Coverage Policies

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).

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:

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

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.

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9. Clinical Pharmacology. Accessed September 19, 2017.