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Date Printed: August 21, 2017: 07:44 PM

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09-J0000-46

Original Effective Date: 01/01/05

Reviewed: 08/10/16

Revised: 10/01/16

Subject: Adalimumab (Humira®)

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:

In the past ten years, parallel advances in technology and research in immune-mediated inflammatory diseases have led to a discovery that clinically unrelated conditions share similar immune dysregulation. This has led to a shift in the treatment for chronic, inflammatory diseases to utilize biological agents designed to target tumor necrosis factor (TNF). TNF, 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. Despite intensive research, the mechanism of action of this class is not completely understood. 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.

Adalimumab (Humira®) is one of five commercially available TNF-alpha inhibitors available in the United States. Adalimumab is approved by the US Food and Drug Administration (FDA) for the treatment of nine indications: ankylosing spondylitis (2006), Crohn’s disease (2007), hidradenitis suppurativa (2015), polyarticular juvenile idiopathic arthritis (2008), plaque psoriasis (2008), psoriatic arthritis (2005), rheumatoid arthritis (2002), ulcerative colitis (2012), and uveitis (2016). Humira also has orphan drug designation for the treatment of pediatric patients with ulcerative colitis (2011). The TNF-alpha inhibitors as a class are considered to have similar efficacy and safety for the majority of indications. Similar to other TNF-alpha inhibitors, the package labeling contains a Boxed Warning regarding potential increased risk of serious infections (e.g., tuberculosis) and certain malignancies during therapy.

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

NOTE: if the member has failed previous biologic therapy, other than adalimumab, (e.g., etanercept, golimumab, etc.) that is FDA-approved for the requested indication listed in Table 1, the member is not required to try and fail additional prerequisite therapy (e.g., for RA, if member has previously tried and failed etancercept, but does not have a history of combination DMARD failure, they do not have to try and fail two DMARDs in combination to meet medical necessity criteria).

Certificate of Medical Necessity

Submit a completed Certificate of Medical Necessity (CMN) along with your request to expedite the medical review process.

1. Click the link Adalimumab (Humira®) - Certificate of Medical Necessity (MS Word) to open the form.

2. Complete all fields on the form thoroughly.

3. Print and submit a copy of the form with your request.

Note: Florida Blue regularly updates CMNs. Ensure you are using the most current copy of a CMN before submitting to Florida Blue. For a complete list of available CMNs, visit the Certificates of Medical Necessity page.

Initiation of adalimumab (Humira) meets the definition of medical necessity when BOTH of the following are met:

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

2. Adalimumab is NOT administered concomitantly with ANY of the following:

a. abatacept (Orencia)

b. anakinra (Kineret

c. apremilast (Otezla)

d. certolizumab (Cimzia)

e. etanercept (Enbrel)

f. golimumab (Simponi)

g. infliximab (Remicade)

h. ixekizumab (Taltz)

i. secukinumab (Cosentyx)

j. tocilizumab (Actemra)

k. tofacitinib (Xeljanz)

l. ustekinumab (Stelara)

m. vedolizumab (Entyvio)

Table 1

Indications and Specific Criteria

Indication

Specific Criteria

Maximum Allowable Dose (SQ)

Axial Spondyloarthritis (axSpA)

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

When BOTH of the following are met:

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

2. Member has tried and failed or has a contraindication to at least TWO NSAID therapies (e.g., celecoxib, diclofenac, ibuprofen, meloxicam, naproxen) (the specific contraindications must be provided)

40 mg every other week

Crohn’s Disease (CD)

When ALL of the following are met:

1. Member is 6 years of age or older

2. Member has a diagnosis of moderately to severely active CD

3. Member has tried and failed or has a contraindication to ONE or more conventional therapies (e.g., sulfasalazine, mesalamine products, aminosalicylate, corticosteroids, immunosuppressants [6-mercaptopurine], azathioprine, cyclosporine, methotrexate) (the specific contraindication must be provided)

≥40 kg (88 lbs.):

• Initial: 160 mg at week 0 (day 1), and 80 mg at week 2 (day 15)

