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The Policy VaultThe Policy Vault

Imuldosa — Blue Cross Blue Shield of Montana

other diagnoses supported in compendia or FDA labeling

Initial criteria

  • A. The requested agent is eligible for continuation of therapy AND one of the following:
  • 1. If the requested agent is NOT a preferred agent, then prescriber states the patient has been treated with the requested agent (starting on samples not approvable) within the past 90 days [chart notes required] AND is at risk if therapy is changed OR
  • 2. If the requested agent is a preferred agent, then prescriber states the patient has been treated with the requested agent (starting on samples not approvable) within the past 90 days AND is at risk if therapy is changed
  • B. ALL of the following:
  • 1. The patient has an FDA labeled indication or compendia-supported indication for the requested agent and route of administration AND one of the following:
  • Psoriatic arthritis (PsA): ONE of the following: tried and inadequate response to ≥1 conventional agent (cyclosporine, leflunomide, methotrexate, sulfasalazine) ≥3 months; intolerance or hypersensitivity to ONE conventional agent; FDA labeled contraindication to all conventional agents; severe active PsA; concomitant severe psoriasis; medication history shows prior biologic immunomodulator or Otezla use.
  • Plaque psoriasis (PS): ONE of the following: tried and inadequate response to ≥1 conventional agent (acitretin, anthralin, calcipotriene, calcitriol, coal tar, cyclosporine, methotrexate, pimecrolimus, PUVA, tacrolimus, tazarotene, topical corticosteroids) ≥3 months; intolerance or hypersensitivity to ONE conventional agent; FDA labeled contraindication to all conventional agents; severe active PS; concomitant severe PsA; medication history shows prior biologic immunomodulator or Otezla use.
  • Crohn’s disease (CD): ONE of the following: currently treated and stable; inadequate response to ≥1 conventional agent (6-mercaptopurine, azathioprine, corticosteroids, methotrexate) ≥3 months; discontinued due to lack of efficacy, diminished effect, or adverse event; intolerance or hypersensitivity; FDA labeled contraindication; conventional agent expected ineffective or unsafe; not in best interest; another drug in same class discontinued due to lack of efficacy or AE; medication history showing prior biologic immunomodulator.
  • Ulcerative colitis (UC): ONE of the following: currently treated and stable; inadequate response to ≥1 conventional agent (6-mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, sulfasalazine) ≥3 months; discontinued due to lack of efficacy or AE; intolerance or hypersensitivity; FDA labeled contraindication; expected ineffective or unsafe; not in best interest; another drug in same class discontinued due to lack of efficacy or AE; severe active UC; medication history showing prior biologic immunomodulator.
  • Other diagnoses: ONE of the following (reference preferred agents table): requested agent is preferred OR (if non-preferred) patient has stage four advanced, metastatic cancer and agent used to treat cancer or related condition with evidence-based support OR patient currently treated and stable OR inadequate response to three preferred agents after ≥6-month trial per agent OR discontinued three preferreds due to lack of efficacy, diminished effect, or AE OR intolerance or hypersensitivity to three preferreds OR FDA labeled contraindication to all preferreds OR three preferreds expected ineffective, pose adherence, comorbidity, or harm risk OR three preferreds not in best interest medically OR prior same-class drug discontinued for same issues.
  • If an ustekinumab product requested for Crohn's disease or UC: ONE of the following: received ustekinumab IV for induction therapy OR new to therapy and will receive ustekinumab IV for induction.
  • If FDA labeled indication, then: patient’s age within FDA labeling OR supported for use by compendia.
  • If ustekinumab 90 mg product requested: ONE of the following applies: diagnosis of psoriasis with weight >100kg OR dual diagnosis of psoriasis and PsA with weight >100kg OR diagnosis of Crohn’s disease or ulcerative colitis.
  • Prescriber is a relevant specialist (rheumatologist for PsA; gastroenterologist for CD, UC; dermatologist for PS) or has consulted with one.
  • The patient will NOT use the agent with other immunomodulatory agents OR if in combination, the prescribing information does not limit combo use AND evidence supports combination therapy.

Reauthorization criteria

  • Continuation criteria: The patient has been treated with the requested agent within the past 90 days (not started from samples) and is at risk if therapy is changed, with chart notes required.