The PADCEV Copay Assistance Program a is for eligible patients who have private commercial health insurance and are not insured by any federal or state healthcare program. The PADCEV Patient Assistance Program a provides PADCEV ® (enfortumab vedotin-ejfv) at no cost to uninsured patients who meet the program eligibility requirements.
Full Answer
When was enfortumab vedotin approved by the FDA?
FDA granted accelerated approval in December 2019 to enfortumab vedotin-ejfv for patients with locally advanced or metastatic urothelial cancer who have received a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.
What is enfortumab-vedotin?
Drug Type: Enfortumab-vedotin is an anti-cancer chemotherapy drug. This medication is classified as a monoclonal antibody, antineoplastic agent, anti-Nectin-4, and antibody conjugate (for more detail see, "How enfortumab-vedotin Works" below). What Enfortumab-Vedotin Is Used For
How much enfortumab-vedotin will I need to take?
The amount of enfortumab-vedotin that you will receive depends on many factors, including your height and weight, your general health or other health problems, and the type of cancer or condition you have. Your doctor will determine your exact dosage and schedule. Important things to remember about the side effects of enfortumab-vedotin:
PADCEV Patient Assistance Program
The PADCEV Patient Assistance Program a (PAP) provides PADCEV ® (enfortumab vedotin-ejfv) at no cost to uninsured patients who meet the program eligibility requirements.
Eligibility Requirements
PADCEV Support Solutions can evaluate whether you are eligible for the PAP program. For more information, contact us at 1‑888‑402‑0627. We are available Monday–Friday, 8:30 am–8:00 pm ET.
Application Process
Your healthcare provider can start the application process by submitting the PAP application, which includes the necessary information so that PADCEV Support Solutions can assess your eligibility for the PAP Program.
Who is eligible for PADCEV?
Patients who have private commercial health insurance and are not insured by any federal or state healthcare program may be eligible for the PADCEV Copay Assistance Program.*
What is PADCEV used for?
PADCEV is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who: 1 have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and platinum-containing chemotherapy, or 2 are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.
How long after PADCEV can you have extravasation?
Reactions may be delayed. Erythema, swelling, increased temperature, and pain worsened until 2-7 days after extravasation and resolved within 1-4 weeks of peak. Two patients (0.3%) developed extravasation reactions with secondary cellulitis, bullae, or exfoliation. Ensure adequate venous access prior to starting PADCEV and monitor for possible extravasation during administration. If extravasation occurs, stop the infusion and monitor for adverse reactions.
What is Patient Connect?
Patient Connect provides patients who have been prescribed PADCEV and their caregivers with information about various independent local and national organizations that may provide emotional, logistical, and informational support. †
How long does it take for a patient to develop pneumonitis?
In clinical trials, the median time to onset of pneumonitis was 2.9 months (range: 0.6 to 6). Monitor patients for signs and symptoms indicative of pneumonitis, such as hypoxia, cough, dyspnea or interstitial infiltrates on radiologic exams. Evaluate and exclude infectious, neoplastic and other causes for such signs and symptoms through appropriate investigations. Withhold PADCEV for patients who develop persistent or recurrent Grade 2 pneumonitis and consider dose reduction. Permanently discontinue PADCEV in all patients with Grade 3 or 4 pneumonitis.
What happens when you enroll in PADCEV?
Once enrolled in PADCEV Support Solutions, your patients will have access to the full range of support offered. See below for information about how to enroll a patient.
Does PADCEV require a prior authorization?
If the patient’s insurer requires a prior authorization (PA) before PADCEV will be covered, PADCEV Support Solutions can obtain the appropriate PA form for completion by the prescriber’s office.
What is Padcev used for?
Padcev (enfortumab vedotin) is a member of the miscellaneous antineoplastics drug class and is commonly used for Urothelial Carcinoma.
How much does a free drug card save?
The free Drugs.com Discount Card works like a coupon and can save you up to 80% or more off the cost of prescription medicines, over-the-counter drugs and pet prescriptions.
How to report PADCEV side effects?
These are not all the possible side effects of PADCEV. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Please see full Prescribing Information/Patient Information for more information, including risk of Serious Side Effects.
How much does PADCEV cost?
Under the program, eligible patients may save up to a maximum of $25,000 per calendar year. There are no income requirements. 1
What is PADCEV copay?
The PADCEV Copay Assistance Program is for eligible patients who have private commercial health insurance and are not insured by any federal or state healthcare program. Eligible patients pay as little as $5 per dose and are enrolled in the program for 12 months. Under the program, eligible patients may save up to a maximum of $25,000 per calendar year. There are no income requirements. a
What insurance is required for a PADCEV?
