CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Rezurock (belumosudil) — Coverage Criteria for chronic graft‑versus‑host disease (cGVHD)

Covers use of Rezurock (belumosudil) for treatment of chronic graft‑versus‑host disease (cGVHD) in members when specified clinical criteria are met; applies to Medicaid scope indicated in the document.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRezurock (belumosudil) — Coverage Criteria for cGVHD

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date6/1/2023

Next Review DateN/A

Key ActionObtain prior authorization documenting member is ≥12 years with confirmed cGVHD and failure of ≥2 prior systemic therapies; authorization may be granted for 6 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12minimum eligible patient age

6 monthsauth period

30/tabquantity limit

≥2prior lines required

Coverage Criteria for Rezurock (belumosudil)

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRezurock (belumosudil) — Coverage Criteria for cGVHD

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date6/1/2023

Next Review DateN/A

Key ActionObtain prior authorization documenting member is ≥12 years with confirmed cGVHD and failure of ≥2 prior systemic therapies; authorization may be granted for 6 months.

SourceLink

On This Page

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Initial Authorization for Rezurock: 1. Member is at least 12 years of age; 2. Documented diagnosis of chronic graft-versus-host disease (cGVHD); 3. Medication prescribed by or in consultation with a hematologist, oncologist, or physician experienced in management of transplant patients; 4. Documentation that the member has failed two or more lines of systemic therapy for cGVHD (examples include methylprednisolone, cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, imatinib); 5. Rezurock will not be prescribed in combination with Imbruvica, Jakafi, or Niktimvo; 6. Documentation that Rezurock will not be taken concomitantly with a proton pump inhibitor (PPI) unless the member has previously experienced an inadequate treatment response to or is contraindicated to histamine H2-receptor antagonist (H2RA) therapy at the highest appropriate dose.

Authorization of 6 months may be granted.

inv-02: Continuation Therapy

Covered for continuation when ALL of the following are met:

Continuation Authorization for Rezurock: 1. No evidence of unacceptable toxicity while on the current Rezurock regimen; 2. No clinically significant progression of cGVHD while on the current regimen (i.e., progression requiring new systemic therapy); 3. Documented response to therapy with improvement in one or more clinician assessments (e.g., NIH Skin Score, Upper GI Response Score, NIH Lung Symptom Score) or patient-reported symptoms (e.g., Lee Symptom Scale); 4. Medication prescribed by or in consultation with a hematologist, oncologist, or physician experienced in management of transplant patients; 5. Rezurock will not be prescribed in combination with Imbruvica, Jakafi, or Niktimvo; 6. Documentation that Rezurock will not be taken concomitantly with a proton pump inhibitor (PPI) unless the member has previously experienced an inadequate response to or is contraindicated to histamine H2-receptor antagonist (H2RA) therapy at the highest appropriate dose.

Authorization of 6 months may be granted.

Provider Requirements and Authorization Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required for Rezurock (belumosudil) for the treatment of chronic graft-versus-host disease (cGVHD). Authorization may be granted for an initial period of up to 6 months when criteria are met. Prescriptions must be by or in consultation with a hematologist, oncologist, or clinician experienced in transplant management. Quantity limit: Rezurock 200 mg — 30 tablets per 30 days (1 tablet per day).

Prior authorization required
Authorization period: up to 6 months
Prescriber: hematologist, oncologist, or physician experienced in transplant care
Quantity limit: Rezurock 200 mg — 30 tablets per 30 days (1 tablet/day)

Step Therapy

Step Therapy Requirement

Members must have failed two or more prior lines of systemic therapy for cGVHD before Rezurock is authorized. Examples of prior systemic agents include methylprednisolone, cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, and imatinib. The member must not have clinically significant progression of cGVHD while on the current regimen and must show documented response to therapy (clinician assessments or patient-reported symptom improvement).

