| 541 | For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments:
A. i) Methotrexate (20mg/week) for at least 3 months, AND
ii) leflunomide (20mg/day) for at least 3 months, in addition to
iii) an adequate trial of at least one combination of DMARDs for 3 months; OR
B. i) Methotrexate (20mg/week) for at least 3 months, AND
ii) leflunomide in combination with methotrexate for at least 3 months; OR
C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.)
Maintenance/Renewal:
After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year.
For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect.
Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology.
The recommended dosing regimen is 3mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of 3mg/kg/dose every 8 weeks up to a maximum of six maintenance doses per year. |
| | LU Authorization Period: 1 year |
| 542 | For the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic evidence (see notes below) with:
I. Age of disease onset less than or equal to 50; AND
II. Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND
III. Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND
IV. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4 for at least 4 weeks while on standard therapy.
Note: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint.
Maintenance/Renewal:
After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect.
Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology.
The recommended dosing regimen is 3 to 5mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of up to 5mg/kg/dose every 6 to 8 weeks. |
| | LU Authorization Period: 1 year |
| 543 | For the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months.
If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required.
Maintenance/Renewal:
After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect.
Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology.
The recommended dosing regimen is 5mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of 5mg/kg/dose every 8 weeks. |
| | LU Authorization Period: 1 year |
| 544 | For the treatment of severe* plaque psoriasis in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**.
Claims for the first 6 months must be written by a dermatologist.
Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required.
Patients not responding adequately at 12 weeks should have treatment discontinued.
*Severe plaque psoriasis:
- Body Surface Area (BSA) involvement of at least 10 percent, or involvement of the face, hands, feet or genital regions, AND
- Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND
- Dermatology Life Quality Index (DLQI) score of at least 10.
**Failure, intolerance or contraindication to adequate trials of standard therapies:
-6 month trial of at least 3 topical agents including vitamin D analogues and steroids, AND
- 12 week trial of phototherapy (unless not accessible), AND
- 6 month trial of at least 2 systemic, oral agents used alone or in combination
- Methotrexate 15 to 30mg/week
- Acitretin (could have been used with phototherapy)
- Cyclosporine
Maintenance/Renewal:
After 3 months of therapy, patients who respond to therapy should have:
- At least a 50% reduction in PASI, AND
- at least a 50% reduction in BSA involvement, AND
- at least a 5 point reduction in DLQI score
The recommended dosing regimen is 5mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of 5mg/kg/dose every 8 weeks. |
| | LU Authorization Period: 1 year |
| 545 | Ulcerative Colitis
For the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria:
A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease);
AND
B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week);
OR
Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine);
OR
Conventional treatment with a corticosteroid is contraindicated;
AND
C. Infliximab is being used to induce remission or as a steroid-sparing maintenance therapy.
*The endoscopy procedure must be done within the 12 months prior to initiation of treatment.
The recommended induction dosing regimen is 5mg/kg/dose at 0,2, and 6 weeks.
The recommended maintenance dosing regimen is 5mg/kg/dose every 8 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.)
Maintenance/Renewal:
Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids.
Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy.
Exclusion criteria (initial and renewal coverage):
-Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded.
Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program. |
| | LU Authorization Period: 1 year |
| 546 | Luminal Crohn's disease
For the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria:
A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease);
AND
B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week);
OR
Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate);
OR
Conventional treatment with a corticosteroid is contraindicated;
AND
C. Infliximab is being used to induce remission or as a steroid-sparing maintenance therapy.
The recommended induction dosing regimen is 5mg/kg/dose at 0, 2, and 6 weeks.
The recommended maintenance dosing regimen is 5mg/kg/dose every 8 weeks. (Note: higher doses up to 10mg/kg/dose may be considered in patients who have failed to respond to lower doses.)
Maintenance/Renewal:
Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids.
Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy.
Exclusion criteria (initial and renewal coverage):
- Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded.
Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program. |
| | LU Authorization Period: 1 year |
| 547 | Fistulising Crohn's disease
For the treatment of fistulising Crohn's disease in patients who meet the following criteria:
- Patient has actively draining perianal or enterocutaneous fistula(e) that have recurred OR persist despite a course of appropriate antibiotic therapy (e.g., ciprofloxacin and/or metronidazole)
The recommended induction dosing regimen is 5mg/kg/dose at 0, 2, and 6 weeks.
The recommended maintenance dosing regimen is 5mg/kg/dose every 8 weeks. (Note: higher doses up to 10mg/kg/dose may be considered in patients who have failed to respond to lower doses.)
Maintenance/Renewal:
Maintenance therapy is funded for patients who met the initiation criteria and achieve and maintain response to therapy (e.g., partial or complete resolution of fistulae and symptom improvement).
Exclusion criteria (initial and renewal coverage):
- Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. |
| | LU Authorization Period: 1 year |
