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09-J1000-16

Original Effective Date: 02/15/10

Reviewed: 08/10/16

Revised: 04/01/17

Subject: Ustekinumab (Stelara®)

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:

Psoriasis occurs in approximately 1 to 3% of the population and while there are several variations, chronic plaque psoriasis is the most common presentation. In 2012, the Canadian Guidelines for the management of plaque psoriasis were reviewed by the National Psoriasis Foundation Medical Board; the updated guideline includes recommendations on the use of newly approved agents and reflects practice patterns in the United States. The guideline supports the use of the following agents as first-line treatment options for moderate to severe plaque psoriasis: cyclosporine, methotrexate, adalimumab (Humira), etanercept (Enbrel), ustekinumab (Stelara), and alefacept (Amevive; removed from the US market in 2012). While methotrexate must be avoided in women who are pregnant or trying to become pregnant, cyclosporine and anti-TNF biologics are considered to be low-risk options during pregnancy if systemic therapy cannot be avoided. While not a first-line agent for psoriasis, sulfasalazine has adequate data supporting safe use (pregnancy Category B), and is consider a preferred DMARD if given with folic acid when systemic treatment is clinically necessary.

Ustekinumab, an interleukin (IL)-12 and IL-23 antagonist, was approved by the US Food and Drug Administration (FDA) in September 2009 for the treatment of adults with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and then for psoriatic arthritis (PsA) in September 2013. In September 2016 ustekinumab received an additional approval for the treatment of adult patients with moderately to severely active Crohn’s disease (CD) who have: (1) failed or were intolerant to treatment with immunomodulators or corticosteroids, but never failed a tumor necrosis factor (TNF) blocker, or (2) failed or were intolerant to treatment with one or more TNF blockers. Unlike for treatment of psoriasis and PsA, treatment of Crohn’s requires an initial weight-based, IV-only loading dose Ustekinumab’s approval for Crohn’s disease was based on the results of three randomized, double-blind, placebo-controlled trials in patients with moderately to severely active Crohn’s disease (Crohn’s Disease Activity Index [CDAI] score of 220 to 450). There were two 8-week IV induction studies (CD-1 and CD-2) followed by a 44-week subcutaneous randomized withdrawal maintenance study (CD-3) representing 52 weeks of therapy. In the CD-3 maintenance study the following results were obtained.

 

Placebo

(n = 131)

Stelara 90 mg q8 weeks

(n = 128)

Treatment difference

(95% CI)

Clinical Remission

47 (36%)

68 (53%)

17%

(5%, 29%)

Clinical Response

58 (44%)

76 (59%)

15%

(3%, 27%)

Clinical Remission in patients in remission at the start of maintenance therapy

36/79 (46%)

52/78 (67%)

21%

(6%, 36%)

Ustekinumab’s approval for plaque psoriasis was based on the results of two multicenter, randomized, double-blind, placebo-controlled phase III trials (PHOENIX 1 and PHOENIX 2). Subjects were randomized to receive ustekinumab 45 mg, ustekinumab 90 mg, or placebo every 12 weeks with crossover to ustekinumab at week 12. The primary efficacy endpoint was the proportion of subjects achieving 75% reduction in Psoriasis Area and Severity Index (PASI 75) and Physician Global Assessment (PGA) of "cleared or minimal" at week 12. In PHOENIX 1, 67% of patients achieved a PASI 75 response and 59% achieved a PGA of "cleared or minimal" in the 45 mg ustekinumab group; similar rates of response were seen in the 90 mg ustekinumab group (66% achieved a PASI 75 response and 61% achieved a PGA of "cleared or minimal"). The results were similar in PHOENIX 2: 67% achieved a PASI 75 and 76% a desired PGA score in the 45 mg group, and 68% in PASI 75 and 73% a PGA score in the 90 mg group.

