Product Details

Rinvoq

Upadacitinib
45 mg
ER Tablet

DIN/PIN/NPN

02539721

Manufacturer

AbbVie Corporation

Formulary Listing Date

2024-08-30

Unit Price

101.8100

Amount MOH Pays

101.8100

Coverage Status

Limited Use Product

ODB Formulary Therapeutic Classification

92:36:00 Disease-Modifying Antirheumatic Agents

Therapeutic Note

NO

ATC Code

L04AF03

Interchangeable Products

NO

LU Clinical Criteria

LU Code	Auth. Period	Clinical Criteria
684	1 year	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 40mg (or a 1 week course of IV equivalent) OR d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (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 40mg (or 1 week of IV equivalent) OR d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (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 45mg once daily for 8 weeks Maintenance: 15mg or 30mg once daily. For patients greater or equal to 65 years of age, the maintenance dose is 15mg 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.

EAP Criteria

Therapeutic Class	Reimbursement Criteria
Psoriatic Arthritis Treatments	Upadacitinib Brand(s): Rinvoq Dosage Form/Strength: 15 mg tablet Effective date: November 16, 2022 For the treatment of psoriatic arthritis (PsA) in patients who have: Severe active disease (Greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite treatment with methotrexate (20 mg/week) for at least 3 months and one of leflunomide (20 mg/day) or sulfasalazine (1 g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20 mg/day) or sulfasalazine (1 g twice daily) for at least 3 months is required. Details of contraindications and intolerances must also be provided. Renewal Criteria: Renewals will be considered for patients with objective evidence of at least a 20% reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, objective evidence of preservation of treatment effect must be provided. Exclusion Criteria: Upadacitinib will not be reimbursed when used in combination with other Janus Kinase (JAK) inhibitor treatments for psoriatic arthritis or other biologic disease-modifying antirheumatic drugs (DMARDs) for psoriatic arthritis. Recommended Dose: 15 mg once daily. Approval durations: - Initials: 1 year - First renewal: 1 year - Second and subsequent renewals: 5 years EAP Drug Request Form: Standard Form for EAP Drug Requests

Product Monograph