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09-J2000-30

Original Effective Date: 03/15/15

Reviewed: 09/13/17

Revised: 10/15/17

Subject: Secukinumab (Cosentyx®)

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:

Secukinumab (Cosentyx) was approved by the U.S. Food and Drug Administration (FDA) in January 2015 for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. In January 2016 the FDA approved two additional indications, the treatment of adult patients with active psoriatic arthritis and the treatment of adult patients with active ankylosing spondylitis. Secukinumab is a human IgG1 monoclonal antibody that selectively binds to the interleukin-17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. It was the first-in-class biologic agent to target IL-17. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Secukinumab inhibits the release of proinflammatory cytokines and chemokines.

Psoriasis is a chronic, inflammatory disease that affects approximately 3% of the adult US population. Approximately 80% of patients with psoriasis have limited disease, and, for the majority of these patients, topical treatments are safe, effective, and convenient. However, some patients require systemic treatment. Without appropriate treatment, patients may experience substantial disease burden and decreased quality of life. The American Academy of Dermatology (AAD) guidelines state that methotrexate is a logical first choice of systemic agent, because it is the most cost-effective systemic psoriasis agent with the longest safety follow-up data. Cyclosporine is cited as particularly useful in the treatment of significant flares of psoriasis unresponsive to other therapies. Intermittent, short-term therapy (12 to 16 weeks) is the most frequently recommended regimen, with treatment withdrawn once significant improvement is achieved. When relapse occurs, cyclosporine therapy is reinstituted at the previously established effective dose, or maintenance therapy for up to 1 year can be used. Acitretin is also mentioned as an important oral option, despite it being normally less effective than other traditional systemic agents, due to its lack of immunosuppression and value in patients with known infection, active malignancy, or HIV. The use of biologic agents (TNF inhibitors and ustekinumab) is discussed as very effective treatment that can be used for patients with extensive disease. Newer biologic agents are not yet addressed in the AAD guidelines.

The safety and efficacy of secukinumab for plaque psoriasis were evaluated in four multicenter, randomized, double-blind, placebo-controlled trials (Trials 1, 2, 3, and 4) enrolling 2403 subjects (691 randomized to COSENTYX 300 mg, 692 to COSENTYX 150 mg, 694 to placebo, and 323 to a biologic active control) 18 years of age and older with plaque psoriasis who had a minimum body surface area involvement of 10%, and Psoriasis Area and Severity Index (PASI) score greater than or equal to 12, and who were candidates for phototherapy or systemic therapy. In all trials, the endpoints were the proportion of subjects who achieved a reduction in PASI score of at least 75% (PASI 75) from baseline to Week 12 and treatment success (clear or almost clear) on the Investigator’s Global Assessment modified 2011 (IGA). Outcomes are seen in table 1 and 2.

Table 1

Clinical Outcomes at Week 12 in Adults with Plaque Psoriasis in Trials 1 and 2

 

Trial 1

Trial 2

 

300 mg
(N=245)
n (%)

150 mg
(N=245)
n (%)

Placebo
(N=248)
n (%)

300 mg
(N=327)
n (%)

150 mg
(N=327)
n (%)

Placebo
(N=326)
n (%)

PASI 75 response

200 (82)

174 (71)

11 (4)

249 (76)

219 (67)

16 (5)

IGA of clear or almost clear

160(65)

125 (51)

6 (2)

202 (62)

167 (51)

9 (3)

Table 2

Clinical Outcomes at Week 12 in Adults with Plaque Psoriasis in Trials 3 and 4

 

Trial 3

Trial 4

 

300 mg
(N=59)
n (%)

150 mg
(N=59)
n (%)

Placebo
(N=59)
n (%)

300 mg
(N=60)
n (%)

150 mg
(N=61)
n (%)

Placebo
(N=61)
n (%)

PASI 75 response

44 (75)

41 (69)

0 (0)

52 (87)

43 (70)

2 (3)

IGA of clear or almost clear

40 (68)

31 (53)

0 (0)

44 (73)

32 (52)

0 (0)

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.

POSITION STATEMENT:

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

NOTE: Members initiating provider-administered (i.e., submitted as a medical claim with J3590 or C9399 with NDC) secukinumab therapy are NOT required to have had an inadequate response to two preferred self-administered (i.e., subcutaneous) biologic products. However, members transitioning to self-administered treatment after a single provider-administered first dose must still meet the preferred self-administered biologic product requirement.