Based on the manufacturer’s labeling, the recommended dose of ustekinumab is weight-based. A study by Lebwohl et al, analyzed data pooled from PHOENIX 1 and 2 to assess the impact of body weight on the efficacy, safety, and pharmacokinetics of ustekinumab. This analysis was based on previous analyses that have suggested that adjusting the dose of biologic agents based on weight may be useful in achieving optimal drug concentrations associated with efficacy, and may prevent excessive drug exposure in lighter weight patients. The differences in PASI 75 response rates between the 45 mg and 90 mg doses were calculated for each 10 kg weight category across studies. In the clinical response evaluation, PASI 75 response rates were similar among subjects receiving 45 mg or 90 mg dose in subpopulations weighing 100 kg or less: 76.9% vs. 80.8% (P = 0.1823). However, in subgroups weighing more than 100 kg, PASI 75 response rates were approximately 20% higher in subjects receiving 90 mg when compared those receiving 45 mg (74.2% vs. 54.6%, p < 0.0001). While PASI 75 response rates were higher in patients >100 kg receiving a 90 mg dosage, the majority of patients (55%) were still able to achieve a PASI 75 with a 45 mg dosage. In addition, over one-quarter (28%) of patients >100 kg were able to achieve a PASI 90 with a 45 mg dosage. This indicates that a starting dose of 45 mg, regardless of weight, is adequate for many patients, and more cost-effective than a 90 mg starting dose. Patients >100 kg with an inadequate response can be increased to a dose of 90 mg.

POSITION STATEMENT:

Comparative Effectiveness

The Food and Drug Administration has deemed the subcutaneous formulations of the drug(s) or biological product(s) in this coverage policy to be appropriate for self-administration or administration by a caregiver (i.e., not a healthcare professional). Therefore, coverage (i.e., administration) of the subcutaneus formulations in a provider-administered setting such as an outpatient hospital, ambulatory surgical suite, physician office, or emergency facility is not considered medically necessary.

 

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 Ustekinumab (Stelara®) - 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.

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 ustekinumab, that is FDA-approved for the requested indication listed in Table 1, the member is not required to try and fail additional non-biologic prerequisite therapy (e.g., for psoriasis, if member has previously tried and failed etanercept, but does not have a history of methotrexate failure, they do not have to try and fail methotrexate to meet medical necessity criteria).

Initiation of intravenous ustekinumab (Stelara) meets the definition of medical necessity when ALL of the following criteria are met:

1. Member has a diagnosis of moderately to severely active Crohn’s disease (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)‡

3. Ustekinumab will NOT be used 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. Infliximab (Remicade)

i. Ixekizumab (Taltz)

j. Tocilizumab (Actemra)

k. Tofacitinib (Xeljanz)

l. Ustekinumab (Stelara)

m. Vedolizumab (Entyvio)

4. Member is 18 years of age or older

5. The dosage does not exceed the following based on the member’s weight:

a. ≤55 kg: 260 mg (two 130 mg vials) X 1 dose

b. >55 to 85 kg: 390 mg (three 130 mg vials) X 1 dose

c. >85 kg: 520 mg (four 130 mg vials) X 1 dose

6. Member has not received a previous dose of ustekinumab (IV or SC) in the past 12 months

Approval duration: one dose only

Initiation of subcutaneous ustekinumab (Stelara) meets the definition of medical necessity when ALL of the following criteria are met:

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

2. Ustekinumab will NOT be used concomitantly with any of the following:

n. Abatacept (Orencia)

o. Adalimumab (Humira)

p. Anakinra (Kineret)

q. Apremilast (Otezla)

r. Certolizumab (Cimzia)

s. Etanercept (Enbrel)

t. Golimumab (Simponi)

u. Infliximab (Remicade)

v. Ixekizumab (Taltz)

w. Tocilizumab (Actemra)

x. Tofacitinib (Xeljanz)

y. Ustekinumab (Stelara)

z. Vedolizumab (Entyvio)

3. Member is 18 years of age or older

Table 1

Indications and Specific Criteria

Indication

Criteria

Max Allowable Dosage

Crohn’s Disease (CD)

When ALL 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)

• 90 mg given 8 weeks after the initial IV dose, then every 8 weeks thereafter (i.e., week 8, week 16, week 24, etc.).The dose to be given on week 32 requires reauthorization.

Psoriatic Arthritis (PsA)

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

When ALL 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

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

• 45 mg every 4 weeks for 2 doses (weeks 0 and 4) during the first 12 weeks of treatment. The dose to be given on week 16 requires reauthorization.

• Exception: members with co-existent moderate-to-severe plaque psoriasis weighing >100 kg (220 lbs.) may receive the 90 mg dose every 4 weeks for 2 doses (weeks 0 and 4) during the first 12 weeks of treatment.

