Study of Utilization Patterns of Dimethyl Fumarate in Germany

Study Overview
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Brief Summary
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The primary objective of this study is to estimate the proportion of DMF use that is prescribed on-label versus off-label. The secondary objectives are: To describe the demographic characteristics and medical history of DMF users; To describe prescription drug history and concomitant medication use of DMF users; To describe the duration of therapy in participants newly initiating DMF treatment; To describe the medical specialties of DMF prescribers.

Detailed Description
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Dimethyl fumarate will not be provided to participants as a part of this study.

Official Title
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Claims Database Study of Utilization Patterns of Dimethyl Fumarate in Germany

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: dimethyl fumarate


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: New users of dimethyl fumarate will be included in the analysis Key Exclusion Criteria: Patients for which data is not available for the 6 months period prior to the index date (baseline observational period) NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
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 |
| --- | --- |
| Off-Label<br>Any DMF prescription for MS patients <18 years of age, or for patients diagnosed with non-MS indications, such as psoriasis. | Drug: dimethyl fumarate<br>* Off-Label Use: All participants <18 years of age and participants without an MS diagnosis who are prescribed dimethyl fumarate On-Label Use: All participants >18 years of age with an MS diagnosis who are prescribed dimethyl fumarate<br>* Other names: Tecfidera, DMF, BG00012;|
| On-Label<br>Prescriptions for patients who are ≥18 years of age and diagnosed with MS | Drug: dimethyl fumarate<br>* Off-Label Use: All participants <18 years of age and participants without an MS diagnosis who are prescribed dimethyl fumarate On-Label Use: All participants >18 years of age with an MS diagnosis who are prescribed dimethyl fumarate<br>* Other names: Tecfidera, DMF, BG00012;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of dimethyl fumarate use that is prescribed on-label versus off-label in Germany |  | Up to 18 months after market introduction of dimethyl fumarate in Germany | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic characteristics of dimethyl fumarate users |  | Up to 18 months after market introduction of dimethyl fumarate in Germany | 
| Prescription drug history of dimethyl fumarate users |  | Up to 18 months after market introduction of dimethyl fumarate in Germany | 
| Duration of therapy in participants newly initiating dimethyl fumarate treatment |  | Up to 18 months after market introduction of dimethyl fumarate in Germany | 
| Number of medical specialists prescribing dimethyl fumarate as identified according to specialty-specific billing codes at outpatient visits. |  | Up to 18 months after market introduction of dimethyl fumarate in Germany | 
| Medical history of dimethyl fumarate users |  | Up to 18 months after market introduction of dimethyl fumarate in Germany | 
| Concomitant medication use of dimethyl fumarate users |  | Up to 18 months after market introduction of dimethyl fumarate in Germany | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tecfidera, Off-label, Utilization