Medical Policy

Effective Date:08/01/2017 Title:Kuvan (Sapropterin)
Revision Date: Document:BI548:00
CPT Code(s):None
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Kuvan (Sapropterin) requires prior authorization.

2)    Kuvan is used to treat Phenylketonuria (PKU).

3)    Kuvan is an oral specialty drug covered under the pharmacy benefit.

Medical Statement

Kuvan (Sapropterin) is considered medically necessary for members meeting the following criteria:

1)    Diagnosis of phenylketonuria (PKU); AND

2)    Patient is actively on a Phenylalanine-restricted diet


As an oral specialty drug, Kuvan is limited to a maximum 30-day supply per fill.


1)    Clinical Pharmacology. Accessed online 7/17/2017

2)    Kuvan Prescribing Information.  Biomarin Pharmaceutical Inc. Novato, CA. August 2016.

Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.

Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.