Commercial

Medical Policy

Title:

Abatacept (Orencia®) for Injection for Intravenous Use

Policy #:

08.00.62p

Policy

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.

MEDICALLY NECESSARY

INITIAL THERAPY

HEMATOPOIETIC CELL TRANSPLANTATION

Prophylaxis of Acute Graft-Versus-Host Disease (aGVHD)

Abatacept (Orencia) injection for intravenous use is considered medically necessary and, therefore, covered for the prophylaxis of acute graft-versus-host disease (aGVHD), in combination with a calcineurin inhibitor (e.g., cyclosporine, tacrolimus) and methotrexate up to four doses when all the following criteria are met:

The individual is undergoing hematopoietic stem cell transplantation (HSCT) from a matched or one allele–mismatched unrelated donor.
Active or latent tuberculosis (TB) has been ruled out.
The individual is 2 years of age or older.
Abatacept (Orencia) will not be used in combination with other biologic disease-modifying antirheumatic drugs [bDMARDs (tumor necrosis factor [TNF] antagonists, e.g., certolizumab, adalimumab, etanercept] or Janus kinase (JAK) inhibitors (e.g., baricitinib, tofacitinib, upadacitinib).

Treatment of Chronic Graft-Versus-Host Disease (GVHD)

Abatacept (Orencia) injection for intravenous use is considered medically necessary and, therefore, covered for the treatment of chronic GVHD as additional therapy in conjunction with systemic corticosteroids following no response (steroid-refractory disease) to first-line therapy options.

IMMUNE CHECKPOINT INHIBITOR–RELATED TOXICITIES

Abatacept (Orencia) injection for intravenous use is considered medically necessary and, therefore, covered as additional therapy for the management of the following immune checkpoint inhibitor–related (e.g., pembrolizumab [Keytruda], nivolumab [Opdivo]) autoimmune-like toxicity (also known as immune-related adverse event): myocarditis, if no improvement within 24 to 48 hours of starting high-dose methylprednisolone.

POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS (pJIA)
Abatacept (Orencia) injection for intravenous use is considered medically necessary and, therefore, covered when used in individuals who have moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA). Abatacept (Orencia) injection for intravenous use may be covered as monotherapy or concomitantly with methotrexate when all of the following inclusion criteria are met:

If the individual has not previously received a bDMARD to treat pJIA, abatacept (Orencia) injection for intravenous use is only eligible for coverage when the individual has a documented failure, contraindication, or intolerance to golimumab (Simponi Aria), or there is a clinical reason that a trial of golimumab (Simponi Aria) would be otherwise inappropriate for the member.
Active or TB has been ruled out.
The individual has had an inadequate response after at least 3 months of one or more DMARDs, or the use of all DMARDs is contraindicated in the individual.
The individual is 6 years of age or older.
Abatacept (Orencia) will not be used in combination with other bDMARDs or JAK inhibitors.

PSORIATIC ARTHRITIS (PsA)
Abatacept (Orencia) injection for intravenous use is considered medically necessary and, therefore, covered for the treatment of active psoriatic arthritis. Abatacept (Orencia) injection for intravenous use may be covered as monotherapy or concomitantly with non-bDMARDs when all of the following inclusion criteria are met:

If the individual has not previously received a bDMARD to treat adult rheumatoid arthritis (RA), abatacept (Orencia) injection for intravenous use is only eligible for coverage when the individual has a documented failure, contraindication, or intolerance to infliximab (Remicade), ustekinumab (Stelara), or golimumab (Simponi Aria), or there is a clinical reason that a trial of infliximab (Remicade), ustekinumab (Stelara), or golimumab (Simponi Aria) would be otherwise inappropriate for the member.
Active or latent TB has been ruled out.
The individual has had an inadequate response after at least 3 months of one or more DMARDs, or the use of all DMARDs is contraindicated in the individual.
The individual is 18 years of age or older.
Abatacept (Orencia) will not be used in combination with other bDMARDs or JAK inhibitors.

