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Branded Narrow Therapeutic Index – Essential

Commercial Policy
Version Date: October 2023

Restricted Product(s):

Restriction applies to Brand products only

  • Carbatrol capsule (carbamazepine cap er 12hr) 
  • Digoxin solution 50mcg/mL 
  • Dilantin capsule (phenytoin sodium extended cap)
  • Dilantin Infatabs (phenytoin chew tab) 
  • Dilantin-125 suspension (phenytoin susp 125mg/mL) 
  • Lanoxin tablet (digoxin tab) 
  • Lithium Carb capsule (lithium carbonate) 
  • Lithobid tablet (lithium carbonate tab er) 
  • Mysoline tablet (primidone tab) 
  • Neoral capsule (cyclosporine modified cap) 
  • Neoral solution (cyclosporine modified oral solution 100mg/mL)
  • Norpace capsule (disopyramide phosphate cap)
  • Prograf capsule (tacrolimus cap) 
  • Rapamune tablet (sirolimus tab) 
  • Rapamune solution (sirolimus oral soln 1mg/mL) 
  • Sandimmune capsule (cyclosporine cap) 
  • Tegretol tablet (carbamazepine tab) 
  • Tegretol suspension (carbamazepine susp 100mg/5mL)
  • Tegretol-XR tablet (carbamazepine tab er 12hr) 
  • Zarontin capsule (ethosuximide cap)
  • Zarontin solution (ethosuximide soln 250mg/5mL) 
  • Zortress tablet (everolimus tab)

Criteria for Approval of Restricted Product(s):

  1. The patient is currently being treated with the requested agent; OR 
  2. The patient is new to therapy with the requested agent; AND 
    1. The patient has been unable to maintain therapeutic levels and/or outcomes using generic manufacturers of the requested product; OR
    2. The patient has a hypersensitivity to an inactive ingredient in the generic product, that is not present in the brand name product AND
  3. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 365 days (1 year)

References:

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information:

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q4 annually.

October 2023: Criteria update: Removed Phenytek from policy.

January 2023: Original utilization management criteria issued.

Blue Cross and Blue Shield of North Carolina does not discriminate on the basis of race, color, national origin, sex, age or disability in its health programs and activities. Learn more about our non-discrimination policy and no-cost services available to you.

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