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Tardive Dyskinesia Research Review

Sanjay Gupta, MD
Joseph P. McEvoy, MD
Released: August 31, 2021

Cost-effectiveness of valbenazine compared with deutetrabenazine for the treatment of tardive dyskinesia

Ganz ML, et al. J Med Econ. 2021; 24:103-113.

This study evaluated the clinical and economic outcomes associated with valbenazine compared with deutetrabenazine in patients with TD.

This study included 1000 patients with TD who were receiving antipsychotic medication for the treatment of the underlying psychiatric illness. Clinical inputs were derived from relevant clinical trials or publicly available sources. Patients were assessed over 1 year using ≥50% improvement from baseline in Abnormal Involuntary Movement Scale (AIMS) total score as the primary definition of response. Responses at 1 year using Clinical Global Impression of Change (CGIC) scores ≤2 were also assessed. Health outcomes included quality-adjusted life-years (QALYs), life-years, proportion responding to treatment at 1 year, and the number of psychiatric relapses.

Patients treated with valbenazine were more likely to have responded to treatment at 1 year, lived longer, and accrued more QALYs than patients who received deutetrabenazine. Using the AIMS response criterion, the incremental cost-effectiveness ratio was $9,951/QALY for valbenazine compared with deutetrabenazine. By comparison, using the CGIC response criterion, valbenazine dominated deutetrabenazine with valbenazine-treated patients, accumulating more QALYs (3.4 vs 3.3 years) and incurring lower lifetime costs ($252,311 vs $283,208) than deutetrabenazine-treated patients.

Both medications are FDA approved for treating TD. Valbenazine is highly cost-effective compared with deutetrabenazine for the treatment of TD.

Clinical Commentary (Sanjay Gupta, MD)
The indirect comparison based on treatment over 1 year used 3 outcome measures.

  • 50% improvement over baseline in AIMS score: better response with valbenazine
  • Response at 1 year using CGIC score ≤2: better response with valbenazine
  • Health outcomes including QALYs: favored valbenazine

There are some significant limitations to be noted. The effects of adverse events on outcomes and costs were not included in the research. There are no head-to-head trials available, so the response was calculated based on an indirect treatment comparison of the results from individual trials of the 2 medications. Deutetrabenazine has data going past 1 year that were not included. Only direct costs such as drug acquisition costs and relapse treatment costs were included in the analysis.

Patient response outcomes, caregiver measures, quality-of-life questionnaires, and functional scales were not done, which may underestimate the value of VMAT2 inhibitors.

Clinical Insights

  • This model analyzed costs from a US third-party payer perspective (insurance company).
  • Please note that these are secondary analyses, and the data are not from a prospective head-to-head study for assessment of costs and value of both FDA-approved treatments. There probably will be no such study.
  • Valbenazine may bemore cost-effective, have better clinical outcomes, and be easier to use compared with deutetrabenazine based on this indirect analysis.
  • Using the CGIC response criteria costs calculated for valbenazine over a lifetime were $252,311 vs $283,208 for deutetrabenazine-treated patients.

In my opinion, based on this indirect comparison study, valbenazine may be the preferred treatment option compared with deutetrabenazine based on cost and efficacy. Valbenazine also has a simple titration and ease of use (once daily), suggesting it to be a first-line medication for the treatment of TD.

Clinical Commentary (Joseph P. McEvoy, MD)
The authors conducted these analyses on a “synthetic cohort”—a cohort that has been created using available studies rather an ideal comparison with a randomized trial of deutetrabenazine vs valbenazine in a single cohort of patients with TD. Instead, this study provides an indirect comparison of 2 separate sets of studies with distinct cohorts and parameters—of either deutetrabenazine vs placebo or valbenazine vs placebo.

Clinical Insights

  • A basic tenet of the randomized controlled trials conceptual framework is that comparisons of 2 or more drugs’ performance across separate trials are not the same as comparisons of the drugs’ performance within a single trial.
  • Recruitment methods may be different in the separate trials leading to different populations, rating methods may be different and may occur at different times, etc.
  • As it turned out, the effect sizes for therapeutic reduction of TD severity favoring valbenazine in the valbenazine vs placebo trials were slightly greaterthan the effect sizes favoring deutetrabenazine in the deutetrabenazine vs placebo trials.
  • The established efficacy and tolerability of these 2 agents created interest during the past few years in the correlates/implications of TD (presence and severity) in affected patients.
  • Patients with TD have more severe mental and physical maladies, are less functional, have lower quality of life, and die earlier than patients without TD. These correlations/implications of TD can be projected over time as life-expectancy and life-quality measures.
  • The differential effect sizes (on severity of TD) in the 2 separate sets of studies, (deutetrabenazine/placebo and valbenazine/placebo) drive differential projections in the synthetic cohorts over time for life expectancy and life quality.

Simply stated, given bigger effect sizes for valbenazine vs placebo in the 2 sets of studies, the long-term projections, not surprisingly, look better for valbenazine.

It will be ideal to have a properly done randomized controlled trial comparing deutetrabenazine vs valbenazine in a single sample of patients all selected, dosed, and rated the same way by the same raters.

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