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Cystadane

Generic: betaine anhydrous for oral solution

Manufacturer: Recordati Rare Diseases Inc.  ·  Program: Cystadane Patient Assistance Program

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Free to apply. Service from $40/month, payable only when your application is ready to submit.

Eligibility Criteria

Insurance Requirement

Patients must have no prescription coverage for the needed medication

Residency

US resident

Income requirements have not been disclosed

Program Information

Processing Time

2–4 weeks

Delivery Method

shipped to patient home

Application Method

Multiple

Reauthorization

Required, annual

Typically Required Documents

ProvisionRX prepares and organizes all required documentation as part of your enrollment management. This list is provided for informational purposes.

  • Referral form from healthcare provider
  • Prescription
  • Proof of income or insurance status

Indicated for

Homocystinuria

About This Medication

Cystadane Patient Assistance Program Patient Guide: How to Get Cystadane at Low or No Cost

Cystadane (betaine anhydrous for oral solution) is a prescription medication used to treat homocystinuria, a rare genetic disorder that causes high levels of homocysteine in the blood. The Cystadane Patient Assistance Program (PAP), offered by Recordati Rare Diseases Inc., helps eligible uninsured or underinsured patients access this vital medication at low or no cost by providing 25-100% assistance for up to one year.[1][6]

About Cystadane

Cystadane helps lower elevated homocysteine levels in people with homocystinuria, a condition affecting how the body processes certain proteins. It's a powder mixed with water, juice, milk, formula, or food (4-6 ounces or 120-180 mL) and taken immediately. Store it at room temperature with the cap tightly closed to protect from moisture.[7][8] Unlike typical medications, Cystadane is only available through a specialty pharmacy called Anovo, which ships it directly to your home—not retail pharmacies.[2][8]

Always follow your doctor's instructions for dosing, often starting at 6 grams daily (divided doses) and adjusted based on blood tests. Discuss diet, other medicines, and monitoring with your healthcare team, as Cystadane works best as part of a comprehensive plan.[2][7]

Who Qualifies for the Program?

This program targets patients facing financial barriers to Cystadane. Key eligibility criteria include:

  • US residency and a medically appropriate diagnosis (homocystinuria).[1]
  • No prescription coverage for Cystadane through insurance.[1][2][8]
  • Meeting undisclosed income guidelines—proof of income is required, but specific thresholds (e.g., Federal Poverty Level percentages) are not public.[1][5][6]
  • Assistance covers 25-100% of costs for up to one year, with possible appeals for denials.[1][6]

Note: A separate Copay Assistance Program exists for commercially insured patients, potentially reducing copays to $0. Contact Anovo to check which fits your situation.[3][4][8]

Income Eligibility Breakdown

Exact income limits are not disclosed by Recordati Rare Diseases Inc., so call for prescreening.[1][5] Here's a summary table based on available details:

Household SizeIncome ThresholdFPL %Notes
IndividualNot disclosedNot specifiedProof of income required; medical expenses may factor in (unpublished).[1][5]
CoupleNot disclosedNot specifiedCall (888) 487-4703 for prescreening.[1]
Family of 3Not disclosedNot specifiedUS residents only.[6]
Family of 4Not disclosedNot specifiedAssistance 25-100% for 1 year.[1]

Since details are limited, contact the program directly at (888) 487-4703 (Monday-Friday, 8am-5pm CT) or through NORD (National Organization for Rare Disorders) for personalized guidance.[1][3]

Insurance Requirements

Patients must have no prescription coverage for Cystadane to qualify for the PAP.[1][2][8] If insured:

  • Use the Copay Assistance Program for copays/coinsurance (potentially $0 for commercial insurance).[3][4]
  • Anovo handles benefit investigation and prior authorizations.[3]

Medicare or other plans may cover Cystadane; if not, PAP applies. Uninsured/underinsured individuals without coverage are primary candidates.[2][8] Anovo confirms eligibility and supports transitions (e.g., hospital to home).[4]

Step-by-Step Application Process

  1. Talk to your doctor: Develop a treatment plan. They complete and sign the referral form/prescription (CYSTADANE treatment form).[1][2][3]
  2. Fax the form: Doctor faxes to 1-855-813-2039 (or call (888) 487-4703 for inpatient/home delivery).[3][4][8]
  3. Contact Anovo/NORD: Call (888) 487-4703 to request an application mailed to you/doctor/social worker. Patients complete/sign their section and attach proof of income.[1][3]
  4. Submit application: Fax or mail to NORD (e.g., 55 Kenosia Ave, Danbury, CT 06810; fax 203-349-3280).[1] Multiple methods available (phone, mail, fax).[1]
  5. Anovo processes: They verify eligibility, ship to your home, and provide ongoing support (calls for refills).[2][3]

Required Documents:

  • Referral form from healthcare provider.
  • Prescription.
  • Proof of income or insurance status.[1]

Patients or providers can initiate.[1][6]

Timeline and Delivery

Processing time varies (not specified), but Anovo ships directly to your home monthly or up to 90-day supply.[2][3][6] Expect:

  • Quick start after faxed prescription.[2]
  • Reauthorization required annually or as needed.[1]
  • Return Anovo calls promptly for refills/continuity.[2]

Negative decisions can be appealed.[1][6]

Alternatives if Denied or Ineligible

  • Copay Program: For insured patients ($0 copay possible).[3][4]
  • Biosimilar/Generic: Betaine Anhydrous for Oral Solution (Eton generic equivalent)—discuss with doctor.[provided]
  • Other PAPs via RxHope/RxAssist or NORD.[1][5]
  • Appeal denial or reapply with updated info.[1]

Disclaimer

This guide is for informational purposes only and based on publicly available data as of 2026. Eligibility, terms, and availability can change—always verify with Recordati Rare Diseases Inc., Anovo at (888) 487-4703, or your healthcare provider. Not medical/financial advice. Consult professionals for personalized guidance. Program run partly through NORD.[1][2]

Program information last verified: March 30, 2026

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