Several factors should be considered when evaluating IgAN patients, including proteinuria level, eGFR level, hematuria, and MEST-C score. Age, comorbidities, and other clinical characteristics are also important to consider.^1-4

The alternative complement pathway is thought to contribute to the pathogenesis of IgA nephropathy (IgAN). IgAN is a multifactorial disease influenced by genetic and environmental factors and is commonly described using a four-hit model of pathogenesis.^5-7
 

Learn more about the alternative complement pathway.

IgAN is considered a heterogeneous disease because clinical presentation, rate of IgAN progression and histologic findings can vary across patients. When assessing disease status and risk, clinicians may consider proteinuria level, eGFR level, hematuria, blood pressure, biopsy findings including MEST-C score, and prior treatment history.^1,2

The 2025 KDIGO Guidelines treatment goals for patients with IgAN at risk of progressive loss of kidney function include reducing the rate of kidney function loss and targeting a proteinuria level of <0.5 g/day, ideally <0.3 g/day (or equivalent).¹

FABHALTA is indicated to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression.⁵

FABHALTA binds to Factor B of the alternative complement pathway and regulates the cleavage of C3, generation of downstream effectors, and amplification of the terminal pathway. By binding to Factor B, FABHALTA inhibits the alternative pathway. FABHALTA is a complement Factor B inhibitor. Not a steroid.⁵

The APPLAUSE-IgAN clinical trial included 477 adults with biospy-proven primary IgAN, eGFR ≥ 20 mL/min/1.73 m², and UPCR ≥ 1 g/g. Patients were primarily treated with a stable dose of maximally tolerated RASi therapy with or without a stable dose of SGTL2i.⁵

Learn more about the APPLAUSE-IgAN clinical trial.

Background supportive care used in APPLAUSE-IgAN included stable doses of maximally tolerated RASi therapy with or without a stable dose of an SGLT2i. This supportive care was used in both treatment arms.⁵

The APPLAUSE-IgAN trial evaluated proteinuria and rate of eGFR decline as key efficacy end points. The interim analysis primary end point was the relative change from baseline in 24-hour UPCR at 9 months. The final analysis primary end point was the annualized total eGFR slope over 24 months.⁵

Learn more about the APPLAUSE-IgAN clinical trial.

Regardless of treatment arm, study participants in the APPLAUSE-IgAN clinical trial continued receiving stable doses of maximally tolerated RASi therapy with or without a stable dose of an SGLT2i. It is important to consider treatment in the context of background standard of care and individual patient management.^1,5

FABHALTA is administered orally twice daily without regard to food.⁵ Refer to the current US Prescribing Information for specific guidance on vaccination requirements, dosing, administration, and monitoring.

FABHALTA was proven to slow kidney function decline in adults with primary IgAN at risk of disease progression. For additional efficacy outcomes, see the clinical data page.⁵

Required vaccinations: Streptococcus pneumoniae and Neisseria meningitidis (serogroups A, C, W, Y, and B). 

Complete or update vaccination against encapsulated bacteria (according to the most current ACIP recommendations for patients receiving a complement inhibitor) at least 2 weeks before starting FABHALTA, unless the risks of delaying FABHALTA outweigh the risk of developing a serious infection. 

If urgent FABHALTA therapy is indicated in a patient who is not up-to-date with these vaccines, provide antibacterial drug prophylaxis and administer the vaccines according to ACIP recommendations as soon as possible. For additional details on antibacterial drug prophylaxis, please see the FABHALTA Prescribing Information, Warnings and Precautions (section 5.1).⁵

For more information, see the Getting Started section.

Patients should be counseled on the purpose of treatment for IgAN, dosing, adherence, infection risk, vaccination requirements, and relevant safety considerations. They should also be advised on when to contact the care team during treatment.⁵

HCPs need to be certified in the FABHALTA REMS program and counsel patients on the risk of serious infections before initiating treatment.⁵ Refer to the page, Getting Started: REMS and Vaccinations.

Time to treatment initiation can vary based on payer requirements, prior authorization, vaccination status, REMS steps, and specialty pharmacy coordination. Office staff and patient support services may help facilitate onboarding.

