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.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

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

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® or The American Hospital Formulary Service Drug Information).

Evidence in the published literature is insufficient to permit conclusions on the health outcomes and effects of abatacept for treatment or prevention of any other condition or disease.

SOURCES

Lexi-Comp Online. (2017). AHFS DI. Abatacept. Retrieved September 1, 2017 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2017, August). Abatacept. Retrieved September 1, 2017  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 September 1, 2017 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125118s209lbl.pdf.

ORIGINAL EFFECTIVE DATE:  7/8/2006

MOST RECENT REVIEW DATE:  10/10/2017

ID_MRx

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

Pharmaceutical Decision Support Tree

Abatacept (Orencia®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #7

  1. Is there absence of ALL of the following?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the individual 18 years of age or older with a diagnosis of moderately to severely active rheumatoid arthritis (RA) and ALL of the following?

If yes, go to question #6

If no, go to question #4

  1. Is the individual 2 years of age or older with a diagnosis of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) (i.e., juvenile rheumatoid arthritis) and ALL of the following?

If yes, go to question #6

If no, go to question #5

  1. Is the individual 18 years of age or older with a diagnosis of moderately to severely active psoriatic arthritis (PsA) and as a requirement of BCBST’s P&T committee, a prior trial of infliximab (Remicade®), ustekinumab (Stelara®) or golimumab injection (Simponi® Aria, Simponi®) has failed, is contraindicated or has not been tolerated with ANY ONE of the following?

If yes, go to question #6

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for IV formulation 100 billable units at weeks 0, 2, & 4 for loading dose OR 100 billable units per 4 weeks for maintenance OR subcutaneous formulation for 13 billable units (1 dose) every week for an authorization period of 6 months at dosage of the following?

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

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual continue to meet the initial approval criteria in questions 2 through 6?

If yes, go to question #8

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is disease response indicated by improvement in signs and symptoms compared to baselines, e.g., number of tender and swollen joint counts?

If yes, go to question #9

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Was there absence of unacceptable toxicity from the agent, e.g., serious infections, respiratory adverse events in those with predisposing conditions?

If yes, go to question #10

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is there ongoing monitoring for tuberculosis (TB)?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.