• Maintenance: 40 mg every other week beginning at week 4

17 kg (37 lbs.) to <40 kg (88 lbs.):

• Initial: 80 mg at week 0 (day 1), and 40 mg at week 2 (day 15)

• Maintenance: 20 mg every other week beginning at week 4

Hidradenitis Suppurativa (HS) (a.k.a., acne inversa)

*Smoking cessation is highly encouraged in members who smoke. Smoking may worsen the disease and make the disease more refractory to treatment*

When ALL of the following are met:

1. The initiation of adalimumab treatment is prescribed by a dermatologist, infectious disease specialist, or surgeon.

2. Member has previously tried and failed at least 60 consecutive days of therapy and/or has contraindications to ALL of the following treatments (the specific contraindications must be provided):

a. Oral clindamycin (or minocycline) in combination with oral rifampin*

*For members with a contraindication, persistent intolerable adverse effects, or unavoidable severe drug interactions with the use of rifampin, a trial of at least one oral anti-infective therapy is needed (failure of ANY or contraindications to ALL of the following):

• Clindamycin

• Dapsone

• Doxycycline

• Minocycline

b. Anti-androgenic therapy (failure of ANY or contraindications to ALL of the following):

• Spironolactone

• Dutasteride

• Finasteride

• Oral contraceptive containing an estrogen plus a non-androgenic progestin (i.e., desogestrel, dienogest, drospirenone, or norgestimate)

3. Member’s HS is determined to be moderate to severe (must meet BOTH of the following):

a. At least ONE of the following:

• Ten or more inflammatory nodules

• Diffuse or near-diffuse inflammatory involvement that precludes quantification of individual nodules

• Two or more abscesses or draining fistulas

• Five or more inflammatory nodules AND at least one abscess or draining fistula

b. EITHER of the following:

• The inflammatory lesions reoccur three or more times during a continuous 6-month time period

• There is persistent involvement of inflammatory lesions for at least 3 months

• Initial: 160 mg at week 0, followed by 80 mg at week 2 (day 15)

• Maintenance: 40 mg every week beginning at week 4 (day 29)

Plaque Psoriasis

When ALL of the following are met:

1. Member is 18 years of age or older

2. Member has moderately to severe chronic plaque psoriasis evidenced by EITHER of the following:

a. psoriasis covers more than 5% of BSA

b. psoriasis covers less than or equal to 5% of BSA, but affects crucial body areas (e.g., face, hands, feet, genitals)

3. Member has tried and failed or has a contraindication to methotrexate, or, if methotrexate is contraindicated, the member has tried and failed EITHER cyclosporine or acitretin, or has a contraindication to BOTH cyclosporine and acitretin (the specific contraindications must be provided; pregnancy is not considered a contraindication to the use of cyclosporine)

• Initial: 80 mg at week 0

• Maintenance: 40 mg every other week beginning at week 1

Polyarticular Juvenile Idiopathic Arthritis (PJIA) [previously known as Polyarticular Juvenile Rheumatoid Arthritis (PJRA)]

When ALL of the following are met:

1. Member is 2 years of age or older

2. Member’s disease is moderately to severely active

3. Member has tried and failed or has a contraindication to ONE or more DMARDs (e.g., methotrexate, sulfasalazine , cyclosporine, leflunomide) (the specific contraindication must be provided)

• ≥ 30 kg (66 lbs.): 40 mg every other week

• 15 kg (33 lbs.) to <30 kg (66 lbs.): 20 mg every other week

• 10 kg (22 lbs.) to <15 kg (33 lbs.): 10 mg every other week

Psoriatic Arthritis (PsA)

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

When BOTH of the following are met:

1. Member’s disease is active

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

a. Axial PsA: Member has tried and failed or has a contraindication to at least TWO different NSAID therapies (e.g., celecoxib, diclofenac, ibuprofen, meloxicam, naproxen) (the specific contraindications must be provided)

b. Peripheral PsA: Member has tried and failed or has a contraindication to at least ONE NSAID therapy (e.g., celecoxib, diclofenac, ibuprofen, meloxicam, naproxen) (the specific contraindication must be provided)

