Evicenter
P&T meetings

LB-102

Schizophrenia

Regulatory submission
Not announced
Launch
Not announced
Last updated
345 sources

Executive summary

Budget impact of LB-102

1 evidence topic · 16 sources

Summary

No price, economic model, cost-effectiveness analysis, budget impact analysis, or health technology assessment of LB-102 has been published, and no published peak sales estimate or market research forecast naming LB-102 was identified. The company has stated no launch date; it expects topline results from the phase 3 NOVA-2 trial in the first half of 2027 and expects to schedule a pre-NDA meeting with the FDA in the second half of 2027. The company sizes the United States branded antipsychotic market at approximately $12 billion, reports that four branded products accounted for approximately 60% of 2025 sales (Vraylar $3.6 billion, Rexulti $1.9 billion, Abilify $1.1 billion, and Caplyta $0.9 billion), and states that antipsychotic development typically starts in schizophrenia “to anchor dose and premium pricing” before expansion to bipolar depression and major depressive disorder. Two analyst firms that initiated coverage in October 2025, Piper Sandler and Stifel, each used the term “blockbuster” for the LB-102 opportunity. The Form 10-K lists price, the level of generic competition, and the availability of reimbursement among the competitive factors for LB-102.

The available cost evidence is disease-level. Estimates of the eligible population depend on method: a weighted national claims analysis for 2022 estimated the diagnosed prevalence of schizophrenia at 0.45% (1.10% in Medicare fee-for-service, 1.10% in Medicare Advantage, 0.91% in Medicaid, and 0.07% in commercial insurance); the 2019 United States economic burden analysis applied a prevalence of 1.19% (3,906,050 people); and the Institute for Clinical and Economic Review (ICER) applied an adult prevalence of 1.8% and an antipsychotic treatment rate of 71.3% to estimate 3,459,146 eligible adults. In the 2019 analysis, excess direct health care costs were $62.3 billion ($15,957 per person), including $30.2 billion for inpatient care and $12.1 billion for pharmacy, and mean total health care costs per patient were $26,904 with commercial insurance, $26,095 with Medicaid, and $34,391 with Medicare. Other claims analyses reported total healthcare costs of $32,920 per patient per year in Medicaid, total annual all-cause costs of $23,662 in Medicare fee-for-service, and a mean cost of $1,806 per patient per month in commercial insurance, compared with $419 per member per month in a demographically adjusted population without schizophrenia. In a Medicaid analysis of 158,763 people with schizophrenia, the 18,771 (11.8%) with a recent relapse had mean total healthcare costs $21,862 higher than their controls ($37,424 compared with $15,563).

Economic evaluations exist for another branded oral treatment for schizophrenia, xanomeline-trospium (Cobenfy, studied as KarXT), and are given here as context. Bristol Myers Squibb executives stated a list price of $1,850 for a month's supply, or $22,500 annually, before insurance and other rebates. ICER evaluated KarXT while its price was unknown, using a placeholder price of $20,000 per year in a lifetime model from the health care sector perspective in which individuals started on KarXT or aripiprazole. The base case estimated $163,000 per quality-adjusted life-year (QALY) gained and $146,000 per equal-value life-year gained, and the health benefit price benchmark was $16,000 to $20,000 per year; the authors identified the assumption that KarXT carries no metabolic risk beyond that of the general population as a key driver of the cost-effectiveness findings. The ICER budget impact analysis assumed that 20% of the 3,459,146 eligible adults would initiate treatment in each of five years and found that approximately 8% of eligible adults could be treated at the placeholder price without crossing the potential budget impact threshold of $735 million per year; ICER issued no access and affordability alert. The appraisal panel voted 10 to 2 that the evidence was inadequate to demonstrate a net health benefit superior to that of aripiprazole, and the published summary stated that limited prior authorization is reasonable for payers, given uncertainty about the long-term effectiveness of KarXT and its presumed high cost relative to generic treatment options. A 2025 conference abstract that used a lifetime Markov model from a United States healthcare perspective estimated $727,796 per QALY gained for xanomeline-trospium compared with aripiprazole. Budget impact for LB-102 therefore cannot be estimated from public data as of October 2026.