Nitisinone Products
Defines prior authorization, medical necessity criteria, and coverage conditions for Cigna-administered benefit plans covering nitisinone products (Orfadin, Nityr, Harliku and generics) for hereditary tyrosinemia type 1 and alkaptonuria.
Harliku was added to the policy and alkaptonuria was added as a condition of approval for Harliku.
Alkaptonuria was added as a condition of approval under other uses with supportive evidence for Orfadin (generics) and Nityr; documentation required was added to the indication.
Preferred product requirements for Employer Plans updated to require two preferred products: nitisinone 2 mg capsules and Nityr 2 mg tablets; substitution/step requirements specified for Harliku and Orfadin.
Coverage Criteria for Nitisinone Products
Initial Therapy — Hereditary Tyrosinemia Type 1
Approve for 1 year if the patient meets ALL of the following (A–E):
Root
- A) Diagnosis confirmation: Diagnosis is supported by ONE of the following: i. Genetic testing confirms biallelic pathogenic or likely pathogenic variants in the FAH gene [documentation required]; OR ii. Elevated succinylacetone in serum or urine [documentation required]
documentation required
- B) Diet: Medication is prescribed in conjunction with a tyrosine- and phenylalanine-restricted diet
- C) Concomitant therapy: Patient will not be taking the requested agent concurrently with another nitisinone product
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