JAKAFI (ruxolitinib)

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 :

   • 6 months

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.