RHEUMATOID ARTHRITIS (RA)
Abatacept (Orencia) injection for intravenous use is considered medically necessary and, therefore, covered in individuals who have moderately to severely active RA. Abatacept (Orencia) injection for intravenous use may be covered as monotherapy or concomitantly with DMARDs, other than JAK inhibitors or biologic DMARDs (bDMARDs) when all of the following inclusion criteria are met:

If the individual has not previously received a bDMARD to treat adult RA, abatacept (Orencia) injection for intravenous use is only eligible for coverage when the individual has a documented failure, contraindication, or intolerance to infliximab (Remicade) or golimumab (Simponi Aria), or there is a clinical reason that a trial of infliximab (Remicade) or golimumab (Simponi Aria) would be otherwise inappropriate for the member.
Active or latent tuberculosis (TB) has been ruled out.
The individual has had an inadequate response after at least 3 months to one or more non-bDMARDs or tumor necrosis factor (TNF) antagonists, or the use of all non-bDMARDs or TNF-antagonists is contraindicated in the individual.
The individual is 18 years of age or older.
Abatacept (Orencia) will not be used in combination with other bDMARDs or JAK inhibitors.

CONTINUATION THERAPY

Chronic GVHD

Abatacept (Orencia) injection for intravenous use is considered medically necessary for the treatment of chronic GVHD and, therefore, covered for the continuation therapy when the individual meets both of the following:

Individual continues to experience chronic GVHD
There is documentation of positive clinical response to therapy (e.g., reduction in symptoms, Global Scoring of Chronic GVHD, and steroid dose)

POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, RHEUMATOID ARTHRITIS, PSORIATIC ARTHRITIS

Abatacept (Orencia) injection for intravenous use is considered medically necessary for the treatment of pJIA, RA, AND PsA, and, therefore, covered for the continuation therapy when the individual meets both of the following:

Individual has met the medical necessity criteria for Initial Therapy
There is documentation of positive clinical response or stabilization to therapy as evidenced by at least one of the following:

Reduction in total active [swollen and tender] joint count from baseline
Improvement in symptoms [e.g., pain, stiffness, inflammation] from baseline

EXPERIMENTAL/INVESTIGATIONAL

All other uses for abatacept (Orencia) injection for intravenous use are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug.

BILLING REQUIREMENTS

For drugs that have more than one method of administration, application of the JA modifier is required to indicate the route of administration.

To report the intravenous route of administration, append the following modifier: JA Administered Intravenously

Inclusion of a code in this policy does not imply reimbursement. Eligibility, benefits, limitations, exclusions, utilization management/referral requirements, provider contracts, and Company policies apply.

Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, abatacept (Orencia) injection for intravenous use is covered under the medical bene(fits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

Abatacept (Orencia) injection for subcutaneous use is not covered under the medical benefits for most of the Company’s products. Abatacept (Orencia) injection for subcutaneous use may be covered under a member’s pharmacy benefit, if applicable.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Initial FDA approval for abatacept (Orencia) injection for intravenous use was granted on December 23, 2005. Supplemental approvals for abatacept (Orencia) injection for intravenous use have since been issued. Abatacept (Orencia) injection for subcutaneous use was approved by the FDA on July 29, 2011.

A single loading dose infusion of abatacept (Orencia) injection for intravenous use may be given to an individual who will receive subcutaneous abatacept (Orencia) for treatment of adult rheumatoid arthritis.

PEDIATRIC USE
For pediatric juvenile idiopathic arthritis, the safety and effectiveness of abatacept (Orencia) injection for intravenous use in pediatric individuals younger than 6 years of age have not been established. Therefore, abatacept (Orencia) injection for intravenous use in polyarticular juvenile idiopathic arthritis is not recommended for use in individuals younger than 6 years of age.

For the prophylaxis of acute graft versus host disease (aGVHD), the safety and effectiveness of abatacept (Orencia) injection for intravenous use in pediatric individuals younger than 2 years of age have not been established. Therefore, abatacept (Orencia) injection for intravenous use in aGVHD is not recommended for use in individuals younger than 2 years of age.

DRUG INTERACTIONS
Concurrent administration of a tumor necrosis factor (TNF) antagonist (e.g., adalimumab [Humira], etanercept [Enbrel], golimumab [Simponi, Simponi Aria], infliximab [Remicade]) with abatacept (Orencia) injection for intravenous use has been associated with an increased risk of serious infections and no significant additional efficacy over use of the TNF antagonists alone. Concurrent therapy with abatacept (Orencia) injection for intravenous use and TNF antagonists is not recommended.

