Anthem Blue Cross California Monoclonal Antibodies to Interleukin-23 Form

Overview Clinical criteria Overview Coding Document history References This document addresses the use of monoclonal antibodies which bind to the interleukin-23 (IL-23) cytokine and disrupt its interaction with the IL-23 receptor thereby inhibiting the release of proinflammatory cytokines and chemokines. IL-23 inhibitors are approved for the treatment of plaque psoriasis. Agents addressed in this clinical criteria document include: • Omvoh (mirikizumab-mrkz) • Ilumya (tildrakizumab-asmn) • Tremfya (guselkumab) • Skyrizi (risankizumab-rzaa) Plaque Psoriasis (otherwise known as psoriasis vulgaris): The American Academy of Dermatology (AAD) and National Psoriasis Foundation (NPF) published joint guidelines on the management and treatment of psoriasis with biologics. The guidelines do not include a treatment algorithm or compare biologics to each other or conventional therapy. The guideline notes that patients with mild- moderate disease may be adequately controlled with topical therapy and/or phototherapy while moderate to severe disease may necessitate treatment with a biologic. Moderate to severe disease is defined as involvement in > 3% of body surface area (BSA) or involvement in sensitive areas that significantly impact daily function (such as palms, soles of feet, head/neck, or genitalia). Tumor necrosis factor inhibitor (TNFi) biologics, ustekinumab, IL17 inhibitors, and IL23 inhibitors are all recommended as monotherapy treatment options for adult patients with moderate to severe plaque psoriasis. Psoriatic Arthritis: The American College of Rheumatology (ACR) guidelines recommend that initial treatment of patients with active severe PsA or concomitant psoriasis should include a TNFi biologic over an oral small molecule (OSM; including methotrexate, sulfasalazine, cyclosporine, leflunomide, and apremilast). For initial therapy, OSMs are preferred over IL-17 and ustekinumab; and may be considered over TNFi biologics in mild to moderate disease without comorbid conditions or in those who prefer oral therapy. Recommendations involving biologics over OSMs as first line therapy are conditional and based on low quality evidence. Evidence cited includes indirect comparisons of placebo-controlled trials, studies with open-label design, and extrapolation from studies in plaque psoriasis. Furthermore, most pivotal trials for TNFi biologics included a study population that were DMARD experienced. Overall, there is a lack of definitive evidence for the safety and efficacy of biologic drugs over conventional therapy for the initial treatment of most patients with psoriatic arthritis. The ACR guidelines precede FDA approval of guselkumab and risankizumab for psoriatic arthritis. Crohn’s Disease: According to the American Gastrointestinal Association clinical practice guidelines, evidence supports the use of methotrexate, corticosteroids, TNFi +/- immunomodulator, ustekinumab, or vedolizumab for induction of remission. Among the biologics, infliximab, adalimumab, ustekinumab, or vedolizumab are recommended or suggested over certolizumab for induction of remission. Evidence supports biologic agents, thiopurines, and methotrexate for maintenance of remission. Ustekinumab and vedolizumab are options for individuals with primary nonresponse to initial treatment with TNFi. Adalimumab, ustekinumab, or vedolizumab may be used in cases where an individual previously responded to infliximab and then lost response (secondary nonresponse). The AGA guidelines precede FDA approval of risankizumab for CD. Ulcerative Colitis: For those with moderately to severely active disease, the American College of Gastroenterology (ACG) guidelines strongly recommend induction of remission using oral budesonide MMX, oral systemic corticosteroids, TNFi, tofacitinib or vedolizumab (moderate to high quality evidence). The American Gastroenterological Association (AGA) guidelines define moderate to severe UC as those who are dependent on or refractory to corticosteroids, have severe endoscopic disease activity, or are at high risk of colectomy. AGA strongly recommends biologics (TNFi, vedolizumab, or ustekinumab) or tofacitinib over no treatment in induction and maintenance of remission (moderate quality of