Kalydeco (ivacaftor)
Patient Assistance Program Guide — Vertex GPS: Guidance & Patient Support
Do You Qualify?
Income
Up to $75,300 for a single person
Insurance
Uninsured, underinsured, or patients with government insurance (Medicare Part D) who meet financial criteria. Commercial patients are eligible for the co-pay program.
Residency
U.S. resident with valid address
Income Limits (500% FPL)
Calculated based on 500% FPL; eligibility may also be determined by specific financial hardship or a flat household income cap of $150,000.
Based on 2025 HHS Federal Poverty Level guidelines.
# Vertex GPS: Guidance & Patient Support — A Patient Guide to Getting Kalydeco at Low or No Cost
Who Qualifies for the Vertex GPS: Guidance & Patient Support?
If you or your child has cystic fibrosis and cannot afford Kalydeco (ivacaftor), you may be able to get it free or at a reduced cost through the Vertex GPS: Guidance & Patient Support program. This program is run directly by Vertex, the company that makes Kalydeco. For a single-person household, the maximum annual income limit is $75,300. Patients who are uninsured, underinsured, or enrolled in Medicare Part D may qualify for free medication if they meet the financial criteria. Patients with commercial (private) insurance are not typically eligible for free drug but may qualify for a co-pay assistance card that lowers their out-of-pocket costs significantly.
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About Kalydeco (ivacaftor)
Kalydeco (ivacaftor) is a prescription medication approved by the FDA to treat cystic fibrosis (CF) in patients with certain gene mutations. It belongs to a class of drugs called CFTR potentiators, which work by targeting the underlying protein defect caused by specific CF mutations rather than just managing symptoms. Kalydeco is approved for use in patients as young as 4 months old who have qualifying mutations. Without insurance or financial assistance, Kalydeco carries a list price that can reach hundreds of thousands of dollars per year, placing it out of reach for most patients who do not have some form of coverage or support.
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Income Eligibility: Full Breakdown
Vertex GPS uses household size and annual income to determine whether you qualify for free medication. The income limits below are based on approximately 500% of the Federal Poverty Level (FPL):
| Household Size | Maximum Annual Income |
|---|---|
| 1 person | $75,300 |
| 2 persons | $102,200 |
| 3 persons | $129,100 |
| 4 persons | $156,000 |
In some cases, eligibility may also be considered for households with income up to a flat cap of $150,000, or for patients who can demonstrate a specific financial hardship even if they exceed the standard thresholds.
To verify your income, Vertex GPS typically accepts your most recent federal tax return (such as a W-2 or full 1040) or three months of recent pay stubs. If your income has changed recently — for example, due to job loss or reduced hours — current pay stubs may reflect your situation more accurately than last year's tax return.
If your income is above the listed limits, you are not automatically disqualified. You may still be evaluated on a case-by-case basis. It is worth applying or calling the program directly to discuss your specific situation before assuming you do not qualify.
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Insurance Requirements Explained
Your insurance status plays an important role in which part of the Vertex GPS program applies to you:
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Step-by-Step: How to Apply
1. Gather your documents before you start. You will need a completed enrollment form, proof of income (W-2, most recent tax return, or three months of pay stubs), and a valid prescription for Kalydeco from your healthcare provider.
2. Choose how you want to apply. Vertex GPS offers multiple ways to enroll:
- Online: Visit https://www.vertexgps.com/ to complete and submit your application digitally.
- By phone: Call (877) 752-5932 to speak with a program specialist who can walk you through the process.
- By fax: Submit your completed forms and supporting documents to (888) 285-8012.
3. Complete the enrollment form. This form requires your personal information, household size, income details, insurance information, and your prescriber's contact information. Your prescriber or their office staff will also need to sign a portion of the form.
4. Submit all documents together. Incomplete applications can slow down processing. Make sure all required documents are included when you apply.
5. Wait for a decision. Vertex GPS typically processes applications within 1 to 2 business days of receiving a complete submission.
6. Receive confirmation. Once approved, you or your prescriber's office will be notified. Your medication will then be arranged for shipment directly to your home.
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What to Expect: Timeline and Delivery
After you submit a complete application, you can expect a decision within 1 to 2 business days. Vertex GPS will notify you (and typically your prescriber) of the approval. Kalydeco is shipped directly to your home, so you do not need to pick it up at a pharmacy. Make sure your shipping address is accurate on the enrollment form. You do not need to do anything special to receive the shipment.
Your enrollment is not permanent. Annual reauthorization is required, meaning you will need to confirm your continued eligibility once per year. Vertex GPS will typically reach out when it is time to renew, but it is a good idea to track your renewal date so your medication supply is not interrupted.
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Alternatives If You Don't Qualify
If you do not meet the requirements for free medication through Vertex GPS, consider these options:
1. Biosimilars: There are currently no FDA-approved biosimilar or generic versions of Kalydeco available. This option is not yet available for this medication.
2. Manufacturer savings card: If you have commercial (private) insurance, you may qualify for the Vertex GPS co-pay assistance card, which can lower what you pay at the pharmacy. You can enroll at https://www.vertexgps.com/copay-assistance.
3. State Pharmaceutical Assistance Programs (SPAPs): Many states offer their own programs to help residents afford expensive medications. Eligibility and benefits vary by state. Contact your state's department of health or aging for information.
4. NeedyMeds.org: This free, independent database lists hundreds of patient assistance programs and discount options by drug name. Visit https://www.needymeds.org to search for additional help.
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*This guide is for informational purposes only and does not constitute medical or legal advice. Eligibility determinations are made solely by Vertex. Program terms may change — verify current requirements at [https://www.vertex.com/en-us/support/assistance-programs](https://www.vertex.com/en-us/support/assistance-programs) before applying.*
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Documents You'll Need
If You Don't Qualify for the Assistance Program
Manufacturer Savings Card (for insured patients)
Vertex offers a savings card that may reduce your out-of-pocket cost if you have commercial insurance. Ask your prescriber or pharmacist for current savings card details.
Common Questions
Vertex GPS typically processes complete applications within 1 to 2 business days. Make sure you submit all required documents — your enrollment form, proof of income, and a valid prescription — at the same time to avoid delays.
Yes. Unlike many patient assistance programs that exclude Medicare beneficiaries, Vertex GPS allows Medicare Part D enrollees to apply for free medication if they meet the income eligibility requirements. Call (877) 752-5932 if you have questions about your specific plan.
If you are approved through the patient assistance program, Kalydeco is shipped directly to your home. You do not need to go to a pharmacy to pick it up. Make sure your mailing address is correct on your enrollment form.
Vertex GPS requires annual reauthorization. Once per year, you will need to confirm that you still meet the eligibility requirements. Vertex GPS will typically contact you when it is time to renew. It is a good idea to track your renewal date so your medication supply is not interrupted.
It may still be worth contacting Vertex GPS directly, as some patients are considered on a case-by-case basis for financial hardship. If you have commercial insurance, you may qualify for the co-pay assistance savings card at vertexgps.com/copay-assistance. You can also explore state pharmaceutical assistance programs or search NeedyMeds.org for additional options.
Ready to Apply for Kalydeco Assistance?
RX Advantages handles the entire Vertex GPS: Guidance & Patient Support application on your behalf — paperwork, physician coordination, and refill tracking. It takes about 15 minutes to get started.
No SSN required on the web form · From $49.95/month