Limited Use Note(s)

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ADALIMUMAB40mg/0.8mL Inj Sol-0.8mL Pref Autoinj (Preservative-Free)
Reason For Use CodeClinical Criteria
600For 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. Approvals will only allow for standard dosing for adalimumab. The recommended dosing regimen is 40mg every two weeks.
LU Authorization Period: 1 year
601For the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of subcutaneously administered methotrexate (i.e. 15mg/m2 per week) for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate, the nature of the intolerance or contraindication should be documented. 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 demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. The recommended dosing regimen is for pediatric patients 2 years of age and older: - 10kg to less than 30kg: 20mg every other week* - 30kg and greater: 40mg every other week *a dose of 10mg every other week can be considered for patients weighing 10kg to less than 15kg It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.
LU Authorization Period: 1 year
602For 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 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.
LU Authorization Period: 1 year
603For the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic evidence (see note below) with: - Age of disease onset equal to or younger than 50; AND - Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND - 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 - 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 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.
LU Authorization Period: 1 year
604Luminal 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. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 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., 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
605Fistulising Crohn's disease For the treatment of fistulising Crohn's disease with concomitant luminal disease in patients who meet the following criteria: A. 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); AND B. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease) The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 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 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
606Ulcerative 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. Adalimumab 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 up to 160mg at week 0, followed by up to 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 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 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
607For the treatment of patients with active moderate to severe hidradenitis suppurativa (HS) who have not responded to conventional therapy (including systemic antibiotics) and who meet all of the following: A. A total abscess and nodule count of 3 or greater; AND B. Lesions in at least two distinct anatomic areas, one of which must be Hurley Stage II or III; AND C. Experienced an inadequate response to a 90-day trial of oral antibiotics. Therapy must be prescribed by a practitioner with expertise in the management of patients with HS. The recommended adult dosing regimen is 160mg at week 0, followed by 80mg at week 2, then 40mg at week 4, and 40mg weekly thereafter. The recommended adolescent dosing regimen is 80mg at week 0, followed by 40mg every other week starting at week 1 up to 40mg weekly in those with inadequate response. If there is no improvement after 12 weeks of treatment with adalimumab at the Health Canada approved dose, higher doses are not recommended and the prescriber should discontinue treatment. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewal: Maintenance therapy is funded for patients beyond the first 12 weeks in those who meet the Ministry initiation criteria and who have responded to treatment defined as at least a 50% reduction in abscesses and inflammatory nodule count with no increase in abscess count or draining fistula count relative to baseline. Maintenance therapy beyond the second year is funded for patients using adalimumab for HS, where there is objective evidence of the preservation of treatment effect (i.e. the current abscess and inflammatory nodule count should be compared to the count prior to initiating treatment with adalimumab). The recommended maintenance dose is 40mg weekly. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.
LU Authorization Period: 1 year
609For 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. *Definition of 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. **Definition of 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 12 week trial of phototherapy (unless not accessible) 6 month trial of at least 2 systemic, oral agents used alone or in combination - Methotrexate 15-30mg per 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 Approvals will only allow for standard dosing for adalimumab. The recommended dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subcutaneously given every other week starting at week 1, as approved by Health Canada. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended, and the physician should consider switching to an alternative biologic agent.
LU Authorization Period: 1 year
611For the treatment of severe uveitis in patients meeting the following criteria: A. Has experienced failure or intolerance to an oral corticosteroid (or topical corticosteroid for anterior uveitis) or where the use of corticosteroids is contraindicated, and has experienced failure or intolerance to at least one immunosuppressive therapy; AND B. Treatment must be prescribed by an opthalmologist specialized in uveitis or retinal disease, a uveitis specialist, or a retina specialist familiar with ocular inflammatory diseases. Requests not meeting the above criteria may be considered on a case-by-case basis through the Exceptional Access Program. The recommended adult dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subsubcutaneously given every other week starting at week 1, as approved by Health Canada. Note: Higher doses up to 40mg weekly may be considered in patients who have failed to respond to lower doses. The recommended dose for pediatric patients (2 years of age and older) with anterior uveitis is: Less than 30kg: 20mg every other week in combination with methotrexate 30kg or greater: 40mg every other week in combination with methotrexate For patients 6 years of age or older and less than 30kg, an optional loading dose of 40mg at week 0 may be administered before starting maintenance therapy. For patients 6 years of age or older and weighing 30kg or greater, an optional loading dose of 80mg at week 0 may be administered before starting maintenance therapy. It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewals: Maintenance therapy is funded for patients who meet the Ministry initiation criteria and who have experienced improvement and/or stability of vision and other treatment goals (e.g. reduction or control of ocular inflammation).
LU Authorization Period: 1 year