ATC codes: N06AX12
Nicotine dependence ICD11 code: 6C4A.2Z
Medicine type
Chemical agent
List type
Oral > Solid: 150 mg sustained-release (hydrochloride)
EML status history
First added in 2021
Adolescents and adults
Therapeutic alternatives
The recommendation is for this specific medicine
Patent information
Patents have expired in most jurisdictions
Expert Committee recommendation
The Expert Committee noted that smoking is a major public health threat worldwide and causes substantial harm to human health as a cause of numerous cancers, and cardiovascular and pulmonary diseases. Currently, the EML only includes nicotine replacement therapy for smoking cessation (chewing gum and transdermal patches). The Expert Committee took into account the evidence shown in the application that there is high-certainty evidence that bupropion increases long-term smoking cessation rates as reported in a Cochrane review with more than 100 studies and that it is well tolerated overall. However, a synthesis of existing evidence also suggests an increased risk of adverse effects, particularly anxiety and agitation and these effects may increase the probability that people stop using the medicine. The Expert Committee recognized that smoking cessation interventions are among the most cost-effective public health interventions. Moreover, there is sufficient evidence on the affordability of bupropion for smoking cessation, although not for low- and middle-income countries. 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 bupropion was mentioned in the WHO Report on the Global Tobacco Epidemic 2019 as non-nicotine pharmacological intervention to help people to quit smoking. Considering the body of evidence supporting the efficacy and tolerability of bupropion, the Expert Committee recommended the inclusion of bupropion for smoking cessation in the core list of the EML. However, considering the limited evidence on bupropion’s affordability in low- and middle-income countries, mechanisms to estimate costs in these countries need to be established with ministries of health.