You have questions.

Frequently Asked Questions about NUCALA

 

HAVE MORE QUESTIONS ABOUT NUCALA?

INTERESTED IN THE CLINICAL STUDY RESULTS?

  • Was the clinical trial completed only by GlaxoSmithKline?

    No. The study was completed with the National Institutes of Health (NIH) across several academic centers.

     

  • What were the details of the clinical trial?

    A total of 136 patients with EGPA were evaluated in a randomized, placebo-controlled, multicenter, 1-year trial. Patients received 300 mg of NUCALA (as three 100-mg injections) or placebo injected subcutaneously (under the skin) once every 4 weeks. Starting at Week 4, patients' oral corticosteroids could be reduced by their healthcare provider if appropriate.

     

  • Who were the patients enrolled in the clinical trial?

    All patients enrolled were aged 18 years or older; 59% were female, and 92% were white. All had received a diagnosis of EGPA (relapsing or refractory) at least 6 months before. They had been taking daily oral steroids (a stable dose of at least 7.5 mg of prednisone or prednisolone) for at least 4 weeks before their first study visit. They may or may not have been taking immunosuppressants when enrolled in the study.

     

  • What is the BVAS?

    Known as the Birmingham Vasculitis Activity Score (BVAS), this scoring tool rates disease activity in patients with vasculitis and is primarily used in clinical studies. The BVAS scores are grouped by 9 organ systems, and assessments are made based off the responses from these systems.

     

  • Could the researchers adjust the patients' oral steroid dose during the clinical trial with NUCALA?

    Yes. Starting at Week 4, healthcare providers could reduce the patients' oral corticosteroids as appropriate.

     

  • How long did it take for patients in the clinical trial to see results?

    The clinical trial was not designed to measure when NUCALA started to work. It was designed to determine the effect of NUCALA on disease activity and oral steroid dose at a certain point in time. NUCALA plus other medicines may help reduce EGPA disease activity more than other medicines alone.

     

    More patients receiving NUCALA who were able to achieve remission in the first 6 months were able to stay in remission during the remainder of the 1-year clinical study. In the clinical trial for NUCALA, "remission" was defined as no active vasculitis and a prednisone or prednisolone dose less than or equal to 4 mg per day.

     

    Some patients were able to have their oral steroid dose reduced as early as 4 weeks after beginning treatment with NUCALA.

     

    Individual results may vary.

     

    It's a good idea to keep a daily journal about how you're feeling during treatment with NUCALA. Use your notes to keep your healthcare provider informed of any changes you're feeling.

NEED MORE DETAILS ON INSURANCE AND GATEWAY TO NUCALA?

  • What is Gateway to NUCALA?

    Gateway to NUCALA representatives can assist you in these ways:

    • answer questions about insurance coverage for NUCALA
    • help share information about out-of-pocket costs for NUCALA
    • explain GSK’s programs that may help you afford NUCALA
    •  

    Information from the Gateway is not a guarantee of coverage; be sure to verify the information provided with your health plan.

  • How do I contact Gateway to NUCALA?

    You can reach a Gateway to NUCALA representative directly by calling 1-844-4-NUCALA (844-468-2252) toll-free, Monday-Friday, 8AM to 8PM ET.

  • How much does NUCALA cost?

    Costs vary. If you have insurance, each insurance policy is different. Your insurance generally pays part of the costs and you pay the remaining part out of pocket — this is typically referred to as your co-payment or co-insurance.

     

    To understand your out-of-pocket costs for NUCALA, contact your insurance company or Gateway to NUCALA.

  • What is the $0 Co-pay Program?

    Even with insurance coverage, it may be difficult to cover your co-payments. That's why the $0 Co-pay Program for NUCALA helps eligible commercially insured patients with their co-payments. The $0 Co-pay Program helps eligible approved patients with their out-of-pocket costs for NUCALA up to $15,000 for 12 months. If approved, you could pay as little as $0 for NUCALA.

     

    To enroll, call Gateway to NUCALA, go to www.NUCALACopayProgram.com, or download and complete a Services Request form and bring it to your doctor's office.

     

    Once you apply, you will receive a letter within 2 weeks about your eligibility. If you are eligible, you can start using the program right away.

     

    Medicare-eligible patients and patients enrolled in government-funded programs are not eligible for the NUCALA Co-pay Program. You must submit an Enrollment Form or complete an eligibility check online at www.NUCALACopayProgram.com to determine your eligibility.

     

    See the Terms and Conditions for full program eligibility details. This is not insurance.

  • How do I enroll in the $0 Co-pay Program?

    You can enroll in the $0 Co-pay Program in one of the following 4 ways:

     

    1. Download the Services Request form (English version or use the Spanish version) and bring it to your healthcare provider's office.
    2. Complete the Services Request form (English version or use the Spanish version) available at your healthcare provider's office.
    3. Call Gateway to NUCALA at 1-844-4- NUCALA  (1-844-468-2252).
    4. Enroll online at www.NUCALACopayProgram.com.

    You may be eligible if you have commercial insurance.

    You are not eligible if you have a state or federal government-funded medical or prescription drug plan, such as Medicare, Medicaid, or TRICARE, or have insurance with a non-participating commercial payer. Medicare-eligible patients, including all patients who are age 65 or older, are not eligible to participate in the Co-pay Program for NUCALA Please see Terms and Conditions for full program eligibility details.

  • What is the Services Request form?

    This form gives the Gateway to NUCALA representatives permission to have your health insurance and financial information in order to investigate your insurance benefits and the potential savings programs for which you may qualify. Services Request form (English version or use the Spanish version) must be completed by your healthcare provider and you.

  • What is benefits investigation?

    If you authorize it, a Gateway to NUCALA representative will contact your health insurance provider to confirm how NUCALA is covered under your current plan. Once the representative has completed their investigation, you will receive a summary of insurance benefits based on the information our representative has received.

  • How long does it take to complete the benefits investigation process?

    Depending on the process with your insurance plan, a benefits investigation may take approximately four to six (4-6) days. Once your benefits have been determined, you will receive a benefits summary letter by mail. You may also receive a phone call from a representative from Gateway to NUCALA and/or the specialty pharmacy that is filling your prescription. It's important to answer or return these calls so there's no delay in starting your treatment.

  • I received a call from a pharmacy asking for more information. What should I do?

    If your healthcare provider orders NUCALA from a specialty pharmacy, the pharmacy may call you to review your insurance coverage and explain your out-of-pocket costs. It's important to answer or return these calls so there's no delay in starting your treatment. To protect your privacy, the pharmacy may not mention NUCALA when leaving a message.

    Since the specialty pharmacy ships NUCALA to you or your doctor, they may ask for your credit card information to pay those costs not covered by your insurance plan. If you have concerns about paying your out-of-pocket costs, contact Gateway to NUCALA for information about support programs for which you may be eligible.

    Ask your healthcare provider if NUCALA is right for you.

 

 

Ask your healthcare provider if NUCALA is right for you.