Neighborhood Health Plan RI Jakafi Coverage Update

Coverage Criteria

Covered Indications

Covered when ALL of the following are met for each indication as specified below

aGVHD indication: Use in adult and pediatric members >= 12 years with steroid-refractory acute graft-versus-host disease.

cGVHD indication: Use in adult and pediatric members >= 12 years with chronic graft-versus-host disease after failure with one or two lines of systemic treatment.

Myelofibrosis indication: Use as monotherapy in members with intermediate or high-risk myelofibrosis (primary, post-PV, or post-ET) AND platelet count >= 50 x 10^9/L prior to treatment.

Polycythemia vera indication: Use as monotherapy in members with polycythemia vera who had inadequate response to or are intolerant of hydroxyurea.

Regimen	Indication	Notes
Ruxolitinib monotherapy
Monotherapy for myelofibrosis (including primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis)
Used in members with intermediate or high-risk myelofibrosis and platelet count ≥ 50 × 10^9/L prior to start of treatment; per policy this is covered when criteria are met.

Regimen	Indication	Notes
Ruxolitinib
Steroid-refractory acute graft-versus-host disease (aGVHD) in patients ≥ 12 years
May be used in adult and pediatric members ≥ 12 years with steroid-refractory aGVHD; coverage contingent on meeting policy criteria.

Coverage will be denied when there is disease progression while the member is taking Jakafi (ruxolitinib). Requests that propose dosing above the policy's single-dose limits will also be excluded: a single dose greater than 25 mg for Myelofibrosis or Polycythemia Vera, or greater than 10 mg for acute or chronic graft‑versus‑host disease (aGVHD/cGVHD).

Treatment that would exceed the documented monthly tablet maximums is not covered. The policy lists maximum limits by strength of 60 tablets per month (applied consistently across 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg strengths).

These exclusion rules are triggers for denial unless the request meets the policy's covered criteria and supporting evidence; providers should ensure the prescribed regimen, dosing, and treatment intent align with the stated indications and limits before submission.

Use of Jakafi (ruxolitinib) for off‑label indications that lack sufficient supporting evidence is considered investigational and not medically necessary. The policy defines insufficient evidence as lack of support from CMS‑recognized compendia or acceptable peer‑reviewed literature.

When assessing evidence, the policy requires consideration of whether the patient and disease characteristics and the administered regimen are represented in published studies, whether outcomes are clinically meaningful (for example, ASCO‑recommended thresholds such as hazard ratios < 0.80 or survival benefits of at least 3 months for OS/PFS), and whether study design and scale provide adequate support. Case reports and abstracts without full peer‑reviewed publications are generally inadequate to establish accepted use.

Line of Therapy

second-line

cGVHD line of therapy: Use after failure with one or two lines of systemic treatment.

second-line

Polycythemia vera line of therapy: Members who had inadequate response to or are intolerant of hydroxyurea; use as monotherapy.

Covered Regimens

Regimen	Indication	Notes
Ruxolitinib monotherapy
Myelofibrosis (primary; post-polycythemia vera; post-essential thrombocythemia)
Use as monotherapy for intermediate or high-risk disease and platelet count ≥ 50 × 10^9/L prior to treatment. Policy covers when criteria are satisfied.

Regimen	Indication	Notes
Ruxolitinib
Steroid-refractory acute or chronic graft‑versus‑host disease (aGVHD or cGVHD) in patients ≥ 12 years
For cGVHD: may be used after failure of one or two lines of systemic treatment. Coverage requires meeting the policy's age and prior‑therapy criteria.

Coding and Laboratory Criteria

Drug HCPCS CodesHCPCSCovered

J8999

ruxolitinib

inv-05: Platelet count

Platelet threshold>= 50 × 10^9/L prior to start of treatment

ContextRequired for myelofibrosis monotherapy (intermediate or high-risk)

Applies toPrimary MF, post-PV MF, and post-ET MF

Provider Actions and Requirements

Prior Authorization

Prior authorization and coding

Prior authorization is required. Evolent processes all medication requests for Jakafi (ruxolitinib); requests must be justified with documentation consistent with accepted indications and evidence (FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature meeting CMS standards). Coding for ruxolitinib should use J8999.

Prior authorization handled by Evolent for all medication requests
Acceptable evidence: FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or CMS‑standard peer‑reviewed literature
Billing code: J8999 for ruxolitinib

Step Therapy

Step therapy for Polycythemia Vera

For polycythemia vera, Jakafi (ruxolitinib) is used as monotherapy only for members who have had an inadequate response to or are intolerant of hydroxyurea.

Definitions

inv-11: Myelofibrosis

DefinitionMyelofibrosis includes primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis

Usage contextJakafi (ruxolitinib) used as monotherapy for intermediate or high-risk disease

Treatment requirementPlatelet count >= 50 × 10^9/L prior to start of treatment

inv-12: Graft-Versus-Host Disease (acute and chronic)

aGVHD definitionSteroid-refractory acute graft-versus-host disease in adult and pediatric members >= 12 years of age

cGVHD definitionChronic graft-versus-host disease in adult and pediatric members >= 12 years of age after failure with one or two lines of systemic treatment

Background

Ruxolitinib (Jakafi) is a Janus kinase (JAK) inhibitor with labeled oncology indications described elsewhere in this policy. The guideline includes recent substantive updates and template conversion notes: the policy clarifies exclusion criteria and dosing limits and reflects additions supporting use in steroid‑refractory acute and chronic graft‑versus‑host disease for patients aged 12 years and older.

Providers should reference the policy's dosing limits, coverage criteria, and evidence requirements when requesting ruxolitinib, since exceeding the stated single‑dose or monthly tablet thresholds or lacking CMS‑recognized compendia/peer‑reviewed support are explicit bases for exclusion.

Revision History

2025-03administrative_updateLatest

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

2024-03material_change

Under the myelofibrosis indication, removed splenomegaly requirement, intermediate- and high-risk defining criteria, and RBC transfusion requirement; added acute and chronic GVHD (aGVHD and cGVHD) indications, related exclusion criteria, and references.

OpenPayer

Jakafi (ruxolitinib) clinical guideline