BlueCross BlueShield of Tennessee Medical Policy Manual

Abatacept

NDC CODE(S)

00003-2814-XX Orencia 50 MG/0.4ML SOSY (B-M SQUIBB U.S.) – SQ

 

00003-2818-XX Orencia 87.5 MG/0.7ML SOSY (B-M SQUIBB U.S.) – SQ

 

00003-2187-XX Orencia 250 MG SOLR (B-M SQUIBB U.S.) – IV

 

00003-2188-XX Orencia 125 MG/ML SOSY (B-M SQUIBB U.S.) – SQ

 

00003-2188-51 Orencia ClickJect 125 MG/ML SOAJ (B-M SQUIBB U.S.) – SQ

DESCRIPTION

Abatacept, a biological response modifier, is a recombinant fusion protein which selectively binds to the proteins CD80 and CD86 on activated B cells and monocytes.  This prevents them from binding to their ligand CD28 on T-cell surfaces which inhibits the costimulatory signal necessary for T-cell activation.

Activated T-cells and the subsequent amplification of the inflammatory cascade are implicated in the pathogenesis of rheumatoid arthritis.  While the full implication of the blockade of the CD80/CD86-CD28 interaction within the body is not known, it is thought that it additionally decreases the proliferation of T-cells and inhibits the production of tumor necrosis factor alpha, interferon gamma and interleukin-2.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

INDICATION(S) DOSAGE & ADMINISTRATION
Rheumatoid Arthritis and Psoriatic Arthritis in adults

Intravenous Dosing

Weight < 60kg:

  • 500 mg at weeks 0, 2, & 4, then every 4 weeks thereafter

Weight 60 to 100 kg:

  •  750 mg at weeks 0, 2, & 4, then every 4 weeks thereafter

Weight > 100 kg:

1,000 mg at weeks 0, 2, & 4, then every 4 weeks thereafter

Subcutaneous Dosing - Subcutaneous Injection ONLY

Administer by subcutaneous injection once weekly

  • May initiate with or without an IV loading dose
  • If initiated with an IV loading dose, a single weight-based infusion (see above) should be followed by the first 125 mg subcutaneous injection within a day
Individuals transitioning from abatacept intravenous therapy to subcutaneous administration should administer the first subcutaneous dose instead of the next scheduled intravenous dose
Polyarticular Juvenile Idiopathic Arthritis

Intravenous Dosing (individuals aged 6 years or older ONLY)

Weight < 75 kg:

  • 10 mg/kg at weeks 0, 2, & 4, then every 4 weeks thereafter

Weight 75 to 100 kg:

  • 750 mg at weeks 0, 2, & 4, then every 4 weeks thereafter

Weight > 100 kg:

1,000 mg at weeks 0, 2, & 4, then every 4 weeks thereafter

Subcutaneous Dosing using prefilled syringes (patients aged 2 years or older)

Weight 10 to < 25 kg:

  • 50 mg weekly

Weight 25 to < 50 kg:

  • 87.5 mg weekly

Weight ≥ 50 kg:

125 mg weekly

LENGTH OF AUTHORIZATION

Coverage will be provided for six months and may be renewed.

Click here to view DOSAGE LIMITS

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION 

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

No controlled studies were found in the published literature that validate the use of abatacept for the treatment or prevention of other conditions or diseases.

SOURCES

Lexi-Comp Online. (2018). AHFS-DI. Abatacept. Retrieved March 22, 2018 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2018, February). Abatacept. Retrieved March 22, 2018  from MICROMEDEX Healthcare Series.

U. S. Food and Drug Administration. (2017, June). Center for Drug Evaluation and Research. Orencia (abatacept) for injection for intravenous use. Retrieved March 22, 2018 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125118s209lbl.pdf.

ORIGINAL EFFECTIVE DATE:  7/8/2006

MOST RECENT REVIEW DATE:  4/10/2018

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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

This document has been classified as public information.

 

 

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit; 1 billable unit = 10 mg.

ALL INDICATIONS

Administration Route

MAXIMUM UNITS

IV Formulation

Loading Dose - 100 billable units at weeks 0, 2, & 4

Maintenance Dose - 100 billable units per 4 weeks

Subcutaneous Formulation

13 billable units (1 dose) every week