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)