KUVAN SAPROPTERIN DIHYDROCHLORIDE Tablets or Powder Instructions

STANDARD COMMERCIAL DRUG FORMULARY
PRIOR AUTHORIZATION GUIDELINES

SAPROPTERIN

SAPROPTERIN
DIHYDROCHLORIDE| KUVAN, JAVYGTOR, SAPROPTERIN DIHYDROCHLORIDE| 35266| | GPI-10
(3090856510)| FDB: ROUTE = ORAL

GUIDELINES FOR USE

INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW)

1. Does the patient have a diagnosis of hyperphenylalaninemia (HPA) due to tetrahydrobiopterin
   (BH4)-responsive phenylketonuria (PKU) and meet ALL of the following criteria?
   The patient is 1 month of age or older
   The patient follows a phenylalanine-restricted diet
   The patient is NOT concurrently using Palynziq (penalize-pqpz)

If yes, approve for 1 month by HICL or GPI-10.
If no, do not approve.
INITIAL DENIAL TEXT: *Some terms are already pre-defined in parenthesis. Please use these definitions if the particular text you need to use does not already have a definition(s) in it.
Our guideline named SAPROPTERIN (Kuvan, Javygtor) requires the following rule(s) be met for approval:
A. You have hyperphenylalaninemia (HPA) due to tetrahydrobiopterin (BH4)-responsive phenylketonuria (PKU) (you have high levels of a type of amino acid phenylalanine and it can be lowered with certain supplement tetrahydrobiopterin)
B. You are 1 month of age or older
C. You follow a phenylalanine-restricted diet
D. You are NOT using Palynziq (penalize-pqpz) at the same time
Our guideline named SAPROPTERIN (Kuvan, Javygtor) requires the following rule(s) be met for approval:
A. You have hyperphenylalaninemia (HPA) due to tetrahydrobiopterin (BH4)-responsive phenylketonuria (PKU) (you have high levels of a type of amino acid phenylalanine and it can be lowered with certain supplement tetrahydrobiopterin)
B. You are 1 month of age or older
C. You follow a phenylalanine-restricted diet
D. You are NOT using Palynziq (penalize-pqpz) at the same time
CONTINUED ON THE NEXT PAGE

RENEWAL CRITERIA

1. Does the patient have a diagnosis of hyperphenylalaninemia (HPA) due to tetrahydrobiopterin (BH4)-responsive phenylketonuria (PKU) and meet ALL of the following criteria?
   • The patient experienced a 30% decrease in blood phenylalanine from baseline after taking sapropterin
   • The patient follows a phenylalanine-restricted diet
   • The patient is NOT concurrently using Palynziq (penalize-pqpz)

If yes, approve for 12 months by HICL or GPI-10. If no, do not approve.
RENEWAL DENIAL TEXT : *Some terms are already pre-defined in parenthesis. Please use these definitions if the particular text you need to use does not already have a definition(s) in it.
Our guideline named SAPROPTERIN (Kuvan, Javygtor) requires the following rule(s) be met for renewal:
A. You have hyperphenylalaninemia (HPA) due to tetrahydrobiopterin (BH4)-responsive phenylketonuria (PKU) (you have high levels of a type of amino acid phenylalanine and it can be lowered with certain supplement tetrahydrobiopterin)
B. You experienced at least a 30 percent decrease in blood phenylalanine from baseline after taking sapropterin
C. You continue to follow a phenylalanine-restricted diet
D. You are NOT using Palynziq (penalize-pqpz) at the same time
Your doctor told us [INSERT PT SPECIFIC INFO PROVIDED]. We do not have information showing you [INSERT UNMET CRITERIA]. This is why your request is denied. Please work with your doctor to use a different medication or get us more information if it will allow us to approve this request.

RATIONALE

For further information, please refer to the Prescribing Information and/or Drug Monograph for Sapropterin (Kuvan, Javygtor).

REFERENCES

Kuvan [Prescribing Information]. Novato, CA: BioMarin Pharmaceutical Inc., February 2021.

Part D Effective: N/A
Commercial Effective: 10/01/22
Created: 01/08
Client Approval: 09/22
P&T Approval: 04/22
Copyright © 2022 MedImpact Healthcare Systems, Inc. All rights reserved. This document is proprietary to MedImpact.
MedImpact maintains the sole and exclusive ownership, right, title, and interest in and to this document.
Revised: 9/16/2022

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