Limited coverage drugs – anifrolumab

Generic name

anifrolumab

Strength & form

300 mg vial

Initial

For the treatment of patients 18 years of age and older with active, autoantibody positive moderate to severe systemic lupus erythematosus (SLE), who meet the following criteria:

• Patient has a systemic lupus erythematosus disease activity index (SLEDAI-2K) score ≥ 6

AND

• Patient requires chronic use of at least 10 mg/day of prednisone (or equivalent) in addition to standard of therapy defined as:
  • hydroxychloroquine, and
  • at least one immunosuppressive agent such as methotrexate, azathioprine, cyclosporine, mycophenolate mofetil, and cyclophosphamide

AND

• Special Authority request is submitted by a rheumatologist or a dermatologist

Note that coverage will not be provided for patients with:

• Severe or unstable neuropsychiatric SLE, or
• Active severe SLE nephritis

Anifrolumab will not be reimbursed when used in combination with other biologic treatments used for SLE.

1 year

Renewal

For renewal of coverage, patient must have attained and maintained:

• Reduction of prednisone (or its equivalent) dose to ≤ 7.5 mg/daily OR decrease by a minimum of 50% from baseline

AND

• Reduction in disease activity measured by:
  • Reduction of the SLEDAI-2K score to 5 or less, or
  • British Isles Lupus Assessment Group (BILAG) index showing improvement in organ systems and no new worsening

AND

• Special Authority requests must be submitted by a rheumatologist or dermatologist