ICER Turns Up the Heat With Dual Assessments: Final Verdict on Cytisinicline, Fresh Scrutiny for IgA Nephropathy Therapies
The Institute for Clinical and Economic Review (ICER) has released two significant updates this week, expanding its assessment activities across smoking cessation and rare kidney disease as both review tracks enter critical next-step phases. The announcements issued on consecutive days signal the organization’s intensifying focus on therapies addressing long-standing clinical gaps and pressing public-health challenges.
Cytisinicline Gains Momentum as ICER Publishes Final Evidence Report on Smoking-Cessation
ICER has published its revised Evidence Report on cytisinicline, a therapy from Achieve Life Sciences designed to support smoking cessation. The report evaluates the drug’s comparative clinical effectiveness and economic value, with varenicline serving as the primary comparator.
According to the findings, cytisinicline, known in Eastern Europe as cytisine, delivers similar quit-rate effectiveness with significantly fewer gastrointestinal side effects than varenicline. ICER’s Chief Medical Officer, David Rind, MD, noted the significance of having an alternative therapy with a more tolerable safety profile, especially for patients who have historically struggled with nausea and vomiting associated with varenicline. “Smoking cigarettes is the number one cause of preventable deaths in the US,” Rind said, adding that any new therapeutic option with strong safety and adherence potential carries substantial public-health value.
ICER’s clinical review extended beyond traditional head-to-head comparisons. The organization examined cytisinicline’s performance against behavioral interventions alone, finding that the therapy provided superior net health benefits. It also showed outcomes comparable, or in some cases directionally better, to combination nicotine replacement therapy.
The final report incorporates revisions based on a month-long public comment period that drew input from patient advocates, clinicians, drug manufacturers, and researchers. ICER has also published updated voting questions, reflecting the refinements made in response to stakeholder feedback.
On the economic side, ICER set a Health Benefit Price Benchmark (HBPB) for cytisinicline between $1,700 and $2,400 for a 12-week course. The organization noted that a slightly higher benchmark may be justified for patients who cannot tolerate varenicline’s side effects, reflecting the therapy’s differentiated safety profile.
The cytisinicline review will advance to a public meeting of the Midwest CEPAC on January 15, 2026, where an independent advisory council will vote on key value questions. The virtual meeting is open to the public via webcast registration.
ICER Issues Draft Evidence Report on IgA Nephropathy Therapies as Public Comment Opens
On Wednesday, ICER released its Draft Evidence Report addressing a different area of unmet need, IgA nephropathy (IgAN), a chronic autoimmune kidney disease with limited therapeutic options and high progression risk.
The draft evaluates three therapies:
• sibeprenlimab (Voyxact®, Otsuka)
• atacicept (Vera Therapeutics)
• delayed-release budesonide (Tarpeyo®, Calliditas)
Each treatment targets abnormal immunoglobulin A complexes, long understood as a fundamental driver of IgAN’s pathophysiology. The draft report marks the midpoint of ICER’s eight-month review cycle and should not be interpreted as the organization’s final position.
As part of its Early Insights Webinar Series, Rind will present initial findings on December 17 during a session open exclusively to ICER Analytics platform users. Registration for the webinar is active.
ICER has opened the public comment period, inviting stakeholders to submit written feedback in Word format to publiccomments@icer.org by January 14, 2026, at 5 PM ET. Comments may address clinical data, economic modeling, unmet-need considerations, or patient-centered perspectives.
Following the review of all submissions, ICER will release a Revised Evidence Report and updated voting questions on February 9, 2026, alongside its formal response to all public comments.
The review will culminate in a California Technology Assessment Forum (CTAF) virtual meeting on February 26, 2026, during which the independent council will vote on the therapies’ comparative clinical value and cost-effectiveness. Stakeholders may also request slots for oral comments during the meeting, with the same January 14 deadline as written submissions.
A Busy Start to 2026 for ICER and Stakeholders
Taken together, the two updates reflect ICER’s increasing evaluation activity heading into 2026. One review addresses a high-prevalence behavioral-health challenge, smoking, while the other focuses on a rare, clinically complex kidney disease. Both introduce opportunities for stakeholders to shape final outputs through public comment and advisory council testimony.
With multiple meetings already scheduled for early 2026, ICER’s assessments are set to influence payer conversations, price-benchmark expectations, and the broader evidence environment for both cytisinicline and emerging IgAN therapies.
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