Overview of Patient Support and Assistance Programs for KUVAN

BioMarin is committed to helping patients and clinicians obtain access to KUVAN via insurance and reimbursement programs. Because KUVAN is the first treatment option of its kind for phenylketonuria, or PKU, you might find it challenging to navigate the insurance process on your own. That’s why BioMarin Patient and Physician Support (BPPS) is here—to work with you, your doctor’s office, and your health insurance company. BPPS does the majority of the work and handles most of the details for you!

This section explains the programs that are in place to help you research insurance coverage and access to KUVAN. Most insurance companies cover KUVAN with a reasonable co-payment (the average co-payment is $50 per month, but this varies from plan to plan). BPPS can work with your insurance company to help obtain coverage for KUVAN, and help you research insurance coverage if you don’t already have it. BPPS is also your gateway to other patient services, such as:

• Specialty pharmacies that can deliver KUVAN directly to your home.
• The KUVAN Patient Assistance Program (K-PAP), which can provide KUVAN at no charge for eligible patients without insurance coverage.
• The National Organization for Rare Disorders (NORD), which can provide premium and co-payment assistance for KUVAN, and other assistance with costs directly related to your PKU treatment.

Please direct any questions on these topics to BPPS at 1-877-MY-KUVAN
(1-877-695-8826) or e-mail bpps@BMRN.com. For Frequently Asked Questions on all of these topics, 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.