Study of Utilization Patterns of Dimethyl Fumarate in Germany

Claims Database Study of Utilization Patterns of Dimethyl Fumarate in Germany

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: dimethyl fumarate

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 930

Contacts and Locations

Study Locations

• Germany
  • Saxony
    • Leipzig, Saxony, Germany, 04109
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Retrospective analysis of a research database, which contains German sick fund claims, to assess the usage of dimethyl fumarate in Germany. The research database is comprised of German sick fund data, which is compiled by Gesundheitsforen Leipzig (GFL). This GFL database currently contains sick fund claims data for approximately 4 million patients, which accounts for approximately 5-6% of the total sick fund population in Germany.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Off-Label; Any DMF prescription for MS patients <18 years of age, or for patients diagnosed with non-MS indications, such as psoriasis.	Drug: dimethyl 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; Other Names: Tecfidera, DMF, BG00012
On-Label; Prescriptions for patients who are ≥18 years of age and diagnosed with MS	Drug: dimethyl 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; Other Names: Tecfidera, DMF, BG00012

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Biogen

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2016
• Primary Completion (Actual): March 2, 2017
• Study Completion (Actual): March 2, 2017

Study Registration Dates

• First Submitted: October 21, 2016
• First Submitted That Met QC Criteria: November 17, 2016
• First Posted (Estimate): November 21, 2016

Study Record Updates

• Last Update Posted (Actual): July 19, 2017
• Last Update Submitted That Met QC Criteria: July 18, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Tecfidera; Off-label; Utilization
• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Dimethyl Fumarate
• Other Study ID Numbers: 109MS409