CurrentDelaware First HealthPolicy CP.PHAR.552

Belumosudil (Rezurock) coverage

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Coverage and medical necessity criteria for belumosudil (Rezurock) for treatment of chronic graft-versus-host disease (cGVHD) and related authorization requirements for Delaware First Health lines of business.

Policy Summary

PayerDelaware First Health

PolicyBelumosudil (Rezurock) coverage

Policy CodePolicy CP.PHAR.552

Change TypeNo material change

Effective DateDec 1, 2021

Next Review DateFeb 1, 2024

Key ActionProvider must submit documentation (e.g., office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥12minimum age for FDA-approved indication

400 mg/day

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CurrentDelaware First HealthPolicy CP.PHAR.552

Belumosudil (Rezurock) coverage

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Policy Summary

PayerDelaware First Health

PolicyBelumosudil (Rezurock) coverage

Policy CodePolicy CP.PHAR.552

Change TypeNo material change

Effective DateDec 1, 2021

Next Review DateFeb 1, 2024

Key ActionProvider must submit documentation (e.g., office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥12minimum age for FDA-approved indication

400 mg/day

12 monthsapproval duration

200 mgtablet strength

MedicaidMedicaid precedence

Coverage Criteria for Belumosudil (Rezurock)

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial Approval Criteria for cGVHD

Diagnosis of chronic graft-versus-host disease (cGVHD).
Prescribed by or in consultation with an oncologist, hematologist, or bone marrow transplant specialist.
Age ≥ 12 years.
History of allogeneic hematopoietic cell transplant (HCT).
Failure of a systemic corticosteroid (see Appendix B for examples) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced.
Failure of a systemic immunosuppressant (see Appendix B for examples) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced.
Rezurock is not prescribed concurrently with Imbruvica, Jakafi, or Niktimvo.
Dose does not exceed 400 mg (2 tablets) per day.dose <= 400 mg/day
Prior authorization may be required.

Continuation Therapy — Continued therapy (must meet all)

Continued therapy (must meet all)

Continued Therapy Criteria

Member is currently receiving Rezurock via the Centene benefit, or documentation supports current use for a covered indication and member has received the medication for at least 30 days.
Member is responding positively to therapy.
Rezurock is not prescribed concurrently with Imbruvica, Jakafi, or Niktimvo.
If request is for a dose increase, the new dose does not exceed 400 mg (2 tablets) per day.dose <= 400 mg/day

Other Indications / Off-label pathway — Other/Off-label uses

Other/Off-label uses

Alternate pathways for other indications

If the drug has undergone a label change within the last 6 months that is not yet reflected in this policy, follow the applicable formulary or non-formulary policy for the relevant line of business (see CP.CPA.190, HIM.PA.33, CP.PMN.255 for formulary; CP.CPA.190, HIM.PA.103, CP.PMN.16 for non-formulary).
If the requested use is not specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) and the label-change clause does not apply, refer to the off-label use policy for the relevant line of business (CP.CPA.09, HIM.PA.154, CP.PMN.53).

Non-FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or other evidence of coverage documents.

Initial Therapy (cGVHD)

Initial Therapy (cGVHD) — Initial approval criteria for cGVHD

Initial approval criteria for cGVHD

Initial Therapy (cGVHD)

Diagnosis of chronic graft-versus-host disease (cGVHD).
Prescribed by or in consultation with an oncologist, hematologist, or bone marrow transplant specialist.
Age ≥ 12 years.
History of allogeneic hematopoietic cell transplant (HCT).
Failure of a systemic corticosteroid at up to maximally indicated doses unless contraindicated or clinically significant adverse effects are experienced.

Continuation Therapy Requirements

Continuation Therapy — Continued therapy requirements

Continued therapy requirements

Continuation Therapy

Member currently receiving Rezurock for a covered indication for at least 30 days or documentation supports current use via Centene benefit.
Member is responding to therapy.
Rezurock is not prescribed concurrently with Imbruvica, Jakafi, or Niktimvo.
If request is for dose increase, dose does not exceed 400 mg (2 tablets) per day.dose <= 400 mg/day

Provider Actions and Requirements

Prior Authorization

Prior authorization and supporting clinical documentation

Prior authorization may be required for Rezurock and for prior systemic immunosuppressant use; the provider must document prior therapy failures and consultation with an oncologist, hematologist, or bone marrow transplant specialist when requesting authorization.

Document failure of a systemic corticosteroid and a systemic immunosuppressant at up to maximally indicated doses unless contraindicated or adverse effects.
Include evidence of specialist involvement (prescribed by or in consultation with an oncologist, hematologist, or bone marrow transplant specialist).

Prior Authorization

Policy governs prior authorization for belumosudil

This clinical policy governs coverage and authorization for belumosudil (Rezurock); providers must follow the policy criteria when requesting authorization.

