Product Details

Jakavi

Ruxolitinib
10 mg
Tablet


DIN/PIN/NPN

02434814

Manufacturer

Novartis Pharma Canada Inc.

Formulary Listing Date

2023-04-28  

Unit Price

91.8338

Amount MOH Pays

91.8338

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L01EJ01

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Oncology Drugs

Ruxolitinib

  • Brand(s): Jakavi
  • Dosage Form/Strength: 5 mg, 10mg, 15 mg, 20 mg tablets

For the treatment of intermediate to high-risk symptomatic Myelofibrosis (MF) in patients meeting the following criteria:

  1. MF is assessed using the Dynamic International Prognostic Scoring System (DIPSS) Plus; or the patient has symptomatic splenomegaly

  1. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3

  1. Patient is previously untreated or refractory to other treatment

Dosing regimen: 5 mg to 25 mg twice a day

Duration of Approval: 1 Year

Initial Renewals are considered for patients who:

  • Have confirmation of either a reduction in spleen size or documented improvement of disease symptoms within 6 months of initiating therapy with Jakavi.

Second and subsequent Renewals are considered for patients who continue to benefit from therapy with Jakavi

For the treatment of patients with polycythemia vera who meet the following criteria:

  1. Demonstrated resistance1 or demonstrated intolerance2 to hydroxyurea (HU); AND

  1. Have a good performance status (ECOG ≤ 3)

1Resistance to Hydroxyurea as defined by:
Use of HU for at least 3 months of treatment at a dose of at least 2 grams per day (or at maximally tolerated doses if unable to take 2 grams per day) meeting one of the following: 

  • Patient continues to require phlebotomy to keep hematocrit (HCT) at less than 45%; OR 

  • Patient demonstrates uncontrolled myeloproliferation (i.e., platelet count > 400 x 109/L and white blood cell count > 10 x 109/L); OR 

2Symptomatic splenomegaly Intolerance to Hydroxyurea as defined:
After any dose of hydroxyurea, patient demonstrates one of the following: 

  • Absolute neutrophil count < 1 x 109/L or platelet < 100 x 109/L or hemoglobin < 100 g/L at the lowest dose of HU required to achieve a response; OR

  • Presence of leg ulcers or other unacceptable HU-related grade 3 or 4 non- hematological toxicities (e.g., Mucocutanous manifestations, gastrointestinal symptoms, pneumonitis, fever); OR

  • If patient demonstrates non-hematological grade 2 toxicities for at least one week: OR

  • If toxicity requires permanent discontinuation of HU, interruption of HU until resolution of toxicity, or requiring hospitalization as a result of HU toxicity.

Renewal:
Patient continues to respond3 to treatment and has not experienced disease progression.

3Response defined by any one or more of the following:

  • Hematocrit less than 45% without phlebotomy

  • Platelet count ≤ 400 x 109/L

  • White blood cell count ≤ 10 x 109/L

  • Non-palpable spleen

Approval duration for initiation and renewal: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests
Oncology – Supportive Management

Ruxolitinib

  • Brand(s): Jakavi
  • Dosage Form/Strength: 5 mg, 10 mg, 15 mg, 20 mg tablets
  • Effective date: July 5, 2023

For the treatment of Acute Graft versus host disease (aGvHD) in patients meeting the following criteria:

  1. Aged 12 years of age or older; AND

  1. Confirmed diagnosis* of aGvHD clinically defined as grade II to IV aGvHD according to the National Institutes of Health (NIH) criteria (Harris et al. [2016]);

    *Prescribers to provide the etiology (i.e., allogeneic stem cell or bone marrow transplant or other transplant type that led to aGvHD), approximate date of diagnosis, stage and clinical details to support the diagnosis and baseline presentation including affected organs or systems. The baseline information is important for discontinuation and renewal criteria.

    AND

  2. Patients have a confirmed diagnosis of corticosteroid-refractory or corticosteroid-dependent aGvHD;
    i) Corticosteroid refractory is defined by one or more of the following criteria:
    a)     Progressing based on an 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;
    AND/OR
    b) 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;
    AND/OR
    c) Patients who fail corticosteroid taper defined as fulfilling either one of the following criteria:
    •     Requirement for an increase in the corticosteroid dose to methylprednisolone ≥2 mg/kg/day (or equivalent prednisone dose ≥2.5 mg/kg/day)
    •     Failure to taper the methylprednisolone dose to less than 0.5 mg/kg/day (or equivalent prednisone dose less than 0.6 mg/kg/day) for a minimum 7 days.
    ii) Corticosteroid dependence is defined as the inability to taper prednisone under 2 mg/kg/day after an initially successful treatment of at least 7 days or as the recurrence of aGvHD activity during steroid taper.

