Pharmacy Prior Authorization Criteria

Jakafi (ruxolitinib)

Indications for Prior Authorization

Jakafi/Jakafi XR (ruxolitinib),

• For diagnosis of Myelofibrosis
  Indicated for treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis in adults.

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

• For diagnosis of Acute Graft Versus Host Disease
  Indicated for treatment of steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older.

• For diagnosis of Chronic Graft Versus Host Disease
  Indicated for 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.

Criteria

Jakafi/XR

Prior Authorization (Initial Authorization)

Length of Approval: 6 Months [A]
For diagnosis of Myelofibrosis

• One of the following diagnoses:
• Primary myelofibrosis
• Post-polycythemia vera myelofibrosis
• Post-essential thrombocythemia myelofibrosis

Jakafi/XR

Prior Authorization (Initial Authorization)

Length of Approval: 8 Months [B]
For diagnosis of Polycythemia Vera

• Diagnosis of polycythemia vera [1]
AND
• Trial and failure, contraindication, or intolerance to hydroxyurea [1]

Jakafi/XR

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Myelofibrosis, Polycythemia Vera

• Patient demonstrates positive clinical response to therapy (e.g., spleen volume reduction, symptom improvement, hematocrit control)

Jakafi/XR

Prior Authorization

Length of Approval: 6 Month(s) [C]
For diagnosis of Acute Graft Versus Host Disease

• Diagnosis of acute graft-versus-host disease
AND
• Disease is steroid-refractory
AND
• Patient is 12 years of age or older

Jakafi/XR

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Chronic Graft Versus Host Disease

• Diagnosis of chronic graft-versus-host disease
AND
• Patient is 12 years of age or older
AND
• Trial and failure of at least one or more lines of systemic therapy (e.g., corticosteroids, mycophenolate, etc.)

Jakafi/XR

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Chronic Graft Versus Host Disease

• Patient demonstrates positive clinical response to therapy

P & T Revisions

2026-06-03, 2026-03-04, 2025-12-18, 2025-12-18, 2025-03-06, 2024-03-14, 2023-12-06, 2023-07-06, 2023-03-02, 2022-05-20, 2022-03-03, 2021-10-26, 2021-09-27, 2021-05-19, 2021-02-11, 2020-02-14, 2019-07-25

References

1. Jakafi/XR Prescribing Information. Incyte Corp. Wilmington, DE. May 2026.

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End Notes

1. Jakafi should be discontinued after 6 months if there is no spleen size reduction or symptom improvement since initiation of therapy. [1]
2. The initial authorization duration of 8 months is based on clinical trials (primary endpoint of hematocrit control and spleen volume reduction was evaluated at 32 weeks). [1]
3. Authorization duration of 6 months is based median time from response to death or need for new therapy for acute GVHD in clinical trials (173 days). Additionally, tapering of Jakafi may be considered after 6 months of treatment in patients with response who have discontinued therapeutic doses of corticosteroids. [1]

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Revision History

• 2026-06-03: Addition of new Jakafi XR formulation as a target drug
• 2026-03-04: 2026 Annual Review - updated references
• 2025-12-18: No criteria change, bulk copy oRX-EHB
• 2025-12-18: no criteria changes, added IL statute operational note
• 2025-03-06: 2025 Annual Review - no changes
• 2024-03-14: 2024 Annual Review - no changes
• 2023-12-06: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-07-06: Removed specialist requirement
• 2023-03-02: 2023 Annual Review
• 2022-05-20: Update Guideline
• 2022-03-03: 2022 Annual Review
• 2021-10-26: Addition of cGVHD criteria - Nov 2021 P&T
• 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-19: Addition of EHB formulary to guideline, no changes to criteria
• 2021-02-11: 2021 Annual Review: no changes
• 2020-02-14: 2020 Annual Review; updated references.
• 2019-07-25: Added indication for acute GVHD eff 10.1.19

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