evidence). For biologic-naïve individuals, Infliximab or vedolizumab are conditionally recommended over adalimumab for induction of remission (moderate quality evidence). Guidelines precede FDA approval of mirikizumab for UC. Clinical Criteria 1 When a drug is being reviewed for coverage under a member’s medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose. Ilumya (tildrakizumab-asmn) Initial requests for Ilumya (tildrakizumab-asmn) may be approved for the following: Plaque psoriasis (Ps) when each of the following criteria are met: A. I. Individual is 18 years of age or older with chronic moderate to severe (that is, extensive or disabling) plaque Ps with either of the following (AAD 2019): 1. Plaque Ps involving greater than three percent (3%) body surface area (BSA); OR 2. Plaque Ps involving less than or equal to three percent (3%) BSA involving sensitive areas or areas that significantly impact daily function (such as palms, soles of feet, head/neck, or genitalia); AND B. C. Individual has had an inadequate response to, or is intolerant of phototherapy or other systemic therapy (such as acitretin, cyclosporine, or methotrexate); OR Individual has a contraindication to phototherapy, acitretin, cyclosporine, and methotrexate. Continuation requests for Ilumya (tildrakizumab-asmn) may be approved if the following criteria are met: I. II. Individual has been receiving and is maintained on a stable dose of Ilumya; AND There is clinically significant improvement or stabilization in clinical signs and symptoms of disease. Requests for Ilumya (tildrakizumab-asmn) may not be approved for the following: I. II. III. IV. In combination with phototherapy; OR In combination with topical or oral JAK inhibitors, apremilast, deucravacitinib, ozanimod, etrasimod, or any of the following biologic immunomodulators: TNF antagonists, other IL-23 inhibitors, IL-17 inhibitors, vedolizumab, ustekinumab, abatacept, IL- 1 inhibitors, IL-6 inhibitors, rituximab or natalizumab; OR Tuberculosis, other active serious infections, or a history of recurrent infections [repeat testing not required for ongoing authorization]; OR If initiating therapy, individual has not had a tuberculin skin test (TST) or a Centers for Disease Control (CDC-) and Prevention -recommended equivalent to evaluate for latent tuberculosis (unless switching therapy from another targeted immune modulator and no new risk factors); OR V. When the above criteria are not met and for all other indications. Omvoh (mirikizumab-mrkz) Initial requests for Omvoh (mirikizumab-mrkz) may be approved for the following: I. Ulcerative colitis (UC) when the following criteria are met: A. For individuals requesting intravenous induction doses: a. b. c. Individual is 18 years of age or older with moderate to severe UC; AND Individual has had an inadequate response to or is intolerant of conventional therapy (such as 5-Aminosalicylic acid products, systemic corticosteroids, or immunosuppressants [such as thiopurines]); OR Individual has a contraindication to 5-ASA products or systemic corticosteroids or thiopurines; OR B. For individuals requesting subcutaneous maintenance therapy: a. b. Individual is 18 years of age or older with moderate to severe UC; AND Individual has completed the intravenous induction doses with Omvoh and will be using subcutaneous Omvoh for maintenance therapy. Continuation requests for Omvoh (mirikizumab-mrkz) [intravenous and subcutaneous] may be approved if the following criteria are met: I. II. Individual has been receiving and is maintained on a stable dose of Omvoh; AND There is clinically significant improvement or stabilization in clinical signs and symptoms of disease. Requests for Omvoh (mirikizumab-mrkz) may not be approved for the following: I. II. III. In combination with topical or oral JAK inhibitors, apremilast, deucravacitinib, ozanimod, etrasimod, or any of the following biologic immunomodulators: TNF antagonists, other IL-23 inhibitors, IL-17 inhibitors, vedolizumab, ustekinumab, abatacept, IL- 1 inhibitors, IL-6 inhibitors, rituximab or natalizumab; OR Tuberculosis, other active serious infections, or a history of recurrent infections [repeat TB testing not required for ongoing therapy]; OR If initiating therapy, Individual has not had a tuberculin skin test (TST) or a Centers for Disease Control (CDC-) and Prevention -recommended equivalent to evaluate for latent tuberculosis (unless switching therapy from another targeted immune modulator and no new risk factors); OR IV. When the above criteria are not met and for all other indications. 