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09-J0000-39

Original Effective Date: 04/25/01

Reviewed: 08/10/16

Revised: 01/01/17

Subject: Infliximab (Remicade®) and Infliximab-dyyb (Inflectra®)

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.

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

DESCRIPTION:

Infliximab (Remicade®) is one of five commercially available tumor necrosis factor (TNF)-alpha inhibitors available in the United States and was the first to be approved in August 1998. In April 2016 a biosimilar version, infliximab-dyyb (Inflectra®), was approved by the FDA. In contrast to other TNF-alpha inhibitors that are typically administered subcutaneously, infliximab products are administered via an intravenous infusion only. It is usually administered in a physician’s office, outpatient setting, or infusion center. 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.

Tumor necrosis factor, a pro-inflammatory 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.

Infliximab is approved by the US Food and Drug Administration (FDA) for the treatment of rheumatoid arthritis, adult and pediatric Crohn’s disease, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and adult and pediatric ulcerative colitis. Infliximab also was granted orphan drug designation by the FDA for the treatment of juvenile rheumatoid arthritis (2002) and chronic sarcoidosis (2003). Biosimilar infliximab-dyyb is approved by the FDA for the same indications as Remicade with the exception of pediatric ulcerative colitis (due to Remicade’s marketing exclusive for this indication until 2018).The TNF-alpha inhibitors as a class are considered to have similar efficacy and safety for the majority of indications.

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., infliximab or infliximab-dyyb) 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:

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 infliximab or infliximab-dyyb, (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 prerequisite therapy (e.g., for RA, if member has previously tried and failed etanercept, 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 Infliximab (Remicade®) - 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 infliximab (Remicade) or infliximab-dyyb (Inflectra) meets the definition of medical necessity when BOTH of the following are met:

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

2. Infliximab or infliximab-dyyb is NOT administered concomitantly with ANY of the following:

a. abatacept (Orencia)

b. adalimumab (Humira)

c. anakinra (Kineret)

d. apremilast (Otezla)

e. certolizumab (Cimzia)

f. etanercept (Enbrel)

g. golimumab (Simponi)

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 (IV)

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 different NSAID therapies (e.g., celecoxib, diclofenac, ibuprofen, meloxicam, naproxen) (the specific contraindications must be provided)

Initial: 5 mg/kg at weeks 0,2, and 6

Maintenance: 5 mg/kg every 6 weeks starting at week 12

Crohn’s disease (CD)

When BOTH of the following are met:

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

2. 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)‡

• Pediatrics:

1. Initial: 5 mg/kg at weeks 0, 2, and 6

2. Maintenance: 5 mg/kg every 8 weeks starting at week 14

• Adults:

1. Initial: 5 mg/kg at weeks 0, 2, and 6

2. Maintenance: 10 mg/kg every 8 weeks starting at week 14

Fistulizing CD

Member has CD with one or more draining fistulas for at least 3 months

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 infliximab or infliximab-dyyb 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: 5 mg/kg at weeks 0, 2, and 6

• Maintenance: 10 mg/kg every 8 weeks starting at week 14

Immune-mediated colitis or enterocolitis induced by checkpoint inhibitor immunotherapy

When ALL of the following are met:

1. The member has severe (Grade 3) or life-threatening (Grade 4) colitis or enterocolitis

2. The member has been receiving treatment with any of the following immune checkpoint inhibitors:

a. Atezolizumab (Tecentriq®)

b. Ipilimumab (Yervoy®)

c. Nivolumab (Opdivo®)

d. Pembrolizumab (Keytruda®)

3. The immune checkpoint inhibitor has been permanently discontinued

4. The member has failed to respond to three or more days of high-dose, systemic corticosteroid treatment (at least 1 mg/kg prednisone or equivalent)

• 5 mg/kg X 1 dose; may repeat a second dose of 5 mg/kg two weeks later if needed

Plaque psoriasis

When ALL of the following are met:

1. Member is 18 years of age or older

2. Member has moderate to severe chronic plaque psoriasis evidence by EITHER of the following:

a. psoriasis covers greater than 5% of body surface area (BSA)

b. psoriasis covers 5% or less 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/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: 5 mg/kg at weeks 0, 2, and 6

