The ENABLE Study (Equitability of Insurance Access to Biologics and its Impact on Effectiveness)

Details of Research

Contact: Reka Thanabalan, Research Coordinator
416-586-4800 ext 7636

Primary Investigator: Dr. Geoffrey Nguyen

Co-investigators: Drs. Justina Sam, Smita Halder, Richmond Sy, Nilesh Chande

Enrolment: Ongoing

Objective: Objective is to formally assess the time interval from application for coverage of anti-TNF therapy (including Remicade and Humira) to first dose for privately vs. publicly insured patients with Inflammatory Bowel Disease (IBD) and to study whether potential delays in access to this therapy will have an effect on health outcomes such as hospitalization or surgery.

Expectation: If this study were to show that inequalities in access to drugs exists based on type of insurance, we can take steps to work with Ontario health policy makers to reform the public drug coverage program.

Eligibility: Biologic Naïve patients over 18 years of age who have a confirmed diagnosis of IBD (either Crohn's Disease or Ulcerative Colitis) and have applied for Remicade or Humira therapy after January 1, 2007 with one of the gastroenterologists at Mount Sinai Hospital.

Exclusion:

• Patients who have undergone IBD-related surgery within the 12 months prior to application for drug coverage
• Patients who are part of a clinical study in which biologic therapy is being provided as part of the research protocol

Participation:

• Signing a consent form allowing us to review your medical charts, contact coordinators for Remicade and Humira for collection of information relevant to your IBD diagnosis and treatment with biologics, and allowing CIHI (the Canadian Institute for Health Information) to locate information about you that is held in its Discharge Abstract Database with regards to surgeries, and hospitalizations.
• If you have applied for, but not started on your biologic therapy you will be asked to fill out a 5-10 minute questionnaire asking you about your demographic information including your education background and income. You may wish to complete the questionnaire online by providing us with your e-mail address, so that a link to the online version can be forwarded to you