A: Phone lines are staffed between 6 AM and 5 PM (PT) Monday through Friday. Callers can leave a message after hours. All messages will be returned within one business day during regular business hours.
A: If your doctor has suggested you try KUVAN Tablets or Powder, you are eligible to receive assistance from BioMarin RareConnections. BioMarin RareConnections is here to help you get access to KUVAN through your insurance company or through alternate sources.
A: No, BioMarin RareConnections works with all patients who have been prescribed KUVAN Tablets or Powder. BioMarin RareConnections can help patients receive KUVAN by managing the insurance approval process and increasing the speed at which it is done.
A: Every patient prescribed KUVAN Tablets or Powder must work with BioMarin RareConnections. BioMarin RareConnections can help guide you through the insurance process, making it easier to understand and faster to accomplish and secure coverage for your medication
A: If you cannot afford your insurance co-payment or require additional financial assistance, a BioMarin RareConnections Case Manager is available to assist you with a referral to non-profit charitable organizations that specialize in this type of assistance for patients with rare diseases.
A: If you do not have insurance, or if your insurance does not cover KUVAN Tablets or Powder, BioMarin RareConnections will assist you to identify an alternative source of coverage. BioMarin RareConnections will research alternative insurance coverage options for you. If an alternative source of coverage is not available, the KUVAN Patient Assistance Program (K-PAP) may be able to provide you with KUVAN at no cost. Patients must first enroll in the program and meet eligibility criteria in order to receive assistance. For an overview of K-PAP, click here.
A: Some insurance companies may need to approve a patient’s treatment with KUVAN Tablets or Powder before treatment is started. This approval is called “prior authorization.” Typically, the insurance company will require the patient’s doctor to provide a Letter of Medical Necessity and/or medical information to your insurance company that explains why the doctor wants you to start this treatment.
A: If your insurance company denies coverage of KUVAN Tablets or Powder, denies the doctor’s request for prior authorization, or simply will not cover the cost of the medication, BioMarin RareConnections will help prepare and file an appeal with the insurance company. The appeal will outline why the patient should be receiving KUVAN and how it may benefit the patient. An appeal is a request to the insurance company for reconsideration of coverage for—as well as access to—KUVAN and may include additional supporting documentation. Appeals are decided case by case based on a patient’s medical situation. Final coverage decisions will vary among insurance companies based on each payer’s requirements. If the appeal fails, BioMarin RareConnections will continue to work with the patient to research alternate options for access to KUVAN.
A: The Affordable Care Act did away with lifetime benefit maximums for essential health benefits. BioMarin RareConnections will help you investigate how your insurance company is updating their coverage policy to adhere to updated laws. For additional information, patients can call toll-free
1-877-MY-KUVAN (1-877-695-8826) or they can email email@example.com.
A: If patients have new insurance or if their coverage with the existing insurance has changed, BioMarin RareConnections is available to help patients taking KUVAN Tablets or Powder to conduct a new benefit investigation and find out how their coverage for KUVAN has changed. BioMarin RareConnections can also assist with health insurance questions related to open enrollment, loss of insurance coverage when a child is no longer covered by his/her parents’ insurance, or other potential changes in health plan coverage. For additional information, patients can call toll-free
1-877-MY-KUVAN (1-877-695-8826) or they can email firstname.lastname@example.org.
A: Yes. Each BioMarin RareConnections Case Manager has a secure, dedicated email address for patients and healthcare professionals to use. A BioMarin RareConnections Case Manager will personally respond to you within 24 hours. We encourage individuals with concerns needing more immediate attention to call the KUVAN Tablets and Powder Hotline at 1-877-MY-KUVAN (1-877-695-8826).
A: Once the signed Patient Authorization Form is received, BioMarin RareConnections calls the patient within one business day to provide an introduction to the Case Manager and program. After the initial telephone call, BioMarin RareConnections contacts the patient to discuss the results of benefit investigations for KUVAN Tablets and Powder.
A: Basic requirements for K-PAP eligibility are as follows:
A: The application packet consists of:
A: 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.
A: You can contact your BioMarin RareConnections Case Manager from 6 AM to 5 PM (PT) Monday through Friday by calling 1-877-MY-KUVAN (1-877-695-8826).
A: Once a fully completed application is received by BioMarin RareConnections, the review is completed within a couple of days.
A: No. The program only provides KUVAN Tablets or Powder at no charge for qualifying patients. It does not provide assistance for medical foods, laboratory tests, or other healthcare services.
A: Yes. BioMarin RareConnections can refer patients to non-profit charitable organizations that specialize in this type of assistance. These organizations often have a fund set up that provides premium and co-payment assistance for patients taking KUVAN and may be able to assist with other PKU-related treatment costs.
A: Initial requirements for NORD are as follows:
A: No, applications to NORD are accepted on an ongoing basis; however, it’s preferable to submit your completed application to NORD within 30 days of receipt. Please complete and return the paperwork as soon as possible in order to begin the review process.
A: Yes. NORD Patient Service Representatives are available to assist patients from 9 AM to 5 PM (ET) Monday through Friday; call toll-free 1-877-798-8716.
A: NORD has set up a fund that covers reasonable expenses required for the diagnosis, treatment, and care for an individual with PKU that are not covered by an individual’s insurance plan.
It also provides premium and co-pay assistance for patients receiving prescription medication treatment for PKU.
A: Please contact a NORD Patient Service Representative directly to review their program requirements.
A: NORD funds come from corporate donations, grants from concerned companies like BioMarin Pharmaceutical Inc., foundation grants, public contributions, and membership dues.
A: Because fund donors 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.
KUVAN® (sapropterin dihydrochloride) Tablets for Oral Use and Powder for Oral Solution are approved to reduce blood Phe levels in people with a certain type of Phenylketonuria (PKU). KUVAN is to be used with a Phe-restricted diet.
It is not possible to know if KUVAN will work for you without a trial of the medicine.
Your doctor will check your blood Phe levels when you start taking KUVAN to see if the medicine is working.
Starting KUVAN does not eliminate the need for ongoing dietary management. Any change to your diet may impact your blood Phe level. Follow your doctor’s instructions carefully. Your doctor and dietitian will continue to monitor your diet and blood Phe levels throughout your treatment with KUVAN to make sure your blood Phe levels are not too high or too low. 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 make any necessary changes to your treatment.
Children younger than 7 years old treated with KUVAN doses of 20 mg/kg per day are at an increased risk for low levels of blood Phe compared with children 7 years and older. Frequent blood monitoring is recommended in this population to ensure that blood Phe levels do not fall too low.
Tell your doctor if you have ever had liver or kidney problems, have poor nutrition or have a loss of appetite, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.
KUVAN is a prescription medicine and should not be taken by people who are allergic to any of its ingredients. KUVAN and other medicines may interact with each other. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal and dietary supplements.
If you forget to take your dose of KUVAN, take it as soon as you remember that day. Do not take 2 doses in a day. If you take too much KUVAN, call your doctor for advice.
The most common side effects reported when using KUVAN are headache, runny nose and nasal congestion, sore throat, diarrhea, vomiting, and cough. Additional adverse reactions reported in connection with worldwide marketing include sore throat, heartburn or pain in the esophagus, inflammation of the lining of the stomach, indigestion, stomach pain, and nausea. These are not all the possible side effects seen with KUVAN. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
KUVAN can cause serious side effects, including:
For more information, call BioMarin RareConnectionsTM at 1-877-MY-KUVAN (1-877-695-8826). Please read the full Patient Information by clicking here.