CurrentHealth NetPolicy CP PHAR.583

Pacritinib (Vonjo) coverage for myelofibrosis

Defines medical necessity criteria, prescribing and documentation requirements, and coverage limits for pacritinib (Vonjo) for adults with myelofibrosis and select NCCN-supported off-label indications for Health Net lines of business.

Policy Summary

PayerHealth Net

PolicyPacritinib (Vonjo) coverage for myelofibrosis

Policy CodePolicy CP PHAR.583

Change TypeNo material changes

Effective DateJun 1, 2022

Next Review DateN/A

Key ActionSubmit prior authorization with documentation showing the member meets diagnosis and clinical criteria and that dosing does not exceed 400 mg/day.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

400 mg/dayFDA maximum dose listed

100 mgcapsule strength available

6 monthsinitial approval duration

12 monthscontinued therapy approval duration

<50 x10^9/Lplatelet threshold

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Initial Therapy

Covered when ALL of the following are met

Initial Approval Criteria: Member has diagnosis of primary or secondary (post‑polycythemia vera or post‑essential thrombocythemia) myelofibrosis; disease is either higher‑risk OR lower‑risk with documentation of a recent (within 30 days) platelet count < 50 x 10^9/L; prescribed by or in consultation with a hematologist or oncologist; patient is age >= 18 years; dosing does not exceed 400 mg per day and 4 capsules per day; prescriber regimen must be FDA‑approved or recommended by NCCN, or for off‑label use the dose/regimen is supported by practice guidelines or peer‑reviewed literature (supporting evidence submitted).

NCCN Compendium Indications (off-label)

NCCN Compendium off-label indications covered when ALL of the following are met

NCCN Compendium Indications: Diagnosis corresponds to an NCCN Compendium indication (e.g., anemia associated with myelofibrosis or accelerated/blast‑phase myeloproliferative neoplasms); prescribed by or in consultation with a hematologist or oncologist; patient is age >= 18 years; for Vonjo requests, member must use pacritinib when available unless contraindicated or clinically significant adverse effects occur; dosing does not exceed 400 mg per day and 4 capsules per day or the dose is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence); prescribed regimen must be FDA‑approved or recommended by NCCN or otherwise supported for the off‑label use.

Continuation Therapy

Covered when ALL of the following are met for continuation therapy

Continued Therapy: Member is currently receiving Vonjo via the Centene benefit or has documentation of Vonjo use for a covered indication for at least 30 days; all indications criteria from the policy are met; member is responding positively to therapy; for requests that include a dose increase, the new dose does not exceed 400 mg per day and 4 capsules per day and is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence); for Vonjo requests, member must use pacritinib when available unless contraindicated or clinically significant adverse effects are experienced; prescribed regimen must be FDA‑approved or recommended by NCCN or otherwise supported for the off‑label use.

Requests for non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the requested use is supported by sufficient documentation of efficacy and safety per the applicable off‑label use policies for the member's line of business (e.g., CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, or CP.PMN.53 for Medicaid) or by the member's evidence of coverage documents.

Coverage and administration of benefits for pacritinib are governed by the member's coverage documents and applicable Health Plan administrative policies. All determinations are subject to the terms, conditions, exclusions, and limitations of the applicable evidence of coverage, certificate of coverage, policy or contract, and to state and federal requirements.

Use of pacritinib for off‑label indications that lack sufficient documentation of efficacy and safety per the referenced off‑label policies is considered not authorized. Providers should follow the specified off‑label use policies for the relevant line of business when submitting supporting clinical evidence.

This clinical policy is a coverage guideline and does not constitute medical advice or direct clinical management. Providers remain responsible for clinical decision making; medical necessity and coverage determinations rely on this policy together with the member's benefit documents and applicable laws and regulations.

Coding and Key Clinical Values

inv-08: Platelet count — < 50 x 10^9/L

ThresholdPlatelet count < 50 x 10^9/L

ContextRequired for FDA‑approved indication: adults with intermediate or high‑risk primary or secondary myelofibrosis (post‑PV or post‑ET)

Documentation timingPlatelet count must be recent (within the last 30 days) when used to meet lower‑risk criteria

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must include documentation that the member meets the policy's diagnosis and clinical criteria and that the drug is prescribed by, or in consultation with, a hematologist or oncologist when required by the criteria. Prior authorization and any coverage determinations are governed by the Health Plan's administrative policies and the member's benefit documents (e.g., evidence of coverage, certificate of coverage, policy, contract of insurance) and are subject to all terms, conditions, exclusions, and limitations of those documents as well as applicable state and federal law.

Prior authorization required for covered indications per policy criteria.
Requests reviewed in accordance with Health Plan administrative policies and member benefit documents.

Documentation Required

Providers must submit supporting clinical documentation with the prior authorization request (for example: office chart notes, relevant laboratory results, pathology reports, imaging, and any peer-reviewed literature or guideline citations when an off-label use is requested). Incomplete documentation may result in denial or delayed review.

Examples of acceptable documentation: office chart notes, lab results, imaging, pathology reports.
If requesting an off-label NCCN-supported indication, include guideline or peer-reviewed literature supporting the regimen.

