For adults with moderately to severely active ulcerative colitis and Crohn’s disease

Indications

Adult Ulcerative Colitis (UC) ENTYVIO (vedolizumab) is indicated in adult patients with moderately to severely active UC who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids for inducing and maintaining clinical response, inducing and maintaining clinical remission, improving endoscopic appearance of the mucosa, and achieving corticosteroid‐free remission.
Adult Crohn’s Disease (CD) ENTYVIO (vedolizumab) is indicated in adult patients with moderately to severely active CD who have had an inadequate response with, lost response to, or were intolerant to a TNF blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids for achieving clinical response, achieving clinical remission, and achieving corticosteroid‐free remission.

Entyvio Connect

Entyvio is covered by 99%* of commercial insurance plans3†

Entyvio Connect can work with you on a payer-by-payer basis to help you navigate patient coverage.

  • 92.2% of benefits investigations conducted by Entyvio Connect have identified patient coverage for Entyvio3‡
Size of insured population does not imply disease prevalence or appropriate population for treatment with Entyvio. Coverage status is subject to change without notice.
*
55% covered, 35% covered with 1 step, 9% covered with 2 steps.
As of October 31, 2016.
Benefits Investigations December 9, 2015 through December 9, 2016.

Entyvio access is supported through Entyvio Connect

Insurance verification support

Case managers work directly with insurers to help verify patient coverage and out-of-pocket (OOP) costs for Entyvio.

Prior authorization (PA) and appeals support

Case managers can identify plan-specific PA requirements to help your office obtain authorization before treatment.

Patient financial assistance

Case managers help provide financial assistance options for eligible patients and help enroll patients into appropriate programs.

Billing and coding support

Case managers respond with timely answers to billing and coding questions, helping to facilitate claims submissions.

Out-of-pocket (OOP) support

Patient Coverage Entyvio Connect Support
Commercial insurance Co-pay assistance program
PPO or HMO through an employer or insurance carrier
  • If eligible, patient pays no more than $5 per infusion every 8 weeks, up to a total of $20,000 per year (terms and conditions apply)*
  • To enroll patients in the co-pay assistance program, download the form here
Government insurance Independent co-pay foundation support
Medicare or Medicaid An Entyvio Connect case manager will help you or your patient understand their benefits and may refer them to an independent patient support foundation for possible assistance with OOP costs
No insurance Patient assistance program (PAP)
No insurance coverage, unemployed, or in need of additional assistance An Entyvio Connect case manager can assist with alternate funding support or PAP options
Patient Coverage
Commercial insurance
PPO or HMO through an employer or insurance carrier
Government insurance
Medicare or Medicaid
No insurance
No insurance coverage, unemployed, or in need of additional assistance
Entyvio Connect Support
Co-pay assistance program
  • If eligible, patient pays no more than $5 per infusion every 8 weeks, up to a total of $20,000 per year (terms and conditions apply)*
  • To enroll patients in the co-pay assistance program, download the form below
Independent co-pay foundation support
An Entyvio Connect case manager will help you or your patient understand their benefits and may refer them to an independent patient support foundation for possible assistance with OOP costs
Patient assistance program (PAP)
An Entyvio Connect case manager can assist with alternate funding support or PAP options
*
Eligibility Requirements: This offer cannot be used if the patient is a beneficiary of, or any part of his or her prescription is covered by: (1) any federal or state healthcare program (Medicare, Medicaid, TriCARE, etc.), including a state pharmaceutical assistance program, (2) the Medicare Prescription Drug Program (Part D), or if the patient is currently in the coverage gap, or (3) insurance that is paying the entire cost of the prescription.
Your office is directly reimbursed for remaining patient co-pay upon submission of EOB from patient’s primary insurance.

Enroll a patient in coverage and co-pay support

Enroll your patient
Healthcare provider (HCP) faxes completed and signed Benefit Investigation Enrollment Form and Patient Authorization and Co-pay Consent Form to Entyvio Connect at 1-877-488-6814
Entyvio Connect verifies coverage
Entyvio Connect verifies the patient’s insurance coverage and sends a summary of benefits to the provider. Eligible patients are automatically enrolled in the Co-pay Assistance Program. Entyvio Connect then gives the patient a welcome call to explain coverage details
Administer Entyvio
Patient receives Entyvio at the HCP’s office or alternate infusion site
Submit
claim(s)
HCP submits claim to insurance provider. Upon receipt of explanation of benefits (EOB), provider submits claim and EOB to the Entyvio Connect Co-Pay Assistance Program§||
If your office does not want the patient to be contacted, select this option on the enrollment form.
§
Your office submits a claim after each infusion and is directly reimbursed for remaining patient co-pay upon submission of EOB from patient’s primary insurance.
||
A W-9 form is required the first time an office requests reimbursement under the Co-pay Assistance Program or if your office has had an address change.