Plaque Psoriasis

When ALL of the following are met:

1. Member’s disease is moderate to severe as evidenced by documentation of EITHER of the following

a. Psoriasis covers more than 5% of member’s body surface area (BSA)

b. Psoriasis covers less than 5% of member’s BSA but affects crucial body areas necessary for daily living activities (e.g., face, hands, feet, genitals)

2. 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)

• 45 mg every 4 weeks for 2 doses (weeks 0 and 4) during the first 12 weeks of treatment. The dose to be given on week 16 requires reauthorization.

• Exception: members with co-existent psoriatic arthritis weighing >100 kg (220 lbs.) may receive the 90 mg dose every 4 weeks for 2 doses (weeks 0 and 4) during the first 12 weeks of treatment.

Approval duration:

Crohn’s Disease: 24 weeks (to allow three SC doses after the initial IV loading dose)

Other Indications: 12 weeks

 

NSAID - non-steroidal anti-inflammatory drug

‡NOTE: If the member has failed previous biologic therapy, other than ustekinumab, that is FDA-approved for the requested indication listed in Table 1, the member is not required to try and fail additional non-biologic prerequisite therapy (e.g., for psoriasis, if member has previously tried and failed etanercept, but does not have a history of methotrexate failure, they do not have to try and fail methotrexate to meet medical necessity criteria).

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

1. An authorization/reauthorization for ustekinumab 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.

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

a. Member has demonstrated a beneficial response to therapy for the treatment of moderate to severe Crohn’s disease, moderate to severe plaque psoriasis or active psoriatic arthritis.

b. ALL of the following (applicable to the psoriasis and psoriatic arthritis indications ONLY):

i. Member’s weight is >100 kg

ii. Member is currently receiving a dose of 45 mg

iii. Member had an inadequate treatment response after the first 90 days

iv. Member’s dose will be increased to 90 mg

3. Ustekinumab 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. Infliximab (Remicade)

i. Ixekizumab (Taltz)

j. Secukinumab (Cosentyx)

k. Tocilizumab (Actemra)

l. Tofacitinib (Xeljanz)

m. Vedolizumab (Entyvio)

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

a. Crohn’s disease

i. 90 mg every 8 weeks (regardless of weight)

b. Psoriatic arthritis

i. Members without co-existent moderate to severe plaque psoriasis (independent of weight): 45 mg every 12 weeks starting 12 weeks after the previous dose

ii. Members with co-existent moderate to severe plaque psoriasis and less than or equal to 100 kg: 45 mg every 12 weeks starting 12 weeks after the previous dose

iii. Members with co-existent moderate to severe plaque psoriasis and greater than 100 kg: 90 mg every 12 weeks starting 12 weeks after the previous dose, AND the member previously had an inadequate response to an initial dose of 45 mg*

c. Plaque psoriasis

i. Members greater than 100 kg: 90 mg every 12 weeks starting 12 weeks after the previous dose, AND the member previously had an inadequate response to an initial dose of 45 mg*

ii. Members less than or equal to 100 kg: 45 mg every 12 weeks starting 12 weeks after the previous dose

*Members who have been previously approved for a dose of 90 mg are NOT required to have tried a 45 mg dose.

Approval duration: 1 year

Ustekinumab meets the definition of medical necessity when administered for the following Orphan Drug Indication when the maintenance dosage does not exceed 90 mg every 12 weeks:

1. Type 1 diabetes mellitus in members with residual beta-cell function

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: ustekinumab is indicated for: (1) the treatment of adults with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, for the treatment of adults with active psoriatic arthritis, alone or in combination with methotrexate, and for the treatment of adult patients with moderately to severely active Crohn’s disease who have: (a) failed or were intolerant to treatment with immunomodulators or corticosteroids, but never failed treatment with a tumor necrosis factor (TNF) blocker or (b) failed or were intolerant to treatment with one or more TNF blockers . The recommended dose is based on weight for the treatment of plaque psoriasis:

• 100 kg or less: 45 mg every 4 weeks at weeks 0 and 4, followed by 45 mg every 12 weeks beginning at week 16.

• Greater than 100 kg: 90 mg every 4 weeks at weeks 0 and 4, followed by 90 mg every 12 weeks beginning at week 16.