Maintenance: 5 mg/kg every 8 weeks starting at week 14

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)

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., hydroxy-chloroquine, 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 hydroxy-chloroquine (the specific contraindications must be provided; pregnancy is not considered a contraindication to the use of sulfasalazine or hydroxychloroquine)

4. Infliximab or infliximab-dyyb will be used in combination with methotrexate unless member has a contraindication or intolerance to methotrexate (the specific contraindication or intolerance must be provided)

Initial: 3 mg/kg at weeks 0, 2, and 6

Maintenance: 10 mg/kg every 8 weeks starting at week 14

Takayasu arteritis

(a.k.a., Takayasu’s disease and aortic arch syndrome)

When ALL of the following are met:

1. Member’s disease is refractory to or member has a contraindication to oral immunosuppressive therapy (e.g., cyclophosphamide, methotrexate, azathioprine) (the specific contraindication must be provided)

2. Member’s disease is refractory to or member has a contraindication to systemic corticosteroids (the specific contraindication must be provided)

Initial: 5 mg/kg at weeks 0,2, and 6

Maintenance: 5 mg/kg every 8 weeks starting at week 14

Ulcerative colitis (UC)

When ALL of the following are met:

1. Member has moderately to severely active UC

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 aminosalicylate (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: 5 mg/kg at weeks 0, 2, and 6

Maintenance: 5 mg/kg every 8 weeks starting at week 14

Uveitis

When ALL of the following are met:

1. The member has a diagnosis of refractory non-infectious uveitis that is causing or threatening vision loss

2. Member’s disease is refractory to or member has a contraindication to oral immunosuppressive therapy (e.g., cyclophosphamide, methotrexate, azathioprine) (the specific contraindication must be provided)

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

a. Member’s disease is refractory to or member has a contraindication to systemic corticosteroids (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: 5 mg/kg at weeks 0,2, and 6

Maintenance: 5 mg/kg every 8 weeks starting at week 14

Wegener’s granulomatosis

When ALL of the following are met:

1. Member’s disease has been confirmed by biopsy

2. Member’s disease is active

3. Member’s disease is refractory to or member has a contraindication to oral immunosuppressive therapy (e.g., cyclophosphamide) (the specific contraindication must be provided)

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

a. Member’s disease is refractory to or member has a contraindication to systemic corticosteroids (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: 5 mg/kg at weeks 0 and 2

Maintenance: 5 mg/kg every 4 weeks starting at week 6

Chronic sarcoidosis

(orphan indication)

Diagnosis only

Initial: 5 mg/kg at weeks 0, 2 and 6

Maintenance: 5 mg/kg every 6 weeks starting at week 12

Juvenile rheumatoid arthritis (JRA) [a.k.a,, juvenile idiopathic arthritis (JIA)]

(orphan indication)

NSAID, non-steroidal anti-inflammatory drug; IV, intravenously; DMARD, Disease modifying anti-rheumatic drug

NOTE: if the member has failed previous biologic therapy, other than infliximab or infliximab-dyyb, (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 prerequisite therapy (e.g., for RA, if member has previously tried and failed etanercept, 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).

Approval duration: 6 months (all indications except immune-mediated colitis or enterocolitis induced by checkpoint inhibitor immunotherapy; 18-day approval for this indication only)

Continuation of infliximab (Remicade) or infliximab-dyyb (Inflectra) therapy meets the definition of medical necessity when ALL of the following are met:

1. Member has a history of beneficial clinical response with infliximab or infliximab-dyyb therapy for the treatment of a condition listed in Table 1 (except immune-mediated colitis or enterocolitis induced by checkpoint inhibitor immunotherapy; use the initiation criteria for this indication)

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

3. Infliximab or infliximab-dyyb is NOT administered concomitantly with ANY of the following:

a. abatacept (Orencia)

b. adalimumab (Humira)

c. anakinra (Kineret)

d. apremilast (Otezla)

e. certolizumab (Cimzia)

f. etanercept (Enbrel)

g. golimumab (Simponi)

h. ixekizumab (Taltz)

i. secukinumab (Cosentyx)

j. tocilizumab (Actemra)

k. tofacitinib (Xeljanz)

l. ustekinumab (Stelara)

m. vedolizumab (Entyvio)

