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09-J0000-77

Original Effective Date: 09/15/08

Reviewed: 09/13/17

Revised: 10/15/17

Subject: Certolizumab Pegol (Cimzia®)

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:

Certolizumab pegol (Cimzia®) is one of five commercially available tumor necrosis factor (TNF) alpha inhibitors available, not counting biosimilars as separate products, in the United States. It was FDA approved for Crohn's disease in April 2008, for rheumatoid arthritis (RA) in May 2009, for psoriatic arthritis (PsA) in September 2013, and for ankylosing spondylitis (AS) in October 2013. 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. However, the TNF-alpha inhibitors as a class are considered to have similar efficacy and safety for the majority of indications. 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.

In 2015, the American College of Rheumatology (ACR) published an updated guideline for the treatment of rheumatoid arthritis (RA). The guidelines support the use of a TNFi (e.g., certolizumab pegol) 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 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, physician office, 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: Members initiating provider administered (i.e., submitted as a medical claim with J0717) certolizumab therapy are NOT required to have had an inadequate response to the preferred self-administered (i.e., subcutaneous) biologic products. However, members transitioning to self-administered treatment after a single provider-administered first dose must still meet the preferred self-administered biologic product requirement.

NOTE: If the member has had an inadequate response to previous biologic therapy, other than certolizumab pegol, 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). However, members self-administering certolizumab pegol must still meet the two preferred self-administered (i.e., subcutaneous) biologic product requirement.

Initiation of certolizumab pegol (Cimzia®) meets the definition of medical necessity when ALL of the following criteria are met:

1. Member is 18 years of age or older

2. Certolizumab 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. 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)

3. Certolizumab will be used for treatment of an indication listed in Table 1, and ALL of the indication-specific criteria are met

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

a. Initial: 400 mg (given as 2 subcutaneous injections of 200 mg) at week 0, 2 and 4

b. Maintenance: 400 mg every 28 days starting at week 8, OR 200 mg every other week starting at week 6

Table 1

Indications and Specific Criteria

Indication

Criteria

Axial spondyloarthritis (axSpA)

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

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

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)

3. Member has had an inadequate response to, or has a contraindication to TWO or more of the following* (the specific contraindications must be provided):

a. adalimumab (Humira)

b. etanercept (Enbrel)

c. golimumab (Simponi)

Crohn’s disease (CD)

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

1. Member has a diagnosis of moderately to severely active CD [e.g., Crohn’s Disease Activity Index (CDAI) greater than 220 points]

2. Member has had an inadequate response to at least ONE or has contraindications to ALL of the following treatments† (the specific contraindication(s) must be provided):

a. azathioprine

b. mercaptopurine (6-MP)

c. methotrexate

d. systemic corticosteroid (e.g. oral prednisone, IV methylprednisolone)

3. Member has had an inadequate response to, or has a contraindication to BOTH of the following* (the specific contraindication(s) must be provided):

a. adalimumab (Humira)

b. ustekinumab (Stelara)

Psoriatic arthritis (PsA)

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

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

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

2. EITHER of the following based on the dominate disease type:

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 each† (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)

3. Member has had an inadequate response to, or has a contraindication to TWO or more of the following* (the specific contraindications must be provided):

a. adalimumab (Humira)

b. etanercept (Enbrel)

c. golimumab (Simponi)

d. ustekinumab (Stelara)

Rheumatoid arthritis (RA)

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

1. Member disease is moderately to severely active

2. 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 TWO or more csDMARDs (e.g., hydroxy-chloroquine, 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)

3. Member has had an inadequate response to, or has a contraindication to two or more of the following self-administered biologic therapies* (the specific contraindications must be provided):

a. adalimumab (Humira)

b. etanercept (Enbrel)

c. golimumab (Simponi)

Approval duration: 6 months

ASAS, Assessment of SpondyloArthritis International Society; NSAID, non-steroidal anti-inflammatory drug

*NOTE: Members initiating provider administered (i.e., submitted as a medical claim with J0717) certolizumab therapy are NOT required to have had an inadequate response to the preferred self-administered (i.e., subcutaneous) biologic products. However, members transitioning to self-administered treatment after a single provider-administered first dose must still meet the preferred self-administered biologic product requirement.

