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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dysport® (abobotulinumtoxinA) | 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) | 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) | 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. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Hospital ambulatory patients
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Medicina de Reabilitação de Alcoitão | Alcabideche | 2649-506 | Portugal | |||
| C. H. A. - Hospital de Faro |
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| Faro |
| 8000-386 |
| Portugal |
| C. H. T. M. A. D. - Unidade Hospitalar de Vila Real | Vila Real | 5000-508 | Portugal |