The recommended dose for the treatment of active psoriatic arthritis is 45 mg every 4 weeks at weeks 0 and 4, followed by 45 mg every 12 weeks beginning at week 16. In persons with co-existent moderate to severe plaque psoriasis who weight greater than 100 kg, the recommended dose is 90 mg every 4 weeks at weeks 0 and 4, followed by 90 mg every 12 weeks beginning at week 16.

The recommended dosage for the treatment of Crohn’s disease is weight-based for the initial IV loading dose but then a fixed maintenance dosage. The loading dose is: ≤55 kg: 260 mg (two 130 mg vials) X 1 dose; >55 to 85 kg: 390 mg (three 130 mg vials) X 1 dose; >85 kg: 520 mg (four 130 mg vials) X 1 dose (on week 0) given as an IV infusion in 250 mL (using normal saline) over at least one hour. The maintenance dose is 90 mg given as a subcutaneous injection 8 weeks after the initial IV dose (week 8), then every 8 weeks thereafter.

Ustekinumab should be administered as a subcutaneous injection with the exception of the initial IV infusion loading dose for Crohn’s disease. Although initially approved only for administration by a healthcare professional, ustekinumab was approved for subcutaneous self-administration in June 2013.

Drug availability: ustekinumab is supplied in the following dosage forms and strengths

• Single-dose prefilled syringe: 45 mg/0.5 mL, 90 mg/1 mL (both for SQ use)

• Single-dose vial: 45 mg/0.5 mL (for SQ use), 130 mg/26 mL (5 mg/mL) (for IV infusion)

PRECAUTIONS:

Contraindication: ustekinumab is contraindicated in persons with clinically significant hypersensitivity to ustekinumab or any of the excipients.

Warnings

• Infections: Serious infections have occurred. Do not start ustekinumab during any clinically important active infection. If a serious infection develops, discontinue therapy until the infection resolves.

• Theoretical Risk for Particular Infections: Serious infections from mycobacteria, salmonella and Bacillus Calmette-Guerin (BCG) vaccinations have been reported in persons genetically deficient in IL-12/IL-23. Diagnostic tests for these infections should be considered as dictated by clinical circumstances.

• Tuberculosis (TB): Evaluate individuals for TB prior to initiating treatment with ustekinumab. Initiate treatment of latent TB before administering ustekinumab

• Malignancies: ustekinumab may increase risk of malignancy. The safety of ustekinumab in persons with a history of or a known malignancy has not been evaluated.

• Anaphylaxis or other clinically significant hypersensitivity reactions may occur.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): One case was reported. If suspected, treat promptly and discontinue ustekinumab.

• Immunization: do not administer live vaccines with ustekinumab.

• Reversible Posterior Leukoencephalopathy Syndrome (RPLS): One case was reported. If suspected, treat promptly and discontinue ustekinumab.

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding:

C9487

Ustekinumab, for intravenous injection, 1 mg (hospital outpatient use ONLY)

J3357

Ustekinumab, for subcutaneous injection, 1 mg

J3590

Unclassified biologics [for the 130 mg/26 mL (5 mg/mL) formulation for IV infusion]

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

E10.10 - E10.9

Type 1 diabetes mellitus

K50.00 – K50.919

Crohn’s disease [regional enteritis]

L40.0

Psoriasis vulgaris

L40.50

Arthropathic psoriasis, unspecified

L40.51

Distal interphalangeal psoriatic arthropathy

L40.52

Psoriatic arthritis mutilans

L40.53

Psoriatic spondylitis

L40.59

Other psoriatic arthropathy

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.

Bacillus Calmette-Guérin (BCG): a vaccine against tuberculosis that is prepared from a strain of the attenuated (weakened) live bovine tuberculosis bacillus, Mycobacterium bovis.

DMARDs: An acronym for disease-modifying antirheumatic drugs.

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: 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.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): a neurological disorder, which is not caused by demyelination or a known infectious agent. RPLS can present with headache, seizures, confusion and visual disturbances. Conditions with which it has been associated include preeclampsia, eclampsia, acute hypertension, cytotoxic agents and immunosuppressive therapy. Fatal outcomes have been reported.

