Limited coverage criteria – nitisinone

nitisinone

2 mg, 5 mg, 10 mg, 20 mg capsule

2 mg, 5 mg, 10 mg tablet

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:

A repeated blood succinylacetone measurement

OR

A urine succinylacetone measurement

Initial: 6 months

Renewal: Indefinite