UnitedHealthcare Jakafi Prior Auth Coverage Update

Coverage and Authorization Criteria

inv-01: Patients less than 19 years

Covered when ALL of the following are met

Pediatric patients: Patient is less than 19 years of age

Authorization issued for 12 months

inv-02: Myelofibrosis - Initial Authorization

Initial authorization will be issued when ONE of the following is met

Diagnosis-based approvals: (1) Diagnosis of symptomatic lower-risk myelofibrosis OR (2) intermediate or higher-risk myelofibrosis OR (3) post-polycythemia vera myelofibrosis OR (4) post-essential thrombocythemia myelofibrosis

Authorization issued for 6 months

Myelofibrosis-associated anemia pathway: Diagnosis of myelofibrosis-associated anemia AND presence of symptomatic splenomegaly and/or constitutional symptoms AND given in combination with one of: luspatercept (Reblozyl), an erythropoiesis-stimulating agent if serum EPO < 500 mU/mL, or danazolEPO < 500 mU/mL for ESA option

Authorization issued for 6 months

inv-03: Myelofibrosis - Reauthorization

Reauthorization will be issued when ONE of the following is met

Response-based reauthorization: Documentation that patient has evidence of symptom improvement or reduction in spleen volume while on Jakafi

Authorization duration per policy

Non-response reauthorization: If documentation does not provide evidence of symptom improvement or reduction in spleen volume while on Jakafi, allow for dose titration with discontinuation of therapy

Allows short-term reauthorization for dose titration

inv-04: Polycythemia vera

Polycythemia vera — Covered when ALL of the following are met

Initial PV: Diagnosis of polycythemia vera AND history of failure, inadequate response, contraindication, or intolerance to hydroxyurea or interferon therapy (examples include ropeginterferon, interferon alfa-2b, peginterferon alfa-2a)

Authorization issued for 6 months

PV reauthorization: (1) Documentation that patient has evidence of symptom improvement or reduction in spleen volume while on Jakafi (authorization 6 months) OR (2) Documentation does not provide evidence of improvement; allow dose titration with discontinuation (authorization 2 months)

inv-05: Essential thrombocythemia

Essential thrombocythemia — Covered when ALL of the following are met

Initial ET: Diagnosis of essential thrombocythemia AND inadequate response or loss of response to hydroxyurea, peginterferon (Pegasys), or anagrelide (Agrylin)

Authorization issued for 6 months

ET reauthorization: (1) Documentation that patient has evidence of symptom improvement or reduction in spleen volume while on Jakafi (authorization 6 months) OR (2) Documentation does not provide evidence of improvement; allow dose titration with discontinuation (authorization 2 months)

inv-06: Graft-versus-host disease (acute and chronic)

Graft-versus-host disease (acute and chronic) — Covered when ONE of the following initial authorization pathways is met

Acute GVHD: Diagnosis of acute GVHD AND disease is steroid refractory

Chronic GVHD: Diagnosis of chronic GVHD AND failure of one or two lines of systemic therapy

GVHD reauthorization: Documentation of symptom improvement while on Jakafi

inv-07: Neoplasms with eosinophilia (JAK2 rearrangement)

Covered when ALL of the following are met

Initial approval for neoplasms with eosinophilia: Diagnosis of lymphoid, myeloid, or mixed lineage neoplasms with eosinophilia AND presence of a JAK2 rearrangement

Reauthorization for neoplasms with eosinophilia: Patient does not show evidence of progressive disease while on Jakafi therapy

inv-08: Initial Authorization — Myeloid/MDS/MPN indications

Initial Authorization — Myeloid/MDS/MPN indications — Jakafi will be approved for initial authorization when one of the following indication-specific AND/OR criteria is met

CMML-2 combination therapy: Diagnosis of chronic myelomonocytic leukemia (CMML)-2 AND use in combination with a hypomethylating agent (e.g., azacitidine, decitabine)

Authorization issued for 12 months

MDS/MPN with neutrophilia and mutation: Diagnosis of myelodysplastic/myeloproliferative neoplasm (MDS/MPN) with neutrophilia AND disease is positive for CSF3R or JAK2 mutation

Authorization issued for 12 months

inv-09: Initial Authorization — Accelerated/Blast Phase MPN

Initial Authorization — Accelerated/Blast Phase MPN — Jakafi will be approved when ALL of the following are met

Accelerated/blast phase MPN: Diagnosis of accelerated/blast phase myeloproliferative neoplasm AND used for splenomegaly or other disease-related symptoms

