JAKAFI (ruxolitinib)

Self-Administration – oral

Diagnosis considered for coverage:
  • Myelofibrosis: Indicated for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocytopenia myelofibrosis in adults

  • Polycythemia Vera: Indicated for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant to hydroxyurea

  • Acute graft-versus-host disease: Indicated for the treatment of steroid-refractory acute graft-versus-host disease (GVHD) in adults and pediatric patients 12 years and older

  • Chronic graft-versus-host disease: Indicated for the treatment of chronic graft-versus-host disease (cGVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older

     

Coverage Criteria:
  1. For diagnosis of myelofibrosis:

    • Dose does not exceed 50 mg daily; AND

    • Prescribed by or in consultation with a hematologist/oncologist; AND

    • One of the following diagnoses:

      • Post-essential thrombocytopenia myelofibrosis

      • Post-polycythemia vera myelofibrosis

      • Primary myelofibrosis

  2. For diagnosis of polycythemia vera:

    • Dose does not exceed 50 mg daily; AND

    • Prescribed by or in consultation with a hematologist/oncologist; AND

    • Diagnosis of polycythemia vera; AND

    • Inadequate response, intolerance, or contraindication to hydroxyurea

  3. For diagnosis of acute graft-versus-host disease:

    • Dose does not exceed 20 mg daily; AND

    • Prescribed by or in consultation with a hematologist, oncologist, or a physician experienced in the management of transplant patients; AND

    • Diagnosis of acute graft-versus-host disease; AND

    • Disease is steroid-refractory

  4. For diagnosis of chronic graft-versus-host disease:

    • Dose does not exceed 20 mg daily; AND

    • Prescribed by or in consultation with a hematologist, oncologist, or a physician experienced in the management of transplant patients; AND

    • Diagnosis of chronic graft-versus-host disease; AND

    • Inadequate response, intolerance, or contraindication to at least one or more lines of systemic therapy (e.g., corticosteroids, mycophenolate, etc.)

Reauthorization Criteria:
 
  1. For diagnosis of myelofibrosis/polycythemia vera:

    • Documentation of positive clinical response to Jakafi therapy (e.g., spleen volume reduction, symptom improvement, hematocrit control)

  2. For diagnosis of chronic graft-versus-host disease:

    • Patient does not show evidence of progressive disease while on therapy

Coverage Duration: 
  1. For diagnosis of myelofibrosis:

    • Initial: 6 months

    • Reauthorization: 1 year

  2. For diagnosis of polycythemia vera:

    • Initial: 8 months 

    • Reauthorization: 1 year

  3. For diagnosis of acute graft-versus-host disease :

  4. For diagnosis of chronic graft-versus-host disease:

    • Initial: 1 year

    • Reauthorization: 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 
  • Dosage and Administration

    • Myelofibrosis: starting dose is based on the patient’s baseline platelet count:

      • Greater than 200 x 109/L: 20 mg given orally twice daily

      • 100 x 109/L to 200 x 109/L: 15 mg given orally twice daily

      • 50 x 109/L to 100 x 109/L: 5 mg twice daily

      • Monitor complete blood counts every 2 to 4 weeks until doses are stabilized, and then as clinically indicated.  Modify or interrupt dosing for thrombocytopenia.

    • Polycythemia Vera: starting dose is 10 mg given orally twice daily

    • Acute Graft-Versus-Host Disease: starting dose is 5 mg orally twice daily

    • Chronic Graft-Versus-Host Disease: starting dose is 10 mg orally twice daily

  • Drug interactions:

    • Fluconazole: avoid concomitant use with fluconazole doses greater than 200 mg.  Reduce Jakafi dosage with fluconazole doses less than or equal to 200 mg

    • Strong CYP3A4 Inhibitors: reduce, interrupt, or discontinue Jakafi doses as recommended except in patients with acute or chronic graft-versus-host-disease

Policy Updates:
  • 3/1/2023 – Updated policy to include expanded indications for PV and GVHD.

  • 12/2/2013 - Initial review

References:
  1. Jakafi Prescribing Information. Incyte Corp. Wilmington, DE. September 2021.

Last review date: March 1, 2023