Adverse reactions reported in ≥3% of adult patients with primary IgAN treated with FABHALTA and occurred ≥2% higher in frequency than placebo in APPLAUSE

ᵃIncludes similar terms.

These data reflect the exposure in patients with primary IgAN (eGFR ≥20 mL/min/1.73 m² at baseline).

The median duration of exposure to FABHALTA was 102 weeks (up to 107 weeks).

Serious infections caused by encapsulated bacteria reported in APPLAUSE occurred in 3 patients (1.2%) on FABHALTA and none on placebo.

Because of the risk of serious infections caused by encapsulated bacteria, FABHALTA is only available through a REMS program that requires vaccinations.

Submit a prescription to a designated specialty pharmacy or complete the Start Form through Novartis Patient Support™ via fax to 1-877-443-2242 or submit via CoverMyMeds ↗. The specialty pharmacy will coordinate next steps, including benefits verification and patient outreach.

• Biologics by McKesson: 1-800-850-4306

• CareMed*: 1-877-227-3405

*CareMed is a subsidiary of Onco360^®.

Office staff should make sure patients complete or update vaccination against encapsulated bacteria according to the most current ACIP recommendations for patients receiving a complement inhibitor, at least 2 weeks before starting FABHALTA.

If urgent treatment is needed in a patient who is not up to date on these vaccines, refer to the current US Prescribing Information and applicable guidance regarding antibacterial prophylaxis and timing of vaccination.

Send prescriptions to one of the designated specialty pharmacies within the limited network.

• Biologics by McKesson: 1-800-850-4306

• CareMed*: 1-877-227-3405

*CareMed is a subsidiary of Onco360^®.

The specialty pharmacy will verify benefits, submit a prior authorization (depending on insurance requirements), coordinate with the patient, and arrange delivery.

Clinical documentation such as diagnosis, lab values, and treatment history is typically required. Strong documentation supports approval.

Most patients are able to access FABHALTA. In fact, prescription claims data show 82%* of prior authorizations are approved, though requirements may vary by plan.

*Between August 2023 and March 2026.

Out-of-pocket costs for FABHALTA depend on the patient’s insurance coverage and other factors. In a recent analysis of patient out-of-pocket cost from May 2025 to April 2026 97% of patients paid $10 or less per month for FABHALTA. The actual cost may be different. Contact the patient’s insurance provider to understand the potential cost.

Encourage use of available support programs. The FABHALTA specialty pharmacies and Novartis Patient Support™ programs can help assess eligibility for the Co-Pay Plus Offer and Bridge Program. For details see the complete Terms and Conditions here.

FABHALTA is dispensed through a specialty pharmacy and shipped directly to the patient’s home. Once approved, the pharmacy will contact the patient to schedule delivery.

Patients may receive calls from specialty pharmacies such as Biologics by McKesson or CareMed*, often from unknown numbers. Advise them to answer or return calls promptly to avoid delays.

*CareMed is a subsidiary of Onco360^®.

Practices should refer to the Resource section of this website and the Onboarding Guide for information about specialty pharmacies and how to order FABHALTA for patients.

If there are delays, follow up on prior authorization status and confirm the patient has connected with the specialty pharmacy, as missed outreach is a common cause.

Specialty pharmacies provide ongoing coordination, education, and adherence support. Novartis Patient Support™ can also assist with access, affordability, and navigation.

Your practice can contact the specialty pharmacy directly or engage Novartis Patient Support™ for additional assistance with coverage, cost, or coordination.

Yes, Novartis provides a patient support program for FABHALTA, called Novartis Patient Support, that helps eligible patients:

• Initiate treatment

• Navigate insurance coverage requirements

• Manage out-of-pocket costs

• Provide resources for ongoing support

You can enroll your patients in Novartis Patient Support for FABHALTA in a few simple steps:

1. Complete the Start Form on the CoverMyMeds^® portal by visiting www.covermymeds.health ↗.

   Quickly enroll patients and track their progress.

   OR

   Download the FABHALTA Start Form at FABHALTA.com. Fill out the required sections with your patient, and ensure both you and your patient sign and date the form to capture consent.