    AND

  3. Prescribed by a clinician who has experience in the diagnosis and management of patients with GvHD.

Notes:

  1. The definition of corticosteroid refractory aGvHD is defined based on criteria in the EBMT-NIH-CIBMTR Task Force position statement, irrespective of the concomitant use of a calcineurin inhibitor.

  1. Treatment with ruxolitinib must not be added to patients’ concurrent treatment of systemic therapies for the treatment of aGvHD other than steroids ± calcineurin inhibitors

Exclusions:

Treatment with ruxolitinib must not be used with’ concurrent treatment of systemic therapies for aGvHD other than steroids ± calcineurin inhibitors

Discontinuation Criteria:

Ruxolitinib should be discontinued upon the occurrence of any of the following:

  • Progression of aGvHD, defined as worsening of aGvHD symptoms or occurrence of new aGvHD symptoms

  • Patient is experiencing unacceptable toxicity to ruxolitinib.

  • Patient must use additional systemic therapies (other than calcineurin inhibitors) for aGvHD after day 28.

  • Recurrence or relapse of underlying hematological malignancy.

Renewal:

Renewal of funding of ruxolitinib for aGvHD will be considered for patients who met the initiation criteria and who do not meet the discontinuation criteria AND who have achieved an overall response (i.e., Complete response (CR), Very good partial response (VGPR), Partial Response (PR), or stable disease with significant reduction in steroid doses), according to standard NIH criteria at day 28 (approximately 4 weeks).

For subsequent renewals, patients should be assessed for treatment response every 2 to 3 months, until the occurrence of any of the discontinuation criteria.

Approval duration of initials: 2 months

Approval duration of renewals: 6 months

Ruxolitinib

  • Brand(s): Jakavi
  • Dosage Form/Strength: 5 mg, 10 mg, 15 mg, 20 mg tablets
  • Effective date: July 5, 2023

Initiation Criteria:

For the treatment of Chronic Graft versus host disease (cGvHD) in patients meeting the following criteria:

  1. Aged 12 years of age or older; AND

  1. Confirmed diagnosis* of cGvHD defined as having moderate to severe cGVHD based on National Institutes of Health (NIH) consensus criteria (Prescribers to provide the stage and clinical details to support the diagnosis and baseline presentation.)

    *Prescribers to provide the etiology (i.e., allogeneic stem cell or bone marrow transplant or other transplant type that caused cGvHD), approximate date of diagnosis, stage and clinical details to support the diagnosis and baseline presentation including affected organs or systems. The baseline information is important for discontinuation and renewal criteria.

    AND

  2. Inadequate response to corticosteroids or systemic therapies as defined by meeting at least one of the below circumstances with prednisone or an equivalent corticosteroid therapy:
    • A lack of response or disease progression after administration of minimum prednisone 1 mg/kg/day for at least one week (or equivalent);
    OR
    •     Disease persistence without improvement despite continued treatment with prednisone at greater than 0.5 mg/kg/day or 1 mg/kg/every other day for at least four (4) weeks (or equivalent);
    OR
    •     Increase prednisone dose to greater than 0.25 mg/kg/day after two unsuccessful attempts to taper the dose (or equivalent).

  3. Prescribed by a clinician who has experience in the diagnosis and management of patients with GvHD.

Notes:

  1. The definition of corticosteroid refractory cGvHD is defined according to the NIH consensus criteria, irrespective of the concomitant use of a calcineurin inhibitor.

  1. Treatment with ruxolitinib must not be added to patients’ concurrent treatment of systemic therapies for the treatment of cGvHD other than steroids ± calcineurin inhibitors.

  1. Request applications must include the clinical baseline presentations, details of the dose, duration, and timelines of corticosteroid treatments used to treat the patient’s GvHD, the doses and relevant other therapies used including calcineurin treatments

Exclusions:

Treatment with ruxolitinib must not be used with concurrent treatment of systemic therapies for cGvHD other than steroids ± calcineurin inhibitors

Discontinuation Criteria:

Ruxolitinib should be discontinued upon the occurrence of any of the following:

  • Progression of cGvHD, defined as worsening of cGvHD symptoms or occurrence of new cGvHD symptoms.

  • Recurrence or relapse of underlying hematological malignancy.

  • Patient is experiencing unacceptable toxicity to ruxolitinib.

Renewal:
Treatment with ruxolitinib for cGvHD should be renewed for patients who met the initiation criteria and who do not meet any of the discontinuation criteria AND who have achieved an overall response (i.e., Complete Response (CR) or Partial Response (PR), or stable disease with significant reduction in steroid doses), according to NIH criteria, after 24 weeks of therapy (approximately 6 months)

Approval duration of initials: 6 months

Approval duration of initial renewal: 6 months

Approval duration of 2nd and subsequent renewal: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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