Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Abatacept (Orencia®) for Injection for Intravenous Use

Policy #:08.00.62i

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, 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. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member’s contract.

MEDICALLY NECESSARY

ADULT RHEUMATOID ARTHRITIS (RA)
Abatacept (Orencia®) injection for intravenous use is considered medically necessary and, therefore, covered when used to reduce signs and symptoms, induce major clinical response, inhibit the progression of structural damage, and improve physical function in individuals who have moderately to severely active RA. Abatacept (Orencia®) injection for intravenous use may be covered as monotherapy or concomitantly with disease-modifying antirheumatic drugs (DMARDs), other than tumor necrosis factor (TNF) antagonists, when all of the following inclusion criteria are met:
  • If the individual has not previously received a biologic DMARD 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 three months to one or more non-biologic disease-modifying antirheumatic drugs (DMARDs) or tumor necrosis factor (TNF) antagonists, or the use of all non-biologic DMARDs or TNF-antagonists is contraindicated in the individual.
  • The individual is 18 years of age or older.

POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS
Abatacept (Orencia®) injection for intravenous use is considered medically necessary and, therefore, covered when used to reduce signs and symptoms in individuals who have moderately to severely active polyarticular juvenile idiopathic arthritis. Abatacept (Orencia®) injection for intravenous use may be covered as monotherapy or concomitantly with methotrexate when all of the following inclusion criteria are met:
  • Active or latent tuberculosis (TB) has been ruled out.
  • The individual has had an inadequate response after at least three 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.

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-biologic DMARDs when all of the following inclusion criteria are met:
  • If the individual has not previously received a biologic DMARD 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®), 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 tuberculosis (TB) has been ruled out.
  • The individual has had an inadequate response after at least three 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.

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.

The use of abatacept (Orencia®) injection for intravenous use with other TNF-antagonists (e.g., adalimumab [Humira®], etanercept [Enbrel®], golimumab [Simponi®, Simponi Aria®], infliximab [Remicade®]) or interleukin-1 (IL-1) inhibitors (e.g., anakinra [Kineret®]) is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of these regimens cannot be established by a review of the available published peer-reviewed literature.

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.
Guidelines

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.

BENEFIT APPLICATION

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

However, services that are identified in this policy as experimental/investigational are not eligible for coverage or reimbursement by the Company.

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.

The following information was taken directly from the FDA-approved product labeling at the time this policy was developed:

PEDIATRIC USE
The safety and effectiveness of abatacept (Orencia®) injection for intravenous use in pediatric patients younger than six years of age have not been established. Therefore, abatacept (Orencia®) injection for intravenous use is not recommended for use in patients younger than six years of age.

The safety and effectiveness of abatacept (Orencia®) injection for intravenous use in pediatric patients for uses other than juvenile idiopathic arthritis have not been established.

DRUG INTERACTIONS
Concurrent administration of a 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.

OTHER BIOLOGIC RHEUMATOID ARTHRITIS THERAPY
There is insufficient data to assess the safety and efficacy of abatacept (Orencia®) injection for intravenous use administered concurrently with other biologic rheumatoid arthritis therapy, such as anakinra (Kineret®). 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) 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 polyarticular juvenile idiopathic arthritis (PJIA).

The American College of Rheumatology's (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 NSAIDs or DMARDs as initial therapy. Although there are no ACR Guidelines for PsA, initial treatment typically includes NSAIDs or DMARDs.

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 the newer 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
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.

Polyarticular Juvenile Idiopathic Arthritis

The safety and efficacy of abatacept (Orencia®) injection for intravenous use in the treatment of juvenile idiopathic arthritis was assessed in a three-part study with individuals ages 6 years to 17 years with moderate to severely active polyarticular juvenile idiopathic arthritis 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 randomized 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 percent, 50 percent, and 28 percent, 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 one year.

Psoriatic Arthritis

The safety and efficacy of abatacept (Orencia®) injection for intravenous use was assessed in a Phase II, randomized, double-blind, multi-center, dose-ranging study of 170 adults with active arthritis (defined as the presence of 3 or more swollen joints and 3 or more tender joints), and active plaque psoriasis (with at least 1 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 randomized (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 (2 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 end point 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 2011, et al performed a non-inferiority 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. Furthermore, the safety and efficacy of abatacept (Orencia®) 125 mg weekly SC injection was performed in a randomized, double-blind, Phase III study in the treatment of 424 adults with active psoriatic arthritis (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 randomized (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).

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]. April 2017. Available at:http://www.rheumatology.org/practice/clinical/patients/diseases_and_conditions/juvenilearthritis.asp. Accessed February 9, 2018.

American Hospital Formulary Service (AHFS). Drug Information 2018. Orencia® (abatacept). [Lexicomp Online Web site]. 01/01/09. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed February 7, 2018.

Beukelman T, Patkar NM, Saag KG, et al. American College of Rheumatology 2011 Recommendations for the Treatment of Juvenile Idiopathic Arthritis: Initiation and Safety Monitoring of Therapeutic Agents for the Treatment of Arthritis and Systemic Features.

Elsevier’s Clinical Pharmacology Compendium. Abatacept (Orencia®). 07/05/17. [Clinical Pharmacology Web site]. Available at: https://www.clinicalkey.com/pharmacology/ [via subscription only]. Accessed February 7, 2018.

Lexi-Drugs Compendium. Abatacept (Orencia®). 02/05/18. [Lexicomp Online Web site]. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed February 7, 2018.

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 Oct;63(10):2854-64.

Matsumoto AK, Bathon J, Bingham CO 3rd. Rheumatoid arthritis treatment. Abatacept (Orencia®) [The Johns Hopkins Arthritis Center Web site]. updated 04/04/17. Available at: http://www.hopkins-arthritis.org/arthritis-info/rheumatoid-arthritis/rheum_treat.html#tcell. Accessed February 9, 2018.

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 & Rheumatism. 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 Sep;76(9):1550-1558.

Orencia® (abatacept) [prescribing information]. Princeton, NJ: Bristol-Myers Squibb; 06/2017. Available at: http://packageinserts.bms.com/pi/pi_orencia.pdf. Accessed February 7, 2018.

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):625-39. doi: 10.1002/acr.21641.

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

Truven Health Analytics. Micromedex® DrugDex® Compendium. Orencia® (abatacept). 01/30/2018. Greenwood Village, CO. [Micromedex® Solutions Web site]. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed February 7, 2018.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Abatacept (Orencia®) [prescribing information]. [FDA Web site]. 06/2017. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/ . Accessed June 20, 2018.





Coding

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

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


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

Coding and Billing Requirements


Cross References

Attachment A: Abatacept (Orencia®) for Injection for Intravenous Use
Description: ICD-10 CODES AND NARRATIVES




Policy History

Revisions from 08.00.62i:
03/13/2019This policy has been reissued in accordance with the Company's annual review process.
07/20/2018This 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:
04/23/2018This 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: 07/20/2018
Version Issued Date: 07/20/2018
Version Reissued Date: 03/14/2019

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