|
BOSTON, February 12, 2026 – The Institute for Clinical and Economic Review (ICER) today released a Final 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.
Downloads: Final Evidence Report | Report-at-a-Glance | Policy Recommendations
“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, MSc. “The drug we reviewed for this assessment, cytisinicline, has been used for decades in Europe and has similar efficacy to varenicline (Chantix®) but with less nausea. Manufacturer decisions on pricing are likely to have substantial effects on how easily smokers can access this medication.”
ICER’s Public Meeting: Voting Results on Clinical Effectiveness and Benefits Beyond Health
ICER’s report was the subject of the January 2026 meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), one of ICER’s three independent evidence appraisal committees.
ICER assessed, and the independent appraisal committee voted on the evidence for the net health benefit of cytisinicline. Some of the voting results on clinical effectiveness include the following:
- The panelists unanimously (14-0) found that for people who smoke cigarettes the current evidence is adequate to demonstrate a net health benefit of cytisinicline is greater than that of behavioral support alone.
- The majority of panelists (13-1) found that for people who smoke cigarettes, the current evidence is not adequate to demonstrate that the net health benefit of cytisinicline with behavioral support is greater than that of varenicline with behavioral support.
Panel members also weighed potential benefits and disadvantages beyond the direct health effects and weighed special ethical priorities. Voting highlighted the following as particularly important for payers and other policymakers to note:
- There is substantial unmet need despite currently available treatments.
- This condition is of substantial relevance for people from a racial/ethnic group that has not been equitably served by the healthcare system.
ICER’s Public Meeting: Voting Results on Long-Term Value for Money
Cytisinicline is currently not FDA-approved, with an expected action date from the FDA in June 2026, and the manufacturer has not yet announced a US price for the therapy if approved.
Consistent with ICER’s process, because there is no firm estimate yet of a potential launch price for the treatment, the panel did not take a vote on the treatment’s long-term value for money.
ICER has calculated a health benefit price benchmark (HBPB) to be between $1,900 and $2,700 per year.
Key Policy Recommendations
ICER’s independent assessment of value informs the critical decisions that stakeholders across the US health system need to make around pricing and coverage. Following the voting session, a policy roundtable of experts — including clinical experts, patients and patient advocates, and representatives from US payers and purchasers — convened to discuss the pricing implications and recommendations to ensure fair access. Key recommendations stemming from the roundtable discussion include:
- Manufacturers should set the price of cytisinicline to align with the value of added patient benefits.
- Pharmacists should be allowed to prescribe cytisinicline.
- The FDA should provide a new pathway for generic drug approval when a drug has extensive evidence of safety and efficacy and is approved.
ICER’s detailed set of policy recommendations is available in the Final Evidence Report and in the standalone Policy Recommendations document.
| 