4. The dose prescribed does not exceed the following indication specific maximum dose unless previously approved by another health plan or Florida Blue:

a. Ankylosing spondylitis, chronic sarcoidosis, juvenile rheumatoid arthritis: 5 mg/kg every 6 weeks

b. Plaque psoriasis, ulcerative colitis, psoriatic arthritis, Crohn’s disease and fistulizing CD (less than 18 years), uveitis associated with Behçet’s disease: 5 mg/kg every 8 weeks

c. Rheumatoid arthritis, Crohn’s disease and fistulizing CD (18 years or older): 10 mg/kg every 8 weeks

d. Wegener’s granulomatosis: 5 mg/kg every 4 weeks

Approval duration: 1 year

Infliximab (Remicade) or infliximab-dyyb (Inflectra) is considered experimental or investigational when administered for conditions other than those listed above, as there is insufficient clinical evidence to support its use.

DOSAGE AND 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:

FDA-approved indications and recommended dosing

Indication

Dosage†

Ankylosing Spondylitis

• Initial: 5 mg/kg at weeks 0, 2, and 6

• Maintenance: 5 mg/kg every 6 weeks (beginning at week 12)

Crohn’s Disease (CD):

Adults and Children (greater than 6 years of age)

Adults and Children (greater than 6 years of age):

• Initial: 5 mg/kg at weeks 0, 2, and 6

• Maintenance: 5 mg/kg every 8 weeks (beginning at week 14)

Note: In adult members the dose may be increased to 10 mg/kg in members who initially respond but then lose their response.

Plaque Psoriasis

• Initial: 5 mg/kg at weeks 0, 2, and 6

• Maintenance: 5 mg/kg every 8 weeks (beginning at week 14)

Psoriatic Arthritis (PsA)

Ulcerative Colitis (UC)

Adults and Children* (greater than 6 years of age)

Rheumatoid Arthritis (RA)

• Initial: 3 mg/kg at weeks 0,2,6

• Maintenance: 3 mg/kg every 8 weeks (beginning at week 14)

• Incomplete response: the dose can be increased up to 10 mg/kg or treatment interval can be decreased to every 4 weeks

Should be given in combination with methotrexate

Administered as an intravenous infusion

*Inflectra does not have an indication for pediatric UC. However, it was determined as safe and effective by the FDA for another pediatric indication (i.e., Crohn’s disease).

Dose Adjustment

• Renal Impairment: dosage adjustments are not required for members with renal impairment.

• Hepatic Impairment: although specific dosage adjustments are not available, infliximab or infliximab-dyyb should be used with caution in members with hepatic impairment.

Drug Availability:

• Remicade - 100 mg lyophilized infliximab in a single-use vial for injection

• Inflectra - 100 mg lyophilized infliximab-dyyb in a single-use vial for injection

PRECAUTIONS:

Boxed Warning

Infections: tuberculosis (TB), bacterial sepsis, invasive fungal infections, and other opportunistic infections, some fatal, have occurred. Discontinue infliximab or infliximab-dyyb if a member develops a serious infection. 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 infliximab products. Post-marketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescents and young adults with inflammatory bowel disease treated with a TNF blocker. Almost all had received azathioprine or 6-mercaptopurine concomitantly with a TNF-blocker at or prior to diagnosis.

CONTRAINDICATIONS

Infliximab and infliximab-dyyb are contraindicated in members who have experienced a severe hypersensitivity reaction to infliximab or infliximab-dyyb, to the inactive components of the product, or to any murine proteins.

Infliximab or infliximab-dyyb at doses greater than 5 mg/kg should not be administered to members with moderate to severe heart failure (New York Heart Association [NYHA] Functional Class III/IV).

WARNINGS

Serious Infections: infliximab or infliximab-dyyb should not be initiated in members during an active infection. If an infection develops, monitor carefully, and discontinue adalimumab if infection becomes serious. Patients greater than 65 years of age, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants such as corticosteroids or methotrexate may be at greater risk of infection.

