Prior-Authorization For Payment Of Orfadin Template - Prescriber'S Statement Of Medical Necessity


Prior-Authorization for payment of Orfadin™ (nitisinone or NTBC)
Maryland Pharmacy Program
Tel#: 410-767-1455 or 1-800-492-5231 Option 3-Fax form to: 410-333-5398
(Incomplete forms will be returned)
Patient Information
Patient location: ____ home; ____ hospital___ Clinic___Office
DOB: ____________
Patient Name:__________________________________
MA ID#:______________________________________
Adddress: _________________________________
Tel.#:(____________) ______________-_________
Prescriber Information
Is Drug prescribed as part of a clinical study?  Yes
Specify sponsoring organization/drug manufacturer______________________________________________________________
List study drug: _________________________. Specify purpose of study: ___________________________________________
Note: For the Program to approve off-label use or use of the drug at dosages other than recommended by FDA, such use must be
medically necessary and be documented in one of the three official compendia (the American Hospital Formulary Service Drug
Information, the Micromedex/Drugdex drug database and the U.S. Pharmacopeia.
I certify that Patient is not enrolled in any study involving the requested drug. I will be supervising the patient’s treatment
accordingly. Supporting medical documentation is kept on file in the patient’s medical record.
_________________________, M.D. Prescriber’s Name: ___________________________________ Date: _______________
(Prescriber’s signature).
(_______) – __________- _________
(________) - _________ - __________
License #: _________________DEA #:____________ Specialty : ____________________________________________
Consultations with:  Biochemical geneticist-  Hepatologist/gastroenterologist -  Hematologist-  Other:_______________
: _________________________________________________________________________________________________________
Prescription/Clinical Information
Drug/strength prescribed: ______________________________________Dosage/ dosage frequency:________________
(Adult dose: 1mg/kg/day divided bid at least 1 hr ac initially; not to exceed 2mg/kg/day;
Pediatric dose: 1mg/kg/day divided bid at least 1 hr ac initially; may increase to 1.5mg/kg/day after 1 month if biochemical
parameters not normalized, not to exceed 2mg/kg/day)
List diagnosis for which the drug was prescribed:
 Transient tyrosinemia of the newborn (TTN)
 Tyrosinemia II (Richner-Hanhart syndrome)
 Tyrosinemia III
 Type I hereditary tyrosenemia (hereditary infantile tyrosinemia)- Homozygous form?  Yes  No
Gene mapped to band 15q23-q25?  Yes  No
 Chronic form
 Acute form
 Other: ___________________________________________________________________________________________
Is patient currently placed on a liver transplantation waiting list?
 Yes
 No
Will Patient likely become a candidate for liver transplantation within the next year?  Yes
 No
Is patient under a care of a skilled nutritionist and on diet restricted in tyrosine and phenylalanine?
Are the dietary restrictions of tyrosine and phenylalanine alone sufficient to maintain the urinary succinylacetone at or below
detectable levels?  Yes
 No
Patient’s Current Weight: _____________lb or ______________kg
Urinary succinylacetone level:__________________________
Plasma tyrosine level: ________________ umol/L
Normal range: ___________________ Test Date: ____/______/____
Serum alpha-fetoprotein concentration: __________________Normal range: ______________ Test Date: ____/______/____
Serum phospate level: ______________ Normal range: ________________
Test Date: _____/_____/____
Blood count, thrombocytes, leukocytes?  Normal
Abnormal range- Date of last blood test measurement: _____/_____/____
Normal slit lamp examination prior to therapy/post-therapy?  Yes
 No Date of last exam: ______/_______/______
A copy of Patient’s Medical History must accompany this request.
Date: _________________Reviewer’s Initials_____
Reason for denial: _________________________________________________________________________________________


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