RELATED GUIDELINES:

Adalimumab (Humira®), 09-J0000-46

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

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) Injection, 09-J2000-62

Natalizumab (Tysabri) IV, 09-J0000-73

Psoralens with Ultraviolet A (PUVA), 02-10000-16

Secukinumab (Cosentyx®), 09-J2000-30

Vedolizumab (Entyvio), 09-J2000-18

OTHER:

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

REFERENCES:

  1. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.;2016. URL www.clinicalpharmacilogy-ip.com, Accessed 7/14/16.
  2. 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.
  3. 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.
  4. Gottlieb A, Menter A, Mendelsohn A, et al. Ustekinumab, a human interleukin 12/23 monoclonal antibody, for psoriatic arthritis: randomised, double-blind, placebo-controlled, crossover trial. Lancet. Feb 21 2009; 373(9664):633-640.
  5. Griffiths CE, Strober BE, van de Kerkhof P, et al. Comparison of Ustekinumab and Etanercept for Moderate-to-Severe Psoriasis. N Engl J Med 2010; 362:118-28.
  6. Hazelwood GS, Rezaie A, Borman M, et al. Comparative effectiveness of immunosuppressants and biologics for inducing and maintaining remission in Crohn’s disease: a network meta-analysis. Gastroenterology 2014; doi: 10.1053/j.gastro.2014.10.011.
  7. Hsu S, Papp KA, Lebwohl MG, et al. Consensus guidelines for the management of plaque psoriasis. Arch Dermatol 2012;148(1):95-102.
  8. Kavanaugh A, Ritchlin C, Rahman P et al. Ustekinumab, an anti-IL-12/23 p40 monoclonal antibody, inhibits radiographic progression in patients with active psoriatic arthritis: results of an integrated analysis of radiographic data from the phase 3, multicentre, randomised, double-blind, placebo-controlled PSUMMIT-1 and PSUMMIT-2 trials. Ann Rheum Dis 2014; 73: 1000-6.
  9. Khanna R, Preiss JC, MacDonald JK, et al. Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease. Cochrane Database Syst Rev. 2015 May 5;(5):CD007572.
  10. Kimball AB, Papp KA, Wasfi Y, et al. Long-term efficacy of ustekinumab in patients with moderate-to-severe psoriasis treated for up to 5 years in the PHOENIX 1 study. J Eur Acad Dermatol Venereol. 2013 Dec;27(12):1535-45. doi: 10.1111/jdv.12046. Epub 2012 Dec 20.
  11. 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.
  12. Lebwohl M, Yeilding N, Szapary P, et al. Impact of weight on the efficacy and safety of ustekinumab in patients with moderate to severe psoriasis: rationale for dosing recommendations. J Am Acad Dermatol 2010;63(4):571-79.
  13. Leonardi CL, Kimball AB, Papp KA, et al. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomized, double-blind, placebo-controlled trial (PHOENIX 1). Lancet 2008;371(9625):1665-74.
  14. Marwaha AK, Tan S, Dutz JP.Targeting the IL-17/IFN-γ axis as a potential new clinical therapy for type 1 diabetes. Clin Immunol. 2014 Sep;154(1):84-9. doi: 10.1016/j.clim.2014.06.006. Epub 2014 Jun 16. Review.
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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:

02/15/10

New Medical Coverage Guideline.

04/15/10

Revision to guideline; consisting of adding specific continuation criteria.

01/01/11

Revision to guideline; consisting of updating coding.

09/15/11

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

09/15/12

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

09/15/13

Review and revision to guideline; consisting of revising description, position statement, dosage/administration, and precautions; updated program exceptions and references.

01/01/14

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

04/15/14

Revision to guideline; consisting of revising position statement.

09/15/14

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

09/15/15

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

11/01/15

Revision: ICD-9 Codes deleted.

11/15/15

Revision to guideline consisting of updating maximum starting dosage in the position statement.

02/24/16

Revision to guideline consisting of updating the position statement.

09/15/16

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

11/15/16

Revision to guideline, based on a new FDA-approved indication and IV formulation, consisting of updating the description section, position statement, dosage/administration section, billing/coding, related guidelines, and references.

01/01/17

Revision: updated HCPCS code J3357 description.

01/15/17

Revision to guideline to separate the authorizations for the IV and SC formulations for Crohn’s disease.

04/01/17

Revision to guideline consisting of adding HCPCS code C9487.

Date Printed: June 23, 2017: 06:31 PM