Authorization issued for 6 months

inv-10: Reauthorization — Accelerated/Blast Phase MPN

Reauthorization will be approved when ONE of the following is met

Response-based reauthorization: Documentation that patient has evidence of symptom improvement or reduction in spleen volume while on Jakafi

Authorization will be issued for 6 months when response is documented

Nonresponse management: If documentation does not show improvement, allow for dose titration with discontinuation of therapy

Short-term reauthorization may be allowed for dose titration

inv-11: Initial Authorization — Pediatric ALL

Jakafi will be approved for pediatric ALL when the following is met

Pediatric ALL: Diagnosis of pediatric acute lymphoblastic leukemia

Authorization issued for 12 months

inv-12: Reauthorization — No progressive disease

Reauthorization — No progressive disease: Reauthorization criteria across several indications require absence of progressive disease while on therapy

No progressive disease: Patient does not show evidence of progressive disease while on Jakafi therapy

Authorization issued per indication-specific duration

inv-13: Initial Authorization — Immunotherapy-Related Toxicities

Jakafi will be approved for certain immunotherapy-related toxicities when one of the following is met

CAR-T induced G4 CRS refractory: Diagnosis of CAR-T induced grade 4 cytokine release syndrome AND disease is refractory to high-dose corticosteroids and anti-IL-6 therapy (e.g., tocilizumab)

Other immunotherapy toxicities: Diagnosis of immunotherapy-related toxicities AND (used in combination with abatacept (Orencia) for concomitant myositis and myocarditis OR used as additional therapy for HLH-like syndrome if no response to corticosteroids after 5 days)

inv-14: Initial Authorization — T-Cell Lymphomas

Jakafi will be approved for T-cell lymphomas when one of the following groups of criteria is met

Peripheral T-cell lymphoma: Diagnosis of peripheral T-cell lymphoma AND used as initial palliative intent therapy or used as second-line and subsequent therapy for relapsed/refractory disease

Specific T-cell diagnoses second-line: Diagnosis of T-cell large granular lymphocytic leukemia OR T-cell prolymphocytic leukemia OR breast implant-associated anaplastic large cell lymphoma (ALCL) AND used as second-line or subsequent therapy

Hepatosplenic T-cell lymphoma refractory: Diagnosis of hepatosplenic T-cell lymphoma AND used for refractory disease after two first-line therapy regimens

Authorization issued for 12 months

inv-15: Additional Coverage — NCCN Recommended Regimens

Additional Coverage — NCCN Recommended Regimens: Additional coverage may be granted for regimens recognized by the NCCN Drugs and Biologics Compendium with specified categories of evidence

NCCN recognized regimens: Drug recognized for treatment of the cancer indication by NCCN Drugs and Biologics Compendium with Category of Evidence and Consensus of 1, 2A, or 2B

Authorization issued per NCCN guidance (typically 12 months)

Coverage criteria in this policy apply to UnitedHealthcare members but may be superseded where state law requires different coverage for off‑label medication use or additional compendia references. Where such state mandates apply, they take precedence over the criteria described here.

Prescribers should confirm member benefit plan terms and any applicable state or federal regulatory requirements before assuming coverage; the policy’s criteria do not override mandatory statutory coverage obligations.

UnitedHealthcare may implement program-level rules that affect how the criteria are applied, including automated approval or reauthorization based on prior claims, medication history, diagnosis codes, or other claim logic. These automated processes vary by program and therapeutic class and may result in approvals that do not require a full criteria review.

In addition, supply limits may be enforced and coverage remains subject to the member’s specific benefit plan and any applicable state mandates. Providers should verify plan-level utilization management constraints (e.g., quantity limits, prior‑authorization requirements) when initiating or continuing therapy.

Coding and Authorization Durations

Automated approval/claim-based logicmixed

affected codes

Placeholder—document references automated approval based on previous claim/medication history and diagnosis codes (ICD-10) but specific codes not listed in this excerpt.

Authorization duration — Accelerated/Blast Phase MPN

Authorization duration6 months for accelerated/blast phase myeloproliferative neoplasm (initial authorization)

Reauthorization — response-basedIf documentation shows symptom improvement or reduction in spleen volume, reauthorization issued for 6 months

Reauthorization — nonresponse managementIf no evidence of improvement, allow dose titration with possible discontinuation (short-term management)

Standard authorization duration

Standard authorization duration12 months for most adult indications and pediatric ALL initial authorizations

Reauthorization — no progressive diseaseReauthorization for multiple indications issued for 12 months when patient shows no evidence of progressive disease while on therapy

Provider Requirements and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization/notification is required for Jakafi (ruxolitinib). Prescriptions for members under age 19 will automatically process without coverage review; for all other members, submit a prior authorization request with supporting clinical documentation. Some state mandates for off-label indications or alternative compendia may supersede these requirements.