There is insufficient experience to assess the safety and efficacy of abatacept (Orencia) administered concurrently with other biologic rheumatoid arthritis therapy, such as anakinra (Kineret), or other biologic rheumatoid arthritis/psoriatic arthritis therapy, and JAK inhibitors. Therefore, such use is not recommended.

Description

Abatacept (Orencia) injection for intravenous use is a soluble fusion protein that is produced by recombinant deoxyribonucleic acid (DNA) technology. It is a selective co-stimulation modulator that consists of human cytotoxic T-lymphocyte-associated antigen-4 linked to a modified portion of human immunoglobulin G1 (IgG1).

The activation of T lymphocytes has been implicated in the pathogenesis of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (pJIA), and psoriatic arthritis (PsA). Because abatacept (Orencia) injection for intravenous use interrupts T-lymphocyte activation, it has been studied to be effective for the treatment of RA and PsA, and is frequently used in the management of adults and children with pJIA.

The American College of Rheumatology (ACR) guidelines for the treatment of RA recommend that newly diagnosed individuals with RA begin treatment with disease-modifying antirheumatic drugs (DMARDs). DMARDs act to slow down disease progression, and some act with mild chemotherapeutic action, causing immunosuppression. The ACR Guidelines for the treatment of pJIA recommend nonsteroidal anti-inflammatory drugs (NSAIDs) or DMARDs as initial therapy. The ACR Guidelines for PsA initial treatment recommend methotrexate (MTX) in individuals with less active disease and biologic TNFi with severe disease.

DMARDs can be subdivided into the traditional small-molecular-mass, chemically synthesized non-biologic DMARDs (such as, but not limited to, methotrexate, sulfasalazine, azathioprine, leflunomide, hydroxychloroquine sulfate, and cyclosporine) and biologic DMARDs. Examples of biologic DMARDs include, but are not limited to, infliximab (Remicade), etanercept (Enbrel), adalimumab (Humira), anakinra (Kineret), golimumab (Simponi, Simponi Aria), tocilizumab (Actemra), and rituximab (Rituxan).

Abatacept (Orencia) is available in two forms: injection for intravenous use and injection for subcutaneous use.

PEER-REVIEWED LITERATURE

SUMMARY
Acute Graft versus Host Disease (aGVHD), Prophylaxis

The safety and efficacy of abatacept (Orencia) injection for intravenous use, in combination with a calcineurin inhibitor (CNI) (e.g., cyclosporine, tacrolimus) and MTX for the prophylaxis of aGVHD was accessed in two clinical studies.

The first was a Phase 2, double-blind, multicenter, two-cohort clinical study (GVHD-1) in individuals 6 years of age and older who underwent hematopoietic stem cell transplantation (HSCT) from a matched or one-allele-mismatched unrelated donor. The two cohorts in GVHD-1 included:

An open-label, single-arm study of 43 individuals who underwent a 7 of 8 human leukocyte antigen (HLA)-matched HSCT (7 of 8 cohort)
A randomized (1:1), double-blind, placebo-controlled study of 142 individuals who underwent an 8 of 8 HLA-matched HSCT who received abatacept (Orencia) or placebo in combination with a CNI and MTX (8 of 8 cohort).

In both cohorts, individuals in the abatacept (Orencia) group received 10 mg/kg (1000 mg maximum dose) IV over 60 minutes on the day before transplantation (Day −1), followed by administration on Days 5, 14, and 28 after transplantation. In cohort 1, an exploratory analysis revealed the following rates of grade III to IV GFS (95%), grade II to IV GFS (53%), and overall survival (98%) at day 180 posttransplantation. In cohort 2, at Day 180 posttransplantation, there was significantly improved overall survival (OS) rate in the abatacept (Orencia) + CNI + MTX group of 97% compared to 84% for the placebo group. There was also a significantly improved rate of aGVHD-free survival (GFS) for moderate-to-severe (grade II-IV) aGVHD in the abatacept (Orencia) + CNI + MTX group (50%), compared to the placebo group (32%). However, severe (grade III-IV) aGVHD-free survival (GFS) was not significantly improved in the abatacept (Orencia) group (87%) compared to those who received a placebo (75%).

