Belumosudil (Rezurock) Form

Belumosudil (Rezurock™) is an inhibitor of rho-associated, coiled-coil containing protein kinase (ROCK). FDA Approved Indication(s) Rezurock is indicated for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Rezurock is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Chronic Graft-Versus-Host Disease (must meet all):

1. Diagnosis of cGVHD;
   2. Prescribed by or in consultation with an oncologist, hematologist, or bone marrow transplant specialist;
2. Age ≥ 12 years;
   4. Member has a history of allogenic hematopoietic cell transplant (HCT);
   5. Failure of a systemic corticosteroid (see Appendix B) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced;
3. Failure of a systemic immunosuppressant (see Appendix B) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced; Prior authorization may be required

4. Rezurock is not prescribed concurrently with Imbruvica® or Jakafi®;

   8. Dose does not exceed both of the following (a and b):
      a. 400 mg per day; b. 2 tablets per day. Approval duration: 12 months

   CLINICAL POLICY Belumosudil B. Other diagnoses/indications (must meet 1 or 2):

5. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
6. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. All Indications in Section I (must meet all):
7. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Rezurock for a covered indication and has received this medication for at least 30 days;
8. Member is responding positively to therapy;
   3. Rezurock is not prescribed concurrently with Imbruvica or Jakafi;
   4. If request is for a dose increase, new dose does not exceed both of the following (i and ii):
      i. 400 mg per day;
      ii. 2 tablets per day. Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2):
9. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

10. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line

    CLINICAL POLICY Belumosudil of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
    III. Diagnoses/Indications for which coverage is NOT authorized:
    A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents.
    IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key cGVHD: chronic graft-versus-host disease NCCN: National Comprehensive Cancer Network FDA: Food and Drug Administration
    ROCK: rho-associated, coiled-coil containing protein kinase
    Appendix B: Therapeutic Alternatives This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
    Drug Name Dosing Regimen Dose Limit/ Maximum Dose Examples of systemic corticosteroids and immunosuppressants for cGVHD Systemic corticosteroids (e.g., methylprednisolone, prednisone) Varies mycophenolate mofetil (Cellcept®) cyclosporine (Gengraf®, Neoral®, Sandimmune®) tacrolimus (Prograf®) sirolimus (Rapamune®) imatinib (Gleevec®) Imbruvica® (ibrutinib) Jakafi® (ruxolitinib) Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Varies Appendix C: Contraindications/Boxed Warnings None reported V. Dosage and Administration
    Indication Dosing Regimen cGVHD 200 mg PO QD Strong CYP3A Inducers, Proton Pump Inhibitor: Increase Rezurock dosage to 200 mg PO BID. VI. Product Availability
    Tablet: 200 mg Maximum Dose 400 mg/day

    CLINICAL POLICY Belumosudil VII.