Limited coverage drugs – nitisinone

nitisinone

2 mg, 5 mg, 10 mg, 20 mg

capsules: 2 mg, 5 mg, 10 mg, 20 mg

tablets: 2 mg, 5 mg, 10 mg

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

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