Celltrion CARES® Co-pay Assistance Program:
Vegzelma Terms and Conditions

These Terms and Conditions are valid for Vegzelma as of the date published until amended or terminated by Celltrion (“Program Period”). As a condition of participation in the Program, participants understand and agree that Celltrion may, in its sole discretion, limit, rescind, revoke, terminate, or amend the Program at any time, for any reason, without notice. It is the responsibility of participants to review these Terms and Conditions each time before relying on any Program benefits.

1. Program Overview

The Celltrion CARES® Co-pay Assistance Program (“Program”) seeks to help Eligible Patients (defined below) with certain out-of-pocket costs (OOP) for Vegzelma. Under the Program, Eligible Patients may pay as little as $0 for Vegzelma for each fill of a one-month prescription. If the pharmacy can fill a 3-month supply, the Eligible Patient may pay no more than $0. The Program is subject to certain limitations set out below, including Qualifying Expenses (defined below), maximum limits, available funding, and patient eligibility requirements or other restrictions. Actual per-prescription savings for Qualifying Expenses may vary, and patients may be responsible for OOP costs not covered under this Program.

2. Patient Eligibility

To qualify for Program benefits, the patient must meet the following eligibility requirements (“Eligible Patients”):

  • Have Commercial Insurance: Patient must have and use private/commercial health insurance that provides at least some coverage for Vegzelma. Patients who do not have coverage for Vegzelma or do not elect to use their commercial health plan to cover at least some of the cost of Vegzelma are ineligible for the Program. Additionally, patients are ineligible for the Program where their insurance policy prohibits such co-pay assistance programs. It is the patient’s responsibility to check with their insurance carrier to confirm that their participation in the Program is not inconsistent with insurance carrier’s requirements; including satisfying any conditions imposed by their carrier for participation in the Program.   
  • Not Have Federal or State Health Insurance: Patients are ineligible for the Program if they are covered, in whole or in part, under:
    • Medicaid (including Medicaid patients enrolled in a qualified health plan purchased through a health insurance exchange marketplace established by a state government or the federal government),
    • Medicare (Part A or B),
    • Medicare Part D or Medicare Advantage plan (regardless of whether a specific prescription is covered),
    • TRICARE, Veterans Affairs healthcare or the Civilian Health and Medical Program (CHAMPVA),
    • Puerto Rico Government Health Insurance Plan (“Healthcare Reform” formerly known as “La Reforma de Salud”),
    • A State prescription drug assistance program, or
    • Any other state or federal medical or pharmaceutical benefit program or pharmaceutical assistance program (collectively, “Government Programs”).

If at any time in the future, a patient begins receiving prescription drug coverage for Vegzelma under any such Government Program(s), the patient is ineligible for the Program and must call Celltrion CARES at 1-877-81CONNC (1-877-812-6662) to stop participation in the Program immediately.

  • Not Self-Pay: The Program is not valid for self-pay or cash-paying patients (i.e., patients without commercial health insurance, patients with health insurance who lack coverage for Vegzelma, or patients who do not seek to use commercial health insurance to pay for Vegzelma under their plan).
  • Residency and Age: Patient must be 18 years of age or older and reside in the United States or the Commonwealth of Puerto Rico for at least 6 months and live within and under the guidance of a healthcare provider (HCP) within the United States or the Commonwealth of Puerto Rico. Additionally, Vegzelma covered under the Program must originate and be shipped to locations in the United States or the Commonwealth of Puerto Rico.
  • On-label Prescription: Patient must be under the care of a physician and prescribed Vegzelma for an FDA-approved indication.

3. Program Enrollment for Co-pay Cards

  • Eligible Patients must be enrolled in the Program and meet all Patient Eligibility requirements. 
  • Patients or their duly licensed provider(s), pharmacist(s), caretakers, or legal guardians may complete the Program enrollment process either via the Celltrion CONNECT® Patient Support Program or online through the Celltrion CARES website.
  • Patients, or those enrolling on behalf of the patient agree to provide all required information and legal consents necessary for Program administration by Celltrion CARES. Anyone enrolling the patient in the Program represents and warrants all information provided is true and accurate as of the date provided.
  • Celltrion CARES will review the application to determine if the patient is eligible for the Program.
  • If the patient is eligible for the Program, Celltrion CARES will provide the Eligible Patient with virtual co-pay card details that can be used to cover the cost of Qualifying Expenses at their dispensing pharmacy.

