Effect of Patient Cost Sharing on Treatment Discontinuation Among Rheumatoid Arthritis Patients

Effect of Patient Cost Sharing on Treatment Discontinuation Among Rheumatoid Arthritis Patients Treated With Biologic Disease Modifying Antirheumatic Drug (DMARD) Therapies

The purpose of this study is to assess the impact of patient cost sharing on treatment discontinuation of biologic agents in patients with Rheumatoid Arthritis (RA)

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis

• Study Type: Observational
• Enrollment (Actual): 3940

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Commercial health plan members

Description

Patients diagnosed with Rheumatoid Arthritis (RA) who newly initiated a biologic DMARD (bDMARD) during a study timeframe of 1/01/06 to 3/31/09.

Inclusion Criteria:

• 18 to 64 years of age at index date
• Diagnosis of RA during the study period (ICD-9CM 714.xx)
• Evidence of at least one biologic DMARD of interest during the study timeframe
• Continuous enrollment during the study timeframe
• Both medical and pharmacy benefits
• No evidence of a claim for a bDMARD in the 6-month pre-period

Exclusion Criteria:

• Patients are excluded if they have a diagnosis of psoriasis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, or ulcerative colitis at any time during the study timeframe; have a claim for Rituxan, IV etanercept, or IV adalimumab; or have Medicare or Medicaid during the study timeframe

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
New to bDMARD; New to bDMARD RA patients with high and low cost share who continue or discontinue treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Effect of patient cost share on discontinuation	Assessed from first prescription date and followed for 1-year

Secondary Outcome Measures

Outcome Measure	Time Frame
RA-related healthcare utilization and costs	Pre-index: 6-month period prior to the index drug date
All-cause healthcare utilization and costs	Pre-index: 6-month period prior to the index drug date
RA-related healthcare utilization and costs	Post-period: Index date+365 days
All-cause healthcare utilization and costs	Post-period: Index date+365 days

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trials Disclosure
• For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: June 3, 2010
• First Submitted That Met QC Criteria: June 4, 2010
• First Posted (Estimate): June 7, 2010

Study Record Updates

• Last Update Posted (Estimate): October 1, 2010
• Last Update Submitted That Met QC Criteria: September 30, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: IM101-256