2 Skyrizi (risankizumab-rzaa) Initial requests for Skyrizi (risankizumab-rzaa) may be approved for the following: Plaque psoriasis (Ps) when each of the following criteria are met: A. I. Individual is 18 years of age or older with chronic moderate to severe (that is, extensive or disabling) plaque Ps with either of the following (AAD 2019): 1. Plaque Ps involving greater than three percent (3%) body surface area (BSA); OR 2. Plaque Ps involving less than or equal to three percent (3%) BSA involving sensitive areas or areas that significantly impact daily function (such as palms, soles of feet, head/neck, or genitalia); AND B. C. Individual has had an inadequate response to, or is intolerant of phototherapy or other systemic therapy (such as acitretin, cyclosporine, or methotrexate); OR Individual has a contraindication to phototherapy, acitretin, cyclosporine, and methotrexate; OR II. Psoriatic arthritis (PsA) when each of the following criteria are met: A. B. Individual is 18 years of age or older with moderate to severe PsA; AND Individual has had an inadequate response to, or is intolerant of conventional therapy [nonbiologic DMARDs (such as methotrexate, sulfasalazine, cyclosporine or leflunomide)]; OR Individual has a contraindication to methotrexate, sulfasalazine, cyclosporine, and leflunomide; OR C. III. Crohn’s Disease (CD) when each of the following criteria are met: A. For individuals requesting intravenous induction doses: 1. 2. 3. Individual is 18 years of age or older with moderate to severe CD; AND Individual has had an inadequate response to, or is intolerant of conventional therapy (such as systemic corticosteroids or immunosuppressants [such as thiopurines or methotrexate]); OR Individual has a contraindication to systemic corticosteroids or thiopurines or methotrexate; OR B. For individuals requesting subcutaneous maintenance therapy: 1. 2. Individual is 18 years of age or older with moderate to severe CD; AND Individual has completed the intravenous induction doses with Skyrizi and will be using subcutaneous Skyrizi for maintenance therapy. Continuation requests for Skyrizi (risankizumab-rzaa) may be approved if the following criteria are met: I. II. Individual has been receiving and is maintained on a stable dose of Skyrizi; AND There is clinically significant improvement or stabilization in clinical signs and symptoms of disease. Requests for Skyrizi (risankizumab-rzaa) may not be approved for the following: I. II. III. IV. In combination with phototherapy; OR In combination with topical or oral JAK inhibitors, apremilast, deucravacitinib, ozanimod, etrasimod, or any of the following biologic immunomodulators: TNF antagonists, other IL-23 inhibitors, IL-17 inhibitors, vedolizumab, ustekinumab, abatacept, IL- 1 inhibitors, IL-6 inhibitors, rituximab or natalizumab; OR Tuberculosis, other active serious infections, or a history of recurrent infections [repeat testing not required for ongoing authorization]; OR If initiating therapy, individual has not had a tuberculin skin test (TST) or a Centers for Disease Control (CDC-) and Prevention -recommended equivalent to evaluate for latent tuberculosis (unless switching therapy from another targeted immune modulator and no new risk factors); OR V. When the above criteria are not met and for all other indications. Tremfya (guselkumab) Initial requests for Tremfya (guselkumab) may be approved for the following: I. Plaque psoriasis (Ps) when each of the following criteria are met: A. Individual is 18 years of age or older with chronic moderate to severe (that is, extensive or disabling) plaque Ps with either of the following (AAD 2019): 1. Plaque Ps involving greater than three percent (3%) body surface area (BSA); OR 2. Plaque Ps involving less than or equal to three percent (3%) BSA involving sensitive areas or areas that significantly impact daily function (such as palms, soles of feet, head/neck, or genitalia); AND B. C. Individual has had an inadequate response to, or is intolerant of phototherapy