Subject:
Belatacept (Nulojix)
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Belatacept (Nulojix), a selective T-cell costimulation blocker was FDA approved on June 15, 2011 for the prophylaxis treatment of organ rejection in adult patients receiving a kidney transplant. The approval was based on two open-labeled, randomized, active-controlled three-year trials of Nulojix in de novo kidney transplant patients. These trials evaluated two dose regimens of Nulojix, the recommended dosage regimen and a regimen with higher cumulative doses and more frequent dosing than the recommended dosage recommendation. All patients also received basiliximab induction, mycophenolate mofetil, and corticosteroids and were treated and followed for 3 years.
In one study, patients treated with Nulojix with the recommended regimen experienced episodes of biopsy proven acute rejection (BPAR) classified as Banff grade IIb or higher more frequently compared to patients treated with cyclosporine (6% at one year and 7% at 3 years versus 2% at one year and 2% at three years, respectively). By three years, 22% (11/50) of NULOJIX-treated patients with a history of BPAR experienced graft loss and/or death compared to 10% (3/31) of cyclosporine-treated patients with a history of BPAR; at that time point, 10% (5/50) of NULOJIX-treated patients experienced graft loss and 12% (6/50) of NULOJIX-treated patients had died following an episode of BPAR, whereas 7% (2/31) of cyclosporine-treated patients experienced graft loss and 7% (2/31) of cyclosporine-treated patients had died following an episode of BPAR.
Another study showed similar results in episodes of BPAR and use of T-cell depleting therapy in comparison to cyclosporine therapy. At Month 12, the difference in mean calculated GFR between patients with and without a history of BPAR was 10 mL/min/1.73 m2 among NULOJIX-treated patients compared to 14 mL/min/1.73 m2 among cyclosporine-treated patients. By three years, 24% (10/42) of NULOJIX-treated patients with a history of BPAR experienced graft loss and/or death compared to 31% (13/42) of cyclosporine-treated patients with a history of BPAR; at that time point, 17% (7/42) of NULOJIX-treated patients experienced graft loss and 14% (6/42) of NULOJIX-treated patients had died following an episode of BPAR, whereas 19% (8/42) of cyclosporine-treated patients experienced graft loss and 19% (8/42) of cyclosporine-treated patients had died following an episode of BPAR.
[INFORMATIONAL NOTE: Belatacept (Nulojix) has a boxed warning for post-transplant lymphoproliferative disorder, other malignancies, progressive multifocal leukoencephalopathy (PML), and serious infections. There is an increased risk for developing post-transplant lymphoproliferative disorder (PTLD), predominantly involving the central nervous system (CNS). Recipients without immunity to Epstein-Barr Virus (EBV) are at a particularly increased risk; therefore, use in EBV seropositive patients only. Do not use Nulojix in transplant recipients who are EBV seronegative or with unknown EBV serostatus. Also, only physicians experienced in immunosuppressive therapy and management of kidney transplant patients should prescribe Nulojix. There is also increased susceptibility to infection and the possible development of malignancies may result from immunosuppression. Use in liver transplant patients its not recommended due to an increased risk of graft loss and death. Additionally, coadministration with antithromocyte globulin may pose a risk for venous thrombosis of the renal allograft. ]
Policy:
(NOTE: For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance)
1. Belatacept (Nulojix) is medically necessary for prophylaxis of organ rejection in adult patients when ALL of the following criteria, based on the FDA approved indication and limitation, are met:
- Receiving kidney transplant AND
- Using in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids AND
- Documentation of Epstein-Barr virus (EBV) seropositive (i.e., presence of anti-viral capsid antigen [anti-VCA] IgG and EBV nuclear antigen [EBNA]).
2. When Belatacept (Nulojix) is medically necessary, initial therapy will be approved for a period 3 months at 10 mg/kg on day 1, day 5, end of week 2, 4, 8 and 12 (a total of 6 doses).
3. Continue therapy will be considered annually if the member shows signs of stability at a dose of 5 mg/kg every 4 weeks.
[INFORMATIONAL NOTE: Total infusion dose of Nulojix should be based on the actual body weight of the patient at the time of transplantation, and should not be modified during the course of therapy, unless there is a change in body weight of greater than 10%. Prescribed doses of Nulojix should also be evenly divisible by 12.5 mg in order for the dose to be prepared accurately using the reconstituted solution and syringe provided.]
4. Other uses of Belatacept (Nulojix) including but not limited to liver transplant, systemic lupus erythematosus, rheumatoid arthritis, psoriatic arthritis, abdominal wall transplant, pancreas transplant, and type 1 diabetes are considered investigational.
Medicare Coverage
Belatacept (Nulojix) is covered when LCD L33824 and Policy Article (A52474) criteria are met. For additional information and eligibility, refer to Local Coverage Determination (LCD): Immunosuppressive Drugs (L33824) and Local Coverage Article: Immunosuppressive Drugs - Policy Article (A52474). Available to be accessed at Noridian Healthcare Services, LLC, (DME MAC), Local Coverage Determinations (LCDs) search page: https://www.cms.gov/medicare-coverage-database/indexes/lcd-list.aspx?Cntrctr=389&ContrVer=1&CntrctrSelected=389*1&s=38&DocType=All&bc=AggAAAAAAAAAAA%3d%3d&#ResultsAnchor.
Per Local Coverage Determination (LCD): Immunosuppressive Drugs (L33824), Parenteral belatacept (J0485) is not proven to be safe when administered in the home setting. Therefore belatacept (J0485 is not covered when provided in the home setting.
Medicaid Coverage
For Horizon NJ Health members, please follow this link for the corresponding HNJH drug policy https://services3.horizon-bcbsnj.com/ddn/NJhealthWeb.nsf
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Belatacept (Nulojix)
Nulojix (Belatacept)
References:
1. Nulojix® (belatacept) [Prescribing Information]. Bristol-Meyers Squibb. Princeton, NJ April 2018.
2. Mease P, Genovese MC, Gladstein G, et al. Abatacept in the treatment of patients with psoriatic arthritis: results of a six-month, multicenter, randomized, double-blind, placebo-controlled, phase II trial. Arthritis Rheum. 2011 Apr;63(4):939-48.
3. Merrill JT, Burgos-Vargas R, Westhovens R, et al. The efficacy and safety of abatacept in patients with non-life-threatening manifestations of systemic lupus erythematosus: results of a twelve-month, multicenter, exploratory, phase IIb, randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2010 Oct;62(10):3077-87.
4. Vincenti F, Blancho G, Durrbach A, et al. Five-year safety and efficacy of belatacept in renal transplantation. J Am Soc Nephrol. 2010 Sep;21(9):1587-96. Epub 2010 Jul 15.
5. Durrbach A, Pestana JM, Pearson T, et al. A phase III study of belatacept versus cyclosporine in kidney transplants from extended criteria donors (BENEFIT-EXT study). Am J Transplant. 2010 Mar;10(3):547-57.
6. Vincenti F, Charpentier B, Vanrenterghem Y, et al. A phase III study of belatacept-based immunosuppression regimens versus cyclosporine in renal transplant recipients (BENEFIT study). Am J Transplant. 2010 Mar;10(3):535-46.
7. ClinicalTrials.gov. Belatacept. http://www.clinicaltrials.gov/ct2/results?term=belatacept&pg=2. Accessed February 19, 2020.
8. Centers for Disease Control and Prevention. Epstein-Barr Virus and Infectious Mononucleosis, Laboratory Testing. https://www.cdc.gov/epstein-barr/laboratory-testing.html. Atlanta, GA: CDC, 2016.
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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