SAMPLE LETTER FOR
XPhe Maxamum

Date:_____________

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       (Insurance Company Name)
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       (Insurance Company Address)
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       (Insurance Company Address)

Dear Sir or Madam:

Phenylketonuria (PKU) is an inherited genetic disorder of protein metabolism that affects approximately 1:19,000 infants in the United States. PKU results from a deficiency in the enzyme responsible for metabolizing the amino acid phenylalanine. This results in the toxic build-up of phenylalanine levels in the body.

In the U.S., newborn screening tests for PKU are mandatory because if left untreated, an individual with PKU will suffer irreversible brain damage and severe mental retardation which can lead to learning disabilities and behavioral disturbances. Other manifestations include vomiting, lethargy and eczema. Currently there is no effective medication or gene therapy available for PKU. However, normal growth and development are possible if a PKU patient is managed by life-long nutrition support.

At this time, the standard of care in the medical community and the only effective treatment currently available for PKU is strict dietary control of phenylalanine intake. Controlling phenylalanine intake is accomplished by restricting high-protein foods (i.e., meat and meat products, milk and milk products, legumes, nuts, etc.) in the PKU patient while simultaneously allowing low protein medical foods, minimal quantities of low-protein grains, fruits and vegetables in combination with fat and sugar.

This stringent diet restricts consumption of natural or whole protein and is best achieved when the majority of a patient’s daily intake of protein comes from phenylalanine-free medical foods complete with vitamins, minerals, trace elements and essential and non-essential amino acids (excluding the offending amino acid phenylalanine). Without additional calories and amino acids (excluding phenylalanine), a PKU patient would experience malnutrition.

Therefore, I am requesting insurance coverage/reimbursement for my patient _______________________ with a diagnosis of _______________________ for whom I have prescribed the use of XPhe Maxamum (manufactured by SHS International and distributed by Nutricia North America).

XPhe Maxamum is an unflavored or orange-flavored, phenylalanine-free amino acid-based powdered medical food used in the dietary management of Phenylketonuria. XPhe Maxamum contains a balanced mixture of all other essential and non-essential amino acids, carbohydrate, and is enriched with vitamins, minerals and trace elements (including selenium and chromium). When given in prescribed amounts XPhe Maxamum provides the correct amino acid profile (exclusion of phenylalanine) for children and adults with PKU.  

XPhe Maxamum is not a drug but is classified by the FDA as a “Medical Food”, which requires usage under strict medical supervision.  XPhe Maxamum has been prescribed and is medically necessary as the optimum treatment for my patient.

Sincerely,

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Product Information for XPhe Maxamum