MEDICAL COVERAGE GUIDELINES ORIGINAL EFFECTIVE DATE: 04/09/18 SECTION: DRUGS LAST REVIEW DATE: LAST CRITERIA REVISION DATE: 09/05/18 ARCHIVE DATE:

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1 ILARIS (canakinumab) Non-Discrimination Statement and Multi-Language Interpreter Services information are located at the end of this document. Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Medical Coverage Guideline must be read in its entirety to determine coverage eligibility, if any. This Medical Coverage Guideline provides information related to coverage determinations only and does not imply that a service or treatment is clinically appropriate or inappropriate. The provider and the member are responsible for all decisions regarding the appropriateness of care. Providers should provide BCBSAZ complete medical rationale when requesting any eceptions to these guidelines. The section identified as Description defines or describes a service, procedure, medical device or drug and is in no way intended as a statement of medical necessity and/or coverage. The section identified as Criteria defines criteria to determine whether a service, procedure, medical device or drug is considered medically necessary or eperimental or investigational. State or federal mandates, e.g., FEP program, may dictate that any drug, device or biological product approved by the U.S. Food and Drug Administration (FDA) may not be considered eperimental or investigational and thus the drug, device or biological product may be assessed only on the basis of medical necessity. Medical Coverage Guidelines are subject to change as new information becomes available. For purposes of this Medical Coverage Guideline, the terms "eperimental" and "investigational" are considered to be interchangeable. BLUE CROSS, BLUE SHIELD and the Cross and Shield Symbols are registered service marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans. All other trademarks and service marks contained in this guideline are the property of their respective owners, which are not affiliated with BCBSAZ. Description: Ilaris is an interleukin-1β blocker, also known as IL-1β that works by specifically addressing the inflammation that results from overproduction of IL-1β. O763.9.doc Page 1 of 10

2 Definitions: Cryopyrin-associated periodic syndrome (CAPS) is a spectrum of autoinflammatory syndromes. Familial Cold Autoinflammatory Syndrome (FACS) is generally caused by mutations in a gene called NLRP3. NLRP3 mutations cause increased activity of cryopyrin, a protein that regulates inflammation in the body. Increased cryopyrin activity causes overproduction of IL-1β.Symptoms of FACS include episodes of fever, skin rash and joint pain after eposure to cold temperatures. Muckle-Wells Syndrome (MWS) occurs when a mutation in the CIAS1 gene leads to increased activity of the protein cryopyrin. This increased activity of cryopyrin leads to an increase in IL-1β. Symptoms of MWS include episodic fever, chills and painful joints. Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS) is caused by a mutation of the TNFRSF1A gene, and is also known as Familial Hibernian Fever (FHF) Symptoms of TRAPS include fever that typically lasts more than 1 week associated with chills and severe muscle pain in the torso and the arms. Hyperimmunogloblin D/Mevalonate Kinase deficiency occurs when there is a defect in the gene causing abnormalities in a protein mevalonate kinase. Symptoms include recurrent fever, abdominal pain, diarrhea, joint pain, mouth sores and swelling of lymph glands. Familial Mediterranean fever (FMF) occurs in a gene called MEFV that is passed from parents to children. Symptoms of FMF include recurrent fevers and painful inflammation of the abdomen, lungs, and joints. Active Systemic Juvenile Idiopathic Arthritis (SJIA) is a type of Juvenile Idiopathic Arthritis (JIA) that generally affects both large and small joints. Symptoms include periodic fevers and rashes. Adult: Age 18 years and older Preferred Tumor Necrosis Factor (TNF Inhibitor) Medications: Enbrel (etanercept) Humira (adalimumab) O763.9.doc Page 2 of 10

3 Definitions: (cont.) FDA approved indications: Drug Name AS CD UC G CA N O MI D pji A sji A PP Ps A RA HS M S Actemra (tocilizumab) (IV) (IV) Cimzia (certolizumab pegol) Cosenty (secukinumab) Enbrel (etanercept) Entyvio (vedolizumab) Humira (adalimumab) Ilaris (canakinumab) Inflectra (infliimab-dyyb) Kevzara (sarilumab) Kineret (anakindra) Olumiant (baricitinib) Orencia (abatacept) (IV) Otezla (apremilast) Remicade (infliimab) Renfleis (infliimababda) Rituan (rituimab) Rituan Hyclea (rituimab) Siliq (brodalumab) Simponi (golimumab) Simponi Aria (golimumab) Stelara (ustekinumab) Taltz (iekizumab) Tremfya (guselkumab) Tysabri (natalizumab) Xeljanz (tofacitinib) Xeljanz XR (tofacitinib) UV NH L CL L GP A/ M PA DL BC L FL AS=ankylosing spondylitis; CD=Crohn s disease; UC=ulcerative colitis; GCA=giant cell arteritis; NOMID=neonatal-onset multisystem inflammatory disease; pjia=polyarticular juvenile idiopathic arthritis; sjia=systemic juvenile idiopathic arthritis; PP=plaque psoriasis; PsA=psoriatic arthritis; RA=rheumatoid arthritis; HS=Hidradenitis Suppurativa, MS=multiple sclerosis; UV=uveitis; NHL=Non Hodgkin's Lymphoma; CLL=Chronic Lymphocytic Leukemia; GPA/MPA=Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA); DLBCL=Diffuse Large B-Cell Lymphoma; FL=Follicular Lymphoma O763.9.doc Page 3 of 10

