Orkambi (lumacaftor/ivacaftor)

Do You Qualify?

Income Limits (500% FPL)

Calculated at 500% FPL; Vertex often uses a $150,000 household income limit or case-by-case assessment for rare disease eligibility.

Based on 2025 HHS Federal Poverty Level guidelines.

# Orkambi (Lumacaftor/Ivacaftor) Patient Assistance Guide

Vertex Guidance & Patient Support (GPS) Program

---

Who Qualifies for the Vertex Guidance & Patient Support (GPS)?

If you need Orkambi but cannot afford it, the Vertex Guidance & Patient Support (GPS) program may be able to provide it to you at little or no cost. This program is run directly by Vertex, the maker of Orkambi. To give you a quick starting point: if you are a single-person household earning up to $75,300 per year, you may meet the income requirement. Larger households may qualify at higher income levels. On the insurance side, this program is designed for patients who are uninsured, underinsured, or on Medicare with no other coverage options. Patients covered by Medicaid or other government programs may not be eligible in most situations, though Vertex reviews some cases individually.

---

About Orkambi (Lumacaftor/Ivacaftor)

Orkambi is a prescription medication made by Vertex Pharmaceuticals. It is approved by the U.S. Food and Drug Administration (FDA) to treat cystic fibrosis (CF) in patients who have two copies of the F508del mutation in the CFTR gene — a condition described as being homozygous for that mutation. Orkambi belongs to a class of medications called CFTR modulators, combining a corrector (lumacaftor) and a potentiator (ivacaftor) in a single tablet. Without insurance or assistance, Orkambi carries a very high list price — often exceeding $300,000 per year — making access extremely difficult for many patients and families. The Vertex GPS program exists specifically to help bridge that gap.

---

Income Eligibility: Full Breakdown

Vertex uses income thresholds set at approximately 500% of the Federal Poverty Level (FPL) to determine eligibility for free or reduced-cost Orkambi through the GPS program. The income limits by household size are:

| Household Size | Max Annual Income |

|---|---|

| 1 person | $75,300 |

| 2 persons | $102,200 |

| 3 persons | $129,100 |

| 4 persons | $156,000 |

If your household is larger than four people, the limit increases for each additional member. If your income is above these thresholds, you are not automatically disqualified. Because Orkambi treats a rare disease, Vertex sometimes considers cases individually and has been known to apply a general guideline of up to $150,000 in household income on a case-by-case basis. It is worth applying even if you are close to or slightly above the limit.

Income is typically verified using your most recent federal tax return, your most recent W-2 form, or three months of recent pay stubs. Vertex will use these documents to calculate your total household income before making an eligibility decision.

---

Insurance Requirements Explained

Your current insurance situation determines how the Vertex GPS program applies to you:

---

Step-by-Step: How to Apply

Follow these steps to apply for Orkambi through the Vertex GPS program:

1. Gather your documents before you start. You will need: a completed patient enrollment form, prescriber sign-off (your doctor must participate), proof of income (most recent tax return, W-2, or three months of pay stubs), and a copy of your insurance card if you have insurance.

2. Choose your application method. You have three options:

- Online: Visit https://www.vertexgps.com to complete and submit your application electronically. This is typically the fastest method.

- Phone: Call (844) 243-6773 to speak with a GPS program representative who can walk you through the process.

- Fax: Submit your completed paperwork by fax to (844) 243-6774.

3. Have your prescriber complete their section. Your doctor or their office staff must sign off on the enrollment form. Many offices are familiar with this process and can submit their portion directly to Vertex.

4. Submit all required documents together. Incomplete applications take longer to process. Make sure every required item is included before submitting.

5. Confirm receipt. After submitting, follow up by phone at (844) 243-6773 to confirm that Vertex has received everything they need.

6. Wait for a decision. Processing typically takes 7 to 10 business days after Vertex receives a complete application.

---

What to Expect: Timeline and Delivery

Once your application is approved, Vertex or a program representative will contact you or your prescriber to confirm your enrollment. You do not need to pick up your medication at a pharmacy. Orkambi is shipped directly to your home address, so there is nothing you need to do at a pickup counter. Make sure your delivery address is accurate on the enrollment form. Your enrollment in the GPS program lasts for one year. Before the year ends, you will need to reauthorize your participation by submitting updated income documentation and a renewed prescriber sign-off. Vertex will typically notify you when reauthorization is due, but it is a good idea to track your renewal date yourself.

---

Alternatives If You Don't Qualify

If you do not qualify for the Vertex GPS free medication program, here are other options to explore:

1. Biosimilars: There are currently no FDA-approved biosimilar or generic versions of Orkambi available. This option does not apply at this time.

2. Vertex Copay Assistance Card (for insured patients): If you have commercial insurance, you may qualify for a savings card that reduces your out-of-pocket costs significantly. Visit https://www.vertexgps.com/copay-assistance to learn more and enroll.

3. State Pharmaceutical Assistance Programs (SPAPs): Many states operate their own prescription drug assistance programs, particularly for residents with Medicare. Search your state's health department website or ask your pharmacist whether a SPAP is available in your state.

4. NeedyMeds.org: This is a free, independent database that lists hundreds of patient assistance programs, disease-specific funds, and other cost-reduction resources. Visit https://www.needymeds.org and search for Orkambi or cystic fibrosis programs that may help cover costs.

---

*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.*

---