Rinvoq

For the treatment of ulcerative colitis disease in patients who meet the following criteria:

1. Moderate disease

a. Mayo score between 6 and 10 (inclusive) AND

b. Endoscopic* subscore of 2 AND

c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40 mg (or a 1 week course of IV equivalent)

OR

d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40 mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated).

2. Severe disease

a. Mayo score greater than 10 AND

b. Endoscopy* subscore of greater than or equal to 2 AND

c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40 mg (or 1 week of IV equivalent)

OR

d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40 mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated).

*The endoscopy procedure must be done within the 12 months prior to initiation of treatment.

Maintenance/Renewal:

Maintenance therapy is funded for patients who meet the Ministry initiation criteria and whose disease is maintained at Mayo score less than 6 AND who demonstrate at least 50% reduction in the dose of prednisone compared with the starting dose following the first 6 months of treatment with upadacitinib or be off corticosteroids after the first year of treatment.

Approved Dose:

Induction: Up to 45 mg once daily for 8 weeks

Maintenance: 15 mg or 30mg once daily.

For patients greater or equal to 65 years of age, the maintenance dose is 15 mg once daily.

Depending on therapeutic response, 30mg once daily may also be used for maintenance in some patients younger than 65 years of age. However, the lowest effective dose possible should be used for maintenance therapy to minimize adverse effects.

Upadacitinib

• Brand(s): Rinvoq
• Dosage Form/Strength: 15 mg Extended Release tablet
• Effective date: November 16, 2022 (PsA)

Upadacitinib

• Brand(s): Rinvoq
• Dosage Form/Strength: 15 mg Extended Release tablet
• Effective date: August 8, 2024 (AS)

Upadacitinib for Ankylosing Spondylitis

Initiation Criteria:

For the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic report with:

1. 18 years of age and older;
   AND
2. Age of disease onset ≤ 50 year;
   AND
3. Low back pain and stiffness for > 3 months that improves with exercise and not relieved by rest;
   AND
4. 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
5. BASDAI score of ≥ 4 for at least 4 weeks while on standard therapy;
   AND
6. A list of current concomitant medications related to the AS/PS, including pain medications (if relevant) with dosing regimens provided.

*NSAIDs include coxibs; use of DMARDS instead of NSAIDs not acceptable

The information submitted with the request must include the following:

• A list of current concomitant medications related to the AS, including pain medications (if relevant). Please include dosing regimens.
• Details of review of radiographic reports for severe active disease.
  • X-ray or CT scan report stating the presence of “SI joint fusion” or “SI joint erosion” OR
  • MRI report stating the presence of “inflammation” or “edema” of the SI joint
  • Actual radiographic reports must be submitted with the request. If the radiographic reports do not specify the above, the request will be reviewed by external medical experts

Additional information that should be provided if applicable:

• Schober measurement and chest expansion measurement
• Evidence of restricted spinal mobility
• If the patient has AS/PS with predominantly peripheral joint involvement, additional information pertaining to trials of DMARDs must be provided, and these requests will be reviewed by external medical experts.

First Renewal:

Renewal will be considered for patients with objective evidence of at least a 50% reduction in BASDAI score or ≥ 2 absolute point reduction in BASDAI score. (Please provide an update on concomitant medications for AS/PS and whether there has been a reduction in pain medication for AS/PS since initiating the biologic, if applicable.)

Second and subsequent renewals:

For renewals beyond the second year, objective evidence of preservation of treatment effect must be provided.

Exclusion criteria (for Initials and Renewals):

• Combination therapy with another biologic or JAK inhibitor treatment used to treat ankylosing spondylitis or other rheumatological condition will not be funded.

Approved dose: 15 mg once daily

Approval duration:
- Initial: 1 year
- First renewal: 1 year
- Second and subsequent renewal: 2 years

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Upadacitinib

• Brand(s): Rinvoq
• Dosage Form/Strength: 15 mg, 30 mg Extended Release tablet
• Effective date: October 31, 2023 (AD)

Upadacitinib for Atopic Dermatitis

Initiation Criteria:

For the treatment of moderate to severe atopic dermatitis in patients meeting all the following criteria;

1. 12 years of age or older;
   AND
2. Diagnosed with moderate-to-severe atopic dermatitis (AD) by the Eczema Area and Severity Index (EASI) score equal to or greater than 16 points and the Investigators (Physician) Global Assessment score of 3 to 4;
   AND
3. Failure to maintain adequate control of their dermatitis with maximally tolerated medical topical therapies for AD combined with phototherapy (where available); (Note 1 and 2)
   AND
4. Failure to maintain adequate control of their dermatitis with maximally tolerated medical topical therapies for AD combined with at least 1 of the 4 systemic immunomodulators (methotrexate, cyclosporine, mycophenolate mofetil, or azathioprine). (Note 1 and 2)
5. Upadacitinib is prescribed by a dermatologist, allergist, pediatrician or clinical immunologist, or in consultation with one of these specialists. (Please include the consult note with the EAP application.)

Exclusion Criteria:

Upadacitinib will not be funded if it is used in combination with phototherapy or any immunomodulatory drugs (including biologics (Note 3) or a Janus kinase [JAK] inhibitor treatment) for treatment of AD.

