CurrentCentenePolicy CP PHAR.583

Pacritinib (Vonjo) coverage policy

Defines medical necessity criteria, initial and continuation approval requirements, dosing limits, applicable indications (FDA-approved myelofibrosis and NCCN compendium off-label use), exclusions, and administrative references for pacritinib (Vonjo) for Centene-affiliated health plans across Commercial, HIM, and Medicaid lines.

Policy Summary

PayerCentene

PolicyPacritinib (Vonjo) coverage policy

Policy CodePolicy CP PHAR.583

Change TypeRevisions and clarifications (2Q2024; 2Q2025); dosing clarification

Effective DateJun 1, 2022

Next Review Date

Key ActionProvider must submit office chart notes, lab results or other clinical information supporting that member meets all approval criteria (including recent platelet count if applicable).

POLICY UPDATE CHANGES

2Q 2024 annual review: removed failure of therapeutic alternative drugs for lower-risk MF per NCCN 2A; revised criteria to approve lower-risk MF with platelet count of <50 x 10^9/L; revised criteria to approve high-risk MF of any platelet count; removed redundant intermediate risk stratification; added off-label criteria for MF-associated anemia per NCCN 2A.

2Q 2025 annual review: revised section I.B title to NCCN Compendium Indications and added off-label diagnosis for accelerated/blast phase myeloproliferative neoplasms per NCCN.

Continued therapy section updated to reflect FDA maximum dosing to mirror prescribing information (400 mg/day, 4 capsules/day).

1FDA-approved indication (MF with platelets <50 x10^9/L)

>=1NCCN off-label indications

400 mg/dayMaximum daily dose enforced

Approval durations (initial / continued)

Coverage Summary

Policy CP PHAR.583 covers pacritinib (Vonjo) for adults with intermediate- or high-risk primary or secondary (post‑polycythemia vera or post‑essential thrombocythemia) myelofibrosis who have a platelet count of < 50 x 10^9/L under the FDA accelerated approval based on spleen volume reduction; continued approval is contingent on confirmatory trials. The policy effective date is 06.01.22 and the last review date is 05.25. In addition to the FDA‑approved indication, the policy incorporates NCCN‑compendium off‑label indications (for example, myelofibrosis‑associated anemia and accelerated/blast‑phase myeloproliferative neoplasms) as covered with criteria.

Quick Facts / Key Thresholds

Platelet count threshold< 50 x 10^9/L

Maximum daily dose400 mg per day

Maximum capsules per day4 capsules per day

Approval durationsInitial 6 months / Continued 12 months

Continuity prior to renewalReceiving medication >= 30 days

Initial Therapy Criteria

Initial Approval Criteria

Vonjo is medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF)
Risk/Platelet branch
- Higher-risk: Disease is higher-risk (see Appendix D)
- Lower-risk + platelets: Disease is lower-risk (see Appendix D) AND documentation of a recent (within the last 30 days) platelet count of < 50 x 10^9/L< 50 x 10^9/L

NCCN Compendium Indications (Off-label)

NCCN Compendium Indications (off-label)

Covered off-label per NCCN when ALL criteria are met:

ALL of the following

Allowed diagnoses: Diagnosis of one of the following: anemia associated with myelofibrosis OR accelerated/blast phase myeloproliferative neoplasms (per NCCN compendium)
Age: Member is >= 18 years of age>= 18 years
Prescriber: Prescribed by or in consultation with a hematologist or oncologist

Continuation Therapy Criteria

Continued Therapy (Renewal) Criteria

Renewal is authorized when ALL of the following are met:

ALL of the following

Continuity of therapy: Member is currently receiving Vonjo via Centene benefit OR documentation supports member has been receiving Vonjo for a covered indication for at least 30 days>= 30 days
Clinical response: Member is responding positively to therapy (documented clinical response)
Pacritinib product use: For Vonjo requests, member must use pacritinib (Vonjo), if available, unless contraindicated or clinically significant adverse effects are experienced

Diagnoses / Indications NOT Authorized

Diagnoses/Indications NOT authorized

Coverage is NOT authorized when:

Not authorized uses: Non-FDA approved indications that are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off-label use policies referenced (CP.CPA.09, HIM.PA.154, CP.PMN.53)

Other Diagnoses/Indications and Non-Formulary References

If the requested use is not listed or drug/formulary status differs, follow applicable Centene policies:

Routing for other uses

On-formulary no-coverage: For drugs on formulary/PDL: follow no coverage criteria policy for the line of business: CP.CPA.190 (commercial), HIM.PA.33 (health insurance marketplace), CP.PMN.255 (Medicaid)

Provider Actions & Authorization Rules

Documentation Required

Submit supporting documentation

Provider must submit office chart notes, lab results, or other clinical information supporting that the member meets all approval criteria. If applicable, include a recent platelet count within the last 30 days.

