nicotine dependence ICD11 code: 6C4A.2Z
Medicine type
Chemical agent
List type
Oral > Solid: 0.5 mg ; 1 mg
EML status history
First added in 2021
Adolescents and adults
Therapeutic alternatives
The recommendation is for this specific medicine
Patent information
Main patents have expired but secondary patents might remain active in some jurisdictions. For more information on specific patents and license status for developing countries visit www.MedsPal.org
Expert Committee recommendation
The Expert Committee noted that smoking is a major public health threat worldwide and causes substantial health and economic harm, including different cancers. Currently, the EML only includes nicotine replacement therapy for smoking cessation (chewing gum and transdermal patches). The Expert Committee considered the evidence shown in the application that the pooled risk ratio for continuous or sustained abstinence at 6 months or longer for varenicline at standard dosage versus placebo was significant. Moreover, varenicline was also significantly better than bupropion for this outcome. The pooled risk ratio for abstinence at 24 weeks was also significantly higher for varenicline than nicotine replacement therapy. As regards the safety of varenicline, neuropsychiatric effects are a concern. Still, the latest evidence from a randomized trial does not support a link between varenicline and these disorders, although people with past or current psychiatric illness may be at slightly higher risk of experiencing neuropsychiatric events than people without these disorders. The Expert Committee was aware that smoking cessation interventions are among the most cost-effective public health interventions. Compared with other agents (bupropion and nicotine replacement therapy), the price of varenicline is higher and its use and availability in low- and middle-income countries are still limited. The Expert Committee noted that the availability of different treatment options may enhance procurement capacity, lower prices and increase affordability through competition. The Expert Committee also noted that no specialist training is required to prescribe or use the medicine. However, the success of medications for quitting smoking is improved when smokers are prepared to quit, and receive quitting advice, counselling and support from health care providers. The Expert Committee therefore noted that while the effectiveness of pharmacological interventions for smoking cessation is high, their success is dependent on a concomitant behavioural education approach such as counselling. In many countries, especially in low- and middle-income countries, the use of this approach as well as the strengthening of tobacco control policies are still not optimal. The Expert Committee noted that varenicline was mentioned in the WHO Report on the Global Tobacco Epidemic 2019 as a non-nicotine pharmacological intervention to help people to quit smoking. Considering the body of evidence supporting the efficacy and tolerability of varenicline, the Expert Committee recommended the inclusion of varenicline for smoking cessation in the core list of the EML. However, considering the limited evidence on the affordability of varenicline in low- and middle-income countries, mechanisms to estimate its costs in these countries need to be established with ministries of health.