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Date Printed: October 23, 2017: 02:14 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: 09/13/17

Revised: 10/15/17

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 first approved as an intravenous (IV) infusion by the US Food and Drug Administration (FDA) in December 2005 for adult rheumatoid arthritis (RA) and then 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 FDA-approved indication for the SQ injection was expanded to include the treatment of JIA in pediatric patients 2 years of age and older. Abatacept (as sponsored by the innovator drug company) has been granted orphan drug designation by the FDA for “treatment of idiopathic inflammatory myopathy (IMM)” in February 2017 and “treatment of giant cell arteritis” in February 2017.

Abatacept’s mechanism of action is distinct from the available non-biological disease-modifying anti-rheumatic drugs (DMARDs) and other biologics (e.g., tumor necrosis factor antagonists [TNFs], interleukin antagonists). 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 RA. 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)].

While the following studies do not include abatacept, they support the use of combination DMARD therapy as a valid option for patients with established moderate to severe RA. 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) of the subcutaneous formulation of abatacept in a provider-administered setting such as an outpatient hospital, ambulatory surgical suite, physician office, or emergency facility is not considered medically necessary. This statement does not apply to the intravenous (IV) formulation of abatacept.

NOTE: Adalimumab (Humira), etanercept (Enbrel), and golimumab (Simponi) are the preferred self-administered biologic products for the treatment of rheumatoid arthritis (RA).

NOTE: If the member has had an inadequate response to previous biologic therapy, other than abatacept, that is FDA-approved for the requested indication listed in Table 1, the member is NOT required to have had an inadequate response to non-biologic prerequisite therapy (e.g., for RA, if member has previously had an inadequate response to etancercept, but does not have a history of inadequate response to combination csDMARDs, they do not have to try two csDMARDs in combination to meet medical necessity criteria). However, members with RA must still meet the two preferred self-administered (i.e., subcutaneous) biologic product requirement.

NOTE: Members with RA initiated and maintained on IV abatacept therapy are NOT required to have had an inadequate response to two preferred self-administered (i.e., subcutaneous) biologic products. However, members with RA transitioning to the subcutaneous formulation after an initial IV dose must still meet the preferred self-administered biologic product requirement.

Initiation of abatacept (Orencia) meets the definition of medical necessity when BOTH of the following are met:

1. Abatacept is administered for an indication listed in Table 1 and ALL of the indication-specific and maximum-allowable dose criteria are met

2. 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, Simponi Aria)

h. guselkumab (Tremfya)

i. infliximab products (Remicade, Inflectra, Renflexis)

j. ixekizumab (Taltz)

k. sarilumab (Kevzara)

l. secukinumab (Cosentyx)

m. tocilizumab (Actemra)

n. tofacitinib (Xeljanz, Xeljanz XR)

o. ustekinumab (Stelara)

p. vedolizumab (Entyvio)

Table 1

Indications and Specific Criteria

Indication

Specific Criteria

Maximum Allowable Dose

Polyarticular juvenile idiopathic arthritis (PJIA)

[previously known as polyarticular juvenile rheumatoid arthritis (PJRA)]

When ALL of the following are met (“1”, “2”, and “3”):

1. EITHER of the following:

a. For SQ use: member is 2 years of age or older

b. For IV use: member is 6 years of age or older

2. Member’s disease is moderately to severely active

3. Member has had an inadequate response to, or has a contraindication to ONE or more csDMARDs* (e.g., methotrexate, sulfasalazine, cyclosporine, leflunomide) (the specific contraindication must be provided)

Intravenous infusion

Initial dose:

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

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

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

Maintenance:

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

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

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

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

Psoriatic arthritis (PsA)

[including both axial and non-axial (peripheral) PsA]

ALL of the following (“1”, “2”, 3”, and “4”):

