Investigator Sponsored Studies (ISS) Areas of Interest

• Evaluation of benefit of early-stage migraine  treatment initiation and/or sustained long-term treatment (>2 years).
• Prospective studies that evaluate migraine treatment patients with active cardiovascular disease or risk factors.
• Migraine or Headache biomarkers related to treatment response.
• Observational RWE studies.
• Basic migraine or headache research in pre-clinical space (e.g. bone density evaluation)
• Pediatric migraine.
• Interictal symptoms / non-headache symptoms of migraine.
• Proposals that do not overlap with Teva current clinical development program.

Areas of interest that are not being considered for review and support:

• Fremanezumab for indications:
  • Post Traumatic Headache.
  • Fibromyalgia.
  • Status migrainosus.
  • Rosacea.
  • Comorbid depression.
• New indications for Fremanezumab.
• Fremanezumab in pregnant patient populations.
• Head-to-Head Comparison.

Huntington’s Disease specific topics:

• Use of deutetrabenazine in conjunction with antipsychotic medications in HD.
• Use of deutetrabenazine in early versus later stage Chorea in HD.

Areas of interest that are not being considered for review and support:

• Pediatric patient populations.

Tardive Dyskinesia specific topics

• Studies that evaluate effect of deutetrabenazine on a range of severity of TD movements.
• Studies that evaluate early disease treatment with deutetrabenazine on TD natural history and/or severity of TD.
• Studies that evaluate deutetrabenazine in management of underlying psychiatric condition symptoms.
• Epidemiology and pathophysiology of TD and long-term health risks.
• Studies exploring deutetrabenazine long-term association with psychiatric outcomes and quality of life.
• Use of deutetrabenazine for TD in the following, but not limited to, subpopulations:
  • elderly patients (>=65).
  • patients with neurological disorders.
  • older adolescents and young adults

Areas of interest that are not being considered for review and support:

• Pediatric patient populations.

HD and/or TD

• Understand real world use patterns of deutetrabenazine (includes patient population, position in the treatment algorithm, outcomes, long term use, and healthcare utilization).
• Studies that evaluate deutetrabenazine in diseases other than HD/TD.
• Studies that evaluate Quality of Life and impact of TD/HD and the effect of deutetrabenazine.
• Burden of Illness (Quality of Life, Physical Functioning and/or impact).
• Real world prospective use of deutetrabenazine in different regions.

Areas of interest that are not being considered for review and support:

• Basic research (pre-clinical).
• Areas that have previously been investigated for deutetrabenazine, e.g. Cerebral Palsy, Tourette Syndrome in pediatric.

• TV-46000 Switching, initiation, persistence and discontinuation.
• Real-world treatment patterns and ease of TV-46000 use.
• Impact of TV-46000 on healthcare resource utilization (HCRU) and costs.
• Further demonstration of TV-46000 efficacy/tolerability from clinical data and real-world populations.
• Real-world use of TV-46000 in early-phase patients with schizophrenia (<5 years since diagnosis including first episode psychosis [FEP]).
• Real-world use of TV-46000 in early-phase patients with Bipolar I disorder (BD-I).
• Characterization of TV-46000 on biomarkers and non-clinical outcomes.
• Use of TV-46000 in additional indications of interest apart from schizophrenia in adolescents.
• Impact of TV-46000 on patient reported outcomes (PROs) – quality of life (QoL), functioning and/or multi-dimensional impact.
• Real world management of LAI administration and patient experience.

• LAI unmet needs and challenges in schizophrenia treatment.
• Predictors and consequences of relapse in patients with schizophrenia including but not limited to breakthrough psychosis in patients treated with LAI antipsychotics.
• Impact of social determinants of health on barriers to utilization of LAI antipsychotics and navigation of these barriers.
• Effect of LAI antipsychotic treatment on clinical outcomes, treatment patterns and healthcare resource utilization (HCRU) prior to treatment resistant schizophrenia (TRS) diagnosis /clozapine use [understand patient treatment journey prior to clozapine use].
• Burden and impact of suboptimally treated psychosis in Schizophrenia.
• Understand lack of LAI persistence in people living with schizophrenia, treatment outcomes following discontinuation and how to mitigate.
• Effect of switching to LAIs on patient reported outcomes (PROs) – quality of life (QoL), functioning and/or multi-dimensional impact.
• Predictors of cardiometabolic side effects in patients with schizophrenia treated with antipsychotic medications.
• Impact of weight mitigation therapies in patients experiencing antipsychotic-induced weight gain.

• LAI unmet needs and challenges in BD-I treatment.
• Predictors and consequences of relapse in patients with BD-I including but not limited to breakthrough mania in patients on LAI antipsychotics.
• Impact of social determinants of health on barriers to utilization of LAI antipsychotics and navigation of these barriers.
• Effect of LAI antipsychotic treatment on clinical outcomes, treatment patterns and healthcare resource utilization (HCRU).
• Understand lack of LAI persistence in people living with BD-I, including impact on treatment outcomes following discontinuation and how to mitigate.
• Effect of switching to LAIs on patient reported outcomes (PROs) – quality of life (QoL), functioning and/or multi-dimensional impact.
• Predictors of cardiometabolic side effects in patients with BD-I treated with antipsychotic medications.
• Impact of weight mitigation therapies in patients experiencing antipsychotic-induced weight gain.