The second clinical study, GVHD-2, used real-world data from the Center for International Blood and Marrow Transplant Research (CIBMTR). The study analyzed the outcomes of individuals 6 years of age or older who underwent HSCT from a one-allele-mismatched unrelated donors between 2011 and 2018 and received abatacept (Orencia) in combination with a CNI and MTX, versus a CNI + MTX alone, for the prophylaxis of aGVHD. The abatacept (Orencia) + CNI + MTX group (n=54) included 42 individuals from the GVHD-1 study, in addition to 12 individuals treated with abatacept (Orencia) outside of GVHD-1. The comparator group (n=162) received CNI + MTX alone, and were randomly selected in a 3:1 ratio to the abatacept (Orencia) + CNI + MTX group from the CIBMTR registry from individuals. The study measured overall survival (OS) 6 months after transplantation. Those in the abatacept (Orencia) + CNI + MTX group saw a 98% overall survival rate compared to 75% for those who received CNI + MTX alone.

The most common side effects of abatacept (Orencia) for prevention of aGVHD included anemia, hypertension, cytomegalovirus (CMV) reactivation/CMV infection, fever, pneumonia, nosebleed, decreased levels of specific white blood cells called CD4 lymphocytes, increased levels of magnesium in the blood, and acute kidney injury.

Polyarticular Juvenile Idiopathic Arthritis

The safety and efficacy of abatacept (Orencia) injection for intravenous use in the treatment of juvenile idiopathic arthritis (JIA) was assessed in a three-part study with individuals ages 6 years to 17 years with moderate to severely active pJIA with inadequate response to one or more DMARDs. The principal measure of clinical response in part A of this study was the ACR pediatric 30 definition of improvement (i.e., 30% or greater improvement in at least 3 of 6 and 30% or greater deterioration in no more than 1 of 6 core set criteria that include physician and child/parent global assessments, active joint count, limitation of motion, functional assessment, and erythrocyte sedimentation rate). Individuals with an "ACR pediatric 30" response at the end of part A were randomly assigned into part B, the double-blind phase. In part B, the primary endpoint was time to disease flare (defined as a 30% or greater deterioration in 3 of 6 and a 30% or greater improvement in no more than 1 of 6 core set criteria). At the end of part B, study participants treated with abatacept (Orencia) injection for intravenous use reported significantly fewer disease flares as compared to individuals treated with placebo. (Part C of the study was an open-label extension.)

At the conclusion of part A, pediatric ACR 30/50/70 responses were 65%, 50%, and 28%, respectively. During part B, study participants reported significantly fewer disease flares compared to placebo-treated study participants. Among study participants who received abatacept (Orencia) injection for intravenous use throughout the study period (part A, B and C), the proportion of pediatric ACR 30/50/70 responders remained consistent for 1 year.

Psoriatic Arthritis

The safety and efficacy of abatacept (Orencia) injection for intravenous use was assessed in a Phase 2, randomized, double-blind, multicenter, dose-ranging study of 170 adults with active arthritis (defined as the presence of three or more swollen joints and three or more tender joints), and active plaque psoriasis (with at least one qualifying target lesion of 2 cm or more in diameter). Participants had an inadequate response to DMARDs, including, but not limited to, MTX or anti-TNF agents. Participants were randomly assigned (1:1:1:1) to receive placebo or abatacept (Orencia) IV infusions at doses of 3 mg/kg, 10 mg/kg, or 30/10 mg/kg (two initial doses of 30 mg/kg, followed by 10 mg/kg) on days 1, 15, and 29 and then once every 28 days thereafter for 6 months. The primary endpoint of this study was ACR 20 response on day 169, resulting in 42% in those who received 30/10 mg/kg of abatacept (Orencia), 48% who received 10 mg/kg, 33% who received 3 mg/kg, and 19% who received placebo. Compared to placebo, the ACR20 responses were statistically significant for the 30/10 mg/kg (P = 0.022) and the 10 mg/kg (P= 0.006), but not the 3 mg/kg (P= 0.121) doses of abatacept (Orencia).

