— Cytisinicline is effective for smoking cessation; a 12-week course of cytisinicline would be cost-effective if priced between $1,700 and $2,400 —
BOSTON, December 11, 2025 – The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of cytisinicline (Achieve Life Sciences, Inc.) for smoking cessation. Our primary comparison was with the smoking cessation drug varenicline.
“Smoking cigarettes is the number one cause of preventable deaths in the US, and so any new therapy to assist with smoking cessation is extremely important,” said ICER’s Chief Medical Officer, David Rind, MD. “The drug we reviewed for this assessment, cytisinicline, is the same molecule as cytisine, a drug long used for smoking cessation in Eastern Europe. Our analyses show that cytisine/cytisinicline has similar efficacy but significantly fewer gastrointestinal side effects than varenicline, a common prescription drug used for smoking cessation in the US. We heard from experts that they are hopeful cytisinicline will be priced so as to be widely available to those who need it.”
This Evidence Report will be reviewed at a virtual public meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), on January 15, 2026. The Midwest CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.
A draft version of this report was previously open for a four-week public comment period. The updated Evidence Report and voting questions reflect changes made based on comments received from patient groups, clinicians, drug manufacturers, and other stakeholders. Detailed responses to public comments can be found here.
Key Clinical Findings
ICER examined several questions of comparative clinical effectiveness for cytisinicline for smoking cessation, and cytisinicline for vaping cessation. ICER found that cytisinicline provided superior net health benefits (A) compared with behavioral interventions alone. Cytisinicline was also compared to a currently available therapy in the US, varenicline. Due to varenicline’s higher rate of gastrointestinal side effects, cytisinicline is felt to be at least as good and possibly somewhat better (C+). This rating remained the same for cytisinicline when compared to combination nicotine replacement therapy (NRT) (C+).
There is insufficient evidence (I) to assess the net health benefit of either cytisinicline compared with varenicline plus combination NRT or cytisinicline compared with electronic cigarettes with nicotine. Cytisinicline was found to have at least somewhat greater net health benefit than bupropion (B+). For vaping cessation, in comparison with varenicline, cytisinicline’s net health benefits were felt to be promising but inconclusive (P/I).
Key Cost-Effectiveness Findings
Cytisinicline is currently not FDA-approved, with an expected action date from the FDA in June 2026. ICER has calculated a health benefit price benchmark (HBPB) for the medication between $1,700 to $2,400 per year. For the subpopulation of patients who have tried to quit smoking with varenicline and been unable to tolerate its gastrointestinal side effects, a somewhat higher price for cytisinicline might be appropriate.
ICER’s HBPB is a price range suggesting the highest US price a manufacturer should charge for a treatment, net of all rebates and discounts, based on the amount of improvement in overall health patients receive from that treatment, when a higher price would cause disproportionately greater losses in health among other patients in the health system due to rising overall costs of health care and health insurance. In short, it is the top price range at which a health system can reward innovation and better health for patients without doing more harm than good.
About ICER
The Institute for Clinical and Economic Review (ICER) is an independent, non-profit research institute that conducts evidence-based reviews of health care interventions, including prescription drugs, other treatments, and diagnostic tests. In collaboration with patients, clinical experts, and other key stakeholders, ICER analyzes the available evidence on the benefits and risks of these interventions to measure their value and suggest fair prices. ICER also regularly reports on the barriers to care for patients and recommends solutions to ensure fair access to prescription drugs. For more information about ICER, please visit www.icer.org.