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A retrospective analysis of Medicare claims found that, among patients with psychotic spectrum disorders and newly diagnosed tardive dyskinesia, starting valbenazine was associated with an 18% lower risk of a 60-day gap in all antipsychotic treatment. The association was not statistically significant in the full study cohort, and the observational design cannot show that valbenazine caused patients to stay on antipsychotics.
A retrospective Medicare claims study found that patients with psychotic spectrum disorders and newly diagnosed tardive dyskinesia who started valbenazine had a lower risk of a 60-day gap in all antipsychotic treatment than patients who did not start it. The association was not seen as statistically significant across the full study cohort, and the findings do not establish that the drug caused better medication continuity.
Researchers analyzed claims for 66,348 Medicare beneficiaries with an incident tardive dyskinesia diagnosis and active antipsychotic coverage. The data covered April 2016 through December 2023. During follow-up, 6,232 beneficiaries started valbenazine, with a median of 36 days between their tardive dyskinesia diagnosis and starting treatment.
In the subgroup with schizophrenia or another psychotic spectrum disorder, valbenazine initiation was associated with an 18% lower adjusted risk of discontinuing all antipsychotics for at least 60 days (adjusted hazard ratio 0.82; 95% confidence interval 0.71 to 0.93). In the overall cohort, which also included people receiving antipsychotics for mood disorders or other reasons, the researchers did not find a statistically significant association using that 60-day definition.
A sensitivity analysis that counted a gap of at least 30 days as discontinuation did find a modest association in the overall cohort (adjusted hazard ratio 0.94; 95% confidence interval 0.88 to 0.99). The researchers said the shorter gap definition may capture a different pattern of medication coverage. Results were presented at the Neuroscience Education Institute Fall Congress in Colorado Springs, Colorado.
Why Antipsychotic Continuity Matters
The finding draws attention to a possible connection between treating tardive dyskinesia and maintaining psychiatric medication. Tardive dyskinesia involves repetitive, involuntary movements and can occur in people treated with antipsychotic medicines. If symptoms or their treatment affect whether patients continue psychiatric medication, addressing both conditions may matter to care planning.
Study author Rimal Bera of the University of California, Irvine, told MedPage Today that the findings suggest valbenazine treatment may help facilitate antipsychotic continuity while addressing tardive dyskinesia. That is a proposed interpretation, not proof of a treatment effect. The subgroup result may be relevant because antipsychotics are often used as maintenance treatment for psychotic spectrum disorders, but the claims analysis cannot explain why any individual stopped or continued treatment.
The potential consequences of treatment gaps are part of the clinical concern. The researchers noted that prior evidence has linked antipsychotic non-persistence among people with schizophrenia to more hospitalizations and emergency department use. This study did not establish that valbenazine reduced those outcomes; it examined antipsychotic discontinuation in claims data.
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How the Medicare Study Was Built
Valbenazine, sold as Ingrezza, is a vesicular monoamine transporter 2 (VMAT2) inhibitor. It was approved in 2017 for tardive dyskinesia. The source report says its approval was based on clinical trial evidence showing improvement on the Abnormal Involuntary Movement Scale, which measures involuntary movements associated with the disorder.
The researchers included adults aged 18 or older with continuous medical and prescription coverage during the 365 days before their tardive dyskinesia diagnosis and active antipsychotic coverage. They excluded people with Huntington’s disease, another condition for which valbenazine is indicated, and those already using a VMAT2 inhibitor at baseline. The average age was 62.9 years; 60.8% were women, and 71.2% qualified for both Medicare and Medicaid.
More than half the cohort had a psychotic spectrum disorder, while 38.6% had a mood disorder alone and 8.6% had neither category. Most were taking a second-generation antipsychotic at baseline. Bera also cited an earlier survey of health professionals that suggested valbenazine treatment might be associated with better antipsychotic adherence, while noting that evidence on real-world persistence, particularly among Medicare beneficiaries, remains limited.
“These findings suggest that treatment of tardive dyskinesia with valbenazine may help facilitate antipsychotic continuity while directly addressing tardive dyskinesia.”
— Rimal Bera, MD, University of California, Irvine, as quoted by MedPage Today
Limits of the Claims Evidence
The study was observational, not randomized, and the authors acknowledged possible residual confounding, including factors that changed over time. People who started valbenazine may have differed from those who did not in ways the analysis could not fully account for, so the association does not demonstrate that the drug prevented antipsychotic discontinuation.
Claims records also cannot show the severity of tardive dyskinesia, why clinicians chose particular treatments, or whether patients actually took medicines dispensed to them. The report does not establish whether the association persists beyond the measured follow-up, differs among specific diagnoses or treatments, or translates into fewer relapses, hospital stays, or emergency visits. The overall cohort result also varied with the definition of a treatment gap.
What Further Research Can Test
The immediate next step is for researchers to test the finding in additional datasets and study designs that can better account for differences between patients who do and do not start valbenazine. Studies with clinical records could add information absent from claims, including movement symptoms, treatment decisions, and medication use.
Further work could also examine whether the association holds under different definitions of antipsychotic discontinuation and whether it is specific to people with psychotic spectrum disorders. The report provides no confirmed timeline for follow-up research. For now, the result is a real-world association that raises a question for clinicians and researchers, rather than evidence that valbenazine should be used to keep patients on antipsychotics.
Key Questions
What did the study find about valbenazine and antipsychotic treatment?
Among patients with psychotic spectrum disorders and newly diagnosed tardive dyskinesia, starting valbenazine was associated with an 18% lower adjusted risk of discontinuing all antipsychotics for at least 60 days. The result is an association from an observational study, not proof of cause and effect.
Did the finding apply to everyone in the study?
No. The association using the 60-day discontinuation definition was not statistically significant in the full cohort. A separate analysis using a 30-day gap found a modest association in that broader group.
How many people were included?
The researchers identified 66,348 Medicare beneficiaries with a new tardive dyskinesia diagnosis and active antipsychotic coverage. Of those, 6,232 initiated valbenazine during follow-up.
Does the study show that valbenazine prevents antipsychotic discontinuation?
No. Because the analysis used retrospective claims data rather than random assignment, it cannot establish that valbenazine caused patients to continue antipsychotic treatment. The records also lacked details about clinical severity, treatment rationale, and actual medication use.
Where were the findings presented?
The results were presented at the Neuroscience Education Institute Fall Congress in Colorado Springs, Colorado, according to the MedPage Today report.
Source: medpagetoday.com
