LCD/NCD Portal

L28754

 

ABATACEPT

 

 

01/01/2012

 

 

Indications and Limitations of Coverage and/or Medical Necessity

 

• Abatacept is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in ADULT patients with moderate to severe active RHEUMATOID ARTHRITIS.

• Abatacept may be used:

o As monotherapy.

Or

o Concomitantly with DMARDS other than TNF antagonists.

• Abatacept is indicated for reducing signs and symptoms in pediatric patients 6 YEARS OF AGE AND OLDER with moderately to severely active polyarticular juvenile idiopathic arthritis.

o Abatacept may be used as monotherapy or concomitantly with methotrexate.

• Abatacept should NOT be administered concomitantly with TNF antagonists.

o It is NOT recommended for use concomitantly with other biologic rheumatoid arthiritis (RA) therapy, such as anakinra.

 

 

CPT/HCPCS Codes

 

J0129 INJECTION, ABATACEPT, 10 MG (CODE MAY BE USED FOR MEDICARE WHEN DRUG ADMINISTERED UNDER THE DIRECT SUPERVISION OF A PHYSICIAN, NOT FOR USE WHEN DRUG IS SELF ADMINISTERED)

 

 

ICD-9 Codes that Support Medical Necessity

 

714.0 RHEUMATOID ARTHRITIS

714.2 OTHER RHEUMATOID ARTHRITIS WITH VISCERAL OR SYSTEMIC INVOLVEMENT

714.30 CHRONIC OR UNSPECIFIED POLYARTICULAR JUVENILE RHEUMATOID ARTHRITIS

 

 

Documentation Requirements

 

• Documentation must be made available to Medicare upon request.

• The medical records should include the following:

o The order/prescription form of the referring/treating physician.

o History of condition being treated.

 This should include onset, duration and other treatment.

o Dosage administered and patient response.

o Weight in kilograms.

 

 

Utilization Guidelines

 

• The patient’s weight determines the dosage of abatacept administration.

• It is expected that the following dosage guidelines will be followed.

• Weight in kilograms(Dosage):

o <60(500 mgm).

o 60-100(750 mgm).

o >100(1000 mgm).

• Following initial administration, abatacept should be given at 2 and 4 weeks after the first infusion, then every 4 weeks.

Treatment Logic

• Abatacept is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderate to severe active rheumatoid arthritis.

• Abatacept may be used as monotherapy or concomitantly with DMARDS other than TNF antagonists.

• Abatacept is indicated for reducing signs and symptoms in pediatric patients 6 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis.

• Abatacept may be used as monotherapy or concomitantly with methotrexate.

 

 

Sources of Information and Basis for Decision

 

AHFS Drug Information® 2006

 

AHA Coding Clinic® for HCPCS Changes for the reporting of drug administration Volume 6 Number 4 Fourth Quarter 2006

 

American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines (2002). Guidelines for the Management of Rheumatoid Arthritis. Arthritis & Rheumatism 46,(2), 328-346.

 

Bristol Meyer website. Full prescribing information. http://www.orencia.com/Accessed April 17, 2008.

 

FCSO LCD 29051, Abatacept, 1/01/2012. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

FDA Website. Approval History: sBLA 125057/114. Available at: http://www.fda.gov/cder/foi/appletter/2008/125057s114ltr.pdf. April 17, 2008.

 

FDA Website. Approval History: sBLA 103795/1001. Available at: http://www.fda.gov/cder/foi/appletter/1999/etanimm052799L.htm. Accessed April 17, 2008.

 

Genovese, M et al (2005). Abatacept for rheumatoid arthritis refractory to tumor necrosis factor ά inhibition. The New England Journal of Medicine 353: 1114-23.

 

Kremer, JM et al (2005). Treatment of rheumatoid arthritis with the selective costimulation modulator abatacept. Arthritis & Rheumatism 52, 8:2263-2271.

 

Kremer, JM et al (2006). Effects of abatacept in patients with methotrexate-resistant active rheumatoid arthritis. Annals of Internal Medicine 144:865-876.

 

U.S. Food and Drug Administration Center for Drug Evaluation and Research http://www.accessdata.fda.gov/scripts/cder/drugssadfda/index.cfm

 

Weinblatt, M et al (2006) Safety of the selective costimulation modulator abatacept in rheumatoid arthritis patients receiving background biologic and nonbiologic disease-modifying antirheumatic drugs. Arthritis and Rheumatism 54, 9:2807-2816.

 

 

AMA CPT Copyright Statement

CPT codes, descriptions and other data only are copyright 2012 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply.

 

 

CMS LCD L28754 ABATACEPT