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:
- The individual is 18 years of age or older with moderate to severe PS; and
- ONE of the following:
- Information has been provided that indicates the individual has been treated with the requested agent (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed; or
- The individual has tried and had an inadequate response to one conventional agent (e.g., 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; or
- The individual has a intolerance or hypersensitivity to ONE conventional agents used in the treatment of PS; or
- The individual has an FDA labeled contraindication to ALL conventional agents used in the treatment of PS; or
- The individual 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); or
- The individual 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); or
- The individual’s medication history indicates use of another biologic immunomodulator agent OR Otezla that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence for the treatment of PS; and
- The prescriber is a specialist in the area of the individual’s diagnosis or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
- The individual will NOT be using tildrakizumab (Ilumya) with another biologic immunomodulator agent or apremilast (Otezla).
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.