Guselkumab (Tremfya®)

Restricted Product(s)

• guselkumab (Tremfya®) intravenous infusion and subcutaneous injection for administration by a healthcare professional

FDA Approved Use

• For the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy 
• For the treatment of adults with active psoriatic arthritis 
• For the treatment of adults with moderately to severely active ulcerative colitis
• For the treatment of adults with moderately to severely active Crohn’s disease

Criteria for Medical Necessity

The restricted product(s) may be considered medically necessary when the following criteria are met:

1. The patient has a diagnosis of moderate to severe plaque psoriasis (PS); AND 
   1. The patient is 18 years of age or older; AND 
   2. The patient has tried and had an inadequate response to ONE conventional agent (i.e., acitretin, anthralin, calcipotriene, calcitriol, coal tar products, cyclosporine, methotrexate, pimecrolimus, PUVA [phototherapy], tacrolimus, tazarotene, topical corticosteroids) used in the treatment of PS for at least 3-months [medical record documentation required]; OR 
   3. The patient has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of PS [medical record documentation required]; OR 
   4. The patient has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of PS [medical record documentation required]; OR 
   5. The patient has severe active PS (e.g., greater than 10% body surface area involvement, occurring on select locations [i.e., hands, feet, scalp, face, or genitals], intractable pruritus, serious emotional consequences) [medical record documentation required]; OR 
   6. The patient has concomitant severe psoriatic arthritis (PsA) (e.g., erosive disease, elevated markers of inflammation [e.g., ESR, CRP] attributable to PsA, long-term damage that interferes with function [i.e., joint deformities], rapidly progressive) [medical record documentation required]; OR 
2. The patient has a diagnosis of active psoriatic arthritis (PsA); AND 
   1. The patient is 18 years of age or older; AND 
   2. The patient has tried and had an inadequate response to ONE conventional agent (i.e., cyclosporine, leflunomide, methotrexate, sulfasalazine) used in the treatment of PsA for at least 3-months [medical record documentation required]; OR
   3. The patient has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of PsA [medical record documentation required]; OR 
   4. The patient has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of PsA [medical record documentation required]; OR 
   5. The patient has severe active PsA (e.g., erosive disease, elevated markers of inflammation [e.g., ESR, CRP] attributable to PsA, long-term damage that interferes with function [i.e., joint deformities], rapidly progressive) [medical record documentation required]; OR 
   6. The patient has concomitant severe psoriasis (PS) (e.g., greater than 10% body surface area involvement, occurring on select locations [i.e., hands, feet, scalp, face, or genitals], intractable pruritus, serious emotional consequences) [medical record documentation required]; OR
3. The patient has a diagnosis of moderately to severely active ulcerative colitis (UC); AND 
   1. The patient is 18 years of age or older; AND 
   2. The patient has tried and had an inadequate response to ONE conventional agent (i.e., 6-mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, sulfasalazine) used in the treatment of UC for at least 3-months [medical record documentation required]; OR 
   3. The patient has severely active ulcerative colitis [medical record documentation required]; OR 
   4. The patient has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of UC [medical record documentation required]; OR 
   5. The patient has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of UC [medical record documentation required]; OR
4. The patient has a diagnosis of moderately to severely active Crohn’s disease (CD); AND
   1. The patient is 18 years of age or older; AND
   2. The patient has tried and had an inadequate response to ONE conventional agent (i.e., 6-mercaptopurine, azathioprine, corticosteroids [e.g., prednisone, budesonide EC capsule], methotrexate) used in the treatment of CD for at least 3-months [medical record documentation required]; OR
   3. The patient has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of CD [medical record documentation required]; OR
   4. The patient has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of CD [medical record documentation required]; AND
5. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., dermatologist for PS; rheumatologist for PsA; gastroenterologist for CD, UC) or has consulted with a specialist in the area of the patient’s diagnosis; AND 
6. The patient will NOT be using guselkumab (Tremfya®) in combination with another biologic immunomodulator agent or Otezla® or Zeposia®; AND 
7. The patient does NOT have any FDA labeled contraindications to guselkumab (Tremfya®); AND 
8. The patient has been tested for latent tuberculosis (TB) when required by the prescribing information for the requested agent AND if positive the patient has begun therapy for latent TB; AND 
9. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below); AND 
10. For requests for injection or infusion administration of the requested medication in an inpatient or outpatient hospital setting, Site of Care Criteria applies (outlined below)*
    