1. Member is 18 years of age or older

2. Member’s disease is active (i.e., persistent joint inflammation)

3. EITHER of the following based on the dominate disease type* (“a” or “b”):

a. Axial PsA: Member has had an inadequate response to, or has a contraindication to at least TWO different NSAID therapies taken continuously for at least 4 weeks each (e.g., celecoxib, diclofenac, ibuprofen, meloxicam, naproxen) (the specific contraindications must be provided)

b. Peripheral PsA: Member has had an inadequate response to, or has a contraindication to at least ONE NSAID therapy taken continuously for at least 4 weeks (e.g., celecoxib, diclofenac, ibuprofen, meloxicam, naproxen) (the specific contraindication must be provided)

AND

Member has had an inadequate response to, or has a contraindication to methotrexate, or, if methotrexate is contraindicated, to another csDMARD (e.g., cyclosporine, leflunomide, sulfasalazine) (the specific contraindication must be provided)‡

4. EITHER of the following (“a” or “b”):

a. Member has had an inadequate response, 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)

ustekinumab (Stelara)

b. BOTH of the following (“i” and “ii”):

i. Member has had an inadequate response to, has persistent and intolerable adverse effect(s), or has a contraindication to ustekinumab (Stelara) (the specific adverse effect and/or contraindication must be provided)

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):

Demyelinating disease (e.g., multiple sclerosis)

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

Intravenous infusion

Initial:

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

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

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

Maintenance:

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

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

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

Subcutaneous injection:

125 mg every week

Rheumatoid arthritis (RA)

When ALL of the following are met (“1”, “2”, “3”, and “4”):

1. Member is 18 years of age or older

2. Member’s disease is moderately to severely active

3. Member has had an inadequate response (i.e., unable to achieve remission or low disease activity) to at least three continuous months of therapy with at least TWO csDMARDs (e.g., hydroxychloroquine, methotrexate, sulfasalazine, leflunomide) used in combination. A trial of csDMARD monotherapy for at least three continuous months 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)

4. EITHER of the following (“a” or “b”):

a. Member has had an inadequate response to, 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)

b. 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):

Demyelinating disease (e.g., multiple sclerosis)

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

Intravenous infusion

Initial:

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

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

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

Maintenance:

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

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

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

Subcutaneous injection:

125 mg every week

Orphan Indications

Giant cell arteritis (GCA)

When ALL of the following are met (“1”, “2”, “3”. and “4”):

1. Member has active disease as defined by BOTH of the following (“a” and “b”):

a. Presence of cranial symptoms, OR symptoms of polymyalgia rheumatica

b. ESR ≥30 mm/hr, OR CRP ≥1 mg/dL

2. Member is currently receiving corticosteroid treatment for their GCA

3. One goal of treatment is to reduce the current daily dose of the corticosteroid

4. Member is 18 years of age or older

Intravenous infusion

Initial:

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

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

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

Maintenance:

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

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

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

Subcutaneous injection:

125 mg every week

Idiopathic inflammatory myopathy (IMM) [includes dermatomyositis (DM) and polymyositis (PM)]

When BOTH of the following are met (“1” and “2”):

1. The members diagnosis has been confirmed by muscle biopsy

2. The member disease is refractory to at least 3 months of continuous combination treatment with a corticosteroid and an immunosuppressant (either azathioprine or methotrexate)

Intravenous infusion

Initial:

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

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

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

Maintenance:

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

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

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

Subcutaneous injection:

125 mg every week

Approval duration: 6 months

NSAID, non-steroidal anti-inflammatory; SQ, subcutaneously; BSA, body surface area; csDMARD, conventional synthetic disease modifying anti-rheumatic drug

*NOTE: If the member has had an inadequate response to previous biologic therapy, other than abatacept, that is FDA-approved for the requested indication listed in Table 1, the member is NOT required to have had an inadequate response to non-biologic prerequisite therapy (e.g., for RA, if member has previously had an inadequate response to etancercept, but does not have a history of inadequate response to combination csDMARDs, they do not have to try two csDMARDs in combination to meet medical necessity criteria). However, members with RA must still meet the two preferred self-administered (i.e., subcutaneous) biologic product requirement.