or other systemic therapy (such as acitretin, cyclosporine, or methotrexate); OR Individual has a contraindication to phototherapy, acitretin, cyclosporine, and methotrexate; OR II. Psoriatic arthritis (PsA) when each of the following criteria are met: A. Individual is 18 years of age or older with moderate to severe PsA; AND 3 B. C. Individual has had an inadequate response to, or is intolerant of conventional therapy [nonbiologic DMARDs (such as methotrexate, sulfasalazine, cyclosporine or leflunomide)]; OR Individual has a contraindication to methotrexate, sulfasalazine, cyclosporine, and leflunomide. Continuation requests for Tremfya (guselkumab) may be approved if the following criteria are met: Individual has been receiving and is maintained on a stable dose of Tremfya; AND There is confirmation of clinically significant improvement or stabilization in clinical signs and symptoms of disease. I. II. Requests for Tremfya (guselkumab) may not be approved for the following: I. II. III. IV. In combination with phototherapy; OR In combination with topical or oral JAK inhibitors, apremilast, deucravacitinib, ozanimod, etrasimod, or any of the following biologic immunomodulators: TNF antagonists, other IL-23 inhibitors, IL-17 inhibitors, vedolizumab, ustekinumab, abatacept, IL- 1 inhibitors, IL-6 inhibitors, rituximab or natalizumab; OR Tuberculosis, other active serious infections, or a history of recurrent infections [repeat testing not required for ongoing authorization]; OR If initiating therapy, individual has not had a tuberculin skin test (TST) or a Centers for Disease Control (CDC-) and Prevention -recommended equivalent to evaluate for latent tuberculosis (unless switching therapy from another targeted immune modulator and no new risk factors); OR V. When the above criteria are not met and for all other indications. Quantity Limits llumya (tildrakizumab-asmn) Quantity Limit Drug Limit Ilumya (tildrakizumab-asmn) 100 mg/mL 1 prefilled syringe per 84 days (12 weeks) Override Criteria *Initiation of therapy for Plaque Psoriasis (Ps): May approve up to 1 additional syringe (100 mg/mL) in the first 28 days (4 weeks) of treatment. Omvoh (mirikizumab-mrkz) Omvoh (mirikizumab-mrkz) 100 mg/mL prefilled pen Omvoh (mirikizumab-mrkz) 300 mg/15 mL single-dose vial 2 pens per 28 days (4 weeks) 3 vials total to last 12 weeks Drug Limit Skyrizi (risankizumab-rzaa) Quantity Limit Drug Skyrizi (risankizumab-rzaa) 75 mg/ 0.83 mL syringe* Skyrizi (risankizumab-rzaa) 150 mg/mL syringe/pen* Skyrizi (Risankizumab-rzaa) 180 mg/ 1.2 mL prefilled cartridge with on-body injector Skyrizi (Risankizumab-rzaa) 360 mg/ 2.4 mL prefilled cartridge with on-body injector Skyrizi (Risankizumab-rzaa) 600 mg/ 10 mL single-dose vial Limit 2 prefilled syringes [1 carton] per 84 days (12 weeks) 1 prefilled syringe/pen [1 carton] per 84 days (12 weeks) 1 kit per 56 days (8 weeks) 1 kit per 56 days (8 weeks) 3 vials total to last 12 weeks *Initiation of therapy for Plaque Psoriasis (Ps) or Psoriatic Arthritis (PsA): May approve 1 additional carton [two 75 mg syringes or one 150 mg pen/syringe] in the first 28 days (4 weeks) of treatment. Override Criteria Tremfya (guselkumab) Quantity Limit Drug Tremfya (guselkumab) 100 mg/mL 1 prefilled syringe/autoinjector per 56 days (8 weeks) Limit Override Criteria *Initiation of therapy for Plaque Psoriasis (Ps) or Psoriatic Arthritis (PsA): May approve up to 1 additional syringe (100 mg/mL) in the first 28 days (4 weeks) of treatment. Coding The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member. 4 HCPCS J1628 J3245 J2327 J3590 Injection, guselkumab, 1 mg [Tremfya] Injection, tildrakizumab, 1 mg [Ilumya] Injection, risankizumab-rzaa, intravenous, 1 mg [Skyrizi] Unclassified biologics [Omvoh] (mirikizumab-mrkz) ICD-10 Diagnosis K50.0-K50.019 Crohn’s disease of small intestine K50.1-K50.119 Crohn’s disease of large intestine K50.8-K50.819 Crohn’s disease of both small and large intestine K50.9-K50.919 Crohn’s disease, unspecified L40.0 L40.50 L40.51 L40.52 L40.53 L40.59 L40.8 L40.9 Plaque psoriasis Arthropathic psoriasis, unspecified Distal interphalangeal psoriatic arthropathy Psoriatic arthritis mutilans Psoriatic spondylitis Other psoriatic arthropathy Other psoriasis Psoriasis, unspecified Document History Revised: 11/17/2023