Multiple Sclerosis
Conditions
Keywords
Multiple sclerosis, Ofatumumab, Ocrelizumab, Anti-CD20 therapy, Comparative effectiveness, Real-world evidence
Brief summary
This study aims to generate real-world evidence on the clinical effectiveness and economic burden of ofatumumab (OMB) versus ocrelizumab (OCR) in patients diagnosed with multiple sclerosis (MS) in the United States (US). Clinical effectiveness will be assessed using annualized relapse rate (ARR), while economic burden will be assessed using healthcare resource utilization (HCRU) and healthcare costs (HCC). This study will use two primary data sources that capture longitudinal, de-identified healthcare utilization derived from claims submitted for reimbursement.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
Patients in the pooled OMB and pooled OCR cohorts are required to meet the following eligibility criteria: * ≥1 incident claim for OMB (pooled OMB cohort) or OCR (pooled OCR cohort) in the patient identification period. * No claims for OMB or OCR within the 12 months prior to the index date. The index date is the date of the first OMB or OCR claim. * ≥2 outpatient (OP) medical claims (at least 30 days apart) with a diagnosis code for MS (International Classification of Diseases, Tenth Revision, Clinical Modification \[ICD-10-CM\] code: G35) in any position, with the first claim occurring in the 12 months prior to or on index date and the second claim up to 6 months after index date, or ≥1 inpatient (IP) claim with MS recorded as the primary diagnosis in the 12 months prior to or on index date. * ≥18 years of age on index date. * Continuous healthcare plan enrollment for ≥12 months prior to index date and ≥6 months after index date. * Persistent use of OMB (pooled OMB cohort) or OCR (pooled OCR cohort) for ≥6 months after index date. Patients in the treatment-naïve OMB and treatment-naïve OCR cohorts are required to meet the following eligibility criteria: * Included in pooled OMB cohort or pooled OCR cohort. * No claims for a disease-modifying therapy (DMT) used for the treatment of MS in the 12-month baseline period.
Exclusion criteria
• Patients who do not meet the study inclusion criteria. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Annualized Relapse Rate (ARR) in Treatment-naïve MS Patients | Up to approximately 5 years, 4 months | ARR is defined as the number of relapse episodes per patient-year (PPY). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ARR in All MS Patients | Up to approximately 5 years, 4 months | ARR is defined as the number of relapse episodes PPY. |
| Number of All-cause and MS-related Healthcare Visits PPY | Up to approximately 5 years, 4 months | Healthcare visits include IP stays, IP days, emergency department (ED) visits, OP visits. |
| Total All-cause and MS-related Healthcare Costs (HCC) PPY | Up to approximately 5 years, 4 months | HCC include total, IP, ED, OP, and pharmacy costs. |
| Time From Treatment Initiation to First Relapse | Up to approximately 5 years, 4 months | — |
Countries
United States
Contacts
CONTACTNovartis Pharmaceuticals
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed