Otulfi (ustekinumab-aauz) — Blue Cross Blue Shield of Montana
active psoriatic arthritis (PsA)
Preferred products
- Ustekinumab-aekn (Selarsdi)
- Ustekinumab-kfce (Yesintek)
Initial criteria
- ONE of the following: (A) The requested agent is eligible for continuation of therapy AND has been used within the past 90 days (starting on samples not approvable) and patient is at risk if therapy is changed; OR (B) ALL of the following: (1) The patient has an FDA labeled or compendia supported indication for the requested agent and route of administration AND ONE of the following indication-specific criteria:
- Psoriatic arthritis (PsA): ONE of the following: (1) Inadequate response to ONE conventional agent (cyclosporine, leflunomide, methotrexate, sulfasalazine) after ≥3 months OR (2) Intolerance or hypersensitivity to ONE conventional agent OR (3) FDA labeled contraindication to ALL conventional agents OR (4) Severe active PsA (e.g., erosive disease, elevated markers, progressive) OR (5) Concomitant severe psoriasis OR (6) Medication history indicates use of another biologic immunomodulator agent or Otezla for PsA.
- Plaque psoriasis (PS): ONE of the following: (1) Inadequate response to ONE conventional agent (acitretin, anthralin, calcipotriene, calcitriol, coal tar products, cyclosporine, methotrexate, pimecrolimus, PUVA [phototherapy], tacrolimus, tazarotene, topical corticosteroids) after ≥3 months OR (2) Intolerance or hypersensitivity to ONE conventional agent OR (3) FDA labeled contraindication to ALL conventional agents OR (4) Severe active PS OR (5) Concomitant severe psoriatic arthritis OR (6) Medication history indicates use of another biologic immunomodulator agent or Otezla for PS.
- Crohn’s disease (CD): ONE of the following: (1) Inadequate response to ONE conventional agent (6-mercaptopurine, azathioprine, corticosteroids [e.g., prednisone, budesonide EC capsule], methotrexate) after ≥3 months OR (2) Intolerance or hypersensitivity to ONE conventional agent OR (3) FDA labeled contraindication to ALL conventional agents OR (4) Medication history indicates use of another biologic immunomodulator agent labeled or supported for CD.
- Ulcerative colitis (UC): ONE of the following: (1) Inadequate response to ONE conventional agent (6-mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, sulfasalazine) after ≥3 months OR (2) Intolerance or hypersensitivity to ONE 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 agent labeled or supported for UC.
- AND ONE of the following relative to preferred agents: (A) The requested agent is a preferred agent OR (B) The patient meets at least one of: (1) Inadequate response to THREE preferred agents after ≥6 months per agent OR (2) Inadequate response to TWO preferred agents after ≥6 months per agent plus intolerance or hypersensitivity to ONE other preferred agent not expected with the requested agent OR (3) Inadequate response to ONE preferred agent after ≥6 months plus intolerance to TWO other preferred agents not expected with requested agent OR (4) Intolerance or hypersensitivity to THREE preferred agents OR (C) FDA labeled contraindication to ALL preferred agents not expected with requested agent.
Reauthorization criteria
- Patient previously approved for the requested agent through plan prior authorization AND patient has had clinical benefit with the requested agent AND ONE of the following: (A) The requested agent is a preferred agent OR (B) The patient meets preferred agent step criteria (inadequate response to three, two plus intolerance, etc.) OR (C) FDA labeled contraindication to all preferred agents OR (D) All preferred agents not clinically appropriate and prescriber has provided list of prior tried agents AND prescriber is a specialist or has consulted a specialist AND patient will not use in combination with another immunomodulatory agent unless labeling allows and use is supported by clinical evidence AND patient has no FDA labeled contraindications.
Approval duration
12 months (UC: 12 weeks)