generic nitisinone capsules — Medica

Initial criteria

• Diagnosis is supported by ONE of the following (i or ii): i) Genetic testing confirms biallelic pathogenic or likely pathogenic variants in the FAH gene; OR ii) Patient has elevated levels of succinylacetone in the serum or urine
• Medication is prescribed in conjunction with a tyrosine- and phenylalanine-restricted diet
• Patient will not be taking another nitisinone product concurrently
• Medication is prescribed by or in consultation with a metabolic disease specialist (or specialist who focuses in the treatment of metabolic diseases)

Approval duration

1 year