Public versus Private Drug Insurance and Outcomes of Patients Requiring Biologic Therapies for Inflammatory Bowel Disease

Table 1

Exceptional access program (EAP) reimbursement criteria for initial approval for use in Crohn’s disease and ulcerative colitis patients. These criteria did not change during the study period.

Reimbursement criteria	Covered drugs
Treatment of fistulising Crohn’s disease in patients with actively draining perianal disease or enterocutaneous fistula(e) that have recurred or persisted despite a course of antibiotic therapy (ciprofloxacin and/or metronidazole) and immunosuppressive therapy (azathioprine or 6-mercaptopurine).	Infliximab; (Remicade®); Adalimumab; (Humira®)
Treatment of moderate to severe (luminal) Crohn’s disease in patients who have; (i) Harvey-Bradshaw Index (HBI) score ≥ 7,; (ii) failed to respond to conventional treatment with corticosteroids (prednisone 40 mg/day or equivalent for at least two weeks) or dose cannot be tapered below prednisone 20 mg/day or equivalent,; (iii) failed to respond to an immunosuppressive agent (azathiopurine, 6-mercaptopurine, methotrexate, or cyclosporine) tried for at least 3 months.	Infliximab; (Remicade®); Adalimumab; (Humira®)
Mild ulcerative colitis: (i) Mayo score < 6; (ii) patients with mild disease will be considered on a case-by-case basis but submission must include rationale for coverage.	Infliximab; (Remicade®)
Moderate ulcerative colitis: (i) Mayo score between 6 and 10 (inclusive),; (ii) endoscopic subscore of 2,; (iii) failed 2 weeks of oral prednisone 40 mg/day (or IV equivalent for at least 1 week) and 3 months of azathioprine or 6-mercaptopurine, or where the use of immunosuppressants is contraindicated,; (iv) stabilized with 2 weeks of oral prednisone ≥ 40 mg/day (or IV equivalent for at least 1 week) but the prednisone dose cannot be tapered despite 3 months of azathioprine or 6-mercaptopurine, or where the use of immunosuppressants is contraindicated.	Infliximab; (Remicade®)
Severe ulcerative colitis: (i) Mayo score between >10,; (ii) endoscopic subscore of 2,; (iii) failed 2 weeks of oral prednisone ≥ 40 mg/day (or IV equivalent for at least 1 week),; (iv) stabilized with 2 weeks of oral prednisone ≥ 40 mg/day (or IV equivalent for at least 1 week) but the prednisone dose cannot be tapered despite 3 months of azathioprine or 6-mercaptopurine, or where the use of immunosuppressants is contraindicated.	Infliximab; (Remicade®)