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Date Printed: June 23, 2017: 11:41 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-J0000-67

Original Effective Date: 06/15/07

Reviewed: 08/10/16

Revised: 06/15/17

Subject: Abatacept (Orencia®)

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Dosage/ Administration Position Statement Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References Updates  
           

DESCRIPTION:

Abatacept (Orencia®), a modulator of T-lymphocyte activation, was approved as an intravenous (IV) infusion by the US Food and Drug Administration (FDA) in 2005 for adult rheumatoid arthritis (RA) and in April 2008 for polyarticular juvenile idiopathic arthritis (JIA) in pediatric patients 6 years of age and older. In July 2011, a subcutaneous (SQ) injection was approved for the treatment of RA. In March 2017, the approved age for JIA was lowered to 2 years of age and older and new subcutaneous dosage recommendations were made. Orencia also was granted orphan drug designation by the FDA for the “treatment of type 1 diabetes mellitus patients with residual beta cell function” in May 2013.

Abatacept’s mechanism of action is distinct from all other available disease-modifying anti-rheumatic drugs (DMARDs) and biologics (e.g., tumor necrosis factor antagonists [TNFs]). Abatacept is a human protein designed to selectively inhibit T-cell activation, a process that plays a central role in the immunopathogenesis of RA. It exerts this mechanism of action by binding to the natural ligands CD80 and CD86, ultimately preventing CD80 and CD86 interaction with CD28 on the T-lymphocyte. Additionally, abatacept indirectly inhibits the production of inflammatory cytokines and auto-antibodies, which are also hypothesized to play a role in the pathogenesis of RA.

In 2015, the American College of Rheumatology (ACR) published an updated guideline for the treatment of rheumatoid arthritis. The guidelines support the use of a non-TNF biologic (e.g., abatacept) in the following scenarios: (1) patients with early RA if disease activity remains moderate or high despite DMARD monotherapy (with or without glucocorticoids), use combination DMARDS or a TNFi or a non-TNF biologic (all choices with or without methotrexate (MTX), in no particular order of preference); (2) patients with established RA if disease activity remains moderate or high despite DMARD monotherapy, use combination traditional DMARDS or add a TNFi or a non-TNF biologic or tofacitinib (all choices with or without MTX, in no particular order of preference); (3) patients with established RA if disease activity remains moderate or high despite use of a single TNFi, use a non-TNF biologic, with or without MTX; (4) patients with established RA if disease activity remains moderate or high despite use of a single non-TNF biologic, use another non-TNF biologic, with or without MTX; (5) patients with established RA if disease activity remains moderate or high despite use of multiple (2+) sequential TNFi therapies, first use a non-TNF biologic, with or without MTX; and (6) patients with established RA if disease activity remains moderate or high despite use of at least one TNFi and at least one non-TNF biologic, first use another non-TNF biologic, with or without MTX. Non-TNF biologics are also recommended when patients must avoid a TNFi due to certain high-risk conditions [i.e., congestive heart failure, lymphoproliferative disorders, and previous serious infection (abatacept only)].

In the 2015 TACIT pragmatic, non-inferiority, randomized controlled trial, 205 persons with established moderate to severe RA received either an anti-TNF biologic with one DMARD (e.g., methotrexate), or conventional DMARD therapy titrated upward to include combination therapy. Most persons in the DMARD group eventually received 2 or 3 DMARDs in combination (e.g., methotrexate + leflunomide). The DMARD group was shown to be non-inferior to the anti-TNF group for the primary outcome of disability measured by a patient-recorded health assessment questionnaire at 12 months with a numerical advantage towards the DMARD group. Further supporting use of combination DMARD therapy, the 2-year follow-up of the SWEFOT trial (438 persons with methotrexate-refractory RA) showed no difference in utility or QALY gain over 21 months when comparing methotrexate + infliximab vs. methotrexate + sulfasalazine + hydroxychloroquine.

While methotrexate must be avoided in women who are pregnant or trying to become pregnant, sulfasalazine has adequate data supporting safe use (pregnancy Category B), and is consider a preferred DMARD when given with folic acid if treatment is clinically necessary. Hydroxychloroquine, cyclosporine, and anti-TNF biologics are also considered to be low-risk options during pregnancy.

POSITION STATEMENT:

Comparative Effectiveness

The Food and Drug Administration has deemed the drug(s) or biological product(s) in this coverage policy to be appropriate for self-administration or administration by a caregiver (i.e., not a healthcare professional). Therefore, coverage (i.e., administration) in a provider-administered setting such as an outpatient hospital, ambulatory surgical suite, or emergency facility is not considered medically necessary.

