CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Vonjo (pacritinib) — Coverage Criteria for Myelofibrosis

Defines indications, requirements, and exclusions for authorization of Vonjo (pacritinib) for treatment of myelofibrosis for Neighborhood Health Plan of Rhode Island members; applies to providers submitting medication requests to Evolent for covered lines of business.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVonjo (pacritinib) — Coverage Criteria for Myelofibrosis

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization through Evolent demonstrating FDA‑approved or compendia‑supported indication and compliance with dosing limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

<50 x10^9/LThrombocytopenia threshold

≤200 mgSingle dose limit

≤120 capsMonthly cap

J8999HCPCS

Commercial, MedicaidLines of business

Coverage Criteria for Vonjo (pacritinib)

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVonjo (pacritinib) — Coverage Criteria for Myelofibrosis

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization through Evolent demonstrating FDA‑approved or compendia‑supported indication and compliance with dosing limits.

SourceLink

On This Page

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Initial therapy or authorization criteria

Covered when ALL of the following are met

ALL of the following

Thrombocytopenia requirement: Platelet count below 50 x10^9/L, either at baseline or after therapy with another JAK inhibitor (e.g., ruxolitinib).<50 x10^9/L
Supporting evidence: Use must be supported by FDA labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer‑reviewed literature.
Documentation per policy required
Dosing limits: Dosing must not exceed a single dose of 200 mg and must not exceed 120 (100 mg) capsules per month.single dose ≤200 mg; monthly ≤120 (100 mg) capsules

Continuation therapy

Continuation authorization allowed when ALL of the following are met

The member has not experienced disease progression while receiving Vonjo (pacritinib).

The requested medication was used within the last year without a lapse of more than 30 days of having an active authorization.

No additional medications are being added to the continuation request.

Requests for Vonjo (pacritinib) that meet exclusion criteria should be considered investigational or not approvable. Exclusion triggers include disease progression while taking Vonjo, any dosing that exceeds a single dose of 200 mg, or monthly treatment that exceeds the maximum of 120 (100 mg) capsules per month. Additionally, use for off‑label indications lacking sufficient supporting evidence (i.e., not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature) is excluded.

When a request exceeds stated dosing limits or proposes an off‑label indication, authorization should be denied unless adequate evidence is provided. The policy defines sufficient evidence as items such as peer‑reviewed studies where the clinical characteristics and regimen match the patient, clinically meaningful outcomes (for example, ASCO‑recommended thresholds), appropriate study design, and supportive non‑randomized trials with substantial subject numbers. Case reports and meeting abstracts without full peer‑reviewed articles do not constitute adequate evidence.

Provider Actions, Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required. Evolent (on behalf of the plan) must process all medication requests for Vonjo (pacritinib). Requests submitted outside Evolent may be denied as not approvable and not reimbursable.

Submit prior authorization requests through Evolent per payer procedures.
Medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Step Therapy

Continuation / Step Considerations

Continuation (renewal) requests may be approved without re‑review under the following conditions: the member has not experienced disease progression on the requested medication; the medication was used within the last year with no lapse >30 days from an active authorization; and no additional medications are being added to the continuation request.

Member has not experienced disease progression while on Vonjo (pacritinib).
Requested medication used within the last 12 months with ≤30 day lapse from prior authorization.
No additional medications are being added to the continuation request.

Documentation Required

Required Supporting Documentation

Required supporting documentation must demonstrate that the use of Vonjo (pacritinib) is supported by one of the following: FDA approved product labeling; CMS‑recognized compendia; NCCN or ASCO clinical guidelines; or peer‑reviewed literature that meets CMS standards (see CMS Medicare Benefit Policy Manual Chapter 15). Documentation should include relevant clinical data to confirm indication, platelet counts, prior therapies (including JAK inhibitors such as ruxolitinib), and dosing rationale.

Acceptable evidence: FDA labeling, CMS‑recognized compendia, NCCN or ASCO guidelines, or acceptable peer‑reviewed literature meeting CMS criteria.
Include documentation of disease type and risk (e.g., intermediate or high‑risk primary or secondary myelofibrosis) and laboratory evidence (platelet count <50 × 10^9/L when applicable).
Document prior therapies and response (e.g., prior ruxolitinib) and evidence that dosing requested does not exceed single‑dose and monthly limits.

Denial Risk

Triggers for Denial

Triggers for denial include investigational or off‑label uses lacking sufficient evidence, documented disease progression on Vonjo (pacritinib), dosing above approved limits, or requests that exceed monthly capsule limits. Insufficient evidence includes lack of CMS compendia support or peer‑reviewed literature that fails CMS standards (e.g., only case reports or abstracts without full peer‑reviewed articles).

Denial risk if use is investigational or off‑label without sufficient evidence or not generally accepted by the medical community.
Denial if member experienced disease progression while taking Vonjo (pacritinib).
Denial if single dose exceeds 200 mg.
Denial if treatment exceeds 120 (100 mg) capsules per month.
Denial when supporting evidence is limited to case reports, meeting abstracts without full articles, or studies that do not represent clinically meaningful outcomes per ASCO/CMS standards.

Background on Vonjo (pacritinib)

Vonjo (pacritinib) is indicated for intermediate‑ or high‑risk primary or secondary myelofibrosis, including post‑polycythemia vera and post‑essential thrombocythemia, in the setting of thrombocytopenia. The policy requires that patients meet a platelet threshold of platelets <50 x10^9/L (either at baseline or after prior JAK inhibitor therapy) and that use be supported by FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidance, or acceptable peer‑reviewed literature. Continuation of therapy may be allowed when there is no disease progression and prior authorization has been maintained per policy criteria.

Regimen	Indication	Dosing limits	Coverage status
Vonjo (pacritinib) per FDA labeling or compendia-supported dosing
Myelofibrosis with thrombocytopenia (platelets < 50 x10^9/L) — intermediate- or high-risk primary or secondary myelofibrosis (post‑PV or post‑ET)
Must not exceed single dose of 200 mg; monthly total not to exceed 120 (100 mg) capsules
Covered when criteria met

OpenPayer

Vonjo (pacritinib) — Coverage Criteria for Myelofibrosis

Coverage Criteria for Vonjo (pacritinib)

Coding and Key Clinical Thresholds

Provider Actions, Authorization & Documentation

Background on Vonjo (pacritinib)

Definitions and Clinical Thresholds

Line of Therapy Considerations

Covered Regimens and Dosing Limits