Sapropterin Support Program for Sapropterin Dihydrochloride
What is Sapropterin Dihydrochloride?
Sapropterin Dihydrochloride is a synthetic form of the naturally occurring cofactor, tetrahydrobiopterin (BH4). Sapropterin Dihydrochloride Tablets for Oral Use and Powder for Oral Solution are indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). Sapropterin Dihydrochloride is to be used in conjunction with a Phe-restricted diet.
Treatment with Sapropterin Dihydrochloride should be directed by physicians knowledgeable in the management of PKU. All patients with PKU who are being treated with Sapropterin Dihydrochloride should also be treated with a Phe-restricted diet, including dietary protein and Phe restriction.1
At Cycle, we know that life-changing treatments need life-improving support to match. That’s why we created Cycle Vita, delivering individualized product support every step of the way with the Sapropterin Support Program.
Support available to you from the Sapropterin Support Program
Start your Sapropterin Support Program enrollment here
Download, complete and fax a PDF
The first 24hrs
Your Cycle Vita team will quickly get to work with your insurance provider to help you understand your coverage.
We will coordinate seamlessly between different parties, such as insurance companies, doctors, and pharmacists to help you with your prior authorization and document requirements
We will route your Sapropterin Dihydrochloride therapy to the appropriate specialty pharmacy and follow-up to ensure swift shipment of your medication.
Additional assistance, when required, throughout your journey
In some cases, an appeal may be needed. Where this is the case, our experienced team will work with your insurer and doctor to understand and help you with any Sapropterin Dihydrochloride reimbursement gaps.
Co-Pay Assistance*
If you have commercial insurance, you may be eligible for the Cycle Vita Co-Pay Assistance Program. Commercially insured eligible patients may pay as little as $0. Please contact our Access Specialists to find out more about this and other programs that may be available to you (such as Quick Start, Bridge Program, etc.).
If you agree, our proactive team will remind your doctor when your Sapropterin Dihydrochloride prescription needs to be renewed, in a timely manner, to ensure an uninterrupted supply of your therapy.
We provide product support to help you manage every aspect of your Sapropterin Dihydrochloride therapeutic routine, such as clinical education and 1-to-1 administration training either at home or in-clinic.
Translation services are available on request.
We provide you with on-going personal guidance and education through the duration of your therapy, to support you in meeting your clinic’s nutrition and adherance plan.
What is phenylalanine hydroxylase (PAH) deficiency, traditionally called phenylketonuria (PKU)?
Phenylketonuria (PKU) is an inherited metabolic disorder caused by a deficiency of the phenylalanine hydroxylase (PAH) enzyme needed to process phenylalanine, leading to phenylalanine build up in the blood. It affects roughly 16,500 people in the United States today.2
The disease affects the brain through increased levels of an amino acid called phenylalanine in the blood.2
Untreated individuals with PKU may have severe intellectual and developmental disabilities. It is also estimated that 90% of people with PKU have light coloration, such as blue eyes. Other signs and symptoms of PKU may include having behavioral problems, a small head, delayed growth or short stature, flat feet, eczema or skin rashes, seizures, jerking movements of the arms or legs, tremors, and musty odor of breath, skin or urine. 2,3,4
Newborns at birth with PKU may appear normal..3,
In the United States, PKU is primarily diagnosed around birth, via the Newborn Screening Program. It involves a heel stick blood test taken at least 12 hours, and generally 24-28 hours, after birth.2
Early testing gives the opportunity to start treating affected babies as early as possible.2
Remember, you’re not alone. The Cycle Vita team is here to support you for life.
Resources
Footnote
*Some areas of support may not be accessible to all patients. Eligibility criteria may apply to ensure compliance with all applicable federal and state requirements, and benefits may be limited to commercially insured patients only. For more detailed information about eligibility, terms and conditions, please contact the Cycle Vita team at +1 (888) 360-8482.
References
- Vockley, J. et al. (2014) ‘Phenylalanine hydroxylase deficiency: diagnosis and management guideline’ Genetics in Medicine 16(2), 188-200. DOI: https://doi.org/10.1038/gim.2013.157
- National PKU Alliance. What is PKU – About PKU. Available at: https://www.npkua.org/What-is-PKU/About-PKU. (Accessed: February 16th 2022.)
- National Institutes of Health. What are common symptoms of phenylketonuria (PKU)? Available at: https://www.nichd.nih.gov/health/topics/pku/conditioninfo/symptoms. (Accessed: February 16th 2022.)
- NORD. Phenylketonuria. Available at: https://rarediseases.org/rare-diseases/phenylketonuria/. (Accessed: February 16th 2022.)