Invasive fungal infections: If a member develops a systemic infection while on infliximab or infliximab-dyyb 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 infliximab or infliximab-dyyb and initiate anti-viral therapy.

Hepatotoxicity: rare severe hepatic reactions, some fatal or necessitating liver transplantation have occurred in those administered infliximab products. If jaundice and/or marked liver enzyme elevations occur, discontinue infliximab or infliximab-dyyb.

Demyelinating disease: exacerbation of new onset may occur

Cytopenia, pancytopenia: advise members to seek immediate medical attention if symptoms develop and consider discontinuing infliximab or infliximab-dyyb.

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

Lupus-like syndrome: discontinue infliximab or infliximab-dyyb 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 infliximab or infliximab-dyyb.

Pregnancy and Lactation

• Infliximab products are 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:

The following codes may be used to report these services:

HCPCS Coding:

J1745

Injection, infliximab, excludes biosimilar, 10 mg

Q5102

Injection, infliximab, biosimilar, 10 mg

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

D86.0 – D86.9

Sarcoidosis

H20.041 – H20.049

Secondary noninfectious iridocyclitis

H44.111 – H44.119

Panuveitis

K31.6

Fistula of stomach and duodenum

K50.00 – K50.919

Crohn's disease (regional enteritis)

K51.00 – K51.919

Ulcerative colitis

K52.3

Indeterminate colitis

K60.3

Anal fistula

K60.4

Rectal fistula

K60.5

Anorectal fistula

K63.2

Fistula of intestine

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

M08.00 – M08.09

Unspecified Juvenile rheumatoid arthritis

M08.1

Juvenile ankylosing spondylitis

M08.20 – M08.29

Juvenile rheumatoid arthritis with systemic onset

M08.3

Juvenile rheumatoid polyarthritis (seronegative)

M08.40 – M08.48

Pauciarticular juvenile rheumatoid arthritis

M08.80 – M08.89

Other juvenile arthritis

M08.80 – M08.99

Juvenile arthritis, unspecified

M31.30 – M31.31

Wegener’s granulomatosis

M31.4

Aortic arch syndrome [Takayasu]

M45.0 – M45.9

Ankylosing spondylitis

M46.81 – M46.89

Other specified inflammatory spondylopathies

N82.2

Fistula of vagina to small intestine

N82.3

Fistula of vagina to large intestine

N82.4

Other female intestinal-genital tract fistulae

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: No National Coverage Determination (NCD) was found at the time of the last guideline review date. The following Local Coverage Determination (LCD) was reviewed on the last guideline revised date: Infliximab (Remicade), (L33704) located at fcso.com.

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: is an inflammatory bowel disease characterized by severe, chronic inflammation of the intestinal wall or any portion of the gastrointestinal tract. The lower portion of the small intestine (ileum) and the rectum are most commonly affected by this disorder. Symptoms may include watery diarrhea and abdominal pain. The symptoms of Crohn's Disease can be difficult to manage and diagnosis is often delayed.

DMARDs: An acronym for disease-modifying antirheumatic drugs.

Enterocutaneous fistula: a fistula between the intestine and skin of the abdomen.

Immune checkpoint inhibitors: drugs that target molecules on certain immune cells that need to be activated (or inactivated) to start an immune response. Some types of cancer cells use these “checkpoints” to avoid being attacked by the body’s own immune system. Examples include CTLA-4 inhibitors [e.g., ipilimumab (Yervoy)]; PD-1 inhibitors (e.g., pembrolizumab (Keytruda), nivolumab (Opdivo)]; and PD-L1 inhibitors (e.g., atezolizumab (Tecentriq)].

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-Severe Crohn’s Disease: Moderate-severe disease applies to members who have failed to respond to treatment for mild-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.

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.

Remission: Remission refers to members who are asymptomatic or without inflammatory sequelae and includes members who have responded to acute medical intervention or have undergone surgical resection without gross evidence of residual disease. Members requiring steroids to maintain well-being are considered to be "steroid-dependent" and are usually not considered to be "in remission."

