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INDEX:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Effective Date: 01/01/2006 Title: Orencia (Abatacept)
Revision Date: 12/01/2020 Document: BI144:00
CPT Code(s): J0129
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Orencia requires pre-authorization.

2)    Orencia (Abatacept) is an injectable medication used in the treatment of severe Rheumatoid arthritis, psoriatic arthritis, and juvenile rheumatoid arthritis.

3)    Orencia will generally be used only where other medications have been tried and have failed to result in or maintain improvement.

4)    Orencia is not used at the same time as TNF inhibitors, such as Remicade (Infliximab), Enbrel (Etanercept), or Humira (Adalimumab).


Medical Statement

Abatacept is considered medically necessary in the treatment of:

 1)    Adults 18 years of age and older with moderately to severely active rheumatoid arthritis (M05.00-M05.9, M06.80-M06.9) with

a.    At least 6 swollen or tender joints AND

b.    At least 45 minutes of morning stiffness AND

c.    Elevated ESR or CRP unless taking corticosteroids AND

d.    Inadequate response to at least one DMARD (i.e. methotrexate) AND

e.    Inadequate response to at least two of Humira, Cimzia, Simponi, Xeljanz/XR, and Rinvoq.

2)    Children age 6 years and older with moderate or severely active polyarticular juvenile rheumatoid arthritis (M08.20-M08.3) or juvenile idiopathic arthritis (M08.89) with an inadequate response to Humira.

3)    Adults 18 years of age or older with moderate to severe psoriatic arthritis with

a.    Greater than 3 swollen and tender joints AND

b.    Inadequate response to at least one DMARD (i.e. methotrexate) AND

c.    Inadequate response to at least 2 of Humira, Cimzia, Tremfya, Stelara, and Simponi.

 

Codes Used In This BI:

J0129             Injection, Abatacept (Orencia) 10mg

Limits

As a specialty drug, Orencia is limited to no more than a 30 day supply per fill.


Background

Abatacept, a selective co stimulation modulator, inhibits T cell (T lymphocyte) activation by binding to CD80 and CD86, thereby blocking interaction with CD28. This interaction provides a co stimulatory signal necessary for full activation of T lymphocytes, implicated in the pathogenesis of rheumatoid arthritis (RA). Activated T lymphocytes are found in the synovium of patients with RA. In vitro, Abatacept decreases T cell proliferation and inhibits the production of the cytokines tumor necrosis factor alpha (TNFα), interferon-γ, and interleukin-2. In a rat collagen-induced arthritis model, Abatacept suppresses inflammation, decreases anti collagen antibody production, and reduces antigen specific production of interferon-γ. The relationship of these biological response markers to the mechanisms by which ORENCIA exerts its effects in RA is unknown.

 

In controlled clinical trials, patients receiving concomitant ORENCIA and TNF antagonist therapy experienced more infections (63%) and serious infections (4.4%) compared to patients treated with only TNF antagonists (43% and 0.8%, respectively). These trials failed to demonstrate an important enhancement of efficacy with concomitant administration of ORENCIA with TNF antagonist; therefore, concurrent therapy with ORENCIA and a TNF antagonist is not recommended. While transitioning from TNF antagonist therapy to ORENCIA therapy, patients should be monitored for signs of infection.


Reference
  1. Bristol-Meyers Squib prescribing information at: http://www.bms.com/cgi- bin/anybin.pl?sql=select%20PPI%20from%20TB_PRODUCT_PPI%20where%20 PPI_SEQ=111&key=PPI
  2. Food and Drug administration approval letter at: http://www.fda.gov/cder/foi/appletter/2005/125118rev2.pdf
  3. Fries JF, Spitz P, Kraines RG, and Holman HR. Measurement of patient outcome in arthritis. Arthritis Rheum. 1980; 23(2):137-145.
  4. Genant HK, Jiang Y, Peterfy C, Lu Y, Re´dei J, Countryman PJ. Assessment of rheumatoid arthritis using a modified scoring method on digitized and original radiographs. Arthritis Rheum. 1998; 41(9):1583-1590.
  5. Pincus T, Summey JA, Soraci SA Jr, Wallston KA, Hummon NP. Assessment of patient satisfaction in activities of daily living using a modified Stanford Health Assessment Questionnaire. Arthritis Rheum. 1983; 26(11):1346-1353.
  6. Ware JE Jr, Gandek B. Overview of the SF-36 Health Survey and the International Quality of Life Assessment (IQOLA) Project. J Clin Epidemiol. 1998; 51(11):903-912.
  7. Ries LAG, Eisner MP, Kosary CL, Hankey BF, Miller BA, Clegg L, Mariotto A, Feuer EF, Edwards BK (eds). SEER Cancer Statistics Review, 1975-2001, National Cancer Institute. Bethesda, MD, http://seer.cancer.gov/csr/1975_2001/. Accessed 2004.
  8. Ringold S, Weiss PF, Beukelman T, et al.  2013 Update of the 2011 American College of Rheumatology Recommendations for the Treatment of Juvenile Idiopathic Arthritis. Arthritis & Rheumatism. 2013; 65:2499-2512
  9. Clinical Pharmacology. Accessed September 19, 2017.

Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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