Pharmacy Prior Authorization Criteria

Jakafi (ruxolitinib)

Indications for Prior Authorization

Jakafi (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

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

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

If the member does not meet the medical necessity reauthorization criteria requirements, a denial should be issued and a 2-month authorization should be issued one time for Jakafi gradual therapy discontinuation.

Prior Authorization (Other)

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

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

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

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

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 Prescribing Information. Incyte Corp. Wilmington, DE. January 2023.

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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

• 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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