Rheumatoid arthritis: usually strikes between ages 20 and 50. Inflammation begins in a joint, usually those of the fingers and hands, resulting in pain, swelling, redness, and eventually joint deformity. It is considered an autoimmune disease, which can affect the entire body, causing fatigue, weight loss, weakness, fever, and loss of appetite. It affects each person differently, with symptoms ranging from mild to debilitating. In many cases, it is difficult to control. In about one in six cases, rheumatoid arthritis becomes severely debilitating and can shorten the life of the person affected.

Severe-Fulminant Disease: Severe-fulminant disease refers to members with persisting symptoms despite the introduction of steroids as outpatients, or individuals presenting with high fever, persistent vomiting, and evidence of intestinal obstruction, rebound tenderness, cachexia, or evidence of an abscess.

Ulcerative colitis: a chronic inflammatory disease of the colon that is of unknown cause and is characterized by diarrhea with discharge of mucus and blood, cramping abdominal pain, and inflammation and edema of the mucous membrane with patches of ulceration.

RELATED GUIDELINES:

Abatacept (Orencia®), 09-J0000-67

Adalimumab (Humira®), 09-J0000-46

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

Ixekizumab (Taltz®), 09-J2000-62

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

Natalizumab (Tysabri®) Injection, 09-J0000-73

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™) Injection, 09-J2000-18

OTHER:

Table 3: DMARDs

DMARD Generic Name

DMARD Brand Name

Auranofin (oral gold)

Ridaura

Azathioprine

Imuran

Cyclophosphamide

Cytoxan

Cyclosporine

Neoral, Sandimmune

Gold sodium thiomalate (injectable gold)