Coding and Dosing Limits

inv-05: Maximum daily dose — 400 mg/day

Maximum daily dose400 mg/day (does not exceed 400 mg; equivalent to 2 x 200 mg tablets)

Typical single-tablet strength200 mg tablet

Common dosing noteDose listed as 200 mg PO QD for cGVHD with maximum 400 mg/day

Definitions

inv-15: cGVHD — Chronic graft-versus-host disease; indication for Rezurock

DefinitionChronic graft-versus-host disease (cGVHD) — indication for Rezurock per FDA-approved labeling

Role in criteriacGVHD is the covered diagnosis specified in the Initial Approval Criteria (must meet all) for Rezurock

AbbreviationcGVHD = chronic graft-versus-host disease

inv-16: HCT — Hematopoietic cell transplant

DefinitionHCT = hematopoietic cell transplant

RelevancePolicy applies to members with history of allogenic HCT as part of initial approval criteria

Abbreviation source

Background

Belumosudil (Rezurock) is a Rho‑associated coiled‑coil kinase (ROCK) inhibitor indicated for the treatment of chronic graft‑versus‑host disease (cGVHD) in patients aged ≥ 12 years after failure of at least two prior lines of systemic therapy. The policy applies to members with a history of allogeneic hematopoietic cell transplant (HCT) and requires that therapy be prescribed by or in consultation with an appropriate specialist (oncologist, hematologist, or bone marrow transplant specialist).

Step Therapy / Prior Treatment Requirements

Required prior therapy	Examples (Appendix B)
Failure of a systemic corticosteroid at up to maximally indicated doses unless contraindicated or clinically significant adverse effects
Systemic corticosteroids (e.g., methylprednisolone, prednisone)
Failure of a systemic immunosuppressant at up to maximally indicated doses unless contraindicated or clinically significant adverse effects
Examples: mycophenolate mofetil (Cellcept), cyclosporine (Gengraf, Neoral), tacrolimus (Prograf), sirolimus (Rapamune), rituximab (Riabni, Rituxan, Ruxience)

Quantity Limits

inv-21: Rezurock (tablet) — product availability / quantity limit note

Tablet strength available200 mg tablet

Quantity limit (per day)Maximum 2 tablets per day to not exceed 400 mg/day

Product availability noteTablet formulation only (200 mg)

Revision History

2021-12-01policy_effective

Policy CP.PHAR.552 effective date (clinical policy for belumosudil [Rezurock]).

2021copyright

2024-02-01next_review_dateLatest

Scheduled next policy review on 2024-02-01.

Policy Summary

PayerDelaware First Health

PolicyBelumosudil (Rezurock) coverage

Policy CodePolicy CP.PHAR.552

Change TypeNo material change

Effective DateDec 1, 2021

Next Review DateFeb 1, 2024

Key ActionProvider must submit documentation (e.g., office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.

SourceLink

On This Page

Failure of a systemic immunosuppressant at up to maximally indicated doses unless contraindicated or clinically significant adverse effects are experienced.

Rezurock is not prescribed concurrently with Imbruvica, Jakafi, or Niktimvo.

Dose does not exceed 400 mg (2 tablets) per day.dose <= 400 mg/day

Step Therapy

Therapeutic alternatives (see Appendix B)

Therapeutic alternatives such as systemic corticosteroids and systemic immunosuppressants are listed as examples in Appendix B and may be preferred alternatives or required prior therapies.

See Appendix B for examples of systemic corticosteroids (e.g., methylprednisolone, prednisone) and immunosuppressants (e.g., mycophenolate mofetil, cyclosporine, tacrolimus, sirolimus).
Documentation of failure of these alternatives is required per step-therapy requirements.

Note

Miscellaneous provider submission notes

When submitting an authorization request, ensure all supporting clinical information is included and verify any plan-specific submission processes to avoid delays.

Confirm plan-specific prior authorization process and required forms.
Ensure submission includes any consultation notes and prior treatment history.

Documentation Required

Required supporting documentation

Provider must submit supporting documentation (such as office chart notes, lab results, or other clinical information) demonstrating that the member has met all approval criteria.

Include documentation of diagnosis, prior therapies and their outcomes, specialist consultation, and current dosing.
Provide lab results or other pertinent clinical data as applicable.

Denial Risk

Denial risk: insufficient documentation or off‑label use

Requests for non‑FDA approved indications or requests lacking sufficient documentation of efficacy/safety or failure of prior therapies may be denied per off‑label use policies.

If the requested use is non‑FDA approved and not addressed in this policy, submit sufficient evidence per the applicable off‑label use policy (CP.CPA.09, HIM.PA.154, CP.PMN.53).
Lack of documentation that the member met approval criteria (e.g., prior therapy failures) may result in denial.

Note

Provider and member obligations

Providers, members, and their representatives are bound by the terms and conditions of this clinical policy when providing services or submitting claims for payment.

Note

Medicaid precedence and conflicting requirements

For Medicaid members, state Medicaid coverage provisions take precedence when they conflict with this clinical policy; providers should follow the state Medicaid manual for applicable requirements.

If state Medicaid rules conflict with this policy, adhere to the state Medicaid coverage provisions.

Listed in Appendix A: Abbreviation/Acronym Key

inv-17: Clinical policy — plan rules and criteria governing coverage and use of a specific medication

DefinitionClinical policy: the plan's rules and criteria governing coverage and use of a specific medication

Binding natureProviders, members, and their representatives are bound by the terms and conditions of this clinical policy per contract or by providing services/submitting claims

Precedence noteFor Medicaid members, state Medicaid coverage provisions take precedence if they conflict with this clinical policy