Patients Eligible for the Celltrion
CONNECT® Patient Assistance Program (PAP)
The Celltrion CONNECT Patient Assistance Program (PAP) is designed to provide
free product to qualified individuals who are uninsured. Celltrion CONNECT will help
activate PAP for eligible participants.
To receive PAP benefits, the patient must enroll in the program and meet the
following eligibility requirements:
Patient has no insurance:
Uninsured includes all payor types
The patient must have tried all other insurance options for
coverage. Some examples of other insurance coverage include private
insurance,
HMOs, Medicaid, Medicare, state pharmacy assistance programs, veterans
assistance, and any other social service agency support.
This program excludes patients whose medication is reimbursed in
whole or in
part by any type of government insurance (e.g., Medicare, Medicaid, TRICARE,
or any other federal or state program). Patients who have Medicare Parts A
and B only (no Medicare Part D) are still excluded.
Patient must have a valid prescription from a licensed healthcare provider (HCP) for
an on-label indication.
Patient must have an adjusted annual household income of <400% of the federal
poverty level (FPL).
Income verification:
Electronic income verification (eIV) will be conducted by the
program. No asset review will be required; however, patients will need to
provide proof of income if eIV does not match what the patient has reported
(proof of income could include one of the following: W-2s, tax returns
(1040, 1099), 3 months of pay stubs).
Patient must show proof of residency by providing valid United States or the
Commonwealth of Puerto Rico address, and product must be administered and shipped
to locations in the United States or the Commonwealth of Puerto Rico. Patient must
have lived in the United States or the Commonwealth of Puerto Rico for at least 6
months.
Diagnosis and dosing are consistent with FDA-approved indication for
Vegzelma.
Patients with insurance plans or employers participating in an alternate funding
program (also sometimes referred to as patient advocacy programs, specialty
networks, SHARx, Paydhealth, or PayerMatrix, among other names) are not eligible for
PAP.
These programs require patients to apply to a manufacturer’s PAP
or otherwise pursue specialty drug prescription coverage through an
alternate funding vendor as a condition of, requirement for, or prerequisite
to coverage of relevant products, or that otherwise denies, restricts,
eliminates, delays, alters, or withholds any insurance benefits or coverage
contingent upon application to, or denial of eligibility for, specialty drug
prescription coverage through the alternate funding program.
Patients must promptly contact the Celltrion CONNECT PAP if
their financial status or insurance coverage changes.
Electronic benefits verification (eBV) will be conducted by the program
every 6 months to determine coverage changes.
You may not seek payment for the value of medicines received from this
program from any health plan, patient assistance foundation, flexible spending
account, or healthcare savings account
This program offer may not be used with any other coupon, discount,
prescription savings card, free trial, or other offer. Offer good only in the United
States or the Commonwealth of Puerto Rico. Void where prohibited, taxed, or limited
by law.
Program terms will expire at the end of each calendar year and may
change or end without notice.
Eligibility rules are subject to change at any time.
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%)
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