    Duration of Approval: 365 days (1 year)

*Site of Care Medical Necessity Criteria

1. For requests for injection or infusion administration in an inpatient setting, the injection or infusion may be given if the above medical necessity criteria are met AND the inpatient admission is NOT for the sole purpose of administering the injection or infusion; OR 
2. For requests for injection or infusion administration in an outpatient hospital setting, the injection or infusion may be given if the above medical necessity criteria are met AND ONE of the following must be met: 
   1. History of mild adverse events that have not been successfully managed through mild pre-medication (e.g., diphenhydramine, acetaminophen, steroids, fluids, etc.); OR
   2. Inability to physically and cognitively adhere to the treatment schedule and regimen complexity; OR 
   3. New to therapy, defined as initial injection or infusion OR less than 3 months since initial injection or infusion; OR 
   4. Re-initiation of therapy, defined as ONE of the following: 
      1. First injection or infusion after 6 months of no injections or infusions for drugs with an approved dosing interval less than 6 months duration; OR 
      2. First injection or infusion after at least a 1-month gap in therapy outside of the approved dosing interval for drugs requiring every 6 months dosing duration; OR 
   5. Requirement of a change in the requested restricted product formulation; AND
3. If the Site of Care Medical Necessity Criteria in #1 or #2 above are not met, the injection or infusion will be administered in a home-based infusion or physician office setting with or without supervision by a certified healthcare professional. 

References

All information referenced is from FDA package insert unless otherwise noted below.

1. Blauvelt A, Papp KA, Griffiths CE, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial. J Am Acad Dermatol. 2017; 76(3):405-417. 
2. Langley RG, Tsai TF, Flavin S, et al. Efficacy and safety of guselkumab in patients with psoriasis who have an inadequate response to ustekinumab: results of the randomized, double-blind, phase 3 NAVIGATE trial. Br J Dermatol. 2018;178(1):114-123. 
3. Menter A, Strober BE, Kaplan DH, et al. Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019;80(4):1029-1072. 
4. Reich K, Armstrong AW, Foley P, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: results from the phase III, double-blind, placebo- and active comparator-controlled VOYAGE 2 trial. J Am Acad Dermatol. 2017;76(3):418-431. 
5. Singh JA, Guyatt G, Ogdie A, et al. 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis. Arthritis Care Res. 2019;71(1):5-32.

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q1 annually.

April 2025: Criteria change: Added newly approved indication for adults with moderately to severely active Crohn’s disease with corresponding criteria and dosing table updates. Updated maximum units according to indication.
September 2024: Criteria change: Added newly approved indication for adults with moderately to severely active ulcerative colitis with corresponding criteria and dosing table updates. Updated maximum units according to indication. 
September 2023: Criteria change: For psoriatic arthritis: Removed hydroxychloroquine from list of conventional agents. Separated out intolerance/hypersensitivity criteria from FDA labeled contraindication criteria for clarity.
October 2021: Criteria change: Added Site of Care medical necessity criteria. Policy notification given 8/2/2021 for effective date 10/1/2021.
August 2021: Criteria change: Removed criteria points regarding medication history indicating use of another biologic immunomodulator agent FDA labeled for the treatment of the same condition. Policy notification given 6/1/2021 for effective date 8/1/2021.
June 2021: Criteria change: Medical record documentation required for all indications.
April 2021: Criteria change: PS: Addition of criteria for history of use of another biologic immunomodulator agent (or Otezla) for the same indication; BSA requirement changed to 10%, added option for concomitant severe PsA; added requirement that patient has no FDA labeled contraindications, and for TB testing; added maximum units; medical policy formatting change. Policy notification given 2/26/2021 for effective date 4/28/2021.
*Further historical criteria changes and updates available upon request from Medical Policy and/or Corporate Pharmacy.