Multiple Sclerosis
Conditions
Keywords
Tecfidera, Off-label, Utilization
Brief summary
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
Dimethyl fumarate will not be provided to participants as a part of this study.
Interventions
DRUGdimethyl fumarate
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
Sponsors
Biogen
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
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/
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| Demographic characteristics of dimethyl fumarate users | 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 |
| 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 |
Countries
Germany
Outcome results
None listed