Pyzchiva (ustekinumab-ttwe) — Blue Cross Blue Shield of Oklahoma

Preferred products

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

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 tried and had an inadequate response to ONE conventional agent (such as doxycycline, minocycline, tetracycline, oral contraceptives, metformin, finasteride, spironolactone, intralesional corticosteroids, clindamycin + rifampin, rifampin + moxifloxacin + metronidazole, cyclosporine, oral retinoids) after ≥3 months OR has intolerance/hypersensitivity to ONE conventional agent OR has FDA labeled contraindication to ALL conventional agents OR has used another biologic immunomodulator agent that is FDA labeled or compendia supported for HS
• For all other diagnoses not mentioned: ONE of the following: (A) requested agent is a preferred agent OR (B) patient with stage IV metastatic cancer and requested agent used to treat the cancer or associated condition and consistent with best practices and FDA approved use OR (C) patient is currently stable on requested agent OR (D) patient has tried and had inadequate response to THREE preferred agents after ≥3 months per agent OR (E) THREE preferred agents discontinued due to lack of efficacy/adverse event OR (F) intolerance/hypersensitivity to THREE preferred agents not expected with requested agent OR (G) FDA labeled contraindication to ALL preferred agents not expected with requested agent OR (H) THREE preferred agents expected to be ineffective or pose barriers, worsen comorbid condition, or cause harm OR (I) THREE preferred agents not in best interest per medical necessity OR (J) tried another drug in same class or mechanism as THREE preferred agents and discontinued due to ineffectiveness/adverse event OR (K) ALL preferred agents not clinically appropriate and prescriber provided full list of tried agents)
• If patient has FDA labeled indication: (A) patient age within or supported for indication, (B) prescriber is relevant specialist or has consulted one, (C) patient will not use with other immunomodulator OR combination use supported and not limited by prescribing info, (D) patient has no FDA labeled contraindications, (E) patient tested for latent TB and treated if positive
• Compendia allowed: AHFS, DrugDex 1/2a/2b, NCCN 1/2a/2b
• Special Ohio provision: member resides in Ohio AND plan is Fully Insured or HIM Shop AND no contraindication AND (has FDA labeled indication OR compendia supported indication OR prescriber submitted two peer-reviewed journal articles supporting use)

Reauthorization criteria

• Previously approved for requested agent through plan's PA process
• Patient has had clinical benefit with requested agent
• AND ONE of: requested agent is preferred OR (stage IV metastatic cancer treated per best practices and FDA approval) OR (patient stable on agent) OR (tried and had inadequate response to THREE preferred agents ≥3 months each) OR (THREE preferred agents discontinued due to lack of efficacy/adverse event) OR (intolerance/hypersensitivity to THREE preferred agents not expected with requested agent) OR (FDA labeled contraindication to ALL preferred agents not expected with requested agent) OR (THREE preferred agents expected ineffective/barrier/worsen comorbidity/harm) OR (THREE preferred agents not in best interest) OR (tried another drug in same class or mechanism as THREE preferred agents and discontinued due to poor outcomes) OR (ALL preferred agents not clinically appropriate and prescriber provided complete tried list)
• Prescriber is appropriate specialist or consulted one
• Patient not using prohibited immunomodulator combination unless supported by prescribing info and clinical evidence
• Patient has no FDA labeled contraindications to requested agent

Approval duration

12 months (exception: ulcerative colitis 12 weeks)