NOTE: etanercept (Enbrel), adalimumab (Humira), golimumab (Simponi), and ustekinumab (Stelara) are preferred self-administered products

NOTE: If the member has failed previous biologic therapy, other than abatacept, that is FDA-approved for the requested indication listed below, the member is NOT required to try and fail additional non-biologic prerequisite therapy (e.g., for RA, if member has previously tried and failed etancercept, but does not have a history of combination DMARD failure, they do not have to try and fail two DMARDs in combination to meet medical necessity criteria).

*NOTE: Members initiating intravenous abatacept therapy are NOT required to try and fail preferred self-administered (i.e., subcutaneous) products.

Initiation of abatacept (Orencia) meets the definition of medical necessity when used to treat EITHER of the following Indications:

1. Rheumatoid arthritis (RA) when ALL of the following are met:

a. Member is 18 years of age or older

b. Member’s disease is moderately to severely active

c. Member has tried and failed therapy with at least TWO DMARDs (e.g., hydroxychloroquine, methotrexate, sulfasalazine, leflunomide) used in combination. Failure of only one DMARD is sufficient if member has a contraindication to BOTH methotrexate AND either sulfasalazine or hydroxychloroquine (the specific contraindications must be provided; pregnancy is not considered a contraindication to the use of sulfasalazine or hydroxychloroquine)

d. EITHER of the following (“i” or “ii”)*:

i. Member has tried and failed, has persistent and intolerable adverse effect(s), or has a contraindication to TWO or more of the following self-administered biologic therapies (the specific adverse effect(s) and/or contraindications must be provided):

• etanercept (Enbrel)

• adalimumab (Humira)

• golimumab (Simponi)

ii. Member should consider alternatives to the use of an anti-TNF biologic due to a product warning and precaution for ANY of the following (the specific condition must be provided):

• Serious, chronic or recurrent infections (the specific infection and duration/frequency of illness must be provided)

• Previously treated lymphoproliferative disorder (e.g., leukemias, lymphomas)#

• Current or worsening congestive heart failure

#The 2015 ACR guideline gives the use of rituximab over a TNFi a strong recommendation, while the use of abatacept over a TNFi is a conditional recommendation

e. The member’s dosage does not exceed EITHER of the following:

i. Intravenous (IV) infusion

o Initial:

• >100 kg: 1,000 mg every 2 weeks for 3 total doses (week 0, 2, and 4)

• 60 to 100 kg: 750 mg every 2 weeks for 3 total doses (week 0, 2, and 4)

• <60 kg: 500 mg every 2 weeks for 3 total doses (week 0, 2, and 4)

o Maintenance:

• >100 kg: 1,000 mg every 4 weeks starting at week 8

• 60 to 100 kg: 750 mg every 4 weeks starting at week 8

• <60 kg: 500 mg every 4 weeks starting at week 8

ii. Subcutaneous injection: 125 mg every week

f. Abatacept is NOT used in combination with ANY of the following:

i. Adalimumab (Humira)

ii. Anakinra (Kineret)

iii. Apremilast (Otezla)

iv. Brodalumab (Siliq)

v. Certolizumab (Cimzia)

vi. Etanercept (Enbrel)

vii. Golimumab (Simponi)

viii. Infliximab product (Remicade, Inflectra, Renflexis)

ix. Ixekizumab (Taltz)

x. Secukinumab (Cosentyx)

xi. Tocilizumab (Actemra)

xii. Tofacitinib (Xeljanz)

xiii. Ustekinumab (Stelara)

xiv. Vedolizumab (Entyvio)

2. Polyarticular juvenile idiopathic arthritis (PJIA) [previously known as polyarticular juvenile rheumatoid arthritis (PJRA)] when ALL of the following are met:

a. Member is 2 years of age or older

b. Member’s disease is moderately to severely active

c. Member has tried and failed or has a contraindication to at least ONE disease-modifying anti-rheumatic drug (DMARD) (e.g., methotrexate, sulfasalazine, cyclosporine, leflunomide)

d. The member’s dosage does not exceed EITHER of the following:

i. Intravenous infusion

o Initial dose:

• >100 kg: 1,000 mg every 2 weeks for 3 total doses (week 0, 2, and 4)

• 75 to 100 kg: 750 mg every 2 weeks for 3 total doses (week 0, 2, and 4)

• <75 kg: 10 mg/kg every 2 weeks for 3 total doses (week 0, 2, and 4)

o Maintenance:

