ustekinumab IV product — Blue Cross Blue Shield of Montana
psoriasis
Preferred products
- Selarsdi
- Steqeyma
- Yesintek
Initial criteria
- The patient received an ustekinumab IV product for induction therapy OR is new to therapy and will receive an ustekinumab IV product for induction therapy
- If the patient has an FDA labeled indication, then ONE of the following: A) The patient’s age is within FDA labeling for the requested indication for the requested agent OR B) There is support for using the requested agent for the patient’s age for the requested indication
- If an ustekinumab 90 mg product is requested, then ONE of the following: A) The patient has a diagnosis of psoriasis AND weighs >100kg OR B) The patient has a dual diagnosis of psoriasis AND psoriatic arthritis AND the patient weighs >100kg OR C) The patient has a diagnosis of Crohn’s disease or ulcerative colitis
- The prescriber is a specialist in the area of the patient’s diagnosis (e.g., rheumatologist for PsA; gastroenterologist for CD, UC; dermatologist for PS), or has consulted with a specialist in the area of the patient’s diagnosis
- ONE of the following: A) The patient will NOT be using the requested agent in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR B) The patient will be using the requested agent in combination with another immunomodulatory agent AND BOTH of the following: 1) The prescribing information for the requested agent does NOT limit the use with another immunomodulatory agent AND 2) There is support for the use of combination therapy (submitted copy of clinical trials, phase III studies, or guidelines required)
- The patient does NOT have any FDA labeled contraindications to the requested agent
- The patient has been tested for latent tuberculosis (TB) AND if positive the patient has begun therapy for latent TB
Reauthorization criteria
- The patient has been previously approved for the requested agent through the plan’s Prior Authorization process (ustekinumab product renewal must be for the same strength as initial approval)
- The patient has had clinical benefit with the requested agent
- ONE of the following (reference preferred agents table): A) The requested agent is a preferred agent OR B) The patient has ONE of the following (medical records required): 1) Has tried and had an inadequate response to THREE preferred agents after at least 6-month duration per agent OR 2) Has tried and had an inadequate response to TWO preferred agents after at least 6-month duration per agent and intolerance or hypersensitivity to ONE preferred agent not expected to recur with requested agent OR 3) Has tried and had an inadequate response to ONE preferred agent after at least 6-month duration and intolerance or hypersensitivity to TWO preferred agents not expected to recur with requested agent OR 4) Has an intolerance or hypersensitivity to THREE preferred agents not expected to recur with requested agent OR C) The patient has an FDA labeled contraindication to ALL preferred agents not expected to recur with requested agent (medical records required)
- The prescriber is a specialist in the area of the patient’s diagnosis (e.g., rheumatologist for PsA; gastroenterologist for CD, UC; dermatologist for PS), or has consulted with a specialist in the area of the patient’s diagnosis
- ONE of the following: A) The patient will NOT be using the requested agent in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR B) The patient will be using the requested agent in combination with another immunomodulatory agent AND BOTH of the following: 1) The prescribing information for the requested agent does NOT limit use with another immunomodulatory agent AND 2) There is support for such combination therapy
- The patient does NOT have any FDA labeled contraindications to the requested agent
Approval duration
12 months