Coverage and Formulary | BENLYSTA (belimumab) for HCPs

BENLYSTA coverage in local plans

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Plans	BENLYSTA IV	Saphnelo
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* “Unknown” means the product is not listed on the plan’s formulary and coverage cannot be determined. An exception process may be available for coverage determination.

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Source: Managed Markets Insight & Technology, LLC (MMIT) database as of .

What you need to know about this formulary information:
Formulary status may vary and is subject to change. Formulary comparisons do not imply comparable indications, safety, or efficacy. This is not a guarantee of partial or full coverage or payment. Consumers may be responsible for varying out-of-pocket costs based on an individual’s plan and its benefit design. Each plan administrator determines actual benefits and out-of-pocket costs per its plan’s policies. Verify coverage with plan sponsor or Centers for Medicare & Medicaid Services. Medicare Part D patients may obtain coverage for products not otherwise covered via the medical necessity process. GSK does not endorse individual plans.

UnitedHealthcare-specific statements
Nothing herein may be construed as an endorsement, approval, recommendation, representation, or warranty of any kind by any plan or insurer referenced herein. This communication is solely the responsibility of GSK. Communication only to Providers — not approved for Prescription Drug Plan member distribution.

PA = prior authorization.

More than 95% of patients with lupus and lupus nephritis nationwide have coverage for BENLYSTA Autoinjector and IV*

Source: Managed Markets Insights & Technology (MMIT) database as of October 2025.

* Covered under a patient's medical benefit or pharmacy benefit. Covered means any potential for reimbursement from a health plan and may include step edits, prior authorizations, and other restrictions based on an analysis of formal coverage policies. Patients reflects the number of lives within a plan, as determined by MMIT. Formulary status may vary and is subject to change. Formulary coverage does not imply clinical efficacy or safety. Verify coverage with the plan sponsor.

Pay As Little As $0

† Program annual maximums apply. Eligibility for the BENLYSTA Copay Program must be determined by the GSK Copay Program. Visit  https://www.benlystacopayprogram.com  for information about eligibility and full program terms and conditions.

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BENLYSTA Cares

Support for your patients at every step of their treatment journey.

How to start a patient on BENLYSTA

BENLYSTA Gateway can help you and your patients access BENLYSTA.

BENLYSTA could help with financial support*

BENLYSTA could help with financial support*

* The BENLYSTA Copay Program helps eligible commercially insured patients with their eligible out-of-pocket costs for BENLYSTA. Eligibility for the BENLYSTA Copay Program must be determined by the GSK Copay Program. Eligibility restrictions and program maximums apply. Visit https://www.benlystacopayprogram.com for complete Program Terms and Conditions.

INDICATION & IMPORTANT SAFETY INFO

INDICATION

BENLYSTA is indicated for patients aged ≥5 with active systemic lupus erythematosus (SLE) or active lupus nephritis who are receiving standard therapy. BENLYSTA is not recommended in patients with severe active central nervous system lupus.

BENLYSTA is indicated for patients aged ≥5 with active systemic lupus erythematosus (SLE) or active lupus nephritis who are receiving standard therapy. BENLYSTA is not recommended in patients with severe active central nervous system lupus.

BENLYSTA is indicated for patients aged ≥5 with active systemic lupus erythematosus (SLE) or active lupus nephritis who are receiving standard therapy. BENLYSTA is not recommended in patients with severe active central nervous system lupus.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION

Previous anaphylaxis with BENLYSTA.

CONTRAINDICATION

Previous anaphylaxis with BENLYSTA.

WARNINGS AND PRECAUTIONS

Serious Infections: Serious and sometimes fatal infections have been reported and occurred more frequently with BENLYSTA.

CONTRAINDICATION

Previous anaphylaxis with BENLYSTA.

WARNINGS AND PRECAUTIONS

Serious Infections: Serious and sometimes fatal infections have been reported and occurred more frequently with BENLYSTA. Use caution in patients with severe or chronic infections, and consider interrupting therapy in patients with a new infection.

Progressive Multifocal Leukoencephalopathy (PML): Cases of JC virus-associated PML resulting in neurological deficits, including fatal cases, have been reported. If PML is suspected, immunosuppressant therapy, including BENLYSTA, must be suspended until PML is excluded. If confirmed, stop immunosuppressant therapy, including BENLYSTA.

Hypersensitivity Reactions (Including Anaphylaxis): Acute hypersensitivity reactions, including anaphylaxis and death, and infusion-related reactions have been reported. Generally, reactions occurred within hours of the infusion but may occur later, including in patients who have previously tolerated BENLYSTA. Non-acute hypersensitivity reactions (eg, rash, nausea, fatigue, myalgia, headache, and facial edema) typically occurred up to a week after infusion. Monitor patients during and after treatment and be prepared to manage anaphylaxis and infusion-related reactions. Be aware of the risk of hypersensitivity reactions, which may present as infusion-related reactions. Discontinue immediately in the event of a serious reaction. With intravenous administration, if an infusion reaction develops, slow or interrupt the infusion.

Depression and Suicidality: Depression and suicidality were reported in patients receiving BENLYSTA. Before adding BENLYSTA, assess patients’ risk of depression and suicide and monitor them during treatment. Instruct patients/caregivers to contact their HCP if they experience new/worsening depression, suicidal thoughts/behavior, or other mood changes.

Malignancy: There is an increased risk of malignancies with the use of immunosuppressants. The impact of BENLYSTA on the development of malignancies is unknown.

Immunization: Live vaccines should not be given for 30 days before or concurrently with BENLYSTA as clinical safety has not been established.

Use With Biologic Therapies: Available data do not support the safety and efficacy of concomitant use of BENLYSTA with rituximab in patients with SLE. An increased incidence of serious infections and post-injection systemic reactions in patients receiving BENLYSTA concomitantly with rituximab compared to patients receiving BENLYSTA alone has been observed. The safety and efficacy of BENLYSTA concomitantly with other biologic therapies, including B-cell-targeted therapies, have not been established. Caution should be exercised if BENLYSTA is administered in combination with other biologic therapies.

ADVERSE REACTIONS

The most common serious adverse reactions in adult SLE clinical trials were serious infections; some were fatal. The most common adverse reactions (≥5%) were nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine, pharyngitis, and injection site reactions (subcutaneous injection).

Adverse reactions reported in clinical trials with SLE pediatric patients (≥5 years) and adult patients with lupus nephritis were consistent with those observed in adult SLE trials.

USE IN SPECIFIC POPULATIONS

Pregnancy: There are insufficient data in pregnant women to establish whether there is drug-associated risk for major birth defects or miscarriage. After a risk/benefit assessment, if prevention is warranted, women of childbearing potential should use contraception during treatment and for ≥4 months after the final treatment.

Pregnancy Registry: HCPs are encouraged to refer patients and pregnant women are encouraged to enroll themselves by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/benlysta-belimumab/.

Please see full Prescribing Information and Medication Guide for BENLYSTA.

To report SUSPECTED ADVERSE REACTIONS, contact GSK at gsk.public.reportum.com or 1-888-825-5249, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Trademarks are owned by or licensed to the GSK group of companies.