AND

Member has tried and failed or has a contraindication to methotrexate therapy, or, if methotrexate is contraindicated, to another DMARD (e.g., cyclosporine, leflunomide, sulfasalazine) (the specific contraindication must be provided)

40 mg every other week

Rheumatoid Arthritis (RA)

When ALL of the following are met:

1. Member is 18 years of age or older

2. Member’s disease is moderately to severely active

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

• 40 mg every other week

Ulcerative Colitis (UC)

When ALL of the following are met:

1. Member’s disease is moderately to severely active

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

a. Member has tried and failed 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]

3. Member has tried and failed 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. Topical aminosalicylates (e.g., enema or suppository)

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

• Initial: 160 mg at week 0, followed by 80 mg at week 2 (day 15)

• Maintenance: 40 mg every other week beginning at week 4 (day 29)

Uveitis

When ALL of the following are met:

1. The member has a diagnosis of non-infectious intermediate, posterior or panuveitis

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

a. Member has tried and failed 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]

• Initial: 80 mg at week 0

• Maintenance: 40 mg every other week beginning at week 1

NSAID, non-steroidal anti-inflammatory; SQ, subcutaneously; BSA, Body surface area; DMARD, Disease modifying anti-rheumatic drug

NOTE: if the member has failed previous biologic therapy, other than adalimumab, (e.g., etanercept, golimumab, etc.) that is FDA-approved for the requested indication listed in Table 1, the member is not required to try and fail additional pre-requisite therapy (e.g., for RA, if member has previously tried and failed etancercept, but does not have a history of combination DMARD failure, they do not have to try and fail two DMARDs in combination to meet medical necessity criteria).

Duration of approval: 6 months

Continuation of adalimumab (Humira®) therapy meets the definition of medical necessity when ALL of the following are met:

1. Member has a history of beneficial clinical response with adalimumab therapy for the treatment of a condition listed in Table 1

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

3. Adalimumab is NOT administered with ANY of the following:

a. abatacept (Orencia)

b. anakinra (Kineret)

c. certolizumab (Cimzia)

d. apremilast (Otezla)

e. etanercept (Enbrel)

f. golimumab (Simponi)

g. infliximab (Remicade)

h. ixekizumab (Taltz)

i. secukinumab (Cosentyx)

j. tocilizumab (Actemra)

k. tofacitinib (Xeljanz)

l. ustekinumab (Stelara)

m. vedolizumab (Entyvio)

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

a. Ankylosing spondylitis, juvenile idiopathic arthritis, uveitis, psoriatic arthritis, Crohn’s disease, ulcerative colitis, or plaque psoriasis: 40 mg once every other week

b. Hidradenitis suppurativa: 40 mg once every week

c. Rheumatoid arthritis: 40 mg once every week (if monotherapy), or 40 mg once every other week (if used in combination with another DMARD)

Duration of approval: 1 year

Adalimumab is considered experimental or investigational for all other indications since safety and effectiveness have not been established.

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.

Table 2

Table 2: FDA-approved indications and recommended dosing

Indication

Dosage

Ankylosing Spondylitis

40 mg every other week

Crohn’s Disease (CD)

Weight 17 kg to less than 40 kg:

• Initial: 80 mg at week 0, and 40 mg at week 2 (day 15)

• Maintenance: 20 mg every other week beginning at week 4

Weight 40 kg or greater:

• Initial: 160 mg at week 0, and 80 mg at week 2 (day 15)

• Maintenance: 40 mg every other week beginning at week 4

Hidradenitis Suppurativa

• Initial: 160 mg at week 0, followed by 80 mg at week 2 (day 15)

• Maintenance: 40 mg every week beginning at week 4 (day 29)

Juvenile Idiopathic Arthritis (JIA)

Dose is based on weight:

