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The Policy VaultThe Policy Vault

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

moderately to severely active ulcerative colitis (UC)

Preferred products

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

Initial criteria

  • ONE of the following:
  • A. Continuation of therapy: The requested agent is eligible for continuation (all target agents except Imuldosa, Otulfi, Pyzchiva, Ustekinumab-ttwe, Stelara, Ustekinumab, Wezlana). If non‑preferred, prescriber states patient has been treated with requested agent within past 90 days and is at risk if therapy is changed (chart notes required). OR If preferred, prescriber states patient has been treated within past 90 days and is at risk if therapy is changed.
  • B. New start: ALL of the following:
  • 1. The patient has an FDA labeled or compendia‑supported indication for the requested agent and route.
  • 2. ONE of the following condition‑specific criteria:
  • A. Psoriatic arthritis (PsA): ONE of the following — (1) Tried and had inadequate response to ≥1 conventional agent (cyclosporine, leflunomide, methotrexate, sulfasalazine) after ≥3 months therapy; OR (2) Intolerance or hypersensitivity to ≥1 conventional agent; OR (3) FDA labeled contraindication to ALL conventional agents; OR (4) Severe active PsA (erosive disease, elevated ESR/CRP, long‑term damage interfering with function, rapidly progressive); OR (5) Concomitant severe psoriasis (≥10% BSA involvement or affecting hands, feet, scalp, face, or genitals, or has intractable pruritus or serious emotional consequences); OR (6) Medication history indicates use of another biologic immunomodulator or Otezla labeled/supported for PsA.
  • B. Plaque psoriasis (PS): ONE of the following — (1) Tried and had inadequate response to ≥1 conventional agent (acitretin, anthralin, calcipotriene, calcitriol, coal tar products, cyclosporine, methotrexate, pimecrolimus, PUVA, tacrolimus, tazarotene, topical corticosteroids) after ≥3 months; OR (2) Intolerance or hypersensitivity to ≥1 conventional agent; OR (3) FDA labeled contraindication to ALL conventional agents; OR (4) Severe active PS (≥10% BSA, critical locations, pruritus, emotional impact); OR (5) Concomitant severe PsA (erosive disease or elevated markers); OR (6) Medication history indicates use of another biologic immunomodulator or Otezla labeled/supported for PS.
  • C. Crohn’s disease (CD): ONE of the following — (1) Tried and inadequate response to ≥1 conventional agent (6‑mercaptopurine, azathioprine, corticosteroids such as prednisone or budesonide EC, methotrexate) after ≥3 months; OR (2) Intolerance or hypersensitivity to ≥1 conventional agent; OR (3) FDA labeled contraindication to ALL conventional agents; OR (4) Medication history indicates use of another biologic immunomodulator labeled/supported for CD.
  • D. Ulcerative colitis (UC): ONE of the following — (1) Tried and inadequate response to ≥1 conventional agent (6‑mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, sulfasalazine) after ≥3 months; OR (2) Intolerance or hypersensitivity to ≥1 conventional agent; OR (3) FDA labeled contraindication to ALL conventional agents; OR (4) Severely active UC; OR (5) Medication history indicates use of another biologic immunomodulator labeled/supported for UC.
  • E. Other indication: must have FDA or compendia support.
  • 3. Preferred agent requirement: ONE of the following — (A) The requested agent is a preferred agent; OR (B) Patient has tried and had inadequate response to three preferred agents (≥6‑month duration per agent) OR two preferred agents (≥6‑month duration) plus intolerance/hypersensitivity to one preferred agent OR one preferred agent (≥6‑month duration) plus intolerance/hypersensitivity to two other preferred agents OR intolerance/hypersensitivity to all three preferred agents; OR (C) Patient has FDA contraindication to all preferred agents.
  • 4. For CD or UC: ONE of the following (continuation of condition‑specific criteria will apply, e.g., initiation and dosing per indication).

Reauthorization criteria

  • 1. Patient previously approved for requested agent through plan's Prior Authorization process.
  • 2. Patient has had clinical benefit with requested agent.
  • 3. ONE of the following — (A) Requested agent is preferred; OR (B) Patient has trial history meeting preferred‑agent trial/inadequate response or intolerance criteria as stated; OR (C) FDA labeled contraindication to all preferreds; OR (D) All preferreds not clinically appropriate and prescriber documented full medication history.
  • 4. Prescriber is or has consulted specialist appropriate to diagnosis.
  • 5. Not used with another immunomodulatory unless both (a) Prescribing info allows combination and (b) Combination supported by clinical trials/guidelines.
  • 6. Patient has no FDA labeled contraindications.

Approval duration

12 months (UC: 12 weeks initial)