Step Therapy

Use of Pacritinib When Available

For Vonjo (pacritinib) requests, pacritinib must be used when it is available unless the member has a contraindication or experiences clinically significant adverse effects that preclude its use. Providers should document the clinical reason pacritinib is not used if requesting an alternative agent.

Pacritinib must be used when available for Vonjo requests unless contraindicated or clinically significant adverse effects exist.
Document clinical rationale if pacritinib is not used.

Denial Risk

Non‑Covered / Off‑Label Indications

Requests for indications not covered by FDA labeling and not addressed in this policy will be denied unless the provider submits sufficient documentation consistent with the Health Plan's off‑label use policies (e.g., CP.CPA.09, HIM.PA.154, CP.PMN.53) demonstrating efficacy and safety.

Non‑FDA approved indications require sufficient supporting evidence per applicable off‑label use policy.
Reference applicable off‑label policies for the member's product line.

Note

Provider Responsibilities and Coverage Limits

Providers must follow the member's coverage documents and applicable Health Plan administrative policies and procedures when requesting and providing services. This clinical policy is a guideline to assist coverage decisions and does not guarantee payment; providers retain responsibility for clinical judgment and for obtaining authorizations required by the plan.

Coverage decisions are subject to the member's coverage documents, plan exclusions, limitations, and applicable law.
This policy does not replace provider clinical judgment; providers remain responsible for patient care.

Background

Myelofibrosis (MF) is a myeloproliferative neoplasm characterized by bone marrow fibrosis, extramedullary hematopoiesis, and risk of progressive cytopenias and splenomegaly. Vonjo (pacritinib) is an oral kinase inhibitor with an accelerated FDA approval for adults with intermediate‑ or high‑risk primary or secondary (post‑polycythemia vera or post‑essential thrombocythemia) MF with platelet counts <50 x 10^9/L. Continued approval may depend on confirmatory trials; dosing is limited to a maximum of 400 mg per day (up to four 100 mg capsules daily).

Definitions and Risk Stratification

inv-18: DIPSS / risk stratification — DIPSS and other NCCN-referenced scoring systems

DefinitionDIPSS and other NCCN‑referenced scoring systems (MIPSS‑70, MIPSS‑70+ v2.0, DIPSS‑Plus, MYSEC‑PM) are used to stratify myelofibrosis into lower‑ and higher‑risk groups

Use in policyDIPSS was used in the pivotal Persist‑2 trial to determine disease risk

Risk group thresholds (examples)Lower‑risk: DIPSS < 2; Higher‑risk: DIPSS > 2 (see Appendix D for full point scales for each scoring system)

inv-19: Definitions — Additional definition entries

Source guidanceNCCN Myelofibrosis guideline stratifies risk into lower‑ and higher‑risk using MIPSS‑70, MIPSS‑70+ v2.0, DIPSS, DIPSS‑Plus, and MYSEC‑PM

Appendix referenceAppendix D provides the point scales and maps scoring-system cutoffs to lower‑ and higher‑risk groups

Clinical implicationRisk stratification determines whether lower‑risk disease requires additional criteria (e.g., platelet <50 x 10^9/L) to qualify for therapy

Initial Therapy Criteria

Initial Therapy

Initial approval criteria for Vonjo

Initial Therapy: Diagnosis of primary or secondary (post‑polycythemia vera or post‑essential thrombocythemia) myelofibrosis; disease is higher‑risk OR disease is lower‑risk with documentation of a recent (within 30 days) platelet count < 50 x 10^9/L; prescribed by or in consultation with a hematologist or oncologist; age >= 18 years; dose does not exceed 400 mg per day and 4 capsules per day; prescribed regimen must be FDA‑approved or recommended by NCCN or, for supported off‑label use, the dose/regimen is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence).

Continuation Therapy Criteria

Continuation Therapy

Criteria to continue Vonjo therapy

Continued Therapy: Member has used Vonjo for at least 30 days or is currently receiving it under the Centene benefit; all policy indication criteria are met; member is responding positively to therapy; if a dose increase is requested the new dose must not exceed 400 mg per day and 4 capsules per day and must be supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence); for Vonjo requests, member must use pacritinib when available unless contraindicated or clinically significant adverse effects are experienced; prescriber documentation is required.

Step Therapy

Step	Requirement
1	For Vonjo (pacritinib) requests, member must use pacritinib if available unless contraindicated or clinically significant adverse effects are experienced.

Quantity Limits

inv-23: Pacritinib (Vonjo) — 400 mg/day

Maximum daily dose400 mg/day

Capsule strength100 mg per capsule

Dispensing limitDose also limited to no more than 4 capsules per day (per initial approval criteria)

Policy Summary

PayerHealth Net

PolicyPacritinib (Vonjo) coverage for myelofibrosis

Policy CodePolicy CP PHAR.583

Change TypeNo material changes

Effective DateJun 1, 2022

Next Review DateN/A

Key ActionSubmit prior authorization with documentation showing the member meets diagnosis and clinical criteria and that dosing does not exceed 400 mg/day.

SourceLink

On This Page

OpenPayer

Pacritinib (Vonjo) coverage for myelofibrosis

Coverage Criteria

Coding and Key Clinical Values

Provider Actions and Requirements

Background

Definitions and Risk Stratification

Initial Therapy Criteria

Continuation Therapy Criteria

Step Therapy

Quantity Limits