1 In order to participate in the PADCEV Copay Assistance Program (“Program”), a patient must have private commercial insurance for PADCEV. The Program is not valid for patients insured by any federal or state healthcare program, including, but not limited to, Medicaid, Medicare, Medigap, Department of Defense (DoD), Veterans Affairs (VA), TRICARE, Puerto Rico Government Insurance, or any state patients or pharmaceutical assistance program. This offer is not valid for cash-paying patients. This Program is void where prohibited by law. Astellas reserves the right to revoke, rescind, or amend this offer without notice. The Program benefits are nontransferable. This Program is not conditioned on any past, present, or future purchase, including additional doses. The benefit available under this Program is valid only for the patient’s out-of-pocket medication costs for PADCEV. The benefit is not valid for any other out-of-pocket costs such as medication administration charges or other healthcare provider services. The Program is Not Insurance.
What is a padcov?
PADCEV is a prescription medicine used to treat adults with bladder cancer and cancers of the urinary tract (renal pelvis, ureter or urethra) that has spread or cannot be removed by surgery. PADCEV may be used if you:
How long does it take for a PADCEV to cause a skin reaction?
Most severe skin reactions occurred during the first cycle (28 days) of treatment but may happen later. Your healthcare provider will monitor you during treatment and may prescribe medicines if you get skin reactions. Tell your healthcare provider right away if you develop any of these signs of a new or worsening skin reaction:
What is a C support?
c Support is provided through third-party organizations that operate independently and are not controlled or endorsed by Astellas or Seagen. Availability of support and eligibility requirements are determined by these organizations.
Warning
Severe skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis) have happened with this drug. These can cause severe health problems that may not go away, and sometimes death. Most of the time, skin reactions happened during the first 28 days of treatment but may happen later.
What do I need to tell my doctor BEFORE I take this drug?
If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
What are some things I need to know or do while I take this drug?
Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
What are some other side effects of this drug?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
How is this drug best taken?
Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
General drug facts
If your symptoms or health problems do not get better or if they become worse, call your doctor.
When was Enfortumab approved?
On July 9, 2021, the Food and Drug Administration approved enfortumab vedotin-ejfv (Padcev, Astellas Pharma US, Inc.), a Nectin-4-directed antibody and microtubule inhibitor conjugate, for adult patients with locally advanced or metastatic urothelial cancer who. have previously received a programmed death receptor-1 ...
How to report adverse events to the FDA?
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.
Is Enfortumab a PD inhibitor?
FDA granted accelerated approval in December 2019 to enfortumab vedotin-ejfv for patients with locally advanced or metastatic urothelial cancer who have received a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy in ...
How is enfortumab given?
How Enfortumab-Vedotin Is Given. As a short infusion through the vein ( intravenous, IV) The amount of enfortumab-vedotin that you will receive depends on many factors, including your height and weight, your general health or other health problems, and the type of cancer or condition you have. Your doctor will determine your exact dosage ...
What happens when enfortumab-vedotin binds to Nectin?
This disruption stops the cell from dividing and copying itself, which ultimately leads to cell death.
How long after enfortumab do you breastfeed?
Do not breast feed while taking enfortumab-vedotin and for at least 3 weeks after the last enfortumab-vedotin dose.
What is the trade name for Padcev?
Trade Name: Padcev®. Enfortumab-vedotin is the generic name for the trade name drug Padcev®. In some cases, health care professional may use the trade name Padcev® when referring to the generic drug name enfortumab-vedotin. Drug Type: Enfortumab-vedotin is an anti-cancer chemotherapy drug. This medication is classified as a monoclonal antibody, ...
How to reduce nausea?
To reduce nausea, take anti-nausea medications as prescribed by your doctor, and eat small, frequent meals.
What is targeted therapy?
Targeted therapy is about identifying other features of cancer cells. Scientists look for specific differences in the cancer cells and the normal cells. This information is used to create a targeted therapy to attack the cancer cells without damaging the normal cells, thus leading to fewer side effects. Each type of targeted therapy works a bit differently, but all interfere with the ability of the cancer cell to grow, divide, repair and/or communicate with other cells.
What are the side effects of enfortumab?
The following side effects are common (occurring in greater than 30%) for patients taking enfortumab-vedotin: Low blood counts. Your white and red blood cells and platelets may temporarily decrease. This can put you at increased risk for infection, anemia and/or bleeding. Hair loss.
