Vigadrone

PROMISE OF SUPPORT Program Patient Guide: How to Get VIGADRONE at Low or No Cost

About This Program

The PROMISE OF SUPPORT Program is a patient assistance program offered by Upsher-Smith Laboratories, LLC, the manufacturer of VIGADRONE (vigabatrin). This program is designed to help patients, caregivers, and healthcare providers access VIGADRONE throughout the treatment journey by offering comprehensive support services, including medication access and copay assistance for eligible patients.[1][4]

About VIGADRONE (Vigabatrin)

VIGADRONE is a prescription medication used to treat two serious seizure conditions:[5][8]

• Infantile Spasms (IS) in patients 1 month to 2 years of age, when you and your healthcare provider decide the possible benefits outweigh the risk of vision loss
• Refractory Complex Partial Seizures (CPS) in adults and children 2 years and older, when seizures do not respond well to other treatments and the benefits outweigh the risks

VIGADRONE is available as 500 mg powder for oral solution and 500 mg tablets.[5]

Important Safety Information: VIGADRONE can cause permanent vision loss, including severe peripheral vision loss or "tunnel vision." Because of this serious risk, VIGADRONE is only available under a special FDA program called the Vigabatrin Risk Evaluation and Mitigation Strategy (REMS) Program. Your healthcare provider will explain this program to you before you start treatment.[8]

Who Qualifies for the PROMISE OF SUPPORT Program

You may be eligible for assistance through this program if you meet the following criteria:

• You are uninsured or functionally uninsured (meaning you have insurance that does not adequately cover VIGADRONE)
• You meet the program's income guidelines
• You have a valid prescription for VIGADRONE from your healthcare provider

Income Eligibility

While specific income thresholds are not publicly listed, the program serves patients who are uninsured or functionally uninsured and meet program income guidelines. Income limits typically vary based on household size. During the application process, you will need to provide proof of your household income to determine eligibility.

If you are unsure whether your income qualifies, contact the program directly or speak with your healthcare provider, who can help you determine eligibility.

Insurance Requirements

This program is designed for patients who are:

• Completely uninsured (have no health insurance coverage)
• Functionally uninsured (have insurance that does not cover VIGADRONE or has high out-of-pocket costs)

If you have Medicare, Medicaid, or other government insurance, you may still qualify if your coverage does not adequately pay for VIGADRONE. Contact the program to discuss your specific situation.

Required Documentation

To apply for the PROMISE OF SUPPORT Program, you will typically need to provide:

• Proof of income (recent pay stubs, tax returns, or benefit statements)
• Proof of residency (utility bill, lease agreement, or government-issued ID)
• Proof of insurance status (insurance card, denial letter, or statement of being uninsured)

Your healthcare provider or the specialty pharmacy partner can help you gather these documents.

How to Apply: Step-by-Step

Step 1: Get a Prescription Your healthcare provider must prescribe VIGADRONE and confirm that you meet the medical criteria for treatment, including understanding the vision loss risks.

Step 2: Contact the Program Reach out to the PROMISE OF SUPPORT Program through your healthcare provider's office or the specialty pharmacy partner, PANTHERx Rare, which works with Upsher-Smith to manage patient enrollment and support.[1][6]

Step 3: Complete Your Application Provide the required documentation (proof of income, residency, and insurance status) as part of your application.

Step 4: Await Approval The program will review your application and determine your eligibility. Once approved, you will be notified of your benefits.

Step 5: Receive Your Medication Once approved, your medication will be shipped directly to you or your healthcare provider.[1]

Program Services and Benefits

Beyond financial assistance, the PROMISE OF SUPPORT Program offers comprehensive support including:[1][4][6]

• Quick start and bridge supply programs to ensure timely access to medication
• Prior authorization support to help navigate insurance requirements
• Patient education materials to help you understand your treatment
• Specialty pharmacy partnership with PANTHERx Rare for expert support
• Copay assistance for eligible patients to reduce out-of-pocket costs
• Streamlined prescribing and enrollment procedures

Timeline and Medication Delivery

While specific processing times are not publicly detailed, the program emphasizes quick start options and timely medication delivery.[1][6] Your medication will be shipped directly to you once your application is approved.[1] For specific timeline information, contact the program through your healthcare provider or PANTHERx Rare.

What If Your Application Is Denied

If your application is denied, ask the program for specific reasons. Common reasons for denial include:

• Income exceeding program guidelines
• Having adequate insurance coverage
• Not meeting medical criteria for VIGADRONE

If denied, discuss alternative options with your healthcare provider, such as:

• Appealing the decision with additional documentation
• Exploring other patient assistance programs
• Discussing generic vigabatrin options (which may be more affordable)
• Consulting with your insurance company about coverage options

Important Disclaimers

• This guide provides general information about the PROMISE OF SUPPORT Program. Program details, eligibility requirements, and benefits may change. Always verify current information directly with the program.
• This program is not insurance and does not replace health insurance coverage.
• Eligibility is determined on a case-by-case basis based on individual circumstances.
• You must have a valid prescription from a licensed healthcare provider to participate.
• VIGADRONE carries serious risks, including permanent vision loss. Discuss all risks and benefits with your healthcare provider before starting treatment.
• For the most current information, visit VIGADRONE.com or contact your healthcare provider.

Contact Information

For more information about the PROMISE OF SUPPORT Program for VIGADRONE, visit VIGADRONE.com or speak with your healthcare provider. Your provider can connect you with PANTHERx Rare, the specialty pharmacy partner that helps manage enrollment and ongoing support.