ModifiedmhnPolicy CP.PHAR.583

Pacritinib (Vonjo)

Policy governs medical necessity criteria, dosing, and coverage for pacritinib (Vonjo) for adults with myelofibrosis and certain NCCN compendium off-label indications for members covered by Centene-affiliated health plans.

Policy Summary

Payermhn

PolicyPacritinib (Vonjo)

Policy CodePolicy CP.PHAR.583

Change TypeRevised coverage criteria (annual reviews)

Effective Date06.01.22

Next Review Date

Key ActionSubmit prior authorization with documentation showing diagnosis, hematologist/oncologist involvement, age ≥18, and platelet count or risk stratification to meet coverage criteria.

SourceLink

POLICY UPDATE CHANGES

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, and removed redundant intermediate risk stratification; added off-label criteria for MF-associated anemia per NCCN 2A recommendation.

Revised section I.B title to NCCN Compendium Indications and added off-label diagnosis for accelerated/blast phase myeloproliferative neoplasms per NCCN.

400 mg/daymaximum FDA daily dose

4 caps/daymaximum capsules per day

Platelets <50lower-risk MF threshold

6 moinitial approval

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Coverage Criteria for Pacritinib (Vonjo)

Initial Therapy — Myelofibrosis

Covered when ALL of the following are met for Initial Approval — Myelofibrosis:

Initial Approval: Myelofibrosis: 1. Diagnosis of primary or secondary (post‑polycythemia vera or post‑essential thrombocythemia) myelofibrosis; 2. Request meets one of the following: (a) disease is lower‑risk and documentation of a recent (within the last 30 days) platelet count < 50 × 10^9/L, OR (b) disease is higher‑risk; 3. Prescribed by or in consultation with a hematologist or oncologist; 4. Age ≥ 18 years; 5. Member must use pacritinib (Vonjo) if available unless contraindicated or clinically significant adverse effects are experienced; 6. Request meets one of the following: (a) dose does not exceed both i) 400 mg per day AND ii) 4 capsules per day, OR (b) dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA‑approved or recommended by NCCN.

Approval duration: 6 months

NCCN Compendium Indications (off‑label)

Covered when ALL of the following are met for NCCN Compendium (off‑label) indications:

Initial Approval: NCCN Compendium Indications: 1. Diagnosis of an NCCN‑listed off‑label indication (e.g., anemia associated with myelofibrosis; accelerated/blast phase myeloproliferative neoplasms); 2. Prescribed by or in consultation with a hematologist or oncologist; 3. Age ≥ 18 years; 4. Member must use pacritinib (Vonjo) if available unless contraindicated or clinically significant adverse effects are experienced; 5. Request meets one of the following: (a) dose does not exceed both i) 400 mg per day AND ii) 4 capsules per day, OR (b) dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA‑approved or recommended by NCCN.

Approval duration: 6 months

Continuation Therapy

Covered when ALL of the following are met for Continued Therapy:

Continued Therapy: 1. Member is currently receiving Vonjo via the Centene benefit, or documentation supports current receipt of Vonjo for a covered indication with at least 30 days of therapy; 2. Member is responding positively to therapy; 3. Member must use pacritinib (Vonjo) if available unless contraindicated or clinically significant adverse effects are experienced; 4. If request is for a dose increase, request meets one of the following: (a) new dose does not exceed both i) 400 mg per day AND ii) 4 capsules per day, OR (b) new dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA‑approved or recommended by NCCN.

Approval duration: 12 months

Non‑FDA approved indications that are not specifically addressed by this policy are excluded from coverage unless the provider supplies sufficient documentation of efficacy and safety in accordance with the Health Plan's off‑label use policies (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or other applicable evidence of coverage provisions.

For Medicaid members, state Medicaid coverage provisions take precedence over the provisions of this clinical policy where there is a conflict; providers should consult the applicable state Medicaid manual for coverage details.

