Status
Active
Medical and Behavioral Health Policy
Section: Medicine
Policy Number: II-161
Effective Date: 04/20/2015
Blue Cross and Blue Shield of Minnesota medical policies do not imply that members should not receive specific services
based on the recommendation of their provider. These policies govern coverage and not clinical practice. Providers are
responsible for medical advice and treatment of patients. Members with specific health care needs should consult an
appropriate health care professional.
ABATACEPT (ORENCIA®)
Description:
Abatacept (Orencia®) is a selective co-stimulation modulator that
inhibits T cell activation. Activated T cells are implicated in the
development of rheumatoid arthritis (RA).
Abatacept (Orencia®) has received FDA approval for the following
indications:
 Moderately to severely active RA in adults. Abatacept may be
used as a monotherapy or concomitantly with disease modifying
antirheumatic drugs (DMARDs) other than TNF antagonists.
Abatacept is approved in intravenous and subcutaneous
formulations for treatment of RA in adults.
 Moderately to severely active polyarticular juvenile idiopathic
arthritis (JIA) in pediatric patients 6 years of age and older.
Abatacept may be used as monotherapy or concomitantly with
methotrexate. Only the intravenous formulation is approved for
treatment of JIA.
FDA labeling includes a limitation on use stating that abatacept
should not be given concomitantly with TNF antagonists.
Definitions:
Disease Modifying Antirheumatic Drug (DMARD): This term
refers to a group of drugs that are not related by drug class or
mechanism of action, but are each used to treat RA and other
inflammatory diseases to slow damage to joints.
Non-Biologic DMARDs: The most common DMARDs are chemical
or non-biologic and include methotrexate, sulfasalazine,
hydroxychloroquine, and leflunomide. Less frequently used
medications include gold salts, azathioprine, and cyclosporine.
Biologic DMARDs: Biologic agents are biologic response modifiers
that target a particular protein that contributes to RA. In addition to
abatacept, biologic DMARDs include B-cell inhibitors [e.g., rituximab
(Rituxan®)], interleukin-1 inhibitors [e.g., anakinra (Kineret®)], and
tumor necrosis factor (TNF) antagonists which belong to a class of
biologics that block TNF alpha, a cytokine produced by
macrophages and T cells. TNF alpha is a key mediator of
inflammation and is produced in response to infection and
immunologic injury. TNF antagonists include:
 Adalimumab (Humira®)
 Certolizumab pegol (Cimzia®)
 Etanercept (Enbrel®)
 Golimumab (Simponi®)
 Infliximab (Remicade®)
Policy:
I.
Abatacept may be considered MEDICALLY NECESSARY for
treatment of the following:
A. Rheumatoid Arthritis
1. Intravenous or subcutaneous formulation as
monotherapy or concomitantly with a non-biologic
disease modifying antirheumatic drug (DMARD) when
ALL of the following indications are met:
a. Moderately to severely active rheumatoid arthritis in
adults (e.g., swollen, tender joints with limited range
of motion); and
b. After consultation with a rheumatologist; and
c. Failure, contraindication, or intolerance to at least
one non-biologic disease modifying anti-rheumatic
drug (DMARD); and
d. Abatacept is not used in combination with another
biologic DMARD;
OR
2. Moderately to severely active rheumatoid arthritis in
adults when the patient has a history of beneficial
response to abatacept.
B. Polyarticular Juvenile Idiopathic Arthritis (JIA)
1. Intravenous formulation as monotherapy or
concomitantly with methotrexate when ALL of the
following indications are met:
a. Moderately to severely active polyarticular juvenile
idiopathic arthritis ( e.g., swollen, tender joints with
limited range of motion); and
b. Patient is six years of age or older; and
c. After consultation with a rheumatologist; and
d. Failure, contraindication, or intolerance to at least
one non-biologic DMARD; and
e. Abatacept is not used in combination with another
biologic DMARD;
OR
2. Moderately to severely active polyarticular JIA when the
patient has a history of beneficial response to abatacept.
II.
Coverage:
Abatacept is considered INVESTIGATIVE for all other
indications, including but not limited to the following due to a
lack of published clinical evidence establishing the role of
abatacept in the treatment of these conditions.
A. Rheumatoid arthritis in patients under age 18
B. Juvenile idiopathic arthritis in patients under age 6
C. Concomitant administration of abatacept with a TNF
antagonist
D. Ankylosing spondylitis
E. Behçet’s disease
F. Crohn’s disease
G. Giant cell arteritis
H. Graft versus host disease
I. Multiple sclerosis
J. Polymyalgia rheumatica
K. Psoriasis vulgaris
L. Psoriatic arthritis
M. Sarcoidosis
N. Scleroderma
O. Systemic lupus erythematosus
P. Systemic vasculitis (e.g., Wegener’s granulomatosis and
Takayasu’s arteritis)
Q. Type I diabetes
R. Ulcerative colitis
S. Uveitis
Blue Cross and Blue Shield of Minnesota medical policies apply
generally to all Blue Cross and Blue Plus plans and products. Benefit
plans vary in coverage and some plans may not provide coverage
for certain services addressed in the medical policies.
Medicaid products and some self-insured plans may have additional
policies and prior authorization requirements. Receipt of benefits is
subject to all terms and conditions of the member’s summary plan
description (SPD). As applicable, review the provisions relating to a
specific coverage determination, including exclusions and limitations.
Blue Cross reserves the right to revise, update and/or add to its
medical policies at any time without notice.
For Medicare NCD and/or Medicare LCD, please consult CMS or
National Government Services websites.
Refer to the Pre-Certification/Pre-Authorization section of the
Medical Behavioral Health Policy Manual for the full list of services,
procedures, prescription drugs, and medical devices that require
Pre-certification/Pre-Authorization. Note that services with specific
coverage criteria may be reviewed retrospectively to determine if
criteria are being met. Retrospective denial of claims may result if
criteria are not met.
Coding:
The following codes are included below for informational purposes
only, and are subject to change without notice. Inclusion or exclusion
of a code does not constitute or imply member coverage or provider
reimbursement.
CPT:
J0129 Injection, abatacept, 10 mg
Policy
History:
Developed February 13, 2013
Most recent history:
Reviewed February 12, 2014
Revised February 11, 2015
Cross
Reference:
Infliximab, II-97
Current Procedural Terminology (CPT®) is copyright 2014 American Medical
Association. All Rights Reserved. No fee schedules, basic units, relative values, or
related listings are included in CPT. The AMA assumes no liability for the data
contained herein. Applicable FARS/DFARS restrictions apply to government use.
Copyright 2015 Blue Cross Blue Shield of Minnesota.