Tardive Dyskinesia (TD) (U.S.), December 2023
The MarketVue®: Tardive Dyskinesia (TD) market landscape report combines primary (KOL interviews and survey data) and secondary market research to empower strategic decision-making and provide a complete view of the market.
Every MarketVue® includes a disease overview, epidemiology (US and EU5), current treatment, unmet needs, pipeline and access and reimbursement chapter.
Topics covered in this report:
- Disease overview: Review the disease pathophysiology and potential druggable targets
- Epidemiology: Understand prevalence, diagnosed and drug-treated prevalence of the population and key market segments
- Current treatment: Understand the treatment decision tree and strengths and weaknesses of current on-label and off-label treatment
- Unmet needs: Identify opportunities to address treatment or disease management gaps
- Pipeline analysis: Compare current and emerging therapy clinical development strategy; their performance on efficacy, safety, and delivery metrics; and their potential to address unmet needs
- Value and access: Gain insights into the drug pricing landscape and payer controls within the disease market or analogous markets
Methodology:
Research for the MarketVue®: Tardive Dyskinesia (TD) report is supported by 7 qualitative interviews with key opinion leaders, a quantitative survey with 24 U.S. physicians and secondary research.
Geographies covered:
United States plus epidemiology for EU5 (France, Germany, Italy, Spain, United Kingdom)
Key companies mentioned:
- Teva Pharmaceuticals
- Neurocrine Biosciences
- Luye Pharma Group
Key drugs mentioned:
- Deutetrabenazine (Austedo)
- Valbenazine (Ingrezza)
- Clonazepam (Klonopin, Rivotril)
- Botulinum toxin injections (Botox)
- Reserpine (Serpasil)
- Tetrabenazine (Nitoman, Xenazine)
- LY03015
- Acamprosate calcium
- Sarizotan
Key takeaways from the report:
Tardive dyskinesia (TD) is a medication-induced neurological disorder which disrupts patients’ quality of life with complications that include:
- Tapping or shaking of the fingers and hands
- Puckering and frowning of the mouth and darting tongue
- Rapid or constant blinking
- Movements of the trunk
According to TD experts interviewed by REACH, most TD patients are well-controlled with one of the two FDA-approved VMAT2 inhibitors. Austedo and Ingrezza are viewed as comparable options due to their similar efficacy, side effect profiles, and now, dosing convenience with the introduction of Austedo extended-release tablets. Consequently, individual physician preference is driven most often by prior experience and familiarity with a drug.
Psychiatrist, U.S.: “I mean it’s amazing to see what they [VMAT2 inhibitors] can do to people who had suffered for many years and whose lives had been very much destroyed by [TD].”
The report indicates that given the success of Austedo and Ingrezza, clinicians do not perceive a high unmet need for novel TD treatments, which is also reflected in the sparse TD pipeline. However, experts say they have observed a rise in prescriptions for dopamine receptor blocking agents beyond use in schizophrenia, expanding to wider use in other conditions:
- Major depressive disorder
- Bipolar disorder
- Gastroparesis
- Behavior conditions (e.g., autism)
This suggests a potential surge in TD cases in the future which underscores the growing demand for efficacious medications that avoid directly inhibiting the dopamine pathway, working to effectively prevent TD.
Psychiatrist, U.S.: “The future is not treating TD. I think the future is not inducing it… we may solve the problem by just not having drugs that cause the problem to begin with.”
1. DISEASE OVERVIEW
A medication-induced neurological disorder causing involuntary, repetitive body movements
Figure 1.1 Problematic symptoms of TD
Table 1.1 Risk factors for TD
The role of dopamine in the disease mechanism of TD
Figure 1.2 The role of dopamine in the hypothesized pathogenesis and current treatment of TD
2. EPIDEMIOLOGY & PATIENT POPULATIONS
Disease Definition
Figure 2.1. Diagnosed prevalent cases of TD by region
Table 2.1 Diagnosed prevalence cases of TD in the US and EU5
Upper-end estimates of the prevalence of TD in the US
Table 2.2 Upper-end estimates of the diagnosed prevalence cases of TD in the US using 2023 MDPS estimates of schizophrenia prevalence
Table 2.3. TD diagnosed prevalence estimates in the U.S. using antipsychotic prescription volume
Figure 2.1. KOL commentary on increasingly widespread antipsychotic use
3. DIAGNOSIS & CURRENT TREATMENT
Diagnosis Overview
Figure 3.1. Diagnostic pathway for TD patients
Treatment flow for TD involves balance between DRAs and VMAT2 inhibitors
Table 3.1. TD treatment goals
Figure 3.2. Treatment algorithm for management of TD
Severity and patient response to VMAT2 inhibitors
Figure 3.3. KOL estimate of diagnosed TD patients receiving drug treatment1
Comparison of FDA approved treatments for TD
Table 3.2. Comparison of FDA approved TD treatments
Clinical trial primary endpoint success drove FDA approval for TD therapies
Figure 3.4. Austedo and Ingrezza pivotal trial primary outcome results
Figure 3.5. Austedo and Ingrezza pivotal trial secondary outcome results
Physician perspectives on Austedo and Ingrezza
Table 3.3. KOL commentary on Austedo and Ingrezza
Table 3.4. Physician perspective on the efficacy of Austedo and Ingrezza
Figure 3.6. KOL estimates of current VMAT2 treatment share (n=24)
Key treatment dynamics that will shape disease management and drug use in TD
Table 3.5. Must-know TD market dynamics
No significant changes are anticipated to disrupt the TD market in the foreseeable future
Figure 3.7. Important dynamics of TD market evolution
4. UNMET NEED
Overview
Figure 4.1. Top unmet needs in TD
Figure 4.2 Physician-reported high unmet need patient types
Physician perspectives on unmet needs in TD
5. PIPELINE
Overview
Table 5.1 Summary of phase 1 trial of LY03015
Physician perspectives on diagnostic and therapeutic developments in TD
6. VALUE & ACCESS
Overview
Table 6.1. Comparison of treatment pricing, U.S.
Table 6.2. Typical U.S. commercial payer coverage
Despite support programs, existing TD drugs still have barriers to access
Figure 6.1. Resources offered by Teva and Neurocrine to help facilitate patient access
Figure 6.2. KOL reported barriers to patient access1
7. METHODOLOGY
Primary market research approach
Epidemiology methodology
Epidemiology methodology: schizophrenia prevalence model
Epidemiology methodology: antipsychotic prescription volume model
Table 7.1 Epidemiology references
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