Myochrysine

Hydroxychloroquine sulfate

Plaquenil

Leflunomide

Arava

Methotrexate

Rheumatrex, Trexall

Minocycline

Minocin

Penicillamine

Cuprimine, Depen

Sulfasalazine

Azulfidine, Azulfidine EN-Tabs

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. Alhusayen R, Shear NH. Pharmacologic interventions for hidradenitis suppurativa: what does the evidence say? Am J Clin Dermatol. 2012 Oct 1;13(5):283-91.
  2. Barry RJ, Nguyen QD, Lee RW, et al. Pharmacotherapy for uveitis: current management and emerging therapy. Clin Ophthalmol. 2014 Sep 22;8:1891-911. doi: 10.2147/OPTH.S47778.
  3. 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.
  4. 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.
  5. Bressler B, Marshall JK, Bernstein CN, et al. Clinical practice guidelines for the medical management of nonhospitalized ulcerative colitis: the Toronto consensus. Gastroenterology. 2015 May;148(5):1035-1058.e3.
  6. Buchner AM, Blonski W, Lichtenstein GR. Update on the management of Crohn’s disease. Curr Gastroenterol Rep 2011;13:465-74.
  7. 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.
  8. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.;2016. URL www.clinicalpharmacilogy-ip.com. Accessed 7/14/16.
  9. Friedman CF, Proverbs-Singh TA, and Postow MA. Treatment of the Immune-Related Adverse Effects of Immune Checkpoint Inhibitors: A Review. JAMA Oncol. 2016 Jun 30.
  10. Gener G, Canoui-Poitrine F, Revuz JE, et al. Combination therapy with clindamycin and rifampicin for hidradenitis suppurativa: a series of 116 consecutive patients. Dermatology. 2009;219(2):148-54.
  11. Giardina A, Ferrante A, Ciccia F, et al. One year study of efficacy and safety of infliximab in the treatment of patients with ocular and neurological Behcet’s disease refractory to standard immunosuppressive drugs. Rheumatol Int 2011;31:33-7.
  12. 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.
  13. Gottlieb A, Korman NJ, Gordon KB, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 2. Psoriatic arthritis: overview and guidelines of care for treatment with an emphasis on the biologics. J Am Acad Dermatol. 2008 May;58(5):851-64. doi: 10.1016/j.jaad.2008.02.040
  14. Graudal N, Hubeck-Graudal T, Tarp S, et al. Effect of combination therapy on joint destruction in rheumatoid arthritis: a network meta-analysis of randomized controlled trials. PLoS One. 2014 Sep 22;9(9):e106408.
  15. Hsu S, Papp KA, Lebwohl MG, et al. Consensus guidelines for the management of plaque psoriasis. Arch Dermatol 2012;148(1):95-102.
  16. Inflectra (infliximab-dyyb) [package insert]. Hospira. Lake Forest (IL): April 2016.
  17. Ingram JR, Woo PN, Chua SL, et al. Interventions for hidradenitis suppurativa. Cochrane Database Syst Rev. 2015 Oct 7;(10):CD010081
  18. Levy-Clarke G, Jabs DA, Read RW, et al. Expert panel recommendations for the use of anti-tumor necrosis factor biologic agents in patients with ocular inflammatory disorders. Ophthalmology. 2014 Mar;121(3):785-96.e3.
  19. Khandalavala BN, Do MV. Finasteride in Hidradenitis Suppurativa: A "Male" Therapy for a Predominantly "Female" Disease. J Clin Aesthet Dermatol. 2016 Jun;9(6):44-50.
  20. Kornbluth A, Sachar DB, et al. Erratum: ulcerative colitis practice guidelines in adults: American College of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol 2010;105:500-23.
  21. Krause ML, Amin A, and Makol A. Use of DMARDs and biologics during pregnancy and lactation in rheumatoid arthritis: what the rheumatologist needs to know. Ther Adv Musculoskelet Dis. 2014 Oct; 6(5): 169–184.
  22. Kroon FP, van der Burg LR, Ramiro S, et al. Non-steroidal anti-inflammatory drugs (NSAIDs) for axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis). Cochrane Database Syst Rev. 2015 Jul 17;7:CD010952.
  23. Lichtenstein GR, Hanauer SB, Sanborn WJ, et al. Management of Crohn’s disease in adults. Am J Gastroenterol 2009;104(2):465-83.
  24. Menter A, Gottlieb A, Feldman SR, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 2008 May;58(5):826-50.
  25. Menter A, Gottlieb A, Feldman SR, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 2008 May;58(5):826-50.
  26. Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions. J Am Acad Dermatol 2011;65:137-74.
  27. Micromedex® Healthcare Series [Internet Database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed 7/14/16.
  28. National Collaborating Centre for Chronic Conditions (UK). Rheumatoid Arthritis: National Clinical Guideline for Management and Treatment in Adults. London: Royal College of Physicians (UK); 2009 Feb (updated 2015 Dec).
  29. National Comprehensive Cancer Network (NCCN). Clinical practice guidelines in oncology. Version 3.2016. Melanoma. Available at http://www.nccn.org/professionals/physician_gls/PDF/melanoma.pdf. Accessed 8/5/16.
  30. National Institute for Health and Clinical Excellence (NICE). Psoriasis: the assessment and management of psoriasis. London (UK): National Institute for Health and Clinical Excellence (NICE); 2012 Oct. 61 p. (NICE clinical guideline; no. 153).
  31. Okada A, Goto H, Ohno S, et al. Multicenter study of infliximab for refractory uveoretinitis in Behcet disease. Arch Opthalmol 2012;130(5):592-98.
  32. Rahimi R, Nikfar S, Rezaie A, et al. Pregnancy outcome in women with inflammatory bowel disease following exposure to 5-aminosalicylic acid drugs: a meta-analysis. Reprod. Toxicol;2008:25,271–275.
  33. Rambhatla PV, Lim HW, Hamzavi I. A systematic review of treatments for hidradenitis suppurativa. Arch Dermatol. 2012 Apr;148(4):439-46.
  34. Remicade (infliximab) [package insert]. Janssen Biotech, Inc. Horsham (PA): February 2016.
  35. Ringold S, Weiss PF, Beukelman T. 2013 Update of the 2011 American College of Rheumatology Recommendations for the Treatment of Juvenile Idiopathic Arthritis, Recommendations for the Medical Therapy of Children With Systemic Juveline Idiopathic Arthritis and Tuberculosis Screening Among Children Receiving Biologic Medications. Arthritis & Rheumatism. Oct 2013;65(10):2499-2512.
  36. Rudwaleit M, van der Heijde D, Landewé R, et al. The Assessment of SpondyloArthritis International Society classification criteria for peripheral spondyloarthritis and for spondyloarthritis in general. Ann Rheum Dis. 2011 Jan;70(1):25-31.
  37. Scott DL, Ibrahim F, Farewell V, et al. Tumour necrosis factor inhibitors versus combination intensive therapy with conventional disease modifying anti-rheumatic drugs in established rheumatoid arthritis: TACIT non-inferiority randomised controlled trial. BMJ. 2015 Mar 13;350:h1046.
  38. Scott DL, Kinglsey GH. Tumor necrosis factor inhibitors in rheumatoid arthritis. N Engl J Med 2006;355:704-12.
  39. Serra R, Butrico L, Fugetto F, et al. Updates in Pathophysiology, Diagnosis and Management of Takayasu Arteritis. Ann Vasc Surg. 2016 May 27.
  40. Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2016 Jan;68(1):1-25
  41. Tracey D, Klareskog L, Sasso EH, et al. Tumor necrosis factor antagonist mechanism of action: a comprehensive review. Pharmacol Ther 2008;117:244-79.
  42. van Vollenhoven RF, Geborek P, Forslind K, et al. Conventional combination treatment versus biological treatment in methotrexate-refractory early rheumatoid arthritis: 2 year follow-up of the randomised, non-blinded, parallel-group Swefot trial. Lancet. 2012 May 5;379(9827):1712-20.