Genovese et al. (2011) performed a noninferiority study in the treatment of RA showing the therapeutic equivalence of abatacept (Orencia) dosing at 10 mg/kg IV every 4 weeks and 125 mg subcutaneously (SC) weekly. Further, the safety and efficacy of abatacept (Orencia), 125 mg weekly SC injection, was performed in a randomized, double-blind, Phase 3 study in the treatment of 424 adults with active PsA (as defined in previous study). Participants had an inadequate response or intolerance to one or more DMARDs, including, but not limited to, MTX or anti-TNF agents. Participants were randomly assigned (1:1) to receive placebo or abatacept (Orencia) subcutaneous 125 mg weekly for 24 weeks followed by open-label subcutaneous abatacept. As the primary endpoint, abatacept (Orencia) significantly increased ACR20 response versus placebo at week 24 (39.4% vs 22.3%; P<0.001).

Rheumatoid Arthritis

Evidence of clinical benefit and safety of abatacept (Orencia) injection for intravenous use in the management of RA is based principally on the results of six randomized, double-blind, placebo-controlled clinical trials in adults (18 years of age or older) with the disease. Improvement in the signs and symptoms of RA after treatment with abatacept (Orencia) injection for intravenous use was consistently reported by the participants of the studies, according to the response rate measured by the ACR scores.

OFF-LABEL INDICATIONS

There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company’s off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.

References

American College of Rheumatology. Juvenile Arthritis. [American College of Rheumatology Web site]. 06/2019. Available at: 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Treatment of Juvenile Idiopathic Arthritis: Therapeutic Approaches for Non‐Systemic Polyarthritis, Sacroiliitis, and Enthesitis (contentstack.io). Accessed July 14, 2023.

American Hospital Formulary Service (AHFS). Drug Information 2023. Orencia (abatacept). [Lexicomp Online Web site]. 11/19/2021. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed July 14, 2023.

Beukelman T, Patkar N, Saag K. 2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: initiation and safety monitoring of therapeutic agents for the treatment of arthritis and systemic features. Arthritis Care Res. 2011;63(4):465-482.

Elsevier’s Clinical Pharmacology Compendium. Abatacept (Orencia®). 12/21/2021. [Clinical Pharmacology Web site]. Available at: https://www.clinicalkey.com/pharmacology/ [via subscription only]. Accessed July 14, 2023.

Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2021 Jul;73(7):924-939.

Lexi-Drugs Compendium. Abatacept (Orencia®). 07/06/2023. [Lexicomp Online Web site]. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed July 14, 2023.

Genovese MC, Covarrubias A, Leon G, et al. Subcutaneous abatacept versus intravenous abatacept: a phase IIIb noninferiority study in patients with an inadequate response to methotrexate. Arthritis Rheum. 2011;63(10):2854-2864.

Mease P, Genovese M, 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;63(4):939-948.

Mease PJ, Gottlieb A, van der Heijde D, et al. Efficacy and safety of abatacept, a T-cell modulator in a randomised, double-blind, placebo-controlled, phase III study in psoriatic arthritis. Ann Rheum Dis. 2017;76(9):1550-1558.

Nahas MR, Soiffer RJ, Kim HT, et al. Phase 1 clinical trial evaluating abatacept in patients with steroid-refractory chronic graft-versus-host disease. Blood. 2018;131(25):2836-2845.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Hematopoeitic Cell Transplantation (HCT). V.1.2023. 03/31/2023. [NCCN Web site]. Available at: https://www.nccn.org/professionals/physician_gls/pdf/hct.pdf [via free subscription]. Accessed July 13, 2023.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Management of Immunotherapy-related Toxicities. V.2.2023. 05/09/2023. [NCCN Web site]. Available at: https://www.nccn.org/professionals/physician_gls/pdf/immunotherapy.pdf [via free subscription]. Accessed July 13, 2023.

National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium. Abatacept. [NCCN Web site]. 2023. Available at: https://www.nccn.org/professionals/drug_compendium/content/. Accessed July 13, 2023.

Novitas Solutions, Inc. Article (A53127) For Self-Administered Drug Exclusion List. [Novitas Medicare Services Web site]. Original: 10/01/2015, Revised: 06/25/2023. Available at: Article - Self-Administered Drug Exclusion List: (A53127) (cms.gov). Accessed July 20, 2023.