• >100 kg: 1,000 mg every 4 weeks starting at week 8

• 75 to 100 kg: 750 mg every 4 weeks starting at week 8

• <75 kg: 10 mg/kg every 4 weeks starting at week 8

ii. Subcutaneous injection

o 10 to <25 kg: 50 mg every week

o 25 to <50 kg: 87.5 mg every week

o ≥50 kg: 125 mg every week

e. Abatacept is NOT used in combination with ANY of the following:

i. Adalimumab (Humira)

ii. Anakinra (Kineret)

iii. Apremilast (Otezla)

iv. Brodalumab (Siliq)

v. Certolizumab (Cimzia)

vi. Etanercept (Enbrel)

vii. Golimumab (Simponi)

viii. Infliximab products (Remicade, Inflectra, Renflexis)

xv. Ixekizumab (Taltz)

ix. Secukinumab (Cosentyx)

x. Tocilizumab (Actemra)

xi. Tofacitinib (Xeljanz)

xii. Ustekinumab (Stelara)

xiii. Vedolizumab (Entyvio)

Approval duration: 6 months

Continuation of abatacept meets the definition of medical necessity when ALL of the following criteria are met:

1. Member has a history of beneficial response to abatacept therapy for treatment of rheumatoid arthritis or polyarticular juvenile idiopathic arthritis/polyarticular juvenile rheumatoid arthritis

2. An authorization/reauthorization for abatacept has been previously approved by Florida Blue or another health plan in the past 2 years for the treatment of RA or PJIA, OR the member previously met ALL indication-specific initiation criteria

3. Abatacept is NOT used in combination with ANY of the following:

a. Adalimumab (Humira)

b. Anakinra (Kineret)

c. Apremilast (Otezla)

d. Brodalumab (Siliq)

e. Certolizumab (Cimzia)

f. Etanercept (Enbrel)

g. Golimumab (Simponi)

h. Infliximab products (Remicade, Inflectra, Renflexis)

i. Ixekizumab (Taltz)

j. Secukinumab (Cosentyx)

k. Tocilizumab (Actemra)

l. Tofacitinib (Xeljanz)

m. Ustekinumab (Stelara)

n. Vedolizumab (Entyvio)

4. The member’s dosage does not exceed the following based on their weight and indication for use:

• Rheumatoid arthritis

o Intravenous infusion

• >100 kg: 1,000 mg every 4 weeks

• 60 to 100 kg: 750 mg every 4 weeks

• <60 kg: 500 mg every 4 weeks

o Subcutaneous injection

• 125 mg every week

• PJIA/PJRA

o Intravenous infusion

• >100 kg: 1,000 mg every 4 weeks

• 75 to 100 kg: 750 mg every 4 weeks

• <75 kg: 10 mg/kg every 4 weeks

o Subcutaneous injection

10 to <25 kg: 50 mg every week

25 to <50 kg: 87.5 mg every week

≥50 kg: 125 mg every week

Approval Duration: 1 year

Abatacept meets the definition of medical necessity when administered for treatment of the following Orphan Drug indications when the member’s maintenance dosage does not exceed 1,000 mg IV every 4 weeks:

1. Treatment of type 1 diabetes mellitus in persons with residual beta cell function

Approval Duration: 1 year

Abatacept is considered experimental or investigational for all other indications since there is insufficient clinical evidence to support its use.

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

FDA-approved: abatacept is indicated for treatment of the following indications

• Moderate to severely active rheumatoid arthritis in adults, as a single-agent or concomitantly with disease-modifying anti-rheumatic drugs (DMARDs) other than tumor-necrosis factor (TNF) antagonists

• Moderate to severely active polyarticular juvenile idiopathic arthritis in pediatric persons 6 years of age or older, as a single agent or in combination with methotrexate.

ADULT RHEUMATOID ARTHRITIS

Abatacept is administered as an intravenous (IV) or subcutaneous (SQ) injection.

• IV infusions should be administered as a 30-minute infusion utilizing weight range-based dosing specified in Table 1. Following the initial IV administration, an IV infusion should be administered at 2 and 4 weeks after the first infusion and every 4 weeks thereafter.