   Fax completed form to Novartis Patient Support at fax 833-99FABHA (833-993-2242)

2. Connect with us.

   Our Novartis Patient Support team is available to work alongside you and your patients every step of the way. Call us at: 833-99FABHA (833-993-2242), Monday-Friday, 8:00 _^AM-8:00 _^PM ET, excluding holidays.

Yes, Novartis Patient Support™ provides you and your patients with a dedicated Novartis team member to help navigate access and reimbursement for FABHALTA.

If additional support is needed, any Novartis Patient Support™ team member can assist you and your patients on their treatment journey by calling us.
Phone: 833-99FABHA (833-993-2242)
Availability: Monday-Friday, 8:00 _^AM-8:00 _^PM ET, excluding holidays

Yes, once your patient is enrolled in Novartis Patient Support, our team will work with their insurance provider and your office to conduct a benefits verification, so that your eligible patient can better understand their coverage.

Novartis Patient Support can help with prior authorization requests or letters of appeal by working directly with you and your office. We provide helpful resources, such as the PA and Appeals Guide, which includes:

• PA Checklist

• Exception Request Checklist

• Appeal Submission Checklist

• Sample Letters

Yes, Novartis Patient Support provides field reimbursement managers who can work with you and your office to help patients. For questions or support, you can reach out to a dedicated Novartis Access and Reimbursement team member by calling Novartis Patient Support at: 833-99FABHA (833-993-2242).

The Novartis Patient Support™ Co-Pay Plus* offer helps make treatment affordable. Eligible privately insured patients may pay as little as $0 for FABHALTA. To sign up patients and their providers can fill out the electronic Start Form on the CoverMyMeds^® portal: www.covermymeds.health ↗.

*Limitations apply. Up to a $20,000 annual limit. Offer not valid under Medicare, Medicaid, or any other federal or state program. Novartis reserves the right to rescind, revoke, or amend this Program without notice. Additional limitations may apply. See complete Terms & Conditions at www.fabhalta.com for details.

Novartis Patient Assistance Foundation, Inc. (NPAF) is an independent, 501(c)(3) non-profit entity that provides certain medications at no cost to eligible patients who cannot afford the cost of their Novartis medication, are uninsured or have government insurance, and meet income guidelines and other eligibility criteria. NPAF does not provide product to individuals having insurance associated with any type of alternative funding program that conditions, restricts, or adjusts coverage based on application to NPAF or any other free goods program. Other terms and conditions may apply. Please visit www.PAP.Novartis.com ↗ or call NPAF at 1-800-277-2254 for more information.

Yes, Novartis Patient Support has the Bridge Program,^† which provides eligible patients up to 12 months of FABHALTA for free while coverage is pursued. Once they sign up for Novartis Patient Support, we automatically identify if your patients are eligible for the Bridge Program, based on the results of the benefits verification.

^†Up to a $20,000 annual co-pay benefit limit for the cost of FABHALTA and up to $1,000 for qualifying vaccination costs. Offer not valid under Medicare, Medicaid, or any other federal or state health insurance program. Patients with private insurance and a prior authorization requirement or an initial denial of coverage may receive up to 12 months of free product while coverage is pursued. Novartis reserves the right to rescind, revoke, or amend this Program without notice. Additional limitations may apply. See complete Terms & Conditions at www.fabhalta.com for details.

Novartis Patient Support offers a range of patient support materials to help patients start and stay on track with FABHALTA, including:

• Dedicated support team that provides ongoing assistance and answers questions throughout treatment

• A Welcome Kit that includes educational resources to help patients get started

• Adherence support tools that offer tips and reminders to help patients maintain their dosing

You can access patient support materials for FABHALTA at FABHALTA.com, where you’ll find resources designed for use in health care provider offices, including educational materials and patient support information.

You can enroll patients who wish to participate in Vaccination Support using the current Start Form and selecting Vaccination Support in Section 6 (Vaccination Information). Patient Navigators will then work with patients to determine their preference of support and work with the patients accordingly.

All patients 18 years or older who have been prescribed on-label FABHALTA will be eligible for in-home vaccination, regardless of insurance type.