Orencia® (abatacept) [prescribing information]. Princeton, NJ: Bristol-Myers Squibb; 12/2021. Available at: http://packageinserts.bms.com/pi/pi_orencia.pdf. Accessed July 13, 2023.

Ringold S, Angeles-Han ST, Beukelman T, et al. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Treatment of Juvenile Idiopathic Arthritis: Therapeutic Approaches for Non-Systemic Polyarthritis, Sacroiliitis, and Enthesitis. Arthritis Care Res (Hoboken). 2019;71(6):717-734.

Ringold S, Weis PF, Beukelman T, et al. 2013 Update of the 2011 American College of Rheumatology Recommendations for the Treatment of Juvenile Idiopathic Arthritis. Arthritis Rheum. 2013;65(10):2499-2512.

Singh JA, Guyatt G, Ogdie A, et al. Special Article: 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis. Arthritis Rheum. 2019;71(1):5-32.

Singh JA, Furst DE, Bharat A, et al. 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken). 2012;64(5):625-639.

Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Rheumatol. 2016;68(1):1-26. Review.

Truven Health Analytics. Micromedex® DrugDex® Compendium. Orencia® (abatacept). 11/19/2022. Greenwood Village, CO. [Micromedex® Solutions Web site]. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed July 14, 2023.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Abatacept (Orencia®) [prescribing information]. [FDA Web site]. 12/15/2021. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/ . Accessed July 13, 2023.

Coding

CPT Procedure Code Number(s)

N/A

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

See Attachment A for ICD-10 Codes and Narratives.

HCPCS Level II Code Number(s)

J0129 Injection, abatacept, 10 mg (code may be used for Medicare when drug administered under the direct supervision of a physician, not for use when drug is self-administered)

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub
Modifiers

THE FOLLOWING MODIFIER IS USED WHEN REPORTING ABATACEPT (ORENCIA) FOR INJECTION FOR INTRAVENOUS USE:

JA Intravenous administration

Coding and Billing Requirements

For drugs that have more than one method of administration, application of the JA modifier is required to indicate the route of administration.

To report the intravenous route of administration, append the following modifier: JA Administered Intravenously

Cross Reference

Policy History

Revisions From 08.00.62p:

12/11/2023

This version of the policy will become effective 12/11/2023.

This policy has been updated to communicate the Company's coverage position for Abatacept (Orencia) injection for intravenous use, in accordance with US Food and Drug Administration (FDA) to include a 4 dose limit for the Prophylaxis of Acute Graft-Versus-Host Disease (aGVHD).

The following ICD-10 CM codes have been removed from this policy, due to specificity:

M05.00 Felty's syndrome, unspecified site

M05.10 Rheumatoid lung disease with rheumatoid arthritis of unspecified site

M05.20 Rheumatoid vasculitis with rheumatoid arthritis of unspecified site

M05.30 Rheumatoid heart disease with rheumatoid arthritis of unspecified site

M05.40 Rheumatoid myopathy with rheumatoid arthritis of unspecified site

M05.50 Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified site

M05.60 Rheumatoid arthritis of unspecified site with involvement of other organs and systems

M05.70 Rheumatoid arthritis with rheumatoid factor of unspecified site without organ or systems involvement

M05.80 Other rheumatoid arthritis with rheumatoid factor of unspecified site

M06.00 Rheumatoid arthritis without rheumatoid factor, unspecified site

M06.80 Other specified rheumatoid arthritis, unspecified site

Additionally, Continuation Therapy was added with specified criteria for the following indications: chronic graft-versus-host disease, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, and rheumatoid arthritis.

Revisions From 08.00.62o:

10/01/2023

This version of the policy will become effective 10/01/2023.

The following ICD-10 CM codes have been added to this policy:

Z29.89 Encounter for other specified prophylactic measures

The following ICD-10 CM codes have been termed (no longer valid codes) and removed from this policy:
Z29.8 Encounter for other specified prophylactic measures

Revisions From 08.00.62n:

06/06/2022

This version of the policy will become effective 06/06/2022.

The policy was updated to communicate the Medically Necessary coverage position of the FDA-approved indication for the Prophylaxis of Acute Graft-Versus-Host Disease (aGVHD).

Additionally, immune checkpoint inhibitor-related autoimmune-like toxicity indication was revised from suspected myocarditis, to myocarditis.

