CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Jakafi (ruxolitinib) — coverage criteria for oncology and transplant-related indications

Defines accepted indications, coverage criteria, and coding for ruxolitinib (Jakafi) for oncology and transplant-related conditions for Neighborhood Health Plan members; applies to providers submitting medication requests through Evolent.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyJakafi (ruxolitinib) — coverage criteria for oncology and transplant-related indications

Policy CodePolicy N/A

Change TypeClinical updates and template conversion (material changes included)

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests through Evolent with supporting documentation (FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature).

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaced prior UM ONC_1242 Jakafi (ruxolitinib) guideline.

Under myelofibrosis indication, removed splenomegaly requirement, intermediate and high-risk defining criteria, and RBC transfusion need; added aGVHD and cGVHD indications, exclusion criteria, and references.

4Listed indications

>=12 yrsMin age for GVHD

>=50 x10^9/LPlatelet requirement (MF)

J8999

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Coverage Criteria and Indications

Acute Graft-Versus-Host Disease (aGVHD)

Covered when ALL of the following are met

aGVHD indication: Member is adult or pediatric >= 12 years with steroid-refractory acute graft-versus-host disease

Supported by REACH1/REACH-3 references

Chronic Graft-Versus-Host Disease (cGVHD)

Covered when ALL of the following are met

cGVHD indication: Member is adult or pediatric >= 12 years with chronic graft-versus-host disease after failure of one or two lines of systemic treatment

Supported by REACH-3 reference

Myelofibrosis

Covered when ALL of the following are met

Myelofibrosis indication: Member has intermediate or high-risk primary, post-polycythemia vera, or post-essential thrombocythemia myelofibrosis; ruxolitinib used as monotherapy; platelet count >= 50 x 10^9/L prior to treatmentplatelets >= 50 x 10^9/L

Prior version removed other numeric risk/splenomegaly/transfusion criteria

Polycythemia Vera

Covered when ALL of the following are met

Polycythemia vera indication: Member has polycythemia vera and has had inadequate response to or intolerance of hydroxyurea; ruxolitinib used as monotherapy

Supported by NEJM trial reference

Requests for ruxolitinib (Jakafi) will be excluded (denied) when any of the following apply: disease progression while taking ruxolitinib; dosing that exceeds single-dose limits—25 mg for Myelofibrosis or Polycythemia Vera or 10 mg for acute or chronic graft‑versus‑host disease; or monthly dispensed tablets that exceed the specified tablet maximums (60 tablets/month for any listed strength).

Use of ruxolitinib for indications that are off‑label and lack sufficient supporting evidence is considered investigational and is not covered. Sufficient evidence is defined by alignment with CMS‑recognized compendia or acceptable peer‑reviewed literature and includes consideration of whether the patient and regimen are represented in published evidence, whether outcomes are clinically meaningful (for example ASCO standards such as hazard ratios and survival benefits), and whether study design and the type of evidence (randomized trials, nonrandomized trials, case reports, abstracts) provide adequate support.

Regimen	Indication	Dosing / Notes
Jakafi (ruxolitinib) monotherapy
Myelofibrosis (intermediate or high-risk; primary, post-polycythemia vera, or post-essential thrombocythemia)
Used as monotherapy; member must have platelet count >= 50 x 10^9/L prior to start of treatment.

Regimen	Indication	Dosing / Notes
Jakafi (ruxolitinib) per labeled/clinical trial indications
Chronic graft-versus-host disease (cGVHD) in adults and pediatric members >= 12 years after failure of one or two lines of systemic treatment
Use consistent with REACH-3/labeling for steroid-refractory cGVHD; single-dose maximum limits and other dosing constraints apply as per policy.

Billing and Coding

Drug HCPCS codeHCPCS

J8999

ruxolitinib

Key numeric requirement — platelet count prerequisite for myelofibrosis

Platelet count prerequisitePlatelets >= 50 x 10^9/L prior to start of treatment for myelofibrosis

Indication contextApplies when ruxolitinib is used as monotherapy for intermediate- or high-risk primary, post-PV, or post-ET myelofibrosis

Scope of requirementNumeric platelet threshold must be documented prior to initiation of therapy

Provider Requirements and Operational Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required through Evolent for requests of Jakafi (ruxolitinib). Continuation requests are exempt from re-review under this Evolent policy only when ALL of the following are met: the member has not experienced disease progression on the requested medication; the requested medication was used within the last year without a lapse of more than 30 days of having an active authorization; and no additional medication(s) are being added to the continuation request.

Prior authorization required via Evolent
Continuation request exemption — member off disease progression; active use within past year with ≤30-day lapse; no new medications added

Step Therapy

Step Therapy Requirement for Polycythemia Vera

For polycythemia vera, Jakafi (ruxolitinib) is covered as monotherapy only when the member has had an inadequate response to, or is intolerant of, hydroxyurea.

Polycythemia vera: trial of hydroxyurea required or documented intolerance

Evidence and Documentation Standards

Acceptable evidence — sources required to support use

Acceptable evidence sources (short list)FDA approved product labeling; CMS-recognized compendia; NCCN or ASCO clinical guidelines; peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 standards

FDA labeling exampleJakafi prescribing information (Incyte Corporation) as referenced in the guideline

Peer-reviewed trials citedKey trials referenced include REACH-1, REACH-3, COMFORT-I/II and pivotal NEJM studies supporting indications

Line of Therapy Designations

second-line

Second-line therapy requirement for cGVHD: For chronic graft-versus-host disease, ruxolitinib is considered second-line and requires failure of one or two prior lines of systemic treatment before approval

Policy-specific line-of-therapy designation

second-line

Second-line therapy requirement for polycythemia vera: For polycythemia vera, ruxolitinib is designated second-line after inadequate response to or intolerance of hydroxyurea

Policy-specific line-of-therapy designation

Clinical Background

Ruxolitinib (Jakafi) is an oral selective inhibitor of JAK1 and JAK2 used in myeloproliferative neoplasms and in steroid‑refractory graft‑versus‑host disease. It is indicated and used as monotherapy for conditions including myelofibrosis and polycythemia vera and has been studied for steroid‑refractory acute and chronic graft‑versus‑host disease in pivotal trials. Clinical evidence and labeling guide its use for these indications.

Policy Revision History

2025-03operational_updateLatest

Converted to new Evolent guideline template, replaced prior UM ONC_1242 Jakafi (ruxolitinib) guideline, and updated references.

2024-03clinical_criteria_change

Removed splenomegaly requirement, intermediate/high-risk defining criteria, and RBC transfusion need for myelofibrosis; added acute and chronic GVHD indications, new exclusion criteria, and updated references and verbiage to Evolent.