JAKAFI (ruxolitinib)
Self-Administration – oral
Diagnosis considered for coverage:
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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
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Polycythemia Vera: Indicated for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant to hydroxyurea
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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
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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:
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For diagnosis of myelofibrosis:
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Dose does not exceed 50 mg daily; AND
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Prescribed by or in consultation with a hematologist/oncologist; AND
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One of the following diagnoses:
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Post-essential thrombocytopenia myelofibrosis
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Post-polycythemia vera myelofibrosis
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Primary myelofibrosis
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For diagnosis of polycythemia vera:
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Dose does not exceed 50 mg daily; AND
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Prescribed by or in consultation with a hematologist/oncologist; AND
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Diagnosis of polycythemia vera; AND
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Inadequate response, intolerance, or contraindication to hydroxyurea
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For diagnosis of acute graft-versus-host disease:
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Dose does not exceed 20 mg daily; AND
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Prescribed by or in consultation with a hematologist, oncologist, or a physician experienced in the management of transplant patients; AND
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Diagnosis of acute graft-versus-host disease; AND
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Disease is steroid-refractory
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For diagnosis of chronic graft-versus-host disease:
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Dose does not exceed 20 mg daily; AND
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Prescribed by or in consultation with a hematologist, oncologist, or a physician experienced in the management of transplant patients; AND
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Diagnosis of chronic graft-versus-host disease; AND
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Inadequate response, intolerance, or contraindication to at least one or more lines of systemic therapy (e.g., corticosteroids, mycophenolate, etc.)
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Reauthorization Criteria:
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For diagnosis of myelofibrosis/polycythemia vera:
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Documentation of positive clinical response to Jakafi therapy (e.g., spleen volume reduction, symptom improvement, hematocrit control)
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For diagnosis of chronic graft-versus-host disease:
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Patient does not show evidence of progressive disease while on therapy
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Coverage Duration:
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For diagnosis of myelofibrosis:
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Initial: 6 months
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Reauthorization: 1 year
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For diagnosis of polycythemia vera:
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Initial: 8 months
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Reauthorization: 1 year
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For diagnosis of acute graft-versus-host disease :
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For diagnosis of chronic graft-versus-host disease:
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Initial: 1 year
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Reauthorization: 1 year
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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:
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Dosage and Administration
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Myelofibrosis: starting dose is based on the patient’s baseline platelet count:
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Greater than 200 x 109/L: 20 mg given orally twice daily
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100 x 109/L to 200 x 109/L: 15 mg given orally twice daily
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50 x 109/L to 100 x 109/L: 5 mg twice daily
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Monitor complete blood counts every 2 to 4 weeks until doses are stabilized, and then as clinically indicated. Modify or interrupt dosing for thrombocytopenia.
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Polycythemia Vera: starting dose is 10 mg given orally twice daily
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Acute Graft-Versus-Host Disease: starting dose is 5 mg orally twice daily
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Chronic Graft-Versus-Host Disease: starting dose is 10 mg orally twice daily
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Drug interactions:
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Fluconazole: avoid concomitant use with fluconazole doses greater than 200 mg. Reduce Jakafi dosage with fluconazole doses less than or equal to 200 mg
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Strong CYP3A4 Inhibitors: reduce, interrupt, or discontinue Jakafi doses as recommended except in patients with acute or chronic graft-versus-host-disease
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Policy Updates:
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3/1/2023 – Updated policy to include expanded indications for PV and GVHD.
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12/2/2013 - Initial review
References:
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Jakafi Prescribing Information. Incyte Corp. Wilmington, DE. September 2021.
Last review date: March 1, 2023