Botulinum Toxin A Associated Costs in the Treatment of Upper Limb Spasticity Post Stroke

Study Overview
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Brief Summary
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This study aims to estimate the costs of botulinum toxin A utilization in standard practice for the treatment of upper limb spasticity post-stroke in Portugal. It will consider the three most used locally available brands of botulinum toxin A which show similar efficacy and safety profiles thus making it relevant to understand if choosing between one or another brand can depend directly on economic factors. The study will estimate direct and indirect drug-associated costs as determinant variables for the price of each drug and the standard drug dose used in clinical practice.

Detailed Description
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A comparison will be performed between direct costs associated with each therapeutic strategy and cost analysis assuming that quality of life values may be different between patients treated with each treatment.

Official Title
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Cost Determination Study For Different Botulinum Toxin A Preparations In The Treatment Of Upper Limb Spasticity Post-Stroke In Portugal

Conditions
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Upper Limb Spasticity Post-Stroke

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with post-stroke upper limb spasticity Patients currently being treated with Dysport®, Botox® or Xeomin® Patients stabilized from a therapeutic point of view - with no switches of treatment in at least the 2 last administrations Patients who gave their written informed consent to participate. Exclusion Criteria: Not applicable.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dysport® (abobotulinumtoxinA)<br>Botulinum Toxin Type A (BoNT-A) preparation, injected doses, number of points, volume per point, in accordance with local Summary of Product Characteristics and locally agreed therapeutic guidelines. | |
| Botox® (onabotulinumtoxinA)<br>Botulinum Toxin Type A (BoNT-A) preparation, injected doses, number of points, volume per point, in accordance with local Summary of Product Characteristics and locally agreed therapeutic guidelines. | |
| Xeomin® (incobotulinumtoxinA)<br>Botulinum Toxin Type A (BoNT-A) preparation, injected doses, number of points, volume per point, in accordance with local Summary of Product Characteristics and locally agreed therapeutic guidelines. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate the cost of botulinum toxin utilization | Direct resource utilization and costs of upper limb spasticity patients treated with BoNT-As, by product | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of work days missed due to spasticity | Assessment of Absenteeism /loss of productivity | 12 months | 
| Carer time needed for patient assistance |  | 12 months |