Steqeyma (ustekinumab-stba) — Blue Cross Blue Shield of Illinois

Preferred products

• Ustekinumab
• Stelara (ustekinumab)
• Ustekinumab-aekn
• Wezlana (ustekinumab-auub)
• Selarsdi (ustekinumab-aekn)
• Yesintek (ustekinumab-kfce)

Initial criteria

• For PJIA: patient's medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in compendia for PJIA
• For HS: patient has moderate to severe HS AND ONE of: (A) tried and had an inadequate response to ONE conventional agent (oral tetracyclines, oral contraceptives [females only], metformin [females only], finasteride [females only], spironolactone [females only], intralesional corticosteroids [triamcinolone], clindamycin + rifampin, rifampin + moxifloxacin + metronidazole, cyclosporine, oral retinoids) after ≥3 months OR (B) has intolerance or hypersensitivity to ONE conventional agent for HS OR (C) has FDA labeled contraindication to ALL conventional agents for HS OR (D) medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in compendia for HS
• For other diagnoses: ONE of the following: (A) requested agent is a preferred agent OR (B) stage four advanced metastatic cancer criteria as listed (either for cancer itself or related condition) and use supported by FDA and evidence-based literature OR (C) patient is stable on requested agent OR (D) patient has tried and had inadequate response to THREE preferred agents after ≥3 months each OR (E) THREE preferred agents discontinued due to lack of efficacy, effectiveness, diminished effect, or adverse event OR (F) intolerance or hypersensitivity to THREE preferred agents not expected to occur with requested agent OR (G) FDA labeled contraindication to ALL preferred agents not expected to occur with requested agent OR (H) THREE preferred agents expected to be ineffective, cause barriers/adherence issues, worsen comorbid condition, reduce functional ability, or cause harm OR (I) THREE preferred agents not in best interest based on medical necessity OR (J) has tried another drug in same class as THREE preferred agents that was discontinued due to lack of efficacy, diminished effect, or adverse event OR (K) ALL preferred agents not clinically appropriate and prescriber provided list of previously tried agents
• If patient has FDA labeled indication: patient's age is within FDA labeling or supported for use AND prescriber is specialist or has consulted with specialist in corresponding field AND patient will not use with other immunomodulators unless supported and allowed by prescribing information AND patient lacks FDA-labeled contraindications AND patient tested for latent TB and begun therapy if positive
• Compendia allowed: AHFS, DrugDex level 1, 2a, or 2b, or NCCN 1, 2a, or 2b recommended use
• For BCBSIL and BCBSTX members: approve for 12 months (starter pack and maintenance each 12 months); for all other plans: 12 months for all indications except ulcerative colitis (UC) = 12 weeks
• For Ohio members (Fully Insured or HIM Shop): requested agent may be approved if no FDA contraindications and ONE of: (a) another FDA-labeled indication and route OR (b) indication supported in compendia for that route OR (c) prescriber submitted two peer-reviewed journal articles demonstrating safety and efficacy

Reauthorization criteria

• Patient previously approved through PA process AND patient had clinical benefit AND ONE of the following: (A) requested agent is preferred agent OR (B) stage four advanced metastatic cancer use criteria met OR (C) patient stable on agent OR (D) inadequate response to THREE preferred agents after ≥3-month trial each OR (E) THREE preferred agents discontinued for lack of efficacy/effectiveness/diminished effect/adverse event OR (F) intolerance/hypersensitivity to THREE preferred agents not expected with requested agent OR (G) FDA contraindication to ALL preferred agents not expected with requested agent OR (H) THREE preferred agents expected to be ineffective, cause adherence barrier, worsen comorbid condition, reduce function, or cause harm OR (I) THREE preferred agents not in best interest based on medical necessity OR (J) tried another drug in same class as THREE preferred agents discontinued for lack of efficacy/effectiveness/adverse event OR (K) all preferred agents not clinically appropriate AND prescriber provided complete list of tried agents
• Prescriber is specialist or has consulted with specialist
• Requested agent not used with another immunomodulatory agent unless labeling and evidence support combination use
• Patient has no FDA labeled contraindications

Approval duration

12 months (UC: 12 weeks)