Coverage Policy Manual
Policy #: 2022048
Category: Pharmacy
Initiated: April 2023
Last Review: December 2023
  Tildrakizumab-asmn (e.g., Ilumya)
Description:
Tildrakizumab-asmn (e.g., Ilumya) is a recombinant humanized IgG1Κ monoclonal antibody, which inhibits the interleukin-23 (IL-23) receptor that specifically binds to the p19 subunit of interleukin-23 blocking the release of proinflammatory cytokines and chemokines during the inflammatory response.
 
Tildrakizumab-asmn as an approved a biologic treatment for adults with moderate-to severe plague psoriasis binds specifically to IL-23p19 and binds to IL-23 molecules and prevents its interaction with the IL-23R, blocking the downstream signaling cascade. IL-23 is a naturally occurring cytokine known to be involved with multiple inflammatory pathways. This block initiates a downstream signaling cascade to induce a transcription of the inflammatory cytokines, IL-17. IL-17 activates inflammatory pathways associated with psoriasis.
 
Regulatory Status
 
Tildrakizumab-asmn (e.g., Ilumya) was approved by the U.S. Food and Drug Administration (FDA) on in March 2018 for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
 
Coding
 
See CPT/HCPCS Code section below.
 
Policy/
Coverage:
Effective April 1, 2023, prior approval is required for Tildrakizumab-asmn (e.g., Ilumya).
 
The initial use of this drug requires documentation of direct physician involvement (MD/DO) in the ordering and evaluation, as well as signature, in the medical records submitted for prior approval. Concurrent review will require continued evidence of appropriate physician involvement.
 
The Step Therapy Medication Act is applicable to fully insured (Arkansas Blue Cross, Health Advantage, and Exchange) and specified governmental (ASE/PSE and ASP) health plans. The law is not applicable to FEP or self-insured ERISA groups (including but not limited to Walmart or other Blue Advantage groups). Initial approval for exigent request is 28 days. Otherwise, initial approval for standard review is up to 1 year.
 
Effective January 2024
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Tildrakizumab-asmn (e.g., Ilumya) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when ALL the following criteria are met:
 
PLAQUE PSORIASIS
 
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
1. Individual is greater than or equal to 18 years of age; AND
2. Individual has a diagnosis of moderate to severe plaque psoriasis established by or in consultation with a dermatologist as indicated by one of the following (AAD, 2019):
a. Plaque psoriasis involving greater than or equal to 3% body surface area (BSA) (Reich, 2017); OR
b. Plaque psoriasis including areas that significantly impact daily function (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas) (AAD, 2019); AND
3. Individual has an active disease with documented inadequate response (trial of greater than or equal to 3 months) to phototherapy (e.g., UVB, PUVA) or at least one oral systemic treatment (e.g., methotrexate, cyclosporine, apremilast, acitretin); OR
4. Individual has an active disease with documented intolerance/contraindication to phototherapy (e.g., UVB, PUVA) or at least one oral systemic treatment (e.g., methotrexate, cyclosporine, apremilast, acitretin); OR
5. Individual has previously received a biologic (e.g., etanercept, infliximab, ustekinumab, adalimumab, certolizumab pegol, brodalumab, tildrakizumab, risankizumab, secukinumab, ixekizumab, guselkumab, alefacept, bimekizumab) or oral tyrosine kinase inhibitor (e.g., deucravacitinib) indicated for plaque psoriasis (Menter, 2020); AND
6. Individual is not using the medication in combination with other biologic intended for treatment of plaque psoriasis, including but not limited to: TNF inhibitor, IL-36 inhibitor, PDE4 inhibitor, any other IL inhibitor, or Janus kinase inhibitor; AND
7. Individual does not have latent tuberculosis or serious active infection; AND
8. Must be dosed in accordance with the FDA label.
 
