UnitedHealthcare® Value & Balance Exchange Medical Benefit Drug Policy Nulojix® (Belatacept)
Policy Number: IEXD0215.02 Effective Date: June 1, 2021 Instructions for Use
Table of Contents Page Related Policies Applicable States ...... 1 None Coverage Rationale ...... 1 Applicable Codes ...... 2 Background...... 2 Clinical Evidence ...... 2 U.S. Food and Drug Administration ...... 2 References ...... 3 Policy History/Revision Information ...... 3 Instructions for Use ...... 3
Applicable States
This Medical Benefit Drug Policy only applies to the states of Arizona, Maryland, North Carolina, Oklahoma, Tennessee, Virginia, and Washington.
Coverage Rationale
Nulojix is proven and medically necessary for the treatment of Kidney transplant when all of the following criteria are met: For initial therapy, all of the following: o Nulojix is prescribed for kidney transplant rejection prophylaxis; and o Patient has no history of liver transplant; and o Nulojix is prescribed by or in consultation with a kidney transplant specialist; and o Patient is 18 years of age or older; and o Nulojix is used in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids; and o Patient is documented as Epstein-Barr virus (EBV) seropositive; and o Nulojix dosing is in accordance with the U.S. Food and Drug Administration (FDA) approved labeling: . Initial phase – Day one (day of transplantation, prior to implantation) – 10mg/kg by intravenous infusion – Day five (approximately 96 hours after Day one dose) – 10 mg/kg by intravenous infusion – End of week two and week four after transplantation - 10 mg/kg by intravenous infusion – End of week eight and week 12 after transplantation - 10 mg/kg by intravenous infusion . Maintenance phase – End of week 16 after transplantation and every four weeks (plus or minus three days) thereafter - 5 mg/kg by intravenous infusion and o Authorization is for no more than six months For continuation of therapy, all of the following: o Patient has previously received Nulojix; and o Documentation of positive clinical response to Nulojix; and
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o Nulojix dosing is in accordance with the U.S. Food and Drug Administration (FDA) approved labeling: dose does not exceed 5 mg/kg given every four weeks; and o Authorization is for no more than 12 months
Applicable Codes
The following list(s) of procedure and/or diagnosis codes is provided for reference purposes only and may not be all inclusive. Listing of a code in this policy does not imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by the member specific benefit plan document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee claim payment. Other Policies and Guidelines may apply.
HCPCS Code Description J0485 Injection, belatacept, 1 mg
Diagnosis Code Description T86.11 Kidney transplant rejection Z94.0 Kidney transplant status
Background
Since 1988, over 455,000 kidney transplants have been performed in the United States. During 2018, a record number of kidney transplants were performed in the US, including 21,167 kidney-alone and 836 kidney plus at least one additional organ. Of those transplants, 6,442 were identified as originating from living-donors (29.3%) and 15,561 (70.7%) from deceased-donors. In 2017, more than 220,000 patients were alive and with a functioning transplanted kidney; currently, more than 90,000 adult patients are waiting for kidney transplants.
Before the advent of immunosuppression, kidney transplantation was limited to identical twins and was not applicable to the vast majority of patients with ESRD. The introduction of combined azathioprine-steroid therapy in 1963 produced encouraging results and became the mainstay of immunosuppression. Although this therapy improved the results of transplantation, acute rejection and complications associated with steroid therapy persisted.
The introduction of cyclosporine in 1983 significantly improved the outcomes of all solid-organ transplants by reducing the risk of rejection. Further innovations, including anti–T cell antibodies (both monoclonal and polyclonal preparations), as well as other maintenance immunosuppressants (e.g., tacrolimus, mycophenolate, sirolimus), have made a significant impact on both patient and graft survival. Currently, one-year patient and graft survival rates exceed 90% in most transplant centers.2
Nulojix, a selective T-cell (lymphocyte) costimulation blocker, binds to CD80 and CD86 on antigen-presenting cells thereby blocking CD28 mediated costimulation of T lymphocytes. In vitro, belatacept inhibits T lymphocyte proliferation and the production of the cytokines interleukin-2, interferon-γ, interleukin-4, and TNF-α. Activated T lymphocytes are the predominant mediators of immunologic rejection.
Clinical Evidence
Reference the Clinical Studies information provided in the product labeling.1
U.S. Food and Drug Administration (FDA)
This section is to be used for informational purposes only. FDA approval alone is not a basis for coverage.
Nulojix is a selective T cell costimulation blocker indicated for prophylaxis of organ rejection in adult patients receiving a kidney transplant. Use in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids.
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Limitations of Use: Use only in patients who are EBV seropositive Use has not been established for the prophylaxis of organ rejection in transplanted organs other than the kidney
References
1. Nulojix [prescribing information]. Princeton, NJ: Bristol-Meyers Squibb Company; April 2018. 2. https://www.uptodate.com/ : Kidney transplantation in adults: Maintenance immunosuppressive therapy. Accessed on March 15, 2021. 3. Masson P, Henderson L, Chapman JR, et al. Belatacept for kidney transplant recipients. Cochrane Database Syst Rev. 2014 Nov 24;2014 Policy History/Revision Information
Date Summary of Changes 06/01/2021 Template Update Removed CMS section Supporting Information Updated References section to reflect the most current information Archived previous policy version IEXD0215.01
Instructions for Use
This Medical Benefit Drug Policy provides assistance in interpreting UnitedHealthcare benefit plans. When deciding coverage, the member specific benefit plan document must be referenced as the terms of the member specific benefit plan may differ from the standard benefit plan. In the event of a conflict, the member specific benefit plan document governs. Before using this policy, please check the member specific benefit plan document and any applicable federal or state mandates. UnitedHealthcare reserves the right to modify its Policies and Guidelines as necessary. This Medical Benefit Drug Policy is provided for informational purposes. It does not constitute medical advice.
UnitedHealthcare may also use tools developed by third parties, such as the InterQual® criteria, to assist us in administering health benefits. UnitedHealthcare Medical Benefit Drug Policies are intended to be used in connection with the independent professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or medical advice.
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