Background

Tremfya is a fully human immunoglobulin (Ig)G monoclonal antibody that binds to interleukin (IL)-23, a pro-inflammatory cytokine. It binds to the p19 subunit of IL-23 and inhibits the intracellular and downstream signaling of IL-23 which is required for the terminal differentiation and survival of T helper (Th)17 cells. Tremfya is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. In plaque psoriasis, the recommended dose is 100 mg subcutaneously (SC) at Weeks 0 and 4 and then once every 8 weeks (Q8W) thereafter. Tremfya is intended for use under the guidance and supervision of a physician. Those trained in SC injection technique using the pen or prefilled syringe may self-inject when deemed appropriate. Warnings/Precautions for Tremfya include concurrent use with other biologics, infection and risk for tuberculosis, and vaccinations.

Policy

Coverage of the Tremfya is provided when ALL the following are met:

1. FDA approved age 18 years old
2. FDA approved indication:
   1. Diagnosis of Psoriatic Arthritis (PsA) — SQ
      1. Treatment with an adequate course of conventional therapy (such as NSAIDs, DMARDs) has been ineffective, is contraindicated, or not tolerated.
   2. Diagnosis of Plaque Psoriasis (PsO) — SQ
      1. Treatment with an adequate course of conventional therapy (such as topical treatments, phototherapy, or systemic treatments) has been ineffective, is contraindicated, or not tolerated.
   3. Diagnosis of Ulcerative Colitis (UC) — SQ & IV
      1. Treatment with an adequate course of conventional therapy (such as NSAIDs, DMARDs) has been ineffective, is contraindicated, or not tolerated; AND/OR
      2. Treatment with advanced therapies (i.e., tumor necrosis factor alpha antagonists, vedolizumab, or tofacitinib) has been ineffective, is contraindicated, or not tolerated.
   4. Diagnosis of Crohn’s Disease (CD) — SQ
      1. Treatment with an adequate course of conventional therapy (such as NSAIDs, DMARDs) has been ineffective, is contraindicated, or not tolerated.
3. Not to be used in combination with other biologics or targeted disease-modifying anti-rheumatic drugs (DMARDs).
4. The medication is prescribed by or in consultation with a specialist in the applicable field is allowed.

Quantity Limitations, Authorization Period and Renewal Criteria:

1. Quantity Limits: Align with FDA recommended dosing
2. Authorization Period: 12 months
3. Renewal Criteria: Clinical benefit seen which could include clinical documentation if plan warranted.

References

1. Tremfya™ injection [prescribing information]. Horsham, PA: Janssen Biotech; March 2016.
2. Blauvelt A, Papp KA, Griffiths CE, et al. Efficacy and safety of guselkumab, an antiinterleukin-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.
3. Reich K, Armstrong AW, Foley P, et al. Efficacy and safety of guselkumab, an antiinterleukin-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.
4. Hsu S, Papp KA, Lebwohl MG, et al. Consensus guidelines for the management of plaque psoriasis. Arch Dermatol. 2012;148(1):95-102.
5. Furst DE, Keystone EC, So AK, et al. Updated consensus statement on biological agents for the treatment of rheumatic diseases, 2012. Ann Rheum Dis. 2013;72 Suppl 2:ii2-34.
6. Otezla^® tablets [prescribing information]. Summit, NJ: Celgene Corporation; December 2015.

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community,and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

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