COMMITTEE APPROVAL:

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

GUIDELINE UPDATE INFORMATION:

04/25/01

Medical Coverage Guideline developed.

04/25/02

Reviewed, revised coverage for Crohn’s disease.

08/15/02

Revised coverage for Crohn’s disease.

04/01/05

Revised with updates: Added maintenance therapy to fistulizing Crohn’s. Added coverage for psoriatic arthropathy and ankylosing spondylitis. Updated dosing.

11/15/05

Revised; added coverage for ulcerative colitis, updated dosage and administration, deleted warnings and contraindications section, updated references and Internet links.

01/01/06

CPT coding update: deleted expired codes 90780, 90781 and added new codes 90765, 90766.

11/15/06

Scheduled review: added psoriasis indication and ICD-9 code, updated code descriptions and updated references.

01/01/07

MCG revised to include Medicare Part D as a program exception.

02/15/07

Revised by adding CPT-4 codes 96413 & 96415.

06/15/07

Review and revision to guideline; consisting of reformatting, removed ICD-9 codes 557.0 and 619.1, added ICD-9 code 714.2, added statement saying Remicade® is a first line agent and updated references.

05/15/08

Review and revision to guideline; consisting of reformatting, added black box warning.

01/01/09

Annual HCPCS coding update: deleted 90765 and 90766; added 96365 and 96366.

05/15/09

Revision to guideline; consisting of adding maximum dose for each indication.

09/15/09

Review and revision to guideline; consisting of updating boxed warning, updating the references, and rewording dosing maximums within the position statement.

04/15/10

Revision to guideline; consisting of adding specific continuation criteria.

09/15/10

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

01/15/11

Revision to guideline; consisting of adding ICD-10 codes.

09/15/11

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

09/15/12

Review and revision to guideline; consisting of modifying continuation criteria, updating dosage, precautions, exceptions and references.

01/15/13

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

4/15/13

Revision to guideline; consisting of adding Orphan Drug Indications and duration of approval.

09/15/13

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

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 revising position statement, updated references, coding, and related guidelines.

09/15/15

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

10/01/15

Revision consisting of update to Program Exceptions section.

11/01/15

Revision: ICD-9 Codes deleted.

07/01/16

Revision to guideline consisting of updating HCPCS codes.

09/15/16

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

10/01/16

Revision: ICD-10 code updates.

01/01/17

Revision: updated HCPCS code J1745 description.

Date Printed: June 28, 2017: 11:54 PM