Harliku — Cigna

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; AND
• Medication is prescribed in conjunction with a tyrosine- and phenylalanine-restricted diet; AND
• Patient will not be taking the requested agent concurrently with another nitisinone product; AND
• 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