NOTE: If the member has had an inadequate response to previous biologic therapy, other than secukinumab, that is FDA-approved for the requested indication listed in Table 3, the member is not required to have had an inadequate response to non-biologic prerequisite therapy (e.g., for psoriasis, if member has previously had an inadequate response to etanercept, but does not have a history of inadequate response to methotrexate, they do not have to try methotrexate to meet medical necessity criteria). However, members self-administering secukinumab must still meet the two preferred self-administered (i.e., subcutaneous) biologic product requirement.

Initiation of secukinumab (Cosentyx) meets the definition of medical necessity when ALL of the following criteria are met (“1”, “2”, and “3”):

1. Secukinumab will be used for the treatment of an indication listed in Table 1, and ALL of the indication-specific and maximum-allowable dosage criteria are met

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

a. abatacept (Orencia)

b. adalimumab (Humira)

c. anakinra (Kineret)

d. apremilast (Otezla)

e. brodalumab (Siliq)

f. certolizumab (Cimzia)

g. etanercept (Enbrel)

h. golimumab (Simponi, Simponi Aria)

i. guselkumab (Tremfya)

j. infliximab products (Remicade, Inflectra, Renflexis)

k. ixekizumab (Taltz)

l. sarilumab (Kevzara)

m. tocilizumab (Actemra)

n. tofacitinib (Xeljanz, Xeljanz XR)

o. ustekinumab (Stelara)

p. vedolizumab (Entyvio)

3. Member is 18 years of age or older

Table 3

Indications and Specific Criteria

Indication

Criteria

Max Allowable Dosage

Axial spondyloarthritis (axSpA)

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

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

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

2. Member has had an inadequate response to, or has a contraindication to at least TWO different NSAID therapies taken continuously for at least 4 weeks each† (e.g., celecoxib, diclofenac, ibuprofen, meloxicam, naproxen) (the specific contraindications)must be provided)

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

a. Member has had an inadequate response to, has persistent and intolerable adverse effect(s), or has a contraindication to TWO or more of the following self-administered biologic therapies (the specific adverse effect(s) and/or contraindications must be provided):

etanercept (Enbrel)

adalimumab (Humira)

golimumab (Simponi)

b. Member should consider alternatives to the use of an anti-TNF biologic due to a product warning and precaution for ANY of the following (the specific condition must be provided):

Demyelinating disease (e.g., multiple sclerosis)

Current or worsening congestive heart failure

Initial

• 150 mg at weeks 0, 1, 2, 3, and 4

Maintenance:

• 150 mg every 4 weeks (starting no sooner than week 8)

Psoriatic arthritis (PsA)

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

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

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

2. EITHER of the following based on the dominate disease type (“a” or “b”):

a. Axial PsA: Member has had an inadequate response to, or has a contraindication to at least TWO different NSAID therapies taken continuously for at least 4 weeks each† (e.g., celecoxib, diclofenac, ibuprofen, meloxicam, naproxen) (the specific contraindication(s) must be provided)

b. Peripheral PsA: Member has had an inadequate response to, or has a contraindication to at least ONE NSAID therapy taken continuously for at least 4 weeks† (e.g., celecoxib, diclofenac, ibuprofen, meloxicam, naproxen) (the specific contraindication must be provided)

AND

Member has had an inadequate response to, or has a contraindication to methotrexate, OR, if methotrexate is contraindicated, to another csDMARD (e.g., cyclosporine, leflunomide, sulfasalazine) (the specific contraindication must be provided)

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

a. Member has had an inadequate response, has persistent and intolerable adverse effect(s), or has a contraindication to TWO or more of the following self-administered biologic therapies (the specific adverse effect(s) and/or contraindications must be provided):

etanercept (Enbrel)

adalimumab (Humira)

golimumab (Simponi)

ustekinumab (Stelara)

b. BOTH of the following (“i” and “ii”):

i. Member has had an inadequate response to, has persistent and intolerable adverse effect(s), or has a contraindication to ustekinumab (Stelara) (the specific adverse effect and/or contraindication must be provided)

ii. Member should consider alternatives to the use of an anti-TNF biologic due to a product warning and precaution for ANY of the following (the specific condition must be provided):

Demyelinating disease (e.g., multiple sclerosis)

Current or worsening congestive heart failure

Initial

• 150 mg at weeks 0, 1, 2, 3, and 4

Maintenance:

• 300 mg every 4 weeks (starting no sooner than week 8)

