CurrentUnitedHealthcarePolicy 2025 P 1385-5

Vonjo (pacritinib) prior authorization / notification policy

Defines prior authorization and coverage criteria for Vonjo (pacritinib) for adults and pediatric members, including initial and reauthorization clinical criteria, NCCN recognition requirement, authorization duration, and program rules. Effective date 2025-10-01; pediatric prescriptions (<19 years) auto-process without review.

Policy Summary

PayerUnitedHealthcare

PolicyVonjo (pacritinib) prior authorization / notification policy

Policy CodePolicy 2025 P 1385-5

Change TypeAnnual reviews with revisions and program initiation

Effective DateOct 1, 2025

Next Review Date

Key ActionProviders must obtain prior authorization meeting the documented clinical criteria for adults; pediatric (<19) prescriptions auto-process without coverage review. Authorization will be issued for 12 months when criteria are met.

POLICY UPDATE CHANGES

7/2025 annual review: Updated clinical criteria for accelerated/blast phase myeloproliferative neoplasms per NCCN and reorganized myelofibrosis criteria without changing clinical intent.

7/2024 annual review: Added accelerated/blast phase myeloproliferative neoplasm to list of MF subtypes; updated criteria for low- and high-risk MF, MF-associated anemia, and splenomegaly per NCCN; updated approval durations to 12 months.

7/2023 annual review: Updated myelofibrosis background and criteria per NCCN guidelines and added state mandate footnote.

7/2022 updated background to include NCCN recommendations and updated criteria to include not a transplant candidate and added coverage criteria for platelets <50 x 10^9/L and lower-risk MF.

5/2022 new program initiation (prior authorization/notification for Vonjo).

12Authorization duration

<50Primary platelet threshold

NCCNCompendium recognition

Coverage Summary

Vonjo (pacritinib) is a kinase inhibitor indicated for adults with intermediate- or high-risk primary or secondary myelofibrosis who have a platelet count < 50 x 10^9/L. The policy defines prior authorization and coverage criteria for Vonjo for adult and pediatric members, with pediatric prescriptions (<19 years) automatically processing without coverage review. NCCN recommendations are incorporated into the clinical criteria (see below) and compendium recognition is required for approval. Effective date: 2025-10-01. Policy status: CURRENT. When criteria are met, authorization will be issued for 12 months.

Quick facts & thresholds

Authorization duration12 months

Primary platelet thresholdPlatelets < 50 x 10^9/L

Pediatric ruleMembers <19 years: prescription auto-processes without coverage review (automatic approval)

NCCN compendium requirementRecognition by NCCN Drugs & Biologics Compendium (Category 1, 2A, or 2B) required for approval

Operational noteAuthorization issued for 12 months when criteria met; prior authorization required for adults

Initial Authorization (Adults)

Vonjo will be approved when ALL of the following sets of conditions are met:

ALL of the following

Diagnosis (one of)
- Primary myelofibrosis
- Post-polycythemia vera myelofibrosis
- Post-essential thrombocythemia myelofibrosis
- Accelerated/blast phase myeloproliferative neoplasm
Clinical scenarios (one of the following nested options)

Pediatric Automatic Approval

Pediatric (<19 years) automatic approval

Authorization for pediatric members is automatic without coverage review:

ALL of the following

Patient is less than 19 years of age

Billing Rule

Pediatric auto-processing and automated approval pathways

Prescriptions for members under age 19 automatically process without a coverage review. UnitedHealthcare may approve initial and reauthorization requests based solely on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic using automated processes; automated approvals and re-approval processes vary by program and supply limits may apply.

Pediatric prescriptions (<19 years) auto-process without coverage review.
Approvals may be based on prior claims/medication history, diagnosis codes, and/or claim logic.

Reauthorization / Continuation Therapy

Reauthorization

Criteria required to approve continued therapy:

ALL of the following

Documentation that patient has evidence of symptom improvement OR reduction in spleen volume while on Vonjo

Documentation Required

Reauthorization documentation

For reauthorization, submit documentation showing evidence of symptom improvement or reduction in spleen volume while on Vonjo to support continued approval.

Compendia / NCCN Recognition Requirement

NCCN Recognition Requirement

Compendia recognition requirement:

The drug is recognized for treatment of the cancer indication by the NCCN Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B

NCCN recognition refers to the drug being listed in the NCCN Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B. This compendium recognition is required for approval and is cited in the policy background and clinical criteria.

The NCCN recommendations referenced in the background support the clinical scenarios and use cases included in the authorization criteria (see Background and Initial Authorization sections).

Applicable Codes

ICD-10 diagnosis codes (permitted basis for approval / claim logic)ICD-10

No codes listed

Provider Actions & Operational Notes

Prior Authorization

Prior authorization required for Vonjo in adults

Providers must obtain prior authorization for Vonjo in adult patients. Action steps: verify the patient meets clinical criteria for authorization, submit the prior authorization request, and note that approval will be issued for 12 months when criteria are met. Pediatric prescriptions (<19 years) auto-process without coverage review and do not require prior authorization. Effective date for this program: 10/01/2025.