Notes:

1. For each treatment used, provide documentation of refractory disease and/or intolerance (including a description of the adverse effect and severity of reaction). If a patient is deemed to be ineligible or contraindicated to receive the treatment, provide the reason(s) for their ineligibility.
2. An adequate trial for patients with AD who undergo therapy with phototherapy, methotrexate, cyclosporine, mycophenolate mofetil, and azathioprine is defined as follows:
   • For phototherapy: the typical duration would be considered 12 weeks (3 times per week).
   • For methotrexate: an adequate trial would be 10 mg to 20 mg per week for 12 weeks.
   • For cyclosporine: an adequate trial would be 2.5 mg/kg to 5 mg/kg per day for 12 weeks.
   • For mycophenolate mofetil: an adequate trial would be 1 g twice daily for 12 weeks.
   • For azathioprine: an adequate trial would be 1.5 to 2.5 mg/kg/day for 12 weeks
3. The concurrent use of upadacitinib used in combination with other biologics used for other conditions will be considered on a case-by-case basis.
4. Funding of patients who meet the above criteria and who are experiencing inadequate response using another systemic treatment (e.g., biologics, steroids) for AD will be considered on a case-by-case basis.

Renewal Criteria:

First renewal:

Renewal of funding will be considered in patients with documentation of benefit from treatment. Benefit from treatment is defined as a 75% or greater improvement from baseline in the Eczema Area and Severity Index (EASI) score (EASI-75) in the first 20 weeks of treatment initiation with upadacitinib.

Subsequent renewals:

Subsequent renewal of funding will be considered in patient who maintain the 75% or greater improvement in EASI score response from baseline.

Duration of Approval for initial requests: 6 months

Duration of Approval for first and second renewal: 6 months

Duration of Approval for 3rd and subsequent renewals: 1 year

Approved dose: Up to 30 mg orally once daily.

Please refer to the product monograph for dose recommendations.

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Upadacitinib

• Brand(s): Rinvoq
• Dosage Form/Strength: 15 mg, 30 mg, 45 mg Extended Release tablet
• Effective date: August 8, 2024 (CD)

Upadacitinib for Luminal Crohn’s disease

Initiation Criteria:

For the treatment of moderate to severe luminal Crohn's disease in patients who meet ALL of the following criteria:

1. Has a Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe luminal Crohn’s disease);
   AND
2. Has failed conventional treatment with a corticosteroid (prednisone 40–60 mg/day [or equivalent]) for a minimum of 14 days (or an intravenous corticosteroid for 1 week);
   OR
   Has responded to or has stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate)
   AND
3. Upadacitinib is being used to induce remission or as a steroid-sparing maintenance therapy.

Notes:

1. Patients with mild Crohn’s disease (e.g., HBI less than 7) may be considered on a case-by-case basis but the application must include the rationale for coverage and other relevant details.
2. Patients who have not demonstrated prior treatment failure, (i.e., an inadequate response to, loss of response to, or intolerance to at least one of conventional and/or biologic therapy) will be considered on a case-by-case basis.

Renewal Criteria:

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 (for Initials and Renewals):

• Combination therapy with another biologic or JAK inhibitor treatment used to treat inflammatory bowel disease will not be funded.

Approved doses:
- Induction dose: Up to 45 mg once daily for 12 weeks
- Maintenance dose:15 mg or 30 mg* once daily.
- For patient 65 years of age or older: 15 mg once daily

*Depending on therapeutic response, 30 mg once daily may also be used for maintenance in some patients younger than 65 years of age. However, the lowest effective dose possible should be used for maintenance therapy to minimize adverse effects.

Approval Durations:
- Initial approval: 6 months
- First EAP renewal: 1 year
- Second and subsequent EAP renewals: 2 years

Upadacitinib for Fistulising Crohn’s disease with concomitant luminal disease

Initiation Criteria:

For the treatment of fistulising Crohn’s disease with concomitant luminal disease in patients who meet ALL the following criteria:

1. Patient has actively draining perianal or enterocutaneous fistula(e) that have recurred or persist despite a course of
   a. appropriate antibiotic therapy (e.g., ciprofloxacin and/or metronidazole) and immunosuppressive therapy (e.g., azathioprine or 6-mercaptopurine)
   OR
   b. appropriate antibiotic therapy (e.g., ciprofloxacin and/or metronidazole) and a biologic (e.g., adalimumab, infliximab, ustekinumab) with or without an immunosuppressive therapy
   AND
2. Harvey Bradshaw Index (HBI) score greater than or the same as 7 (or other validated disease activity score confirming moderate to severe disease)

Initial approved dose:

Doses exceeding the standard recommended doses will be considered on a case-by-case basis. Please provide clinical rationale to support the request for higher doses.

Renewal Criteria

Maintenance therapy is funded for patients who met the initiation criteria and who achieve and maintain response to therapy (e.g., partial or complete resolution of fistulae and symptom improvement). Please include information describing the patient’s fistula(e) resolution (e.g., partial or complete resolution) and HBI score.

Exclusion criteria (for Initials and Renewals):

• Combination therapy with another biologic or other JAK inhibitor treatments used to treat inflammatory bowel disease will not be funded.

Approved doses:
- Induction dose: Up to 45 mg once daily for 12 weeks
- Maintenance dose:15 mg or 30 mg* once daily.
- For patient 65 years of age or older: 15 mg once daily

*Depending on therapeutic response, 30 mg once daily may also be used for maintenance in some patients younger than 65 years of age. However, the lowest effective dose possible should be used for maintenance therapy to minimize adverse effects

Approval durations:
- Initial approval: 6 months
- First renewal: 6 months to 1 year pending fistula(e) resolution
- Second and subsequent renewals: 2 years with complete resolution

The duration of approval for patients with partial resolution will be provided on a case-by-case basis.

EAP Drug Request Form:

Standard Form for EAP Drug Requests