Plaque psoriasis

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

1. Member’s disease is moderate to severe as evidenced by EITHER of the following before or after systemic drug therapy (“a” or “b”):

a. Psoriasis covers 10% or more of member’s BSA

b. Psoriasis covers less than 10% of member’s BSA but affects crucial body areas necessary for daily living activities (i.e., face, palms of hands, soles of feet, or genitals)

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

a. Member has had an inadequate response to at least 3 months of continuous treatment with methotrexate or has a contraindication to methotrexate

b. If methotrexate is contraindicated, the member has had an inadequate response to at least 3 months of continuous treatment with 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)

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

a. Member has had an inadequate response, has persistent and intolerable adverse effect(s), or has a contraindication to TWO or more of the following self-administered biologic therapies (the specific adverse effect(s) and/or contraindications must be provided):

etanercept (Enbrel)

adalimumab (Humira)

ustekinumab (Stelara)

b. BOTH of the following (“i” and “ii”):

i. Member has had an inadequate response to, has persistent and intolerable adverse effect(s), or has a contraindication to ustekinumab (Stelara) (the specific adverse effect and/or contraindication must be provided)

ii. Member should consider alternatives to the use of an anti-TNF biologic due to a product warning and precaution for ANY of the following (the specific condition must be provided):

Demyelinating disease (e.g., multiple sclerosis)

Current or worsening congestive heart failure

Initial

• 300 mg at weeks 0, 1, 2, 3, and 4

Maintenance:

• 300 mg every 4 weeks (starting no sooner than week 8)

Approval duration: 12 weeks

ASAS, Assessment of SpondyloArthritis International Society; BSA, body surface area; csDMARD, conventional synthetic disease-modifying antirheumatic drug; NSAID, non-steroidal anti-inflammatory drug

*NOTE: Members initiating provider-administered (i.e., submitted as a medical claim with J3590 or C9399 with NDC) secukinumab therapy are NOT required to have had an inadequate response to two preferred self-administered (i.e., subcutaneous) biologic products. However, members transitioning to self-administered treatment after a single provider-administered first dose must still meet the preferred self-administered biologic product requirement.

NOTE: If the member has had an inadequate response to previous biologic therapy, other than secukinumab, that is FDA-approved for the requested indication listed in Table 3, the member is not required to have had an inadequate response to non-biologic prerequisite therapy (e.g., for psoriasis, if member has previously had an inadequate response to etanercept, but does not have a history of inadequate response to methotrexate, they do not have to try methotrexate to meet medical necessity criteria). However, members self-administering secukinumab must still meet the two preferred self-administered (i.e., subcutaneous) biologic product requirement.

Continuation of secukinumab (Cosentyx) meets the definition of medical necessity when ALL of the following criteria are met (“1”, “2”, “3”, and “4”):

1. An authorization or reauthorization for secukinumab 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 3, OR the member previously met ALL indication-specific initiation criteria

2. Member has demonstrated a beneficial response to secukinumab therapy

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

a. abatacept (Orencia)

b. adalimumab (Humira)

c. anakinra (Kineret)

d. apremilast (Otezla)

e. brodalumab (Siliq)

f. certolizumab (Cimzia)

g. etanercept (Enbrel)

h. golimumab (Simponi, Simponi Aria)

i. guselkumab (Tremfya)

j. infliximab products (Remicade, Inflectra, Renflexis)

k. ixekizumab (Taltz)

l. sarilumab (Kevzara)

m. tocilizumab (Actemra)

n. tofacitinib (Xeljanz, Xeljanz XR)

o. ustekinumab (Stelara)

p. vedolizumab (Entyvio)

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

• Plaque psoriasis - 300 mg every 4 weeks

• Psoriatic arthritis - 300 mg every 4 weeks

• Axial spondyloarthritis (including both ankylosing spondylitis and non-radiographic axial spondyloarthritis) – 150 mg every 4 weeks

Duration of approval: 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

• Moderate to severe plaque psoriasis

o 300 mg by subcutaneous injection at weeks 0, 1, 2, 3, and 4 followed by 300 mg every 4 weeks

o For some patients, a dose of 150 mg may be acceptable

• Psoriatic arthritis

o For psoriatic arthritis patients with coexistent moderate to severe plaque psoriasis, use the dosing and administration recommendations for plaque psoriasis.

o For other psoriatic arthritis patients, administer with or without a loading dosage by subcutaneous injection.

­ With a loading dosage: 150 mg at weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter

­ Without a loading dosage: 150 mg every 4 weeks

­ If a patient continues to have active psoriatic arthritis, consider a dosage of 300 mg.

o May be administered with or without methotrexate

• Ankylosing spondylitis

o May be administered with or without a loading dosage.

