Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Abatacept (Orencia®) for Injection for Intravenous Use
Policy #:MA08.028d

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


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. 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. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

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 Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

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

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) have been ruled out.
  • The individual has had an inadequate response after at least three months of one or more disease-modifying antirheumatic drugs (DMARDs), or the use of all DMARDs is contraindicated in the individual.
  • The individual is six 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:
  • Active or latent tuberculosis (TB) have 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.

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 DMARDs, other than tumor necrosis factor (TNF) antagonists, when all of the following inclusion criteria are met:
  • Active or latent tuberculosis (TB) have been ruled out.
  • The individual has had an inadequate response after at least three months to one or more DMARDs or tumor necrosis factor (TNF) antagonists, or the use of all DMARDs or TNF-antagonists 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. Uses of abatacept (Orencia®) injection for intravenous uses that are not supported in either this medical policy or the off-label coverage policy are considered experimental/investigational and, therefore, not covered.

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.

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.
Policy Guidelines

This policy is consistent with Medicare’s coverage determination. The Company’s payment methodology may differ from Medicare.

DRUG ADMINISTRATION

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 Evidence of Coverage, abatacept (Orencia®) injection for intravenous use is covered under the medical benefits of the Company’s Medicare Advantage 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.

Certain drugs are available through either the member's medical benefit (Part B benefit) or pharmacy benefit (Part D benefit), depending on how the drug is prescribed, dispensed, or administered. This medical policy only addresses instances when abatacept (Orencia®) injection for intravenous use is covered under a member's medical benefit. It does not address instances when abatacept (Orencia®) injection for intravenous use is covered under a member’s pharmacy benefit.

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 costimulation 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 rheumatoid arthritis (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 six years to 17 years with moderate to severely active polyarticular juvenile idiopathic arthritis with inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDS). The principal measure of clinical response in part A of this study was the American College of Rheumatology (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 six 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]. March 2019. Available at: http://www.rheumatology.org/practice/clinical/patients/diseases_and_conditions/juvenilearthritis.asp. Accessed March 30, 2020.

American Hospital Formulary Service (AHFS). Drug Information 2020. Orencia® (abatacept). [Lexicomp Online Web site]. 01/01/09. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed March 30, 2020.

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®). 07/05/17. [Clinical Pharmacology Web site]. Available at: https://www.clinicalkey.com/pharmacology/ [via subscription only]. Accessed March 30, 2020.

Lexi-Drugs Compendium. Abatacept (Orencia®). 01/27/2020. [Lexicomp Online Web site]. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed FMarch 30, 2020.

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: https://www.hopkinsarthritis.org/arthritis-info/rheumatoid-arthritis/ra-treatment/. Accessed March 30, 2020.

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.

Novitas Solutions, Inc. Article (A53127) For Self-Administered Drug Exclusion List. [Novitas Medicare Services Web site]. Original: 10/01/2015, Revised: 12/02/2019. Available at:
https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=53127&ver=88&name=331*1&UpdatePeriod=855&bc=AAAAEAAAAAAA& . Accessed March 20, 2020.

Novitas Solutions, Inc. FUTURE Article (A53127) For Self-Administered Drug Exclusion List. [Novitas Medicare Services Web site]. Original: 10/01/2015, Revised: 05/03/2020. Available at:
https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=53127&ver=96&name=331*1&UpdatePeriod=877&bc=AAAACAAAAAAA& . Accessed March 23, 2020.

Orencia® (abatacept) [prescribing information]. Princeton, NJ: Bristol-Myers Squibb; 03/2019. Available at: http://packageinserts.bms.com/pi/pi_orencia.pdf. Accessed March 30, 2020.

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 Jun;71(6):717-734.

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 Rheumatol. 2019 Jan;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):625-39.

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). 12/06/2019. Greenwood Village, CO. [Micromedex® Solutions Web site]. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed March 30, 2020.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Abatacept (Orencia®) [prescribing information]. [FDA Web site]. 03/2019. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/ . Accessed March 30, 2020.


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.


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


Misc Code

:


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

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.

Cross References

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






Policy History

REVISIONS FROM MA08.028d:
06/08/2020This 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, per Novitas Solutions, Inc. Article (A53127) For Self-Administered Drug Exclusion List.

REVISIONS FROM MA08.028c:
03/13/2019This policy has been reissued in accordance with the Company's annual review process.
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.

REVISIONS FROM MA08.028b:
06/21/2017This policy has been reissued in accordance with the Company's annual review process.
12/28/2016This policy was modified by removing the criterion that a rheumatologist has to have recommended the use of the drug.

REVISIONS FROM MA08.028a:
06/17/2015This policy was updated to clarify coverage of abatacept (Orencia®) injection for intravenous use for the treatment of adult rheumatoid arthritis.

REVISIONS FROM MA08.028:
01/01/2015This is a new policy.




Version Effective Date: 06/08/2020
Version Issued Date: 06/08/2020
Version Reissued Date: N/A