4. Retroactive Enrollment

  • For OOP costs incurred by Eligible Patients for Vegzelma under their commercial insurance plan before Program enrollment. The Program will cover eligible costs with a look back date not to exceed 90 days prior to the date the Eligible Patient was enrolled in the Program.
  • Claims must be processed at the point of sale by the pharmacy where the claim originated for the dispense.

5. Qualifying Expenses

  • Qualifying Expenses: Are those OOP costs incurred by Eligible Patients for Vegzelma under their commercial insurance plan during the Program period, subject to maximum allowable limits. Qualifying Expenses are not valid for ancillary services including office visit charges or medication administration charges even if such costs are associated with the administration of Vegzelma. Enrolled patients are responsible for all co-pays, deductibles, coinsurance, and any other balances not covered by the Program.
  • Maximum Limit: Is the total maximum limit an Eligible Patient may receive for Qualifying Expenses during the Program calendar year. The maximum limit is set by Celltrion CARES and may be subject to change.
  • Adjustments: Qualifying Expenses may be adjusted if accumulator or maximizer programs are in effect to ensure that the Program is for the sole benefit of the patient.

6. Additional Criteria

  • The co-pay card is limited to one Eligible Patient per application and may only be used by such patient during the Program Period. The co-pay card is void if transferred or substituted to any other person, or if combined with any other co-pay assistance program, free trial, discount, prescription savings card, or other offer. Co-pay cards may also not be offered for sale, sold, purchased, traded, reproduced, counterfeited, or duplicated.
  • Patient, pharmacy, and provider agree not to seek reimbursement for all, or any part of the benefit received by the patient through the Program and are responsible for reporting receipt of Program benefits to any insurer, health plan, or other third party who pays for or reimburses any part of the medication cost paid for by the Program, as may be required.
  • Patients must promptly contact Celltrion CARES if their insurance coverage changes.
  • The maximum number of uses per calendar year is 14.
  • Automatic re-enrollment in 2027 is only for patients who are utilizing the Program.
  • The Program is not contingent on any past or future commercial sale of Vegzelma or otherwise void where prohibited by law, taxed, or restricted.

7. Consents and Disclaimers

  • Data Use and Consent: Data related to a patient’s participation in the Program may be collected, analyzed, or shared with Celltrion CARES for market research and other purposes related to assessing its co-pay assistance programs. Data shared with Celltrion CARES for these purposes will be de-identified, meaning it will not identify the patient specifically.
  • Modification and Termination of Program: Celltrion CARES reserves the right to limit, rescind, revoke, terminate, or amend the Program at any time without notice.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Gastrointestinal Perforations and Fistulae: 

Serious, and sometimes fatal, gastrointestinal perforation occurred at a higher incidence in patients receiving bevacizumab products vs chemotherapy. The incidence ranged from 0.3% to 3% across clinical studies, with the highest incidence in patients with a history of prior pelvic radiation. Serious fistulae incidence ranged from < 1% to 1.8% across clinical studies, with the highest incidence in patients with cervical cancer. Avoid VEGZELMA in patients with ovarian cancer who have evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction. Discontinue VEGZELMA in patients who develop gastrointestinal perforation, tracheoesophageal fistula, or any Grade 4 fistula. Discontinue in patients with fistula formation involving any internal organ.

Surgery and Wound Healing Complications: 

The incidence of surgery and wound healing complications, including serious and fatal complications, was increased in patients receiving bevacizumab products. In patients who experience wound healing complications during treatment, withhold VEGZELMA until adequate wound healing. Discontinue VEGZELMA in patients who develop necrotizing fasciitis. 

Hemorrhage: 

Severe or fatal hemorrhage occurred up to 5-fold more frequently in patients receiving bevacizumab products vs chemotherapy alone. Discontinue VEGZELMA in patients who develop a Grades 3-4 hemorrhage. 

Arterial Thromboembolic Events: 

Serious, sometimes fatal, arterial thromboembolic events (ATE) occurred at a higher incidence in patients receiving bevacizumab vs chemotherapy. Discontinue VEGZELMA in patients who develop a severe ATE. The safety of reinitiating bevacizumab products after an ATE is resolved is not known. 