NOTE: If the member has had an inadequate response to previous biologic therapy, other than certolizumab pegol, 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 an inadequate response to combination csDMARD, they do not have to try two csDMARDs in combination to meet medical necessity criteria). However, members self-administering certolizumab pegol must still meet the two preferred self-administered (i.e., subcutaneous) biologic product requirement.

Continuation of certolizumab (Cimzia) therapy meets the definition of medical necessity when ALL of the following are met:

1. Member has demonstrated a beneficial clinical response to certolizumab pegol therapy

2. An authorization or reauthorization for certolizumab 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. Certolizumab is not used in combination with ANY of the following:

a. abatacept (Orencia)

b. adalimumab (Humira)

c. anakinra (Kineret)

d. apremilast (Otezla)

e. brodalumab (Siliq)

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 certolizumab dosage does not exceed 400 mg every 28 days OR 200 mg every other 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 indications:

Certolizumab pegol is indication for:

• Reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy

• Treatment of adults with moderately to severely active rheumatoid arthritis

• Treatment of adult patients with active psoriatic arthritis

• Treatment of adults with active ankylosing spondylitis

Crohn’s Disease:

Initial Dose: 400 mg (given as 2 subcutaneous injections of 200 mg) initially, and at weeks 2 and 4.

Maintenance Dose: In members who obtain a clinical response, the recommended maintenance regimen is 400 mg every 4 weeks (starting at week 8).

Rheumatoid Arthritis, Active Psoriatic Arthritis, Active Ankylosing Spondylitis:

Initial Dose: 400 mg (given as 2 subcutaneous injections of 200 mg) initially, and at weeks 2 and 4.

Maintenance Dose: 200 mg every other week (starting at week 6). 400 mg every 4 weeks can be considered (starting at week 8).

Administration: Certolizumab is administered by subcutaneous injection. Rotate injection sites and do not give injections into areas where the skin is tender, bruised, red, or hard. When a 400 mg dose is needed (given as 2 subcutaneous injections of 200 mg), injections should occur at separate sites in the thigh or abdomen

Powder for solution: Prepare the lyophilized powder and administer by a health care provider.

Prefilled syringe: A member may self-inject certolizumab if a health care provider determines that it is appropriate, with medical follow-up, as necessary, after proper training in subcutaneous injection technique. Instruct members using certolizumab to inject the full amount in the syringe (1 mL).

Drug Availability: certolizumab is available as:

• 400 mg Kit Powder for Injection (requires reconstitution)

• 200 mg/mL prefilled syringe for injection

• 200 mg/mL starter kit

Refrigerate intact carton between 2 to 8 °C (36 to 46 °F). Do not freeze. Do not separate contents of carton prior to use. Protect solution from light.

PRECAUTIONS:

Contraindications - None

Boxed Warning

Infections: Increased risk of serious infections leading to hospitalization or death including 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 treatment 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 certolizumab. Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescents and young adults with inflammatory bowel disease. Certolizumab pegol is not indicated for use in pediatric patients.

WARNINGS

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

Invasive fungal infections: If a member develops a systemic infection while on certolizumab 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 certolizumab 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 certolizumab.

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

Lupus-like syndrome: discontinue certolizumab if syndrome develops.

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

Laboratory tests: may interfere with certain aPTT tests

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

Pregnancy and Lactation

o Certolizumab is classified as pregnancy category B. Developmental toxicity studies performed in animals have revealed no evidence of harm to the fetus.

