What are the general eligibility requirements?
What are the different components of the application?
Is there an application deadline?
Can a patient get help completing the application?
Is there a brochure available that explains the program?
What is the breakdown of income levels?
Can a patient apply to the program for reimbursement of co-payments that
have already been made?
Will the NORD prescription medication program help pay for lab tests
and other costs necessary for PKU treatment?
Can NORD help pay for the costs of medical foods or formulas used to
treat PKU?
How does NORD define compliance?
Where does funding for NORD come from?
What happens if NORD’s funding for this program runs out?
What are the general eligibility requirements?
Initial requirements for NORD are as follows:
- Patients must complete the application packet, as explained in the next question
and answer
- Must be on a prescription medication for PKU
- 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 an application process
- Must provide supporting documentation upon request (federal tax return, bank statement)
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What are the different components of the application?
The NORD 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 to NORD 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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Can a patient get help completing the application?
Yes. NORD Patient Service Representatives are available to assist patients from
9 AM to 5 PM (ET) Monday through Friday; call toll-free 1-800-999-6673 (option
3).
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Is there a brochure available that explains the program?
Yes, an informational brochure IS available for you to download by clicking
here.
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What is the breakdown of income levels?
There is no pre-set income threshold for applying to the program. However, NORD
examines household income and available assets versus household expenses and medical
expenses in determining eligibility.
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Can a patient apply to the program for reimbursement of
co-payments that have already
been made?
Yes. NORD will evaluate patient eligibility for reimbursement of previous
co-payments
on a case-by-case basis. Patients will receive direct cash payment from NORD for
out-of-pocket co-pays that qualify for the program as long as a receipt is submitted.
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Will the NORD prescription medication program help pay for lab tests and other costs
necessary for PKU treatment?
Yes. Other costs associated with starting or staying on prescription medication
for PKU are eligible for coverage. NORD will evaluate patient eligibility for coverage
of these additional costs on a case-by-case basis.
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Can NORD help pay for the costs of medical foods or formulas used to treat PKU?
Yes. NORD has recently established a separate program to cover qualifying patient expenses
for medical foods and formulas. NORD Patient Service Representatives are available
to assist patients from 9 AM to 5 PM (ET) Monday through Friday; call toll-free
1-800-999-6673 (option 3).
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How does NORD define compliance?
Compliance is generally defined as taking ≥90% of prescribed medications as tracked
by the specialty pharmacies. All compliance-related issues will be reviewed on a
case-by-case basis.
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Where does funding for NORD come from?
NORD funds come from corporate donations, grants from concerned companies like BioMarin
Pharmaceutical Inc., foundation grants, public contributions, and membership dues.
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What happens if NORD’s funding for this program runs out?
Because donors to the fund are permitted to change or discontinue their contributions
at any time, NORD maintains enough funding to assist PKU patients enrolled in the
program during their eligibility period of up to 12 months. NORD cannot make guarantees
of support beyond each patient’s eligibility period.
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Next: Links
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 in conjunction 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.