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Date Printed: December 17, 2017: 04:34 PM

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09-J1000-11

Original Effective Date: 08/15/09

Reviewed: 09/13/17

Revised: 10/15/17

Subject: Golimumab (Simponi®, Simponi® Aria)

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:

Golimumab (Simponi, Simponi Aria) is one of five commercially available tumor necrosis factor (TNF)-alpha inhibitors, not counting biosimilars as separate products, available in the United States. Tumor necrosis factor, a proinflammatory cytokine, initiates the body’s defense response to local injury by stimulating the production of inflammatory mediators and signaling immune cells. TNF may augment host defense mechanisms when in low concentration, but large amounts of TNF can lead to excessive inflammation and tissue deterioration. In rheumatoid arthritis, activated T-cells migrate into the synovial lining of the joint where TNF is released and joint destruction begins. The intestinal mucosa from patients with Crohn’s disease or ulcerative colitis has been associated with high levels of TNF as compared to healthy individuals; a similar elevation in TNF has been demonstrated in patients with psoriasis.

Biological agents exhibiting antagonistic properties for TNF bind to the cytokine with a high affinity and prevent TNF binding to receptors on immune, inflammatory, and endothelial cells. TNF-inhibitors may exert action using a variety of biologic activities that may be agent-specific or synergistic with other immunosuppressive agents. Interestingly, many individuals initially non-responsive or intolerant of one TNF-inhibitor have responded when switched to a different agent within the class. Research in this area is imperative in understanding and identifying potential risks and adverse effects associated with use. Combined data from randomized, controlled trials and safety registries have raised concerns that TNF-inhibitors increase the risk of infections and malignancies; although, some studies have found no increased risk as compared to the frequency of infections and malignancies observed in a population predisposed to an immune-mediated inflammatory disease.

Golimumab was approved by the US Food and Drug Administration (FDA) for the treatment of moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate, active psoriatic arthritis (PsA) as monotherapy or in combination with methotrexate, and active ankylosing spondylitis (AS) in 2009. In May 2013, the approval was expanded to include treatment of ulcerative colitis in persons 18 years of age and older refractory to conventional therapy. An intravenous (IV) formulation of golimumab (Simponi Aria) indicated for the treatment of adults with moderate or severe rheumatoid arthritis in combination with methotrexate was FDA-approved in July 2013. The TNF-alpha inhibitors as a class are considered to have similar efficacy and safety for the majority of indications. Golimumab also has orphan designations for the treatment of pediatric ulcerative colitis (2012) and polyarticular juvenile idiopathic arthritis in pediatric patients (2015). Golimumab is administered as a subcutaneous injection every 4 weeks, which is similar to certolizumab pegol (Cimzia) but less frequently than the indicated dosing frequency of the other two FDA-approved subcutaneously administered TNF-alpha inhibitors, adalimumab (Humira) and etanercept (Enbrel). The IV formulation is administered every 8 weeks.

In 2015, the American College of Rheumatology (ACR) published an updated guideline for treatment of rheumatoid arthritis (RA). The guidelines support the use of a TNFi (e.g., golimumab) 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 early RA if disease activity remains moderate or high despite DMARDs, use a TNFi over tofacitinib, (3) 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); and (4) patients with established RA if disease activity remains moderate or high despite TNFi therapy in patients who are currently not on DMARDs, add one or two DMARDs to TNFI therapy rather than continuation TNFi therapy alone. The avoidance of TNFi therapy and use of alternatives is recommended in certain high-risk conditions (i.e., congestive heart failure, hepatitis C infection and not receiving or requiring antiviral treatment, lymphoproliferative disorders, previously treated or untreated skin cancer, and previous serious infection).

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 if given with folic acid when treatment is clinically necessary. Hydroxychloroquine, cyclosporine, and anti-TNF biologics are also considered to be low-risk options during pregnancy.

POSITION STATEMENT:

Comparative Effectiveness

Simponi ONLY (does NOT include Simponi Aria)

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: Adalimumab (Humira), etanercept (Enbrel), golimumab (Simponi), and ustekinumab (Stelara) are the preferred self-administered biologic products

NOTE: If the member has had an inadequate response to previous biologic therapy, other than golimumab, 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 etanercept, but does not have a history of inadequate response to combination csDMARD, they do not have to try two csDMARDs in combination to meet medical necessity criteria).