†NOTE: Members with RA initiated and maintained on IV abatacept therapy are NOT required to have had an inadequate response to two preferred self-administered (i.e., subcutaneous) biologic products. However, members with RA transitioning to the subcutaneous formulation after an initial IV dose must still meet the preferred self-administered biologic product requirement.

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

1. Member has demonstrated a beneficial clinical response with abatacept therapy

2. An authorization or reauthorization for abatacept has been previously approved by Florida Blue or another health plan in the past 2 years for the treatment of a condition in Table 1, 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, Simponi Aria)

h. guselkumab (Tremfya)

i. infliximab products (Remicade, Inflectra, Renflexis)

j. ixekizumab (Taltz)

k. sarilumab (Kevzara)

l. secukinumab (Cosentyx)

m. tocilizumab (Actemra)

n. tofacitinib (Xeljanz, Xeljanz XR)

o. ustekinumab (Stelara)

p. vedolizumab (Entyvio)

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

• Rheumatoid arthritis, psoriatic arthritis. GCA, and IMM

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

o Intravenous infusion (age 6 year or older)

• >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 (age 2 years or older)

• 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

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

• For reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis in adults, as monotherapy or concomitantly with disease-modifying anti-rheumatic drugs (DMARDs) other than tumor-necrosis factor (TNF) antagonists

For reducing signs and symptoms in patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis, as monotherapy or in combination with methotrexate

For the treatment of adult patients with active psoriatic arthritis (PsA)

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 2. 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 2

Table 2: 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

ADULT PSORIATIC ARTHRITIS

Abatacept is administered as an intravenous (IV) or subcutaneous (SQ) injection with or without non-biological DMARDs.

IV infusions should be administered as a 30-minute infusion utilizing weight range-based dosing specified in Table 2. 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.

The SQ injections administered once weekly without the need for an IV loading dose. Persons transitioning from abatacept IV therapy to SQ administration should administer the first SQ dose instead of the next scheduled IV dose.

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:

Contraindications

None

Warnings:

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.

Immunizations: 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.

Chronic Obstructive Pulmonary Disease (COPD): 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 Diagnosis Codes That Support Medical Necessity:

L40.50

Arthropathic psoriasis, unspecified

L40.51

Distal interphalangeal psoriatic arthropathy

L40.52

Psoriatic arthritis mutilans

L40.53

Psoriatic spondylitis

L40.59

Other psoriatic arthropathy

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

M31.5

Giant cell arteritis with polymyalgia rheumatica

M31.6

Other giant cell arteritis

M33.00 – M33.09

Juvenile dermatopolymyositis

M33.10 – M33.19

Other dermatopolymyositis

M33.20 – M33.29

Polymyositis

M33.90 – M33.99

Dermatopolymyositis, unspecified

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 review 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:

Axial PsA (a.k.a., psoriatic spondylitis): a subset of psoriatic arthritis that affects the spine (i.e., spondylitis) and/or spinal joints (e.g., the sacroiliac joint between the sacrum and ilium of pelvis). Axial PsA shares similar clinical findings to patients with ankylosing spondylitis (AS); however, patients with axial PsA are often less symptomatic, have asymmetric disease, and tend to have less severe disease. In addition, the psoriatic plaques or nail changes present in patients with axial PsA are absent in patients with AS. About 5% of PsA patients have exclusively axial involvement, and 20 to 50% have both spinal and peripheral involvement, with peripheral joint involvement being the predominant pattern.

DMARD: An acronym for disease-modifying antirheumatic drug. These are drugs that modify the rheumatic disease processes, and slow or inhibit structural damage to cartilage and bone. These drugs are unlike symptomatic treatments such as NSAIDs that do not alter disease progression. DMARDs can be further subcategorized. With the release of biologic agents (e.g., anti-TNF drugs), DMARDs were divided into either: (1) conventional, traditional, synthetic, or non-biological DMARDs; or as (2) biological DMARDs. However, with the release of newer targeted non-biologic drugs and biosimilars, DMARDs are now best categorized as: (1) conventional synthetic DMARDs (csDMARD) (e.g., MTX, sulfasalazine), (2) targeted synthetic DMARDs (tsDMARD) (e.g., tofacitinib, apremilast), and (3) biological DMARDs (bDMARD), which can be either a biosimilar DMARD (bsDMARD) or biological originator DMARD (boDMARD).