• 15 kg to 29.9 kg (33-66 lbs): 20 mg every other week

• 30 kg or more: 40 mg every other week

Plaque Psoriasis

• Initial: 80 mg at week 0

• Maintenance: 40 mg every other week beginning at week 1

Psoriatic Arthritis (PsA)

40 mg every other week

Rheumatoid Arthritis (RA)

• Concomitant DMARD: 40 mg every other week

• Monotherapy: 40 mg weekly

Ulcerative Colitis (UC)

• Initial: 160 mg at week 0, followed by 80 mg at week 2 (day 15)

• Maintenance: 40 mg every other week beginning at week 4 (day 29)

Uveitis

(non-infectious intermediate, posterior and panuveitis)

• Initial: 80 mg at week 0

• Maintenance: 40 mg every other week beginning at week 1

Administered as a subcutaneous injection

Dose Adjustments: dosage adjustments are not required for members with hepatic or renal impairment.

Drug Availability: adalimumab is available as a 20 mg/0.4 mL disposable prefilled syringe, a 40 mg/0.8 mL disposable pre-filled syringe, and a 40 mg/0.8 mL prefilled injection pen.

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.

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

WARNINGS

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

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

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

Lupus-like syndrome: discontinue adalimumab 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 adalimumab.

Pregnancy and Lactation

• Adalimumab is classified as pregnancy category B. Developmental toxicity studies performed in animals have revealed no evidence of harm to the fetus. There are no studies in pregnant women and use during pregnancy should only occur if clearly needed.

• 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:

HCPCS Coding:

J0135

Adalimumab (Humira) Injection 20 mg

ICD-10 Diagnoses Codes That Support Medical Necessity: (Effective 10/01/15)

H20.041 – H20.049

Secondary noninfectious iridocyclitis

H44.111 – H44.119

Panuveitis

K50.00 – K50.919

Crohn’s disease [regional enteritis]

K51.00 – K51.919

Ulcerative colitis

K52.3

Indeterminate colitis

L40.0

Psoriasis vulgaris

L40.50 – L40.59

Arthropathic psoriasis

L73.2

Hidradenitis suppurativa

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

M08.1

Juvenile ankylosing spondylitis

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

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.

DMARDs: An acronym for disease-modifying antirheumatic drugs.

Hidradenitis suppurativa (HS) (a.k.a., acne inversa): a chronic, inflammatory, recurrent, debilitating skin disease of the hair follicle that usually presents after puberty with painful, deep-seated, inflamed lesions in the apocrine gland-bearing areas of the body, most commonly the axillae, inguinal and anogenital regions. HS may have a large impact on quality of life, often causing depression, impaired sexual health, and embarrassment. Squamous cell carcinoma may arise from chronic (10-30 years of evolution) lesions. The main goals of treatment are to prevent the formation of new lesion, treat new lesions, and eliminate existing nodules and sinus tract to limit or prevent scar formation.

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.

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.

Plaque psoriasis: It is the most common form of psoriasis. It affects 80 to 90% of people with psoriasis. Plaque psoriasis typically appears as raised areas of inflamed skin covered with silvery white scaly skin. These areas are called plaques.

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 which 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

Anakinra (Kineret®), 09-J0000-45

Apremilast (Otezla®) Tablet, 09-J2000-19

Canakinumab (Ilaris®) Injection, 09-J1000-14

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

Etanercept (Enbrel®), 09-J0000-38

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

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

Ixekizumab (Taltz®), 09-J2000-62

Rilonacept (Arcalyst®) Injection, 09-J0000-89

Rituximab (Rituxan®), 09-J0000-59

Secukinumab (Cosentyx®), 09-J2000-30

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

Tofacitinib (Xeljanz) Tablets, 09-J1000-86

Ustekinumab (Stelara™), 09-J1000-16

Vedolizumab (Entyvio), 09-J2000-18

OTHER:

Table 3: DMARDs

DMARD Generic Name

DMARD Brand Name

Auranofin (oral gold)