Initiation of golimumab (Simponi, Simponi Aria) meets the definition of medical necessity when BOTH of the following are met (“1” and “2”):

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

2. Golimumab will NOT be used in combination with ANY of the following:

a. abatacept (Orencia)

b. adalimumab (Humira)

c. anakinra (Kineret)

d. apremilast (Otezla)

e. brodalumab (Siliq)

f. certolizumab (Cimzia)

g. etanercept (Enbrel)

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

Axial spondyloarthritis (axSpA)

[including both ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA)]

(SQ only - Simponi)

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

1. Member has a diagnosis of axial spondyloarthritis per ASAS criteria

2. 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)

50 mg SQ every 28 days

Psoriatic arthritis (PsA)

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

(SQ only - Simponi)

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

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

2. 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)

50 mg SQ every 28 days

Rheumatoid arthritis

(SQ or IV – Simponi or Simponi Aria)

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

1. Member’s disease is moderately to severely active

2. Golimumab is used in combination with methotrexate, unless member has an contraindication or intolerance to methotrexate therapy (the specific contraindication or intolerance must be provided)

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)

• SQ: 50 mg every 28 days

• IV: 2 mg/kg at weeks 0 and 4, then every 8 weeks thereafter starting at week 12

Ulcerative colitis

[orphan indication for pediatric use]

(SQ only – Simponi)

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

1. Member’s disease is moderately to severely active EITHER of the following* (“a” or “b”):

a. Member has had an inadequate response to, or has a contraindication to systemic corticosteroid therapy (the specific contraindication must be provided)

b. Member is dependent on systemic corticosteroids [i.e., unable to successfully taper corticosteroids to less than 10 mg of prednisone (or equivalent) within 3 months of initiation without return of symptoms]

2. Member has had an inadequate response to ANY, or has a contraindication to ALL of the following (the specific contraindications must be provided):

a. Oral aminosalicylates (i.e., sulfasalazine, olsalazine, mesalamine, or balsalazide)

b. Non-oral aminosalicylates (e.g., enema or suppository)

c. Thiopurine therapy (e.g., azathioprine or 6-mercaptopurine [6-MP])

• Initial: 300 mg SQ in 28 days

• Maintenance: 100 mg SQ every 28 days

Orphan Indication (non-FDA approved)

Polyarticular juvenile idiopathic arthritis (PJIA)

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

(SQ ONLY - Simponi)

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

1. Member’s disease is moderately to severely active

2. 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)

50 mg SQ every 28 days

Approval duration: 6 months

ASAS, Assessment of SpondyloArthritis International Society; NSAID, non-steroidal anti-inflammatory drug; csDMARD, conventional synthetic disease modifying anti-rheumatic drug; SQ, subcutaneous; IV, intravenous

*NOTE: If the member has had an inadequate response to previous biologic therapy, other than golimumab, 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 etanercept, but does not have a history of inadequate response to combination csDMARD, they do not have to try two csDMARDs in combination to meet medical necessity criteria).

Continuation of golimumab (Simponi, Simponi Aria) meets the definition of medical necessity when ALL of the following are met:

1. Member has demonstrated a beneficial clinical response to golimumab therapy

2. An authorization or reauthorization for golimumab has been previously approved by Florida Blue or another health plan in the past 2 years for the treatment of a condition listed in Table 1, OR the member previously met ALL indication-specific initiation criteria

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

a. abatacept (Orencia)

b. adalimumab (Humira)

c. anakinra (Kineret)

d. apremilast (Otezla)

1. brodalumab (Siliq)

e. certolizumab (Cimzia)

f. etanercept (Enbrel)

1. guselkumab (Tremfya)

g. infliximab products (Remicade, Inflectra, Renflexis)

h. ixekizumab (Taltz)

1. sarilumab (Kevzara)

i. secukinumab (Cosentyx)

j. tocilizumab (Actemra)

k. tofacitinib (Xeljanz, Xeljanz XR)

l. ustekinumab (Stelara)

m. vedolizumab (Entyvio)

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

a. Axial spondyloarthritis, PJIA, or psoriatic arthritis: 50 mg every 28 days (SQ)

b. Rheumatoid arthritis: 50 mg every 28 days (SQ) OR 2 mg/kg every 8 weeks (IV)

c. Ulcerative colitis: 100 mg every 28 days (SQ)