­ With a loading dosage: 150 mg at weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter

­ Without a loading dosage: 150 mg every 4 weeks

Dose Adjustments

Refer to prescribing information.

Drug Availability

• Injection: 150 mg/mL solution in a single-use Sensoready® pen

• Injection: 150 mg/mL solution in a single-use prefilled syringe

• For Injection: 150 mg, lyophilized powder in a single-use vial for reconstitution for healthcare professional use only

PRECAUTIONS:

Boxed Warning

• None

Contraindications

• Serious hypersensitivity reaction to secukinumab or to any of the excipients

Warnings

Infections: In clinical trials, a higher rate of infections was observed in secukinumab treated subjects compared to placebo-treated subjects. Serious infections have occurred.

Tuberculosis (TB): Prior to initiating treatment, evaluate for TB. Monitored closely for signs and symptoms of active TB during and after treatment.

Inflammatory Bowel Disease: Exacerbations observed in clinical trials. Caution should be exercised when prescribing to patients with inflammatory bowel disease.

Hypersensitivity Reactions: Anaphylaxis and cases of urticaria have occurred.

Risk of Hypersensitivity in Latex-sensitive Individuals: The removable cap of the Cosentyx Sensoready pen and the Cosentyx prefilled syringe contains natural rubber latex which may cause an allergic reaction in latex-sensitive individuals.

Vaccinations: Live vaccines should not be given with secukinumab. Non-live vaccinations during treatment may not elicit an immune response sufficient to prevent disease.

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding

C9399

Unclassified drugs or biologicals (Hospital outpatient use ONLY)

J3590

Unclassified biologics

ICD-10 Diagnoses Codes That Support Medical Necessity

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

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 Part D: BCBSF has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline.

Medicare Advantage: No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline review date.

DEFINITIONS:

Axial PsA (a.k.a., psoriatic spondylitis): a subset of psoriatic arthritis that affects the spine (i.e., spondylitis) and/or spinal joints (e.g., the sacroiliac joint between the sacrum and ilium of pelvis). Axial PsA shares similar clinical findings to patients with ankylosing spondylitis (AS); however, patients with axial PsA are often less symptomatic, have asymmetric disease, and tend to have less severe disease. In addition, the psoriatic plaques or nail changes present in patients with axial PsA are absent in patients with AS. About 5% of PsA patients have exclusively axial involvement, and 20 to 50% have both spinal and peripheral involvement, with peripheral joint involvement being the predominant pattern.

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

DMARDs: An acronym for disease-modifying antirheumatic drugs. These are drugs that modify the rheumatic disease processes, and slow or inhibit structural damage to cartilage and bone. These drugs are unlike symptomatic treatments such as NSAIDs that do not alter disease progression. DMARDs can be further subcategorized. With the release of biologic agents (e.g., anti-TNF drugs), DMARDs were divided into either: (1) conventional, traditional, synthetic, or non-biological DMARDs; or as (2) biological DMARDs. However, with the release of newer targeted non-biologic drugs and biosimilars, DMARDs are now best categorized as: (1) conventional synthetic DMARDs (csDMARD) (e.g., MTX, sulfasalazine), (2) targeted synthetic DMARDs (tsDMARD) (e.g., tofacitinib, apremilast), and (3) biological DMARDs (bDMARD), which can be either a biosimilar DMARD (bsDMARD) or biological originator DMARD (boDMARD).

Non-axial or peripheral PsA: a subset of psoriatic arthritis that does NOT affect the spine or spinal joints [e.g. elbow, wrist, knees, hands, feet, and digits (dactylitis)]. Peripheral involvement may be polyarticular (5 or more joints affected) or oligoarticular (a.k.a., pauciarticular) (4 or fewer joints affected). Approximately 95% of patients with PsA have involvement of the peripheral joints, predominantly the polyarticular form, whereas a minority has the oligoarticular form.

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.

Psoriasis Area Severity Index (PASI): An index used to express the severity of psoriasis. It combines the severity (erythema, induration and desquamation) and percentage of affected area. The score ranges from 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis). A score of 11 or greater suggests moderate-to-severe psoriasis. A web-based calculator can be found at: http://www.pasitraining.com

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.

