NULOJIX, Belatacept Form

Belatacept (Nulojix®) is a selective T-cell costimulation blocker. FDA Approved Indication(s) Nulojix is indicated for prophylaxis of organ rejection in adult patients receiving a kidney transplant. Nulojix is to be used in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids. Limitation(s) of use:
• Use Nulojix only in patients who are Epstein-Barr virus (EBV) seropositive. • Use of Nulojix for the prophylaxis of organ rejection in transplanted organs other than kidney has not been established. 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 Nulojix is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Kidney Transplant (must meet all):

1. Prescribed for kidney transplant rejection prophylaxis;
   
   2. Prescribed by or in consultation with a kidney transplant specialist;
   3. Age ≥ 18 years;
   4. Request is for use in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids;

2. Member is EBV seropositive;

   6. Dose does not exceed the following: a. Initial: 10 mg/kg on Day 1 (day of transplantation) and Day 5, end of Week 2, Week 4, Week 8, and Week 12 post-transplantation; b. Maintenance: 5 mg/kg at the end of Week 16 post-transplantation and every 4 weeks (± 3 days) thereafter. Approval duration: 6 months Page 1 of 6

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

3. 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
4. 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. Kidney Transplant (must meet all):
5. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Nulojix for a covered indication and has received this medication for at least 30 days;
6. Member is responding positively to therapy;
   3. If request is for a dose increase, new dose does not exceed 5 mg/kg per infusion at the end of week 16 (after the first 6 doses) after transplantation and every 4 weeks (± 3 days) thereafter.
      Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2):
7. 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

8. 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.
   Page 2 of 6

   CLINICAL POLICY
   Belatacept 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 EBV: Epstein-Barr virus
   FDA: Food and Drug Administration 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 20 mg/dose 3 g/day Simulect® (basiliximab) mycophenolate mofetil (Cellcept®) 20 mg IV within 2 hours prior to transplantation surgery, followed by 20 mg IV 4 days after transplantation 1 g PO BID after transplantation
   1 g IV over at least 2 hours BID initiated within 24 hours after transplantation for up to 14 days (recommended for patients unable to take an oral formulation) Varies corticosteroids (e.g., prednisone, methylprednisolone) 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 • Contraindication(s): transplant recipients who are EBV seronegative or with unknown EBV serostatus due to the risk of post-transplant lymphoproliferative disorder, predominantly involving the central nervous system • Boxed warning(s): post-transplant lymphoproliferative disorder, other malignancies, and serious infections V. Dosage and Administration
   Indication Prophylaxis of organ rejection in kidney transplant recipients Dosing Regimen Dosing for Initial Phase: • Day 1 (day of transplantation, prior to implantation) and Day 5 (approximately 96 hours after Day 1 dose): 10 mg per kg Maximum Dose 10 mg/kg/dose for first 6 doses then 5 mg/kg/dose Page 3 of 6

   CLINICAL POLICY
   Belatacept Indication Maximum Dose Dosing Regimen • End of Week 2 and Week 4 after transplantation: 10 mg per kg • End of Week 8 and Week 12 after transplantation: 10 mg per kg Dosing for Maintenance Phase: End of Week 16 after transplantation and every 4 weeks (plus or minus 3 days) thereafter: 5 mg per kg The prescribed dose must be evenly divisible by 12.5 mg in order for the dose to be prepared accurately using the reconstituted solution and provided syringe. VI. Product Availability
   Vial: 250 mg VII.