Olumiant

For the treatment of rheumatoid arthritis (RA) in combination with methotrexate 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.)

In patients who demonstrated initial response to treatment (defined as an achievement of an American College of Rheumatology [ACR] improvement criteria of at least 20% [ACR20] at week 12), ongoing maintenance therapy is funded.

Maintenance/Renewal:

After 12 weeks of treatment, maintenance therapy is funded for patients who achieved an American College of Rheumatology (ACR) improvement criteria of at least 20% (ACR20) and a minimum of improvement in 2 swollen joints by week 12.

For renewals beyond 12 months, 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 2mg administered once daily.

Baricitinib should not be used in combination with other Janus kinase (JAK) inhibitors or other biologic DMARDs to treat the patient's RA

Initiation criteria:

For the treatment of adult patients with severe alopecia areata (AA) who meet the following criteria:

1. Have a Severity of Alopecia Tool (SALT) score of 50 or above, and
2. Have experienced the current episode of AA for more than 6 months but less than 8 years.

The maximum duration of initial authorization is 36 weeks.

Renewal criteria:

For continuation of reimbursement, the patient must demonstrate beneficial clinical effect, defined as achieving a SALT score of 20 or less at 36 weeks after treatment initiation. Maintenance of a SALT score of 20 or less every 12 months thereafter is required for reimbursement renewal.

Dosing and prescribing:

The recommended dose is 2mg once daily. The maximum funded dose is 4mg once daily.

Baricitinib should be prescribed by a dermatologist with expertise managing patients with severe AA.

Baricitinib should not be used in combination with other JAK inhibitors, biologic immunomodulators, or systemic immunosuppressants.