Prior Authorization

Prior authorization required

Requests must meet the policy clinical criteria for initial or continued therapy to be approved. Approval durations: initial approvals are for 6 months; continued therapy (renewal) approvals are for 12 months.

Applicable Codes & Product Availability

Product availability (NDC / formulation)NDC|mixed

100 mg capsule

Vonjo capsule strength; product available as 100 mg capsules (packaging/NDC not specified)

Clinical Evidence & References

Key evidence cited in the policy includes the Persist‑2 pivotal trial (Mascarenhas et al., JAMA Oncol. 2018) which used the DIPSS scoring system for disease risk determination, and the Vonjo Prescribing Information (CTI BioPharma, November 2024; accessed Feb 5, 2025).

Definitions / References

DIPSS (definition)Dynamic International Prognostic Scoring System used to determine disease risk in myelofibrosis.

NCCN (reference)National Comprehensive Cancer Network clinical practice guidelines; referenced for off-label and dosing recommendations.

Background

Background: Pacritinib (Vonjo) is a kinase inhibitor indicated under accelerated approval for adults with intermediate‑ or high‑risk primary or secondary myelofibrosis with a platelet count below 50 x 10^9/L based on spleen volume reduction; continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The policy enforces an FDA maximum daily dose of 400 mg per day and availability as 100 mg capsules. The NCCN Compendium supports certain off‑label uses such as myelofibrosis‑associated anemia and accelerated/blast‑phase myeloproliferative neoplasms, which are included in the policy as covered off‑label indications when criteria are met.

Revision History

2Q 2024revised

2Q 2025revisedLatest

2Q 2025 annual review: revised section I.B title to NCCN Compendium Indications and added off-label diagnosis for accelerated/blast phase myeloproliferative neoplasms per NCCN.

2023-02-20clarified

Policy Summary

PayerCentene

PolicyPacritinib (Vonjo) coverage policy

Policy CodePolicy CP PHAR.583

Change TypeRevisions and clarifications (2Q2024; 2Q2025); dosing clarification

Effective DateJun 1, 2022

Next Review Date

Key ActionProvider must submit office chart notes, lab results or other clinical information supporting that member meets all approval criteria (including recent platelet count if applicable).

On This Page

Prescriber: Prescribed by or in consultation with a hematologist or oncologist

Pacritinib product use: For Vonjo requests, member must use pacritinib (Vonjo), if available, unless contraindicated or clinically significant adverse effects are experienced

Age: Member is >= 18 years of age>= 18 years

Dose

FDA dosing: 400 mg per day (FDA-approved dosing)400 mg/day
Guideline or literature supported dosing: Prescribed regimen is FDA-approved OR recommended by NCCN; OR dose is supported by practice guidelines or peer-reviewed literature for relevant off-label use (prescriber must submit supporting evidence)
Prescriber must submit supporting evidence for off-label dosing

Pacritinib product use: For Vonjo requests, member must use pacritinib (Vonjo), if available, unless contraindicated or clinically significant adverse effects are experienced

Dose limits

Max mg: 400 mg per day400 mg/day
Max capsules: 4 capsules per day4 capsules/day

Off-label evidence: If off-label, prescribed regimen must be FDA-approved or recommended by NCCN OR dose is supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence)

Dose increase limits

Max mg: 400 mg per day400 mg/day
Max capsules: 4 capsules per day4 capsules/day

Off-label dosing evidence: If new dose is off-label, it must be supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence)

Non-formulary policy: For drugs NOT on formulary/PDL: follow non-formulary policy for line of business: CP.CPA.190 (commercial), HIM.PA.103 (health insurance marketplace), CP.PMN.16 (Medicaid)

Off-label referral: If requested use is NOT specifically listed and initial criteria do not apply, refer to off-label use policy: CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace), CP.PMN.53 (Medicaid)

Billing Rule

Dose limits enforced

Claims or requests exceeding 400 mg per day or more than 4 capsules per day require supporting practice guideline or peer‑reviewed literature evidence and a justification for off‑label dosing; requests that exceed these limits without such support will not be approved.

Documentation Required

Specialty prescriber requirement

Prescriptions must be written by or in consultation with a hematologist or oncologist.

Continued therapy section updated to reflect FDA maximum dosing to mirror prescribing information (400 mg/day, 4 capsules/day).