Requests for use of pacritinib for non‑FDA approved indications that are not covered by this policy must be supported by adequate documentation of efficacy and safety according to the Health Plan's off‑label use policies (see CP.CPA.09, HIM.PA.154, CP.PMN.53). Without such documentation, off‑label use will be considered not authorized.

Dosing and Regimens

Indication	Dosing regimen	Product availability
Myelofibrosis	200 mg PO twice daily (maximum 400 mg/day)	100 mg capsules

Key Dosing Limits and Coding

inv-07: Maximum daily dose

Maximum daily dose400 mg/day

Dosing regimen reference200 mg PO twice daily (MF regimen) — maximum 400 mg/day

Approval constraintDose must not exceed 400 mg/day unless supported by practice guidelines or peer‑reviewed literature (prescriber must submit evidence)

inv-08: Maximum capsules per day

Maximum capsules per day4 capsules per day

Dose formProduct available as 100 mg capsules (200 mg PO twice daily = 2 capsules each dose; max 4 capsules/day)

Approval constraint

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. The provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member meets all approval criteria, including diagnosis, hematologist/oncologist involvement, age ≥ 18 years, and platelet criteria or risk stratification as applicable. Requests for Vonjo (pacritinib) must document whether pacritinib is available and, if so, that pacritinib was used unless contraindicated or clinically significant adverse effects occurred. Dose limits (≤ 400 mg/day and ≤ 4 capsules/day) or supporting literature for off‑label dosing must be provided.

Documentation: office chart notes, lab results, other clinical information
Diagnosis: primary or secondary myelofibrosis (or NCCN‑listed indication for off‑label use)
Prescriber: hematologist or oncologist or documented consultation
Age: ≥ 18 years
Platelet criteria or risk stratification: recent platelet count <50×10^9/L for lower‑risk MF or higher‑risk MF per Appendix D
Pacritinib: member must use pacritinib if available unless contraindicated or adverse effects experienced
Dose: does not exceed 400 mg/day and 4 capsules/day OR dosing supported by practice guidelines/peer‑reviewed literature

Line of Therapy Considerations

Informational — Line of therapy

Line of therapy: Policy does not specify explicit line numbering (first‑line vs later); coverage is determined by diagnosis, platelet count/risk stratification, and FDA/NCCN recommendations.

Definitions and FDA Indication

inv-18: FDA approved indication

FDA approved indicationAdults with intermediate or high‑risk primary or secondary (post‑PV or post‑ET) myelofibrosis with platelet count below 50 x 10^9/L (accelerated approval based on spleen volume reduction)

PopulationAdults (age ≥18) with primary or secondary MF

Regulatory noteApproved under accelerated approval; continued approval may be contingent on confirmatory trial(s)

Background

Pacritinib (Vonjo) is a selective kinase inhibitor approved under accelerated approval for adults with intermediate‑ or high‑risk primary or secondary myelofibrosis with platelet counts <50 x 10^9/L based on spleen volume reduction. Continued approval is contingent on confirmatory trials. NCCN compendium recommendations also inform off‑label uses such as anemia associated with myelofibrosis and accelerated/blast‑phase myeloproliferative neoplasms; when considering these off‑label indications, coverage is determined by the criteria in this policy and the referenced off‑label use policies.

Revision History

2025-02-05annual reviewLatest

Revised section I.B title to 'NCCN Compendium Indications' and added an off-label diagnosis for accelerated/blast phase myeloproliferative neoplasms per NCCN; references reviewed and updated.

2024-02-12annual review

Removed failure of therapeutic alternative drugs for lower‑risk MF per NCCN 2A; revised criteria to approve lower‑risk MF with platelet count <50 x 10^9/L, revised criteria to approve high‑risk MF of any platelet count, removed redundant intermediate risk stratification, and added off‑label criteria for MF‑associated anemia per NCCN 2A; references reviewed and updated.

2023-02-20