Prior authorization required for members ≥19 years
Members <19 years: auto-process for 12 months (no coverage review)

Prior Authorization

Indication‑based Prior Authorization

Prior authorization is indication-specific. Approval criteria vary by diagnosis and may include diagnosis confirmation, mutation status, combination therapy requirements, prior-line therapies, and documented response. Examples of indication-based requirements: polycythemia vera requires diagnosis plus prior trial and inadequate response/intolerance/contraindication to hydroxyurea or interferon; CMML‑2 requires use in combination with a hypomethylating agent; MDS/MPN with neutrophilia requires CSF3R or JAK2 mutation positivity.

Polycythemia vera: diagnosis AND history of failure/inadequate response/contraindication/intolerance to hydroxyurea or interferon therapy

Clinical Background

Ruxolitinib (Jakafi) is a Janus kinase (JAK) inhibitor indicated for several myeloproliferative and immune‑mediated hematology indications. FDA‑labeled uses include treatment of patients with intermediate‑ or high‑risk myelofibrosis (primary, post‑polycythemia vera, or post‑essential thrombocythemia), polycythemia vera in patients with inadequate response or intolerance to hydroxyurea, steroid‑refractory acute graft‑versus‑host disease, and chronic graft‑versus‑host disease after failure of one or two systemic therapies.

Clinical use is focused on symptom control (for example, reduction of splenomegaly and constitutional symptoms) and management of disease‑related complications across a range of myeloproliferative neoplasms and select off‑label hematologic indications recognized by compendia such as NCCN.

Key Definitions

Steroid-refractory acute GVHD — definition

DefinitionSteroid-refractory acute GVHD: acute graft-versus-host disease that has not responded to steroid therapy.

ApplicabilityIndication includes adult and pediatric patients 12 years and older per drug labeling and policy context

Reauthorization requirementDocumentation of symptom improvement while on Jakafi is required for reauthorization in GVHD

CMML-2 — definition

DefinitionCMML-2: chronic myelomonocytic leukemia, category CMML-2 for which Jakafi is covered in combination with a hypomethylating agent (e.g., azacitidine, decitabine)

Coverage contextInitial authorization requires use in combination with a hypomethylating agent

Line of Therapy Specifications

inv-33: second-line

second-line: Steroid-refractory acute GVHD (implies after steroid therapy)

inv-34: second-line

second-line: Failure of one or two lines of systemic therapy for chronic GVHD

inv-35: first-line | second-line | salvage

Peripheral T-cell lymphoma: Used as initial palliative intent therapy OR used as second-line and subsequent therapy for relapsed/refractory disease

Biomarker and Testing Requirements

JAK2 rearrangement — biomarker requirement

Biomarker requirementPresence of a JAK2 rearrangement is required for approval of lymphoid, myeloid, or mixed lineage neoplasms with eosinophilia

Indication exampleUsed to support coverage for neoplasms with eosinophilia per NCCN and policy criteria

DocumentationTesting demonstrating JAK2 rearrangement must be provided for authorization

Serum erythropoietin (EPO) — threshold

ThresholdSerum erythropoietin (EPO) < 500 mU/mL required to support use of an erythropoiesis-stimulating agent (ESA) in the myelofibrosis-associated anemia pathway

ContextESA option is one of combination choices (Reblozyl, ESA if EPO < 500 mU/mL, or danazol) when treating myelofibrosis-associated anemia

Regimens Recognized for Coverage

Regimen / Source	Coverage status
As specified in the NCCN Drugs and Biologics Compendium (recognized with Category of Evidence and Consensus 1, 2A, or 2B)	Covered
Drug recognized for treatment of the cancer indication by The National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium with Category 1, 2A, or 2B	Covered

OpenPayer

Ruxolitinib (Jakafi) prior authorization and coverage criteria

Coverage and Authorization Criteria

Coding and Authorization Durations

Provider Requirements and Documentation

Clinical Background

Key Definitions

Line of Therapy Specifications

Biomarker and Testing Requirements

Regimens Recognized for Coverage