4 Criteria: Initial therapy will be reviewed by the medical director(s) and/or clinical advisor(s). See Resources section for FDA-approved dosage and American College of Rheumatology 30 Percent Improvement Criteria (ACR30). Ilaris is considered medically necessary for treatment of adults and children 4 years of age and older with Cryopyrin-Associated Periodic Syndromes (CAPS) including, Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Weiss Syndrome (MWS) with documentation of ALL the following: 1. No chronic or active or latent infection present (e.g. TB, HIV, Hepatitis B, Hepatitis C, or other viral or opportunistic organisms) that requires medical intervention 2. Not scheduled to receive any live vaccines 3. Not concurrently on any TNF-inhibitors (Enbrel (etanercept), Humira (adalimumab), Remicade (infliimab), Simponi (golimumab), Cimzia (certolizumab)) or Interleukin-1 blocking agents (Arcalyst (rilonacept), Kineret (anakinra)) 4. Not currently on Otezla (apremilast), Xeljanz (tofacitinib), or Xeljanz XR (tofacitinib) 5. Absence of hypersensitivity to the active substance or to any of the ecipients Continuation of therapy for CAPS, including FCAS and MWS, is considered medically necessary with documentation of ONE of the following: 1. Reduced C-reactive protein to < 10 mg/dl 2. Reduced serum amyloid A (SAA) to < 10 mg/dl Ilaris is considered medically necessary for treatment of individuals 2 years of age and older with Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), Hyperimmunoglobulin D Syndrome/Mevalonate Kinase Deficiency (HIDS/MKD), and Familial Mediterranean Fever (FMF) with documentation of ALL of the following: 1. No chronic or active or latent infection present (e.g. TB, HIV, Hepatitis B, Hepatitis C, or other viral or opportunistic organisms) that requires medical intervention 2. Not scheduled to receive any live vaccines 3. Not concurrently on any TNF-inhibitors (Enbrel (etanercept), Humira (adalimumab), Remicade (infliimab), Simponi (golimumab), Cimzia (certolizumab)) or Interleukin-1 blocking agents (Arcalyst (rilonacept), Kineret (anakinra)) 4. Not currently on Otezla (apremilast), Xeljanz (tofacitinib), or Xeljanz XR (tofacitinib) 5. Absence of hypersensitivity to the active substance or to any of the ecipients Continuation of therapy for TRAPS, HIDS/MKD, and FMF is considered medically necessary with documentation of the following: 1. Reduced C-reactive protein to < 10 mg/dl or a reduction > of 70% from baseline O763.9.doc Page 4 of 10

5 Criteria: (cont.) Ilaris is considered medically necessary for treatment of individuals 2 years of age and older with active systemic juvenile idiopathic arthritis (SJIA) with documentation of ALL the following: 1. Failure of, contraindication to or intolerance to BOTH of the preferred TNF inhibitor medications Enbrel, and Humira (refer to, Small Molecules and Biologics Chart in Definitions section) for the preferred medication(s) labeled indications). 2. No chronic or active or latent infection present (e.g. TB, HIV, Hepatitis B, Hepatitis C, or other viral or opportunistic organisms) that requires medical intervention 3. Not scheduled to receive any live vaccines 4. Not concurrently on any TNF-inhibitors (Enbrel (etanercept), Humira (adalimumab), Remicade (infliimab), Simponi (golimumab), Cimzia (certolizumab)) or Interleukin-1 blocking agents (Arcalyst (rilonacept), Kineret (anakinra)) 5. Not currently on Otezla (apremilast), Xeljanz (tofacitinib), or Xeljanz XR (tofacitinib) 6. Absence of hypersensitivity to the active substance or to any of the ecipients Continuation of therapy for SJIA is considered medically necessary with documentation of ONE of the following: 1. Achieved or maintains an ACR30 (American College of Rheumatology) without fevers 2. Reduced number of joints with active arthritis over baseline 3. Reduced number of joints with limited range of motion over baseline 4. Reduced pain 5. Reduced number of acute flares 6. Achieved or maintains a reduction in dose of corticosteroid or is corticosteroid free 7. C-reactive protein is less than 10 mg/dl or at least a 30% improvement over baseline O763.9.doc Page 5 of 10