Table 1

Table 1: Abatacept IV dose in adult RA persons

Body weight

Dose

Number of vials

Less than 60 kg

500 mg

2

60 to 100 kg

750 mg

3

More than 100 kg

1,000 mg

4

Each vial provides 250 mg of abatacept for administration

• Following a single IV loading dose (as per body weight categories listed in Table 1), the first 125 mg SQ injection of abatacept should be given within a day, followed by 125 mg SQ injections once weekly.

o Persons unable to receive an infusion may initiate weekly injections of SQ abatacept without an IV loading dose

o Persons transitioning from abatacept IV therapy to SQ administration should administer the first SQ dose instead of the next scheduled IV dose.

JUVENILE IDIOPATHIC ARTHRITIS

• The recommended intravenous dosage for persons aged 6 to 17 years of age:

o Less than 75 kg: 10 mg/kg IV on week 0, 2, 4, and every 4 weeks thereafter

o Greater than 75 kg: use adult IV dosing regimen, not to exceed a maximum dose of 1,000 mg

o Intravenous dosing has not been studied in patients younger than 6 years of age

The recommended subcutaneous dosage for persons aged 2 to 17 years of age:

o 10 to less than 25 kg: 50 kg once weekly

o 25 to less than 50 kg: 87.5 mg once weekly

o 50 kg or more: 125 mg once weekly

Drug Availability:

Intravenous infusion:

o 250 mg lyophilized powder in a single use vial

Subcutaneous injection:

o 50 mg/0.4 mL, 87.5 mg/0.7 mL, and 125 mg/mL single-dose prefilled glass syringes

o 125 mg/mL solution in a single-dose prefilled autoinjector (ClickJect)

PRECAUTIONS:

Concomitant Use with TNF Antagonists: concomitant use with a TNF antagonist can increase the risk of infections and serious infections.

Hypersensitivity: hypersensitivity, anaphylaxis, and anaphylactoid reactions have occurred following abatacept administration.

Infections: persons with a history of recurrent infections or underlying conditions predisposing to infections may experience more infections; discontinue if a serious infection occurs.

Tuberculosis: screen for latent TB infection prior to initiating therapy. Members testing positive should be treated prior to initiating abatacept.

Vaccination: live vaccines should not be given concurrently or within three months of discontinuation. Members with juvenile idiopathic arthritis should be brought up to date with all immunizations prior to abatacept therapy. Abatacept may blunt the effectiveness of some immunizations based on its mechanism of action.

Respiratory: Persons with COPD may develop more frequent respiratory events.

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding:

J0129

Injection, abatacept, 10mg

ICD-10 Diagnoses Codes That Support Medical Necessity:

E10.10 – E10.9

Type 1 diabetes mellitus

M05.00 – M05.09

Felty's syndrome

M05.10 – M05.19

Rheumatoid lung disease with rheumatoid arthritis

M05.20 – M05.29

Rheumatoid vasculitis with rheumatoid arthritis

M05.30 – M05.39

Rheumatoid heart disease with rheumatoid arthritis

M05.40 – M05.49

Rheumatoid myopathy with rheumatoid arthritis

M05.50 – M05.59

Rheumatoid polyneuropathy with rheumatoid arthritis

M05.60 – M05.69

Rheumatoid arthritis with involvement of other organs and systems

M05.70 – M05.79

Rheumatoid arthritis with rheumatoid factor without organ or systems involvement

M05.80 – M05.89

Other rheumatoid arthritis with rheumatoid factor

M05.9

Rheumatoid arthritis with rheumatoid factor, unspecified

M06.00 – M06.09

Rheumatoid arthritis without rheumatoid factor

M06.20 – M06.29

Rheumatoid bursitis

M06.30 – M06.39

Rheumatoid nodule

M06.80 – M06.89

Other specified rheumatoid arthritis

M06.9

Rheumatoid arthritis, unspecified

M08.09

Unspecified juvenile rheumatoid arthritis, multiple sites

M08.3

Juvenile rheumatoid polyarthritis (seronegative)

M08.89

Other juvenile arthritis, multiple sites

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products: No National Coverage Determination (NCD) was found at the time of the last guideline revised date. The following Local Coverage Determination (LCD) was reviewed on the last guideline review date: Abatacept (L33257) located at fcso.com.

Medicare Part D: Florida Blue has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline.

DEFINITIONS:

Anti-rheumatic: An agent that relieves or prevents musculoskeletal pain.

DMARD: An acronym for disease-modifying antirheumatic drug.

Rheumatoid arthritis: An inflammatory disease of the synovium, or lining of the joint that results in pain stiffness, and swelling of multiple joints. The inflammation may extend to other joints and cause bone and cartilage erosion, joint deformities, movement problems, and activity limitations.