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: golimumab is indicated for the treatment of moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate, active psoriatic arthritis (PsA) as monotherapy or in combination with methotrexate, active ankylosing spondylitis (AS), and ulcerative colitis in adults refractory to conventional therapy. For treatment of RA golimumab can be administered as a subcutaneous injection or intravenous infusion. The IV infusion should be administered over 30 minutes and the recommended dose is 2 mg/kg. The subcutaneous injection should be administered at a dose of 50 mg once monthly. For treatment of PsA, and AS golimumab should be administered as a 50 mg subcutaneous injection once a month. For members with RA, PsA, or AS, corticosteroids, non-biologic DMARDs, and/or NSAIDs may be continued during treatment with golimumab. The initial dose of golimumab for treatment of UC is 200 mg subcutaneously (SQ) at week 0, followed by 100 mg SQ at week 2; thereafter, golimumab should be administered as 100 mg subcutaneous injection once monthly.

Dose Adjustments: It appears that no dosage adjustments are required for members with hepatic or renal impairment.

Drug Availability: golimumab is available in the following formulations

For SQ administration:

• 50 mg/0.5 mL or 100 mg/mL single dose prefilled SmartJect® autoinjector

• 50 mg/0.5 mL or 100 mg/mL single dose prefilled syringe

For IV administration: 50 mg/4 mL single-use vial

PRECAUTIONS:

Boxed Warning

Infections: tuberculosis (TB), invasive fungal, and other opportunistic infections, some fatal, have occurred. Perform test for latent TB; if positive, start treatment for TB prior to starting therapy. Monitor all patients for active TB, even if initial tuberculin skin test is negative. Discontinue if a patient develops a serious infection or sepsis.

Malignancy: lymphoma and other malignancies, some fatal have been reported in children and adolescent individuals treated with TNF blockers including golimumab.

Contraindications – None

Warnings

Serious Infections: golimumab should not be initiated in members during an active infection. If an infection develops, monitor carefully, and discontinue golimumab if infection becomes serious.

Invasive fungal infections: If a member develops a systemic infection while on golimumab therapy, consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic

Anaphylaxis: anaphylaxis or serious allergic reactions may occur.

Hepatitis B virus reactivation: members who are HBV caries should be monitored during and several months after therapy. If reactivation occurs during therapy, discontinue golimumab and initiate anti-viral therapy.

Demyelinating disease: exacerbation of new onset may occur

Cytopenia, pancytopenia: advise members to seek immediate medical attention if symptoms develop and consider discontinuing golimumab.

Heart failure: worsening or new onset heart failure may occur.

Lupus-like syndrome: discontinue golimumab if syndrome develops.

Drug Interactions: avoid concomitant use with abatacept (Orencia®) and anakinra (Kineret®), due to increased risk of serious infection.

Live vaccines: Avoid administration of live vaccines (e.g., varicella and MMR) in members taking golimumab.

Pregnancy and Lactation

o Golimumab is classified as pregnancy category B. Developmental toxicity studies performed in animals have revealed no evidence of harm to the fetus. Use during pregnancy should occur only if clearly needed.

o Because many immunoglobulins are secreted in milk and the potential for serious adverse reactions exists, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding (Simponi):

C9399

Unclassified drugs or biologicals (Hospital Outpatient Use ONLY)

J3590

Unclassified biologicals

HCPCS Coding (Simponi Aria):

J1602

Injection, golimumab, 1 mg, for intravenous use

ICD-10 Diagnosis Codes That Support Medical Necessity (Simponi):

K51.00 – 51.919

Ulcerative colitis

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

M45.0 – M45.9

Ankylosing spondylitis

M46.81 – M46.89

Other specified inflammatory spondylopathies

ICD-10 Diagnosis Codes That Support Medical Necessity: (Simponi Aria)

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

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) and/or Local Coverage Determination (LCD) were found at the time of the last guideline review date.

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.

Axial Spondyloarthritis (SpA): an inflammatory disease where the main symptom is back pain, and where the x-ray changes of sacroiliitis may or may not be present. In ankylosing spondylitis (AS), the x-ray changes are clearly present. In non-radiographic axial spondyloarthritis (nr-axSpA); the x-ray changes are not present but you have symptoms. It is thought that nr-axSpA may be an earlier form of AS.