Ridaura®

Azathioprine

Imuran®

Chlorambucil

Leukeran®

Cyclophosphamide

Cytoxan®

Cyclosporine

Neoral, Sandimmune®

Gold sodium thiomalate (injectable gold)

Myochrysine®

Hydroxychloroquine sulfate

Plaquenil®

Leflunomide

Arava®

Methotrexate

Rheumatrex®, Trexall®

Minocycline

Minocin®

Penicillamine

Cuprimine®, Depen®

Sulfasalazine

Azulfidine®, Azulfidine EN-Tabs®

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

Physician global assessment (PGA) of HS

• Clear: no inflammatory or non-inflammatory nodules

• Minimal: Only the presence of non-inflammatory nodules

• Mild: Less than 5 inflammatory nodules or 1 abscess or draining fistula and no inflammatory nodules

• Moderate: Less than 5 inflammatory nodules or one abscess or draining fistula and one or more inflammatory nodules or 2–5 abscesses or draining fistulas and less than ten inflammatory nodules

• Severe: 2–5 abscesses or draining fistulas and ten or more inflammatory nodules

• Very severe: More than 5 abscesses or draining fistulas

Table 4

Hurley’s classification of hydradenitis suppurativa

Stage

Description

I

Abscess formation, single or multiple without sinus tracts and scarring

II

Recurrent abscesses with sinus tracts and scarring; single or multiple widely separated lesions

III

Diffuse or almost diffuse involvement or multiple interconnected tracts and abscesses.

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

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COMMITTEE APPROVAL:

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

GUIDELINE UPDATE INFORMATION:

01/01/05

New Medical Coverage Guideline.

08/15/05

Revised and Updated: Updated description, dosage/administration. Deleted precautions, updated when services are not covered, billing/coding information, and definitions, table 1, references.

11/15/05

Updated when services are covered for psoriatic arthritis, updated ICD-9 codes, definitions, and references.

11/15/06

Scheduled review: added indication of ankylosing spondylitis, added ICD-9 code, corrected CPT-4 coding and updated references.

01/01/07

MCG revised to include Medicare Part D as program exception.

04/15/07

Revision; consisting of adding Crohn’s disease indication and ICD-9 code, related guidelines and definitions.

06/15/07

Review and revision; consisting of reformatting, updating related guidelines and references.

03/15/08

Revision; consisting of adding plaque psoriasis and juvenile idiopathic arthritis (JIA) as covered indications, rewording coverage criteria for Crohn’s disease, updated dosage and administration section, added ICD-9 codes and updated references.

05/15/08

Review and revision; consisting of reformatting, adding a black box warning under “PRECAUTIONS”, adding related guideline and updating references.

09/15/08

Revision of guideline; consisting of adding 3 ICD-9 codes.

01/01/09

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

09/15/09

Review and revision; consisting of updating references, boxed warning and ICD-9 coding.

04/15/10

Revision; consisting of adding specific continuation criteria.

08/15/10

Review and revision; consisting of adding age criteria to all indications, updated precautions and references.

01/15/11

Revision; consisting of adding ICD-10 codes.

04/01/11

Revision; consisting of adding dosage limitations.

08/15/11

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

08/15/12

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

09/15/12

Revision to guideline consisting of modifying plaque psoriasis criteria and continuation criteria.

11/15/12

Revision to guideline consisting of adding new indication of ulcerative colitis.

01/15/13

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

04/15/13

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

09/15/13

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

01/01/14

Revision to guideline; consisting of updating position statement.

04/15/14

Revision to guideline; consisting of reformatting and revising position statement to include clarifying language.

09/15/14

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

12/15/14

Revision to guideline; consisting of position statement, dosage/administration, references

09/15/15

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

11/01/15

Revision: ICD-9 Codes deleted.

11/15/15

Revision to guideline; consisting of updating description section, position statement, dosage/administration, and references based on a new FDA-approved indication.

02/15/16

Revision to guideline consisting of updating maximum dosages for pediatric patients in the position statement.

09/15/16

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

10/01/16

Revision: ICD-10 code updates

Date Printed: August 21, 2017: 07:44 PM