RELATED GUIDELINES:

Abatacept (Orencia®), 09-J0000-67

Adalimumab (Humira®), 09-J0000-46

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

Brodalumab (Siliq®) Injection, 09-J2000-74

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

Etanercept (Enbrel®), 09-J0000-38

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

Guselkumab (Tremfya), 09-J2000-87

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

Ixekizumab (Taltz) Injection, 09-J2000-62

Psoralens with Ultraviolet A (PUVA), 09-10000-16

Ustekinumab (Stelara), 09-J1000-16

OTHER:

Table 4: Conventional Synthetic DMARDs

DMARD Generic Name

DMARD Brand Name

Auranofin (oral gold)

Ridaura

Azathioprine

Imuran

Cyclosporine

Neoral, Sandimmune

Hydroxychloroquine

Plaquenil

Leflunomide

Arava

Methotrexate

Rheumatrex, Trexall

Sulfasalazine

Azulfidine, Azulfidine EN-Tabs

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

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

1. Imaging arm:

a. Sacroiliitis on imaging*

AND

b. ≥1 SpA feature

2. Clinical arm:

a. HLA-B27 positive

AND

b. ≥2 other SpA features

SpA features:

• Inflammatory back pain

• Arthritis

• Enthesitis (heel)

• Uveitis

• Dactylitis

• Psoriasis

• Crohn’s/colitis

• Good response to NSAIDs

• Family history of SpA

• HLA-B27

• Elevated CRP

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

REFERENCES:

  1. Armstrong AW, Siegel MP, Bagel J, et al. From the Medical Board of the National Psoriasis Foundation: Treatment targets for plaque psoriasis. J Am Acad Dermatol. 2017 Feb;76(2):290-298.
  2. Blauvelt A, Prinz JC, Gottlieb AB, et al. Secukinumab administration by pre-filled syringe: efficacy, safety and usability results from a randomized controlled trial in psoriasis (FEATURE). Br J Dermatol 2015;172(2):484-93.
  3. Blauvelt A, Reich K, Tsai TF, et al. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate-to-severe plaque psoriasis up to 1 year: Results from the CLEAR study. J Am Acad Dermatol. 2017 Jan;76(1):60-69.e9.
  4. Braun J, Baraliakos X, Deodhar A, et al.; MEASURE 1 study group. Effect of secukinumab on clinical and radiographic outcomes in ankylosing spondylitis: 2-year results from the randomised phase III MEASURE 1 study. Ann Rheum Dis. 2017 Jun;76(6):1070-1077.
  5. Canadian Psoriasis Guidelines Addendum Committee. 2016 Addendum to the Canadian Guidelines for the Management of Plaque Psoriasis 2009. J Cutan Med Surg. 2016 Sep;20(5):375-431.
  6. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2017. Available at: www.clinicalpharmacilogy-ip.com. Accessed 8/8/17.
  7. Coates LC, Kavanaugh A, Mease PJ et al. Group for Research and Assessment of Psoriasis and Psoriatic Arthritis: Treatment Recommendations for Psoriatic Arthritis 2015. Arthritis Rheumatol 2016;68:1060–71
  8. Cosentyx (secukinumab) injection [package insert]. Novartis Pharmaceuticals Corporation. East Hanover, NJ. January 2016.
  9. Dogra S, Jain A, Kanwar AJ. Efficacy and safety of acitretin in three fixed doses of 25, 35 and 50 mg in adult patients with severe plaque type psoriasis: a randomized, double blind, parallel group, dose ranging study. J Eur Acad Dermatol Venereol. 2013 Mar;27(3):e305-11.
  10. Dogra S, Krishna V, Kanwar AJ. Efficacy and safety of systemic methotrexate in two fixed doses of 10 mg or 25 mg orally once weekly in adult patients with severe plaque-type psoriasis: a prospective, randomized, double-blind, dose-ranging study. Clin Exp Dermatol. 2012 Oct;37(7):729-34.
  11. FDA Orphan Drug Designations and Approvals [Internet]. Washington, D.C. [cited 2017 August 8]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/.
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COMMITTEE APPROVAL:

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

GUIDELINE UPDATE INFORMATION:

03/15/15

New Medical Coverage Guideline.

04/15/15

Revision to guideline; updated HCPCS coding

06/15/15

Revision to guideline; updated position statement

09/15/15

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

11/01/15

Revision: ICD-9 Codes deleted.

03/15/16

Revision to guidelines consisting of description, position statement, dosage/administration, billing/coding, definitions, and references resulting from two new FDA-approved indications.

09/15/16

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

10/15/17

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

Date Printed: October 23, 2017: 07:23 AM