6 Criteria: (cont.) Ilaris for all other indications not previously listed or if above criteria not met is considered eperimental or investigational based upon: 1. Lack of final approval from the Food and Drug Administration, and 2. Insufficient scientific evidence to permit conclusions concerning the effect on health outcomes, and 3. Insufficient evidence to support improvement of the net health outcome, and 4. Insufficient evidence to support improvement of the net health outcome as much as, or more than, established alternatives, and 5. Insufficient evidence to support improvement outside the investigational setting. These indications include, but are not limited to: Treatment with dosing or frequency outside the FDA-approved dosing and frequency O763.9.doc Page 6 of 10

7 Resources: Literature reviewed 04/09/18. We do not include marketing materials, poster boards and nonpublished literature in our review. Ilaris Package Insert - FDA-approved indication and dosage: Indication Cryopyrin-Associated Periodic Syndromes (CAPS) including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) Tumor necrosis Factor receptor Associated Periodic Syndrome (TRAPS), Hyperimmunoglobulin D Syndrome/Mevalonate Kinase Deficiency (HIDS/MKD), and Familial Mediterranean Fever (FMF) Systemic Juvenile Idiopathic Arthritis (SJIA) Recommended Dose Administer subcutaneously every 8 weeks. -Body weight of greater than 40 kg give 150mg. -Body weight of greater than 15 kg to less than 40 kg give 2 mg/kg. For children 15 to 40 kg with an inadequate response, the dose can be increased to 3 mg/kg. Administered subcutaneously every 4 weeks -Body weight less than or equal to 40 kg give 2 mg/kg as a starting dose. The dose can be increased to 4 mg/kg every 4 weeks if the response is inadequate. -Body weight greater than 40kg give 150 mg as a starting dose. The dose can be increased to 300 mg every 4 weeks if the response is inadequate. Administer subcutaneously every 4 weeks. -Body weight greater than or equal to 7.5kg give 4 mg/kg (with a maimum of 300mg). Initial Approval Duration: 6 months Renewal Approval Duration: 12 months O763.9.doc Page 7 of 10

8 Resources: (cont.) American College of Rheumatology 30 Percent Improvement Criteria (ACR30): At least 30 percent improvement in the following: 1. Swollen joint count 2. Tender joint count And three of the following five variables: 3. Patient-assessed global disease activity (e.g., by VAS) 4. Evaluator-assessed global disease activity (e.g., by VAS) 5. Patient pain assessment (e.g., by VAS) 6. Functional disability (e.g., by HAQ) 7. Acute phase response (ESR or CRP) A 50 and 70 percent ACR response (ACR50 and ACR70, respectively) represents respective improvement of at least 50 or 70 percent UpToDate, Inc. 1. Felson DT, Anderson JJ, Lange ML, et al. Should improvement in rheumatoid arthritis clinical trials be defined as fifty percent or seventy percent improvement in core set measures, rather than twenty percent?. Arthritis Rheum 1998; 41: Felson DT, Anderson JJ, Boers M, et al. American College of Rheumatology preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum 1995; 38:727. O763.9.doc Page 8 of 10

9 Non-Discrimination Statement: Blue Cross Blue Shield of Arizona (BCBSAZ) complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability or se. BCBSAZ provides appropriate free aids and services, such as qualified interpreters and written information in other formats, to people with disabilities to communicate effectively with us. BCBSAZ also provides free language services to people whose primary language is not English, such as qualified interpreters and information written in other languages. If you need these services, call (602) for Spanish and (877) for all other languages and other aids and services. If you believe that BCBSAZ has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability or se, you can file a grievance with: BCBSAZ s Civil Rights Coordinator, Attn: Civil Rights Coordinator, Blue Cross Blue Shield of Arizona, P.O. Bo 13466, Phoeni, AZ , (602) , TTY/TDD (602) , crc@azblue.com. You can file a grievance in person or by mail or . If you need help filing a grievance BCBSAZ s Civil Rights Coordinator is available to help you. You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at or by mail or phone at: U.S. Department of Health and Human Services, 200 Independence Avenue SW., Room 509F, HHH Building, Washington, DC 20201, , (TDD). Complaint forms are available at Multi-Language Interpreter Services: O763.9.doc Page 9 of 10

10 Multi-Language Interpreter Services: (cont.) O763.9.doc Page 10 of 10

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