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:

J0717

Injection, certolizumab pegol, 1 mg (code may be used for Medicare when drug administered under the direct supervision of a physician, not for use when self-administered)

ICD-10 Diagnosis Codes That Support Medical Necessity:

K50.00 – K50.919

Crohn’s disease [regional enteritis]

L40.50 – L40.59

Arthropathic psoriasis

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

M45.0 – M45.9

Ankylosing spondylitis

M46.81 – M46.89

Other specified inflammatory spondylopathies

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.

Crohn’s disease: a chronic granulomatous inflammatory disease of unknown etiology, involving any part of the gastrointestinal tract from mouth to anus, but commonly involving the terminal ileum with scarring and thickening of the bowel wall. It frequently leads to intestinal obstruction and fistula and abscess formation and has a high rate of recurrence after treatment.

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).

Mild-Moderate Crohn’s Disease: Mild-moderate Crohn's disease applies to ambulatory members able to tolerate oral alimentation without manifestations of dehydration, toxicity (high fevers, rigors, prostration), abdominal tenderness, painful mass, obstruction, or >10% weight loss.

Moderate to Severe Crohn’s Disease: Moderate to severe disease applies to patients who have failed to respond to treatment for mild to moderate disease or those with more prominent symptoms of fevers, significant weight loss, abdominal pain or tenderness, intermittent nausea or vomiting (without obstructive findings), or significant anemia.

Monoclonal antibody: derived from a single cell; pertaining to a single clone. Widely used to measure proteins and drugs in the serum, type tissue and blood, identify infectious agents, identify classification and follow-up therapy of leukemias and lymphomas, and identify tumor antibodies.

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.

RELATED GUIDELINES:

Abatacept (Orencia), 09-J0000-67

Adalimumab (Humira), 09-J0000-46

Anakinra (Kineret), 09-J0000-45

Apremilast (Otezla), 09-J2000-19

Etanercept (Enbrel), 09-J0000-38

Golimumab (Simponi), 09-J1000-11

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

Tocilizumab (Actemra) IV, 09-J1000-21

Tofacitinib (Xeljanz, Xeljanz XR), 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. Buchner AM, Blonski W, Lichtenstein GR. Update on the management of Crohn’s disease. Curr Gastroenterol Rep 2011;13:465-74.
  2. 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.
  3. Cimzia (certolizumab pegol) [package insert]. UCB Pharma Inc., Smyrna (GA): May 2016.
  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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COMMITTEE APPROVAL:

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

GUIDELINE UPDATE INFORMATION:

09/15/08

New Medical Coverage Guideline.

01/01/09

Annual HCPCS coding update: deleted code 90772; added codes 96372.

04/01/09

Annual HCPCS coding update: added HCPCS code C9249 & deleted J3490.

04/15/09

Revision; consisting adding ICD-9 codes.

06/15/09

Revision; consisting of adding rheumatoid arthritis indication and updating boxed warning.

10/15/09

Review and revision; consisting of updating administration and dosage section and references.

01/01/10

Annual HCPCS coding update: added HCPCS code J0718 and deleted code C9249.

04/15/10

Revision; consisting of adding specific continuation criteria.

08/15/10

Review and revision; consisting of updating precautions and references.

01/15/11

Revision; consisting of adding ICD-10 codes.

08/15/11

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

08/15/12

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

10/15/12

Revision to guideline; consisting of modifying continuation criteria.

01/15/13

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

03/07/13

Revision to guideline; additions to position statement.

04/15/13

Revision to guideline; consisting of revising position statement to include duration of approval.

09/15/13

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

01/01/14

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

04/15/14

Revision to guideline; consisting of updating position statement.

09/15/14

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

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.

12/15/15

Revision to guideline consisting of updating the position statement.

09/15/16

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

11/15/16

Revision to guideline consisting of updating position statement with ustekinumab prerequisite therapy requirement for Crohn’s disease indication.

10/15/17

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

Date Printed: December 18, 2017: 03:19 PM