CONTINUED APPROVAL for up to 1 year: 
1. Individual has met criteria for initial approval; AND
2. Individual has experienced a documented positive clinical response; AND
3. Individual is not using the medication in combination with other biologic intended for treatment of plaque psoriasis, including but not limited to: TNF inhibitor, IL-36 inhibitor, PDE4 inhibitor, any other IL inhibitor, or Janus kinase inhibitor; AND
4. Must be dosed in accordance with the FDA label.
 
Dosage and Administration
Dosing per FDA Guidelines
 
The recommended dose of tildrakizumab-asmn is 100 mg at Weeks 0, 4, and every 12 weeks thereafter.
 
Tildrakizumab-asmn is available as a 100mg/mL prefilled syringe.
 
Tildrakizumab-asmn should be administered as a subcutaneous injection by a healthcare professional.
 
Please refer to separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Tildrakizumab-asmn, for any indication or circumstance not described above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, tildrakizumab-asmn, for any indication or circumstance not described above, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
 
 
Effective April 19, 2023
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
 
Tildrakizumab-asmn (e.g., Ilumya) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when ALL the following criteria are met:
 
Plaque Psoriasis
    1. The individual is at least 18 years old or greater (AAD, 2019); AND      
    2. The individual must have an established diagnosis of moderate to severe plaque psoriasis established by or in consultation with a dermatologist (AAD, 2019); AND       
    3. One of the following:
a.  Plaque psoriasis involving greater than ten percent (>10%) body surface area (BSA) (Reich, 2017); OR
b.  Plaque psoriasis involving less than or equal to ten percent (<10%) BSA involving sensitive areas or areas that significantly impact daily function (such as palms, soles of feet, head/neck, or genitalia) (AAD, 2019); AND
4.  Individual has had an inadequate response to phototherapy or other systemic therapy (such as acitretin, cyclosporine, methotrexate, azathioprine, tacrolimus, leflunomide, mycophenolate) (AAD, 2019); AND  
5.  Individual will not be receiving in combination with any other biologic (e.g. including but not limited to: TNF inhibitor, IL 36 inhibitor, PDE4 inhibitor, any other IL inhibitor, or Janus kinase inhibitor); AND
6.  Must be dosed in accordance with the FDA label.
 
CONTINUED APPROVAL for 1 year:
 
    1. Individual meets criteria for initial approval based on indication; AND            
    2. Individual has experienced a positive clinical response to tildrakizumab-asmn; AND            
    3. Individual is not taking tildrakizumab-asmn in combination with any other biologic DMARD (e.g., adalimumab, etanercept, ustekinumab) or targeted synthetic DMARD (e.g., apremilast or tofacitinib); AND            
    4. Dosed in accordance with FDA labeling.
 
Dosage and Administration
Dosing per FDA Guidelines
 
The recommended dose of tildrakizumab-asmn is 100 mg at Weeks 0, 4, and every twelve weeks thereafter.
 
Tildrakizumab-asmn is available as a 100mg/mL prefilled syringe.
 
Tildrakizumab-asmn should be administered as a subcutaneous injection by a healthcare professional.
 
Please refer to separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Tildrakizumab-asmn, for any indication or circumstance not described above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, tildrakizumab-asmn, for any indication or circumstance not described above, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective April 1, 2023 to April 18, 2023
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
Tildrakizumab-asmn (e.g., Ilumya) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when ALL the following criteria are met:
 
Plaque Psoriasis
    1. The individual is at least 18 years old or greater, AND      
    2. The individual must have an established diagnosis of moderate to severe plaque psoriasis (extensive and disabling) established by or in consultation with a dermatologist, AND       
    3. One of the following:
a.  Plaque psoriasis involving greater than ten percent (>10%) body surface area (BSA) OR
b.  Plaque psoriasis involving less than or equal to ten percent (>10) BSA involving sensitive areas or areas that significantly impact daily function (such as palms, soles of feet, head/neck, or genitalia), AND
 
4.  Individual has had an inadequate response to phototherapy or other systemic therapy (such as acitretin, cyclosporine, methotrexate, azathioprine, tacrolimus, leflunomide, mycophenolate) AND  
5.  Individual will not be receiving in combination with any other biologic (e.g. including but not limited to: TNF inhibitor, IL 36 inhibitor, PDE4 inhibitor, any other IL inhibitor, or Janus kinase inhibitor).
6.  Must be dosed in accordance with the FDA label unless otherwise specified.
 
