generic nitisinone — Medical Mutual

Preferred products

• generic nitisinone

Initial criteria

• Nitisinone is prescribed by or in consultation with a physician who specializes in treatment of inherited metabolic disorder/genetic diseases; AND
• Laboratory baseline succinylacetone (SA) level are provided and elevated prior to treatment; AND
• The patient is following a diet consisting of tyrosine and phenylalanine restriction; AND
• Baseline hepatic imaging and baseline labs have been obtained and reviewed such as: liver evaluation (PT, PTT, ALT/AST), renal function (BUN, creatine, etc), plasma amino acids, and a complete blood count (CBC); AND
• Baseline ophthalmologic examination including slit-lamp examination has been completed prior to treatment; AND
• If the request is for brand Orfadin or Nityr, the patient has a documented intolerance to or has failed at least a three-month trial of generic nitisinone.

Reauthorization criteria

• The provider has been monitoring for plasma amino acids, blood or urinary SA, liver function, serum AFP increases, and CBC; AND
• The provider is regularly monitoring for ophthalmologic changes including eye pain, or signs of inflammation such as redness, swelling, or burning of the eyes and conducted slit-lamp reexamination if tyrosine levels are > 500 micromol/L; AND
• The provider states the patient is having a beneficial response to therapy based on assessment; AND
• The patient continues to follow a diet consisting of tyrosine and phenylalanine restriction; AND
• If the request is for brand Orfadin, the patient has a documented intolerance to or has failed at least a three-month trial of generic nitisinone.

Approval duration

6 months