Tildrakizumab-asmn (Ilumya)

Section: Injections
Effective Date: February 01, 2020
Revised Date: January 28, 2020

Description

Tildrakizumab-asmn (IlumyaTM) is a humanized IgG1/k monoclonal antibody that selectively and specifically binds to the p19 subunit of interleukin-23(IL-23) and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses. Tildrakizumab (Ilumya) inhibits the release of proinflammatory cytokines and chemokines.

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Initial Approval Criteria

Tildrakizumab (Ilumya) may be considered medically necessary when an individual meets the criteria for the following indication:

  • Plaque Psoriasis (PsO)
    • The individual is 18 years of age or older with moderate or severe PsO; and
    • Treatment with phototherapy (e.g. PUVA, UVB) was ineffective, not tolerated or contraindicated. If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), treatment with systemic therapy (e.g. methotrexate, cyclosporine) must have been ineffective or not tolerated, or all systemic therapies are contraindicated; or
    • Treatment with systemic therapy (e.g. methotrexate, cyclosporine) was ineffective or not tolerated, or all systemic therapies are contraindicated; or
    • Information has been provided that indicated the individual is currently being treated with the requested agent (starting on samples is not approvable); or
    • The prescriber states the patient is currently being treated with the requested agent (starting on samples is not approvable) and is at risk if therapy is changed; and
    • Tildrakizumab (Ilumya) will not be used with other biologic immunomodulators.

The use of tildrakizumab (Ilumya) for any other indication is considered experimental/investigational, and therefore, non-covered. Scientific evidence does not support the use for any other indication.

Procedure Codes

J3245

Renewal Approval Criteria

  • Continuation of therapy with tildrakizumab (Ilumya) may be considered medically necessary when the following criteria is met:
    • The individual has previously been approved for tildrakizumab (Ilumya) through the BCBSND approval process; and
    • Provider attestation that individual has demonstrated a disease stability or beneficial response to therapy; and
    • Tildrakizumab (Ilumya) will not be used with other biologic immunomodulators.

Procedure Codes

J3245

Note: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Diagnosis Codes

L40.0

Professional Statements and Societal Positions Guidelines

NA

Links