CONTINUED APPROVAL for 1 year:
    1. Individual meets criteria for initial approval based on indication.            
    2. Individual has experienced a positive clinical response to tildrakizumab-asmn.             
    3. Individual is not taking tildrakizumab-asmn in combination with any other biologic DMARD (e.g., adalimumab, etanercept, ustekinumab) or targeted synthetic DMARD (e.g., apremilast or tofacitinib).            
    4. Dosed in accordance with FDA labeling.
 
Dosage and Administration
The recommended dose of tildrakizumab-asmn is 100 mg at Weeks 0, 4, and every twelve weeks thereafter.
 
Tildrakizumab-asmn is available as a 100mg/mL prefilled syringe.
 
Tildrakizumab-asmn should be administered as a subcutaneous injection by a healthcare professional.
 
Please refer to separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Tildrakizumab-asmn, for any indication or circumstance not described above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, tildrakizumab-asmn, for any indication or circumstance not described above, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Rationale:
Phase 3 trials (reSURFACE 1, reSURFACE 2) support superiority of tildrakizumab compared with placebo and etanercept [223]. In reSURFACE 1, 772 adults with moderate to severe plaque psoriasis were randomly assigned to receive tildrakizumab 200 mg, tildrakizumab 100 mg, or placebo at weeks 0 and 4 and then every 12 weeks. After 12 weeks, 62, 64, and 6 percent of patients in the 200 mg, 100 mg, and placebo groups, respectively, achieved PASI 75.
 
The reSURFACE 2 trial randomly assigned 1090 patients to similar groups plus an etanercept group. After 12 weeks, 66, 61, 6, and 48 percent of patients in the tildrakizumab 200 mg, tildrakizumab 100 mg, placebo, and etanercept groups, respectively, achieved PASI 75. Rates of serious adverse effects were similar among the groups in both reSURFACE 1 and reSURFACE 2. One patient in the tildrakizumab 100 mg group died of an unclear cause during reSURFACE 2.
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2023. No new literature was identified that would prompt a change in the coverage statement.
 
CPT/HCPCS:
J3245Injection, tildrakizumab, 1 mg
References: Coates LC, Soriano ER, Corp N, et al.(2021) Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA): updated treatment recommendations for plaque psoriasis 2021. Nat Rev Rheumatol. 2022;18(8):465-479.

Elmets CA, Korman NJ, Prater EF, Wong EB, Rupani RN, Kivelevitch D, Armstrong AW, Connor C, Cordoro KM, Davis DM, Elewski BE.(2021) Joint AAD–NPF Guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures. Journal of the American Academy of Dermatology. 2021 Feb 1;84(2):432-70.

Ilumya [package insert] Cranbury, NJ: Sun Pharmaceutical Industries, Inc. 2020.

Menter A, Gelfand JM, Connor C, et al.(2020) Joint AAD-NPF guidelines of care for the management of psoriasis with systemic nonbiologic therapies. J Am Acad Dermatol. 2020;82(6):1445-1486.

Menter A, Strober BE, Kaplan DH, et al.(2019) Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019; 80: 1029-72.

Reich K, Papp KA, Blauvelt A, et al.(2017) Tildrakizumab versus placebo or etanercept for chronic plaque psoriasis (reSURFACE 1 and reSURFACE 2): results from two randomised controlled, phase 3 trials. Lancet 2017; 390:276.

Tildrakizumab: Ilumya [package insert]. Cranbury (NJ): Sun Pharmaceutical Industries, 2022.
Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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