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Limited coverage drugs – ruxolitinib

Last updated on September 27, 2024

Generic name

ruxolitinib

Strength

5 mg, 10 mg

Form

tablets

Special Authority criteria

Approval period 

Acute graft-versus-host disease (aGvHD) in adult and pediatric patients aged 12 years and older

Initial coverage

Patient has acute graft-versus-host disease (aGvHD) grade II to IV 

AND

Has confirmed diagnosis of corticosteroid refractory or corticosteroid dependent aGvHD1

AND

Patient must not be receiving treatment with systemic therapies for aGvHD (except for calcineurin inhibitors)

AND

The treatment is prescribed by a specialist physician with the BC Leukemia/Bone Marrow Transplant (BCL/BMT) program

4 weeks

Renewal coverage

Patient has achieved an overall response (i.e., complete response, very good partial response, partial response, or stable disease with significant reduction in steroid doses) at Day 28 of treatment and maintains an ongoing clinical benefit  

12 weeks

Chronic graft-versus-host-disease (cGvHD) in adults and pediatric aged 12 years and older

Initial

Patient has moderate to severe chronic graft-versus-host disease (cGvHD) according to National Institutes of Health (NIH) consensus criteria

AND

Patient has experienced inadequate response to corticosteroids2 or corticosteroids with other systemic therapies

AND

Patient must not be receiving additional treatment with systemic therapies for cGvHD (except for calcineurin inhibitors)

AND

The treatment is prescribed by a specialist physician with the BCL/BMT program

24 weeks

Renewal

Patient has achieved an overall response (i.e., complete response, very good partial response, partial response, or stable disease with significant reduction in steroid doses), after 24 weeks of treatment and maintains an on-going clinical benefit

24 weeks

Practitioner exemptions

  • None

Special notes

  1. Corticosteroid refractory in aGvHD is defined by one or more of the following criteria:
    1. Progressing based on organ assessment after at least 3 days compared to organ stage at the time of initiation of high-dose systemic corticosteroid ± calcineurin inhibitor for the treatment of Grade II-IV aGvHD
    2. Failure to achieve at a minimum partial response based on organ assessment after 7 days compared to organ stage at the time of initiation of high-dose systemic corticosteroid ± calcineurin inhibitor for the treatment of Grade II-IV aGvHD
    3. Patients who fail corticosteroid taper defined as fulfilling either one of the following criteria:
      1. Requirement for an increase in the corticosteroid dose to methylprednisolone ≥2 mg/kg/day (or equivalent prednisone dose ≥2.5 mg/kg/day)
      2. Failure to taper the methylprednisolone dose to < 0.5 mg/kg/day (or equivalent prednisone dose < 0.6 mg/kg/day) for a minimum 7 days
    4. Patients who have recurrent flare ups during prednisone taper or with significant steroid toxicities precluding higher steroid doses
  2. Corticosteroid refractory in cGvHD is defined according to the NIH consensus criteria is, irrespective of the concomitant use of a calcineurin inhibitor:
    1. A lack of response or disease progression after administration of minimum prednisone 1mg/kg/day for at least 1 week (or equivalent); or
    2. Disease persistence without improvement despite continued treatment with prednisone at > 0.5 mg/kg/day or 1 mg/kg/every other day for at least 4 weeks (or equivalent); or
    3. Increase to prednisone dose to > 0.25 mg/kg/day after two unsuccessful attempts to taper the dose (or equivalent)
    4. Patients who have recurrent flare ups or who develop prednisone toxicity during the prednisone taper

Special Authority requests