Venous Thromboembolic Events: 

An increased risk of venous thromboembolic events (VTE) was observed across clinical studies. Discontinue VEGZELMA in patients with a Grade 4 VTE, including pulmonary embolism. 

Hypertension: 

Severe hypertension occurred at a higher incidence in patients receiving bevacizumab products vs chemotherapy alone. Monitor blood pressure every two to three weeks during treatment with VEGZELMA. Treat with appropriate anti-hypertensive therapy and monitor blood pressure regularly. Discontinue in patients who develop hypertensive crisis or hypertensive encephalopathy. 

Posterior Reversible Encephalopathy Syndrome: 

Posterior reversible encephalopathy syndrome (PRES) was reported in < 0.5% of patients across clinical studies. Discontinue VEGZELMA in patients who develop PRES. 

Renal Injury and Proteinuria: 

The incidence and severity of proteinuria was higher in patients receiving bevacizumab products vs chemotherapy. Nephrotic syndrome occurred in < 1% of patients receiving bevacizumab products across clinical studies, in some instances with fatal outcome. Discontinue VEGZELMA in patients who develop nephrotic syndrome.

Infusion-Related Reactions: 

In clinical studies, infusion-related reactions with the first dose of bevacizumab products occurred in <3% of patients and severe reactions occurred in 0.4% of patients. Decrease the rate of infusion for mild, clinically insignificant infusion-related reactions. Interrupt the infusion in patients with clinically significant infusion-related reactions and consider resuming at a slower rate following resolution. Discontinue VEGZELMA in patients who develop a severe infusion-related reaction and administer appropriate medical therapy. 

Embryo-Fetal Toxicity: 

Bevacizumab products may cause fetal harm when administered to pregnant women. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with VEGZELMA and for 6 months after the last dose. 

Ovarian Failure: 

The incidence of ovarian failure was 34% vs 2% in premenopausal women receiving bevacizumab with chemotherapy vs chemotherapy alone for adjuvant treatment of a solid tumor. Inform females of reproductive potential of the risk of ovarian failure prior to initiating treatment with VEGZELMA. 

Congestive Heart Failure (CHF): 

VEGZELMA is not indicated for use with anthracycline-based chemotherapy. Discontinue VEGZELMA in patients who develop CHF.

MOST COMMON ADVERSE REACTIONS

The most common adverse reactions observed in patients receiving bevacizumab products as a single agent or in combination with other anti-cancer therapies at a rate >10% were epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, hemorrhage, lacrimation disorder, back pain, and exfoliative dermatitis. 

Across clinical studies, bevacizumab was discontinued in 8% to 22% of patients because of adverse reactions. 

ADVERSE REACTIONS BY INDICATION

Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment 

  • Study AVF2107g: Grades 3-4 adverse reactions occurring at higher incidence (≥2%) in patients receiving bevacizumab with IFL (N=392) vs placebo with IFL (N=396) were leukopenia (37% vs 31%), neutropenia (21% vs 14%), diarrhea (34% vs 25%), abdominal pain (8% vs 5%), constipation (4% vs 2%), hypertension (12% vs 2%), deep vein thrombosis (9% vs 5%), intra-abdominal thrombosis (3% vs 1%), syncope (3% vs 1%), asthenia (10% vs 7%), and pain (8% vs 5%) 

Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen 

  • Study E3200: Selected Grades 3-5 (non-hematologic) and Grades 4-5 (hematologic) reactions occurring at a higher incidence (≥2%) in patients receiving bevacizumab with FOLFOX4 (N=521) vs FOLFOX4 alone were fatigue (19% vs 13%), diarrhea (18% vs 13%), sensory neuropathy (17% vs 9%), nausea (12% vs 5%), vomiting (11% vs 4%), dehydration (10% vs 5%), hypertension (9% vs 2%), abdominal pain (8% vs 5%), hemorrhage (5% vs 1%), other neurological (5% vs 3%), ileus (4% vs 1%), and headache (3% vs 0%) 

Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment 

  • Study E4599: Grades 3-5 (non-hematologic) and Grades 4-5 (hematologic) adverse reactions occurring at a higher incidence (≥2%) in patients receiving bevacizumab with paclitaxel and carboplatin (N=422) vs chemotherapy alone were neutropenia (27% vs 17%), fatigue (16% vs 13%), hypertension (8% vs 0.7%), infection without neutropenia (7% vs 3%), venous thromboembolism (5% vs 3%), febrile neutropenia (5% vs 2%), pneumonitis/pulmonary infiltrates (5% vs 3%), infection with Grade 3 or 4 neutropenia (4% vs 2%), hyponatremia (4% vs 1%), headache (3% vs 1%), and proteinuria (3% vs 0%) 

Recurrent glioblastoma in adults

  • Study EORTC 26101: In the bevacizumab with lomustine arm (N=278), 22% of patients discontinued treatment due to adverse reactions vs 10% of patients in the lomustine arm. In patients receiving bevacizumab with lomustine, the adverse reaction profile was similar to that observed in other approved indications

Metastatic renal cell carcinoma in combination with interferon alfa 

  • Study BO17705: Grades 3-5 adverse reactions occurring at a higher incidence (>2%) in patients receiving bevacizumab with interferon alfa (N=337) vs placebo with interferon alfa (N=304) were fatigue (13% vs 8%), asthenia (10% vs 7%), proteinuria (7% vs 0%), hypertension (6% vs 1%; including hypertension and hypertensive crisis), and hemorrhage (3% vs 0.3%; including epistaxis, small intestinal hemorrhage, aneurysm ruptured, gastric ulcer hemorrhage, gingival bleeding, hemoptysis, hemorrhage intracranial, large intestinal hemorrhage, respiratory tract hemorrhage, and traumatic hematoma) 

Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin, or paclitaxel and topotecan 

  • Study GOG-0240: Grades 3-4 adverse reactions occurring at a higher incidence (≥2%) in patients receiving bevacizumab with chemotherapy (N=218) vs chemotherapy alone (N=222) were abdominal pain (12% vs 10%), hypertension (11% vs 0.5%), thrombosis (8% vs 3%), diarrhea (6% vs 3%), anal fistula (4% vs 0%), proctalgia (3% vs 0%), urinary tract infection (8% vs 6%), cellulitis (3% vs 0.5%), fatigue (14% vs 10%), hypokalemia (7% vs 4%), hyponatremia (4% vs 1%), dehydration (4% vs 0.5%), neutropenia (8% vs 4%), lymphopenia (6% vs 3%), back pain (6% vs 3%), and pelvic pain (6% vs 1%) 

Epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by VEGZELMA as a single agent, for stage III or IV disease following initial surgical resection 

  • Study BO17705: Grades 3-4 adverse reactions occurring at a higher incidence (≥2%) in either of the bevacizumab arms (N=608, N=607) vs control arm (N=602) were fatigue (CPB15+ – 9%, CPB15 – 6%, CPP – 6%), hypertension (CPB15+ – 10%, CPB15 – 6%, CPP – 2%), thrombocytopenia (CPB15+ – 21%, CPB15 – 20%, CPP – 15%), and leukopenia (CPB15+ – 51%, CPB15 – 53%, CPP – 50%) 

Epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens 

  • Study MO22224: Grades 3-4 adverse reactions occurring at a higher incidence (≥2%) in patients receiving bevacizumab with chemotherapy (N=179) vs chemotherapy alone (N=181) were hypertension (6.7% vs 1.1%) and palmar-plantar erythrodysaesthesia syndrome (4.5% vs 1.7%) 

Epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by VEGZELMA as a single agent, for platinum-sensitive recurrent disease  

  • Study AVF4095g: Grades 3-4 adverse reactions occurring at a higher incidence (≥2%) in patients receiving bevacizumab with chemotherapy (N=247) vs placebo with chemotherapy (N=233) were thrombocytopenia (40% vs 34%), nausea (4% vs 1.3%), fatigue (6% vs 4%), headache (4% vs 0.9%), proteinuria (10% vs 0.4%), dyspnea (4% vs 1.7%), epistaxis (5% vs 0.4%), and hypertension (17% vs 0.9%) 

You may report side effects by calling Celltrion USA Inc. at 1-800-560-9414, FDA at 1-800-FDA-1088, or visit www.fda.gov/medwatch.

For more information about Vegzelma, see full Prescribing Information.
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