Non-axial or peripheral PsA: a subset of psoriatic arthritis that does NOT affect the spine or spinal joints [e.g. elbow, wrist, knees, hands, feet, and digits (dactylitis)]. Peripheral involvement may be polyarticular (5 or more joints affected) or oligoarticular (a.k.a., pauciarticular) (4 or fewer joints affected). Approximately 95% of patients with PsA have involvement of the peripheral joints, predominantly the polyarticular form, whereas a minority have the oligoarticular form.

Psoriatic arthritis (PsA): joint inflammation that occurs in about 5% to 10% of people with psoriasis (a common skin disorder). It is a severe form of arthritis accompanied by inflammation, psoriasis of the skin or nails, and a negative test for rheumatoid factor. Enthesitis refers to inflammation of entheses, the site where ligaments or tendons insert into the bones. It is a distinctive feature of PsA and does not occur with other forms of arthritis. Common locations for enthesitis include the bottoms of the feet, the Achilles' tendons, and the places where ligaments attach to the ribs, spine, and pelvis.

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

Anakinra (Kineret®), 09-J0000-45

Apremilast (Otezla) Tablets, 09-J2000-19

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

Etanercept (Enbrel®), 09-J0000-38

Golimumab (Simponi™, Simponi Aria), 09-J1000-11

Infliximab Products [infliximab (Remicade®), infliximab-dyyb (Inflectra®), and infliximab-abda (Renflexis®)], 09-J0000-39

Rituximab (Rituxan®), 09-J0000-59

Sarilumab (Kevzara), 09-J2000-87

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

Tofacitinib (Xeljanz, Xeljanz XR), 09-J1000-86

OTHER:

Table 2: Conventional Synthetic DMARDs

Generic Name

Brand Name

Auranofin (oral gold)

Ridaura

Azathioprine

Imuran

Cyclosporine

Neoral, Sandimmune

Hydroxychloroquine

Plaquenil

Leflunomide

Arava

Methotrexate

Rheumatrex, Trexall

Sulfasalazine

Azulfidine, Azulfidine EN-Tabs

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.; 2017. Available at: www.clinicalpharmacilogy-ip.com. Accessed 8/8/17.
  3. Coates LC, Kavanaugh A, Mease PJ et al. Group for Research and Assessment of Psoriasis and Psoriatic Arthritis: Treatment Recommendations for Psoriatic Arthritis 2015. Arthritis Rheumatol 2016;68:1060–71
  4. FDA Orphan Drug Designations and Approvals [Internet]. Washington, D.C. [cited 2017 August 8]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/.
  5. 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.
  6. 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.
  7. Gottlieb A, Korman NJ, Gordon KB, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 2. Psoriatic arthritis: overview and guidelines of care for treatment with an emphasis on the biologics. J Am Acad Dermatol. 2008 May;58(5):851-64. doi: 10.1016/j.jaad.2008.02.040
  8. 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.
  9. 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.
  10. 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.
  11. Micromedex® Healthcare Series [Internet Database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed 8/8/17.
  12. Menter A, Gottlieb A, Feldman SR, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 2008 May;58(5):826-50.
  13. Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions. J Am Acad Dermatol 2011;65:137
  14. Orencia (abatacept) [package insert]. Bristol-Myers Squibb Co. Princeton (NJ): June 2017.
  15. 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.
  16. 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.
  17. 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.
  18. 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.
  19. 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.
  20. Smolen JS, Landewé R, Bijlsma J, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis. 2017 Jun;76(6):960-977.
  21. 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.
  22. 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.
  23. 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.
  24. 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 09/13/17.

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.

10/15/17

Review and revision to guideline consisting of updating description, position statement, dosage/administration, coding/billing, definitions, related guidelines, and references.

Date Printed: October 23, 2017: 02:14 AM