The following ICD CM codes have been added to this policy:

D89.811 Chronic graft-versus-host disease
D89.812 Acute on chronic graft-versus-host disease
I40.8 Other acute myocarditis
I40.9 Acute myocarditis, unspecified

Z94.84 Stem cell transplantation status
Z29.8 Encounter for other specified prophylactic measures

The following ICD CM codes have been deleted from this policy, due to specificity/laterality:
M05.019, M05.029, M05.039, M05.049, M05.059, M05.069, M05.079,
M05.119, M05.129, M05.139, M05.149, M05.159, M05.169, M05.179,
M05.219, M05.229, M05.239, M05.249, M05.259, M05.269, M05.279,
M05.319, M05.329, M05.339, M05.349, M05.359, M05.369, M05.379,
M05.419, M05.429, M05.439, M05.449, M05.459, M05.469, M05.479,
M05.519, M05.529, M05.539, M05.549, M05.559, M05.569, M05.579,
M05.619, M05.629, M05.639, M05.649, M05.659, M05.669, M05.679,
M05.719, M05.729, M05.739, M05.749, M05.759, M05.769, M05.779,
M05.819, M05.829, M05.839, M05.849, M05.859, M05.869, M05.879,
M06.019, M06.029, M06.039, M06.049, M06.059, M06.069, M06.079,

M06.819, M06.829, M06.839, M06.849, M06.859, M06.869, M06.879

Revisions From 08.00.62m:

09/27/2021

This version of the policy will become effective 09/27/2021.

The policy has been updated due to revisions to US Food and Drug Administration (FDA) prescribing information and National Comprehensive Cancer Network (NCCN) compendia for abatacept (Orencia®).

The following indications were added to this policy as Medically Necessary, per NCCN Compendium:

chronic graft-versus-host disease (GVHD) after hematopoeitic cell transplantation

management of suspected myocarditis (as a result of immunotherapy-related toxicities)

The policy criteria was revised per FDA labeling to state that there is insufficeient experience to assess the safety and efficacy of abatacept (Orencia) administered concurrently with other biologic DMARDs or Janus kinase (JAK) inhibitors; therefore such use together is not recommended.

The following ICD-10 CM codes have been added to this policy:

D89.811 Chronic graft-versus-host disease

I51.4 Myocarditis, unspecified

Revisions From 08.00.62l:

03/08/2021

The Medical Necessity statement in the Policy was updated for active polyarticular juvenile idiopathic arthritis (PJIA) to include specified criteria for individuals who are naive to biologic therapy.

Revisions From 08.00.62k:

10/01/2020

This policy has been identified for the ICD-10 CM code update, effective 10/01/2020.

The following ICD-10 CM codes have been added to this policy:

M05.7A Rheumatoid arthritis with rheumatoid factor of other specified site without organ or systems involvement

M05.8A Other rheumatoid arthritis with rheumatoid factor of other specified site

M06.0A Rheumatoid arthritis without rheumatoid factor, other specified site

M06.8A Other specified rheumatoid arthritis, other specified site

Revisions From 08.00.62j:

06/08/2020

This version of the policy will become effective 06/08/2020.

This policy was updated to add a Billing Requirement regarding the Coding Modifier: JA Intravenous administration.

Revisions From 08.00.62i:

03/13/2019	This policy has been reissued in accordance with the Company's annual review process.
07/20/2018	This version of the policy will become effective 07/20/2018. This policy was updated to communicate the addition of ustekinumab (Stelara®) as a prior therapy for the treatment of psoriatic arthritis.

Revisions From 08.00.62h:

04/23/2018

This policy has undergone a routine review, and the medical necessity criteria have been revised as follows:

This policy was updated to expand the Company's coverage position for the indication of psoriatic arthritis.

Effective 10/05/2017 this policy has been updated to the new policy template format.

Version Effective Date:

12/11/2023

Version Issued Date:

12/11/2023

Version Reissued Date:

Commercial

Medical Policy

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Policy

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Description

References

Coding

CPT Procedure Code Number(s)

ICD - 10 Procedure Code Number(s)

ICD - 10 Diagnosis Code Number(s)

HCPCS Level II Code Number(s)

Revenue Code Number(s)

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Coding and Billing Requirements

Cross Reference

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