Limited Coverage Drugs - Nitisinone

Generic Name

nitisinone

Strength

2 mg, 5 mg, 10 mg, 20 mg

Form

Capsules: 2 mg, 5 mg, 10 mg, 20 mg
Tablets: 2 mg, 5 mg, 10 mg

Special Authority Criteria for Patients Identified Prenatally

Approval Period

Initial and Ongoing:

  • For the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with a dietary restriction of tyrosine and phenylalanine, a prenatal diagnosis through genetic testing is required.

Indefinite

Special Authority Criteria for Patients Identified through Newborn Screening

Approval Period

Initial:

For the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with a dietary restriction of tyrosine and phenylalanine, a positive newborn screen for HT-1, specifically a blood succinylacetone measurement is required.

Renewal:

The HT-1 diagnosis is confirmed by:

  1. A repeated blood succinylacetone measurement

    OR
     
  2. A urine succinylacetone measurement

First approval: 6 months

Renewal: Indefinite

Practitioner Exemptions

  • None

Special Notes

  • None

Special Authority Request Form(s)