What are the general eligibility requirements?
What are the different components of the application?
Is there an application deadline?
How can a patient get help completing the application?
What is the average turnaround time for review and of an application and determination of eligibility?
Once accepted into K-PAP, how is a patient notified?
What can a patient do if the application is denied?
Does K-PAP pay for other costs associated with the treatment of PKU?
Are there any other programs available to help pay for PKU treatment costs?
What are the general eligibility requirements?
Basic requirements for K-PAP eligibility are as follows:
- Patients must complete the application packet, as explained in the next question and answer
- Must have a valid prescription for KUVAN
- Limited to US citizens and documented residents of the US or its territories
- Must have a diagnosis of PKU or hyperphenylalaninemia
- Income, assets, household expenses, and other medical expenses are taken into account through the application process
- Must provide supporting documentation upon request (federal tax return, bank statement)
- Must be willing to work with BPPS to identify alternative sources for prescription coverage
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What are the different components of the application?
The application packet consists of:
- Patient mailing information (cover letter & check-off list)
- Financial section (1 page)
- Waiver & Release of Liability (1 page)
- Addressed return envelope
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Is there an application deadline?
No, applications are accepted on an ongoing basis. Please complete and return the paperwork as soon as possible in order to begin the review process.
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How can a patient get help completing the application?
You can contact BPPS case managers who provide K-PAP assistance to patients from 7 AM to 4 PM (PT) Monday through Friday by calling 1-877-MY-KUVAN (1-877-695-8826).
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What is the average turnaround time for review of an application and determination of eligibility?
Approval for an initial 30-day supply of KUVAN through the program may be granted after BPPS completes the initial benefits investigation process. It is important to note, however, that the process cannot
begin until K-PAP receives a fully completed application.
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Once accepted into K-PAP, how is a patient notified?
The patient, the referring healthcare professional, and the BPPS case manager are notified by letter explaining the details of the assistance.
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What can a patient do if the application is denied?
Applicants are encouraged to appeal denials by re-submitting their application to K-PAP along with additional information explaining why their case should be reconsidered.
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Does K-PAP pay for other costs associated with the treatment of PKU?
No. The program only provides KUVAN at no charge for qualifying patients. It does not provide assistance for medical foods, laboratory tests, or other healthcare services.
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Are there any other programs available to help pay for PKU treatment costs?
Yes. BPPS can refer patients to the National Organization for Rare Disorders (NORD), an organization that specializes in this type of assistance for patients with rare diseases. NORD has set up a fund
that provides premium and
co-payment assistance for patients receiving prescription medication for PKU, as well as assistance with costs directly related to PKU treatment. For an overview of NORD, click
here. For more FAQs about NORD, click here.
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Indication
KUVAN® (sapropterin dihydrochloride) Tablets is approved to reduce blood Phe levels
in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-)
responsive Phenylketonuria (PKU). KUVAN is to be used with a Phe-restricted diet.
Important Safety Information
High blood Phe levels are toxic to the brain and can lead to lower intelligence
and decrease in the ability to focus, remember and organize information. Any change
you make to your diet may impact your blood Phe level. Follow your doctor’s instructions
carefully. Your doctor and dietitian will continue to monitor and may adjust your
diet throughout your treatment with KUVAN.
If you have a fever, or if you are sick, your Phe level may go up. Tell your doctor
and dietitian as soon as possible so they can see if they have to adjust your treatment
to help keep your blood Phe levels in the desired range.
KUVAN is a prescription medicine and should not be taken by people who are allergic
to any of its ingredients. Tell your doctor if you have ever had liver or kidney
problems, are nursing or pregnant or may become pregnant, have poor nutrition or
are anorexic. Your doctor will decide if KUVAN is right for you. Tell your doctor
about all the medicines you take.
The most common side effects reported when using KUVAN are headache, diarrhea, abdominal
pain, upper respiratory tract infection (like a cold), throat pain, vomiting, and
nausea.
To report SUSPECTED ADVERSE REACTIONS, contact BioMarin Pharmaceutical Inc. at 1-866-906-6100, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please read the full Patient Information by clicking here.