DMARDs: an acronym for disease-modifying antirheumatic drugs. 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 has 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.

Ulcerative Colitis: a form of inflammatory bowel disease that includes characteristic ulcers or open sores. The main symptoms of active disease is usually consistent with diarrhea mixed with blood, of gradual onset. It is an intermittent disease, with periods of exacerbated symptoms, and periods that are relatively symptom-free.

RELATED GUIDELINES:

Abatacept (Orencia®), 09-J0000-67

Adalimumab (Humira®), 09-J0000-46

Anakinra (Kineret®), 09-J0000-45

Apremilast (Otezla), 09-J2000-19

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

Etanercept (Enbrel®), 09-J0000-38

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

Natalizumab (Tysabri) IV, 09-J0000-73

Rituximab (Rituxan®), 09-J0000-59

Sarilumab (Kevzara), 09-J2000-87

Secukinumab (Cosentyx®), 09-J2000-30

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

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

Ustekinumab (Stelara™), 09-J1000-16

Vedolizumab (Entyvio), 09-J2000-18

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

Assessment of Spondyloarthritis International Society (ASAS) Diagnostic Criteria for Axial Spondylarthritis (SpA)

Patients with chronic (≥3 months) back pain, the onset of which occurs at <45 years of age, AND EITHER of the following:

1. Imaging arm:

a. Sacroiliitis on imaging*

AND

b. ≥1 SpA feature

2. Clinical arm:

a. HLA-B27 positive

AND

b. ≥2 other SpA features

SpA features:

• Inflammatory back pain

• Arthritis

• Enthesitis (heel)

• Uveitis

• Dactylitis

• Psoriasis

• Crohn’s/colitis

• Good response to NSAIDs

• Family history of SpA

• HLA-B27

• Elevated CRP

*Active (acute) inflammation on MRI highly suggestive of sacroiliitis associated with SpA, or definite radiographic sacroiliitis according to modified New York criteria

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, Patkar 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. Braun J, van den Berg R, Baraliakos X, et al. 2010 update of the ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann Rheum Dis 2011;70:896-904.
  3. Callhoff J, Sieper J, Weiß A, et al. Efficacy of TNFα blockers in patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis: a meta-analysis. Ann Rheum Dis. 2015 Jun;74(6):1241-8.
  4. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2017. Available at: www.clinicalpharmacilogy-ip.com. Accessed 8/8/17.
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  6. FDA Orphan Drug Designations and Approvals [Internet]. Washington, D.C. [cited 2017 August 8]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/.
  7. Gossec L, Smolen JS, Ramiro S, et al. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. Ann Rheum Dis. 2016 Mar;75(3):499-510.
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COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 09/13/17.

GUIDELINE UPDATE INFORMATION:

08/15/09

New Medical Coverage Guideline.

04/15/10

Revision; consisting of adding specific continuation criteria.

09/15/10

Review and revision; consisting of Updating boxed warning, precautions section and references.

01/15/11

Revision; consisting of adding ICD-10 codes.

04/01/11

Revision; consisting of adding dosage limits.

09/15/11

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

04/15/12

Revision to guideline consisting of removing failure of DMARD for ankylosing spondylitis.

09/15/12

Review and revision to guideline; consisting of modifying continuation criteria, reformatting position statement, updating precautions, program exceptions and references.

01/15/13

Revision to guideline; consisting of reformatting/revising the position statement, dosage/administration, precautions sections; updating references and decision tree.

4/15/13

Revision of guideline; consisting of revising position statement to include duration of approval and Orphan Drug indications.

09/15/13

Review and revision to guideline; consisting of revising position statement to include coverage of ulcerative colitis, revising dosage/administration section, updating references, related guidelines, definitions, program exceptions, and coding.

11/15/13

Revision to guideline; consisting of adding new product to guideline, updating position statement, coding, and references.

01/01/14

Revision to guideline, consisting of coding update.

04/15/14

Revision to guideline; consisting of adding clarification statement and reformatting 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, dosage/administration, warnings/precautions, billing/coding, related guidelines, and references.

11/01/15

Revision: ICD-9 Codes deleted.

09/15/16

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

10/15/17

Review and revision to guideline consisting of updating description, position statement, definitions, related guidelines, and references

Date Printed: December 17, 2017: 04:34 PM