RELATED GUIDELINES:

Adalimumab (Humira®, 09-J0000-46

Kineret (Anakinra), 09-J0000-45

Apremilast (Otezla) Tablets, 09-J2000-19

Certolizumab Pegol (Cimzia®), 09-J0000-77

Etanercept (Enbrel®), 09-J0000-38

Golimumab (Simponi™), 09-J1000-11

Infliximab (Remicade®) and Infliximab-dyyb (Inflectra®), 09-J0000-39

Rituximab (Rituxan®), 09-J0000-59

Tocilizumab (Actemra®) IV, 09-J1000-21

Tofacitinib (Xeljanz), 09-J1000-86

OTHER:

Table 2: DMARDs

DMARD Generic Name

DMARD Brand Name

Auranofin (oral gold)

Ridaura

Azathioprine

Imuran

Cyclophosphamide

Cytoxan

Cyclosporine

Neoral, Sandimmune

Gold sodium thiomalate (injectable gold)

Myochrysine

Hydroxychloroquine sulfate

Plaquenil

Leflunomide

Arava

Methotrexate

Rheumatrex, Trexall

Minocycline

Minocin

Penicillamine

Cuprimine, Depen

Sulfasalazine

Azulfidine, Azulfidine EN-Tabs

Auranofin (oral gold)

Ridaura

Grading of Severity of Rheumatoid Arthritis

Severity

Criteria

Mild

Joint pain
Inflammation of at least 3 joints
No inflammation in tissues other than the joints
Usually, a negative result on a rheumatoid factor test
An elevated erythrocyte sedimentation rate (ESR) or C reactive protein (CRP) level
No evidence of bone or cartilage damage on x-rays

Moderate

Between 6 and 20 inflamed joints
Usually no inflammation in tissues other than the joints
An elevated ESR or CRP levels
A positive rheumatoid factor test or anti-cyclic citrullinated peptide (anti-CCP) antibodies
Evidence of inflammation but no evidence of bone damage on x-rays

Severe

More than 20 persistently inflamed joints or a rapid loss of functional abilities
Elevated ESR or CRP levels
Anemia related to chronic illness
Low blood albumin level
A positive rheumatoid factor test, often with a high level
Evidence of bone and cartilage damage on x-ray
Inflammation in tissues other than joints

REFERENCES:

