Javygtor — Medical Mutual

Initial criteria

• The drug is prescribed by or in consultation with a metabolic diseases specialist or a provider who specializes in the treatment of PKU and other metabolic diseases; AND
• The patient has PKU that is responsive to tetrahydrobiopterin (BH4); AND
• The patient is using the drug in combination with a phenylalanine (Phe)-restricted diet

Reauthorization criteria

• The patient has had at least a 20% reduction in Phe levels; OR
• The patient has responded to use of sapropterin dihydrochloride (e.g. cognitive and/or behavioral improvements), as determined by the prescriber

Approval duration

Initial: 3 months; Reauthorization: 1 year