Confirm adult patient meets the documented clinical criteria before submitting PA.
Submit prior authorization request for adults; authorization duration = 12 months if approved.
No PA required for patients <19 years (auto-process).

Documentation Required

Reauthorization documentation

Clinical Evidence & Background

Vonjo is a kinase inhibitor indicated for adults with intermediate- or high-risk primary or secondary myelofibrosis with a platelet count below 50 x 10^9/L. NCCN recommends Vonjo for higher-risk MF when the patient is not a transplant candidate and platelets are 50 x 10^9/L or in the presence of symptomatic splenomegaly and/or constitutional symptoms. NCCN also recommends Vonjo for symptomatic lower-risk MF with platelets 50 x 10^9/L, for MF-associated anemia, and in accelerated/blast phase myeloproliferative neoplasms for specific transplant-related scenarios (continued use near start of conditioning to improve splenomegaly and symptoms; palliation in combination with hypomethylating agents as bridging therapy to transplant or if not a transplant candidate).

Recent updates reorganized the myelofibrosis criteria and added accelerated/blast phase myeloproliferative neoplasm to the list of included diagnoses; clinical intent and use cases per NCCN were maintained while approval durations were standardized to 12 months.

Definitions & timeline

Authorization duration (definition)Approved therapy duration when criteria met: 12 months

NCCN recognition (definition)Recognition by the NCCN Drugs and Biologics Compendium with Category of Evidence and Consensus 1, 2A, or 2B required for approval

P&T approval timeline

Revision History

5/2022added

Program initiated: new prior authorization/notification program for Vonjo (pacritinib).

7/2022revised

Material: Updated background to include NCCN recommendations; criteria expanded to note patient not a transplant candidate and to add coverage criteria for platelets <50 x 10^9/L and lower-risk myelofibrosis.

7/2023revised

Annual review: Updated myelofibrosis background and criteria per NCCN guidelines and added state mandate footnote.

Policy Summary

PayerUnitedHealthcare

PolicyVonjo (pacritinib) prior authorization / notification policy

Policy CodePolicy 2025 P 1385-5

Change TypeAnnual reviews with revisions and program initiation

Effective DateOct 1, 2025

Next Review Date

On This Page

Symptomatic lower-risk MF scenario
- Patient has symptomatic lower-risk myelofibrosis
- Patient has a platelet count < 50 x 10^9/L< 50 x 10^9/L
Higher-risk MF scenario
- Patient has higher-risk myelofibrosis
- Patient has a platelet count < 50 x 10^9/L< 50 x 10^9/L
- Patient has symptomatic splenomegaly and/or constitutional symptoms
MF-associated anemia or splenomegaly with platelets >=50 x 10^9/L (per NCCN language): Used for treatment of myelofibrosis-associated anemia OR for symptomatic splenomegaly and/or constitutional symptoms with platelet count ≥ 50 x 10^9/L (per NCCN recommendations)≥ 50 x 10^9/L
Accelerated/blast phase transplant-related scenarios (if diagnosis is accelerated/blast phase MP neoplasm)
- Continued treatment near the start of conditioning therapy in transplant candidates for improvement of splenomegaly and other disease-related symptoms
- Palliation in combination with hypomethylating agents (azacitidine or decitabine) as bridging therapy to transplant
- Palliation in combination with hypomethylating agents (azacitidine or decitabine) if not a candidate for transplant

Prior Authorization

Prior authorization required for Vonjo in adults

Providers must obtain prior authorization for Vonjo for adult patients. Authorization will be issued for 12 months when criteria are met. For pediatric patients (<19 years), prescriptions will automatically process without a coverage review (pediatric auto-approval applies). Effective date: 10/01/2025.

Automated approvals and supply limits may apply.

For reauthorization, submit documentation that the patient has evidence of symptom improvement or a reduction in spleen volume while on Vonjo to support continued approval.

Billing Rule

Automated approval pathways

UnitedHealthcare may approve initial and reauthorization requests based solely on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic using automated processes. Use of automated approval and re-approval processes varies by program. Supply limits may be in place.

Approvals may be based on prior claims/medication history and diagnosis codes (ICD-10).
Automated approval and re-approval processes vary by program.
Supply limits may apply.

P&T approval dates: 5/2022; 7/2022; 7/2023; 7/2024; 7/2025

7/2024revised

Material: Added accelerated/blast phase myeloproliferative neoplasm to list of MF subtypes; updated criteria for low- and high-risk MF, MF-associated anemia, and splenomegaly and other disease-related symptoms per NCCN; updated approval durations to 12 months.

7/2025revisedLatest

Section title updated to Myeloproliferative neoplasms; clinical intent unchanged (annual review updated clinical criteria for accelerated/blast phase myeloproliferative neoplasms and reorganized myelofibrosis criteria).