  1. Beukelman T, Atkar NM, Saag KG, et al. 2011 American College of Rheumatology Recommendations for the treatment of juvenile idiopathic arthritis: initiation and safety monitoring of therapeutic agents for the treatment of arthritis and systemic features. Arthritis Care Res 2011;63(4):465-82.
  2. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.;2016. URL www.clinicalpharmacilogy-ip.com. Accessed 7/7/16.
  3. Genant HK, Peterfy CG, Westhovens R, Becker JC, Aranda R, Vratsanos G, Teng J, Kremer JM. Abatacept inhibits structural damage progression in rheumatoid arthritis: results from the long-term extension of the AIM trial. Ann Rheum Dis. 2007 Dec 17.
  4. Genovese MC, Schiff M, Luggen M, et al. Longterm safety and efficacy of abatacept through 5 years of treatment in patients with rheumatoid arthritis and an inadequate response to tumor necrosis factor inhibitor therapy. J Rheumatol. 2012 Aug;39(8):1546-54.
  5. Graudal N, Hubeck-Graudal T, Tarp S, et al. Effect of combination therapy on joint destruction in rheumatoid arthritis: a network meta-analysis of randomized controlled trials. PLoS One. 2014 Sep 22;9(9):e106408.
  6. Karlsson JA, Neovius M, Nilsson JA, et al. Addition of infliximab compared with addition of sulfasalazine and hydroxychloroquine to methotrexate in early rheumatoid arthritis: 2-year quality-of-life results of the randomised, controlled, SWEFOT trial. Ann Rheum Dis. 2013 Dec;72(12):1927-33.
  7. Krause ML, Amin A, and Makol A. Use of DMARDs and biologics during pregnancy and lactation in rheumatoid arthritis: what the rheumatologist needs to know. Ther Adv Musculoskelet Dis. 2014 Oct; 6(5): 169–184.
  8. Micromedex® Healthcare Series [Internet Database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed 7/7/16.
  9. National Collaborating Centre for Chronic Conditions (UK). Rheumatoid Arthritis: National Clinical Guideline for Management and Treatment in Adults. London: Royal College of Physicians (UK); 2009 Feb (updated 2015 Dec).
  10. Orencia (abatacept) [package insert]. Bristol-Myers Squibb Co. Princeton (NJ): March 2017.
  11. Rahimi R, Nikfar S, Rezaie A, et al. Pregnancy outcome in women with inflammatory bowel disease following exposure to 5-aminosalicylic acid drugs: a meta-analysis. Reprod. Toxicol;2008:25,271–275.
  12. Ringold S, Weiss PF, Beukelman T. 2013 Update of the 2011 American College of Rheumatology Recommendations for the Treatment of Juvenile Idiopathic Arthritis, Recommendations for the Medical Therapy of Children With Systemic Juveline Idiopathic Arthritis and Tuberculosis Screening Among Children Receiving Biologic Medications. Arthritis & Rheumatism. Oct 2013;65(10):2499-2512.
  13. Salliot C, Dougados M, Gossec L. Risk of serious infections during rituximab, abatacept and anakinra therapies for rheumatoid arthritis: meta-analyses of randomized placebo-controlled trials. Ann Rheum Dis. 2008 Jan 18.
  14. Scott DL, Ibrahim F, Farewell V, et al. Tumour necrosis factor inhibitors versus combination intensive therapy with conventional disease modifying anti-rheumatic drugs in established rheumatoid arthritis: TACIT non-inferiority randomised controlled trial. BMJ. 2015 Mar 13;350:h1046.
  15. Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2016 Jan;68(1):1-25.
  16. Tynjälä P, Vähäsalo P, Tarkiainen M, et al. Aggressive combination drug therapy in very early polyarticular juvenile idiopathic arthritis (ACUTE-JIA): a multicentre randomised open-label clinical trial. Ann Rheum Dis. 2011 Sep;70(9):1605-12.
  17. van Vollenhoven RF, Geborek P, Forslind K, et al. Conventional combination treatment versus biological treatment in methotrexate-refractory early rheumatoid arthritis: 2 year follow-up of the randomised, non-blinded, parallel-group Swefot trial. Lancet. 2012 May 5;379(9827):1712-20.
  18. Vera-Llonch M, Massarotti E, Wolfe F, et al. Cost-effectiveness of abatacept in patients with moderately to severely active rheumatoid arthritis and inadequate response to methotrexate. Rheumatology (Oxford). 2008 Apr; 47(4): 535-41.
  19. Weinblatt ME, Schiff M, Valente R, et al. Head-to-head comparison of subcutaneous abatacept versus adalimumab for rheumatoid arthritis: findings of a phase IIIb, multinational, prospective, randomized study. Arthritis Rheum. 2013 Jan;65(1):28-38.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Coverage Committee on 08/10/16.

GUIDELINE UPDATE INFORMATION:

06/15/07

New Medical Coverage Guideline.

10/15/07

Revision; consisting of updating ICD-9 coding.

05/15/08

Review and revision; consisting of adding new JIA indication, updating dosage and administration section, updating references and updating ICD-9 file.

09/15/09

Review and revision; consisting of updating references and updating precautions.

04/15/10

Revision; consisting of adding specific continuation criteria.

08/15/10

Review and revision; consisting of updating references, description and precautions.

02/15/11

Revision; consisting of formatting changes and ICD-10 codes.

08/15/11

Review and revision to guideline; consisting of updating coding and references.

11/15/11

Revision to guideline; consisting of adding new dosage formulation and maximum dose.

08/15/12

Review and revision to guideline; consisting of updating position statement, precautions, exceptions and references.

09/15/12

Revision to guideline; consisting of modifying continuation criteria.

04/15/13

Revision to guideline; consisting of revising and reformatting position statement; revising and reformatting description, dosage/administration, and precautions sections; updating references and related guidelines.

09/15/13

Review and revision to guideline; consisting of updating quantity limit, adding Orphan drug indications, program exceptions, and updating references.

01/01/14

Revision to guideline; consisting of updating preferred language.

04/15/14

Revision to guideline; consisting of revising position statement.

09/15/14

Review and revision to guideline; consisting of updating position statement, references, coding, and related guidelines.

09/15/15

Review and revision to guideline; consisting of updating description section, position statement, billing/coding, and references.

10/01/15

Revision consisting of update to Program Exceptions section.

12/15/15

Revision consisting of ICD-10 coding updates.

09/15/16

Review and revision to guideline consisting of updating description section, position statement, billing/coding, and references.

06/15/17

Revision to guideline consisting of updating description section, position statement, dosage/administration section, and references based on expanded FDA-approval of JIA indication to age 2 years of age and older and new SQ dosage recommendations for JIA.

Date Printed: June 23, 2017: 11:41 AM