Failure of ≥2 prior systemic therapies required (e.g., methylprednisolone, cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, imatinib)
No clinically significant progression of cGVHD on current regimen
Documented response to prior therapy (e.g., NIH Skin Score, Lee Symptom Scale)

Denial Risk

Non‑approved Indications / Not Covered

Use of Rezurock for indications other than cGVHD, or for patients who do not meet the specified criteria (including age, diagnosis, prior therapies, prescriber specialty, and concomitant medication restrictions), is considered experimental/investigational and is not covered.

Not covered for indications other than cGVHD
Not covered if member is <12 years of age
Not covered if failure of ≥2 prior systemic therapies is not documented
Rezurock must not be used concomitantly with Imbruvica, Jakafi, or Niktimvo
Rezurock should not be taken with a proton pump inhibitor (PPI) unless H2RA at highest appropriate dose was inadequate or contraindicated

Documentation Required

Required Documentation

Documentation to support authorization must include diagnosis of cGVHD, age (≥12 years), records showing failure of two or more prior systemic therapies, documentation of response/non-progression as applicable, and confirmation of prescriber specialty or consultation. Also include documentation that Rezurock will not be used with prohibited concomitant therapies or with a PPI unless criteria for PPI use are met.

Diagnosis of cGVHD and member age (≥12 years)
Clinical records documenting failure of ≥2 prior systemic therapies
Evidence of clinical response or absence of clinically significant progression
Prescribing clinician specialty or consultation note (hematology/oncology/transplant-experienced physician)
Medication reconciliation showing Rezurock will not be coadministered with Imbruvica, Jakafi, or Niktimvo
Documentation regarding PPI avoidance or rationale for PPI when H2RA is contraindicated or ineffective

Background on Rezurock (belumosudil)

Rezurock (belumosudil) is indicated for treatment of chronic graft-versus-host disease (cGVHD) in patients aged 12 years and older who have failed at least two prior lines of systemic therapy. Authorization may be granted for up to 6 months when all required criteria are documented: age ≥12, a documented diagnosis of cGVHD, prescribing by or in consultation with a hematologist/oncologist or a clinician experienced in transplant care, documentation of failure of ≥2 prior systemic therapies (for example: methylprednisolone, cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, imatinib), assurance that Rezurock will not be co-prescribed with Imbruvica, Jakafi, or Niktimvo, and documentation that Rezurock will not be taken with a proton pump inhibitor (PPI) unless there is prior inadequate response to or contraindication to a histamine H2‑receptor antagonist (H2RA) at the highest appropriate dose.

Key Definitions

cGVHD — definition and brief description

DefinitionChronic graft-versus-host disease (cGVHD) — a complication following allogeneic hematopoietic stem cell transplantation characterized by immune-mediated damage to host tissues requiring systemic therapy.

Indication age thresholdRezurock is indicated for treatment of patients 12 years of age and older.

Indication contextIndicated for cGVHD after failure of at least two prior lines of systemic therapy.

Prescriber requirementMedication must be prescribed by or in consultation with a hematologist, oncologist, or physician experienced in management of transplant patients.

Concomitant therapy restrictionsRezurock must not be prescribed in combination with Imbruvica, Jakafi, or Niktimvo.

PPI guidanceRezurock should not be taken concomitantly with a proton pump inhibitor (PPI) unless the member had an inadequate response to or is contraindicated to an H2‑receptor antagonist at the highest appropriate dose.

Covered Regimens and Dosing

Regimen	Indication / Patient eligibility	Key restrictions & interactions	Quantity limit / Authorization period
Belumosudil (Rezurock) 200 mg once daily	Treatment of chronic graft-versus-host disease (cGVHD) in patients ≥12 years of age after failure of ≥2 prior lines of systemic therapy	Do not prescribe in combination with Imbruvica (ibrutinib), Jakafi (ruxolitinib), or Niktimvo; avoid concomitant proton pump inhibitors (PPIs) unless member had inadequate response to or contraindication to H2RA at highest appropriate dose; medication must be prescribed by or in consultation with a hematologist, oncologist, or physician experienced in transplant care	30 tablets per 30 days (200 mg once daily); prior authorization required — initial and continuation authorizations may be granted for 6 months

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