Enroll a patient in co-pay assistance only

Complete and submit enrollment form
Complete and submit Entyvio Connect Co-Pay Assistance-Only Enrollment Form to Entyvio Connect.
Patient and provider notified of co-pay enrollment
Both you and your patient will receive a co-pay Welcome Letter with all the program enrollment details, including co-pay ID number and expiration date. You will also receive co-pay specific reimbursement instructions to guide you through program reimbursement.
Entyvio payment
Your patient receives Entyvio and pays the co-pay. By enrolling in the Co-Pay Assistance Program, your patient will pay no more than $5 per infusion.#
If this is your office’s first time requesting reimbursement in this program or your office has had an address change, please submit a W-9 form along with the enrollment forms.
#
If your patient’s Entyvio prescription is covered as a pharmacy benefit or will be shipped to your office by a specialty pharmacy (SP), provide the SP with your patient’s co-pay program enrollment details and the Entyvio Connect contact phone number.

Questions? Call 1-855 ENTYVIO (1-855-368-9846)

Call Monday to Friday, from 8 AM to 8 PM EST (except holidays) to speak to an Entyvio Connect case manager today.

Entyvio Connect FAQs

How does a patient know if he or she is eligible?

A: The Entyvio Connect Co-Pay Assistance Program is open to patients who meet the following main criteria:

  • Patient’s HCP has determined that Entyvio is appropriate for him or her
  • He or she currently has commercial health insurance that covers Entyvio
  • He or she is not a participant in Medicare, Medicaid, or another federal- or state-funded healthcare program

To determine if he or she meets eligibility requirements or for more information, patients can call 1-855 ENTYVIO (1-855-368-9846), Monday to Friday, from 8 AM to 8 PM EST (except holidays).

What if the patient is not insured?

A: If a patient does not have insurance, he or she may be eligible for financial assistance through Takeda’s patient assistance program. Call 1-855 ENTYVIO (1-855-368-9846) for more information.

Does Entyvio Connect offer co-pay assistance for patients who have government-funded insurance?

A: While patients with government-funded insurance, such as Medicaid and Medicare, are not eligible for co-pay assistance, they may be referred to a patient support foundation to determine if they are eligible for financial assistance. Call 1-855 ENTYVIO (1-855-368-9846) for more information.

Where and for how long is the Entyvio Connect Co-Pay Assistance Program valid?

A: Once qualified, the co-pay assistance program is valid for one year:

  • Eligible patients may re-enroll annually throughout the existence of the program
  • The program is still valid if a patient switches providers. Patients must inform Entyvio Connect if this happens by calling 1-855 ENTYVIO (1-855-368-9846).

Is there a cap or limit on the Entyvio Connect Co-Pay Assistance Program?

A: Yes. For eligible patients, the program covers a maximum benefit of up to $20,000 for a 12-month period. The maximum benefit then simply restarts on the first day of a new 12-month period after re-enrollment.

What if Entyvio Connect did not receive my patient’s co-pay authorization form?

A: No problem. Patients can call Entyvio Connect at 1-855 ENTYVIO (1-855-368-9846) and a case manager will help them enroll.

IMPORTANT SAFETY INFORMATION

Expand
  • ENTYVIO (vedolizumab) for injection is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients.
  • Infusion‐related reactions and hypersensitivity reactions including anaphylaxis have occurred. Allergic reactions including dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate have also been observed. If anaphylaxis or other serious allergic reactions occur, discontinue administration of ENTYVIO immediately and initiate appropriate treatment.
  • Patients treated with ENTYVIO are at increased risk for developing infections. Serious infections have been reported in patients treated with ENTYVIO, including anal abscess, sepsis (some fatal), tuberculosis, salmonella sepsis, Listeria meningitis, giardiasis, and cytomegaloviral colitis. ENTYVIO is not recommended in patients with active, severe infections until the infections are controlled. Consider withholding ENTYVIO in patients who develop a severe infection while on treatment with ENTYVIO. Exercise caution in patients with a history of recurring severe infections. Consider screening for tuberculosis (TB) according to the local practice.
  • Although no cases of PML have been observed in ENTYVIO clinical trials, JC virus infection resulting in progressive multifocal leukoencephalopathy (PML) and death has occurred in patients treated with another integrin receptor antagonist. A risk of PML cannot be ruled out. Monitor patients for any new or worsening neurological signs or symptoms. Typical signs and symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. If PML is suspected, withhold dosing with ENTYVIO and refer to a neurologist; if confirmed, discontinue ENTYVIO dosing permanently.
  • There have been reports of elevations of transaminase and/or bilirubin in patients receiving ENTYVIO. ENTYVIO should be discontinued in patients with jaundice or other evidence of significant liver injury.
  • Prior to initiating treatment with ENTYVIO, all patients should be brought up to date with all immunizations according to current immunization guidelines. Patients receiving ENTYVIO may receive non‐live vaccines and may receive live vaccines if the benefits outweigh the risks.
  • Most common adverse reactions (incidence ≥3% and ≥1% higher than placebo): nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, and pain in extremities.

Indications

Adult Ulcerative Colitis (UC)

ENTYVIO (vedolizumab) is indicated in adult patients with moderately to severely active UC who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids for inducing and maintaining clinical response, inducing and maintaining clinical remission, improving endoscopic appearance of the mucosa, and achieving corticosteroid‐free remission.

Adult Crohn’s Disease (CD)

ENTYVIO (vedolizumab) is indicated in adult patients with moderately to severely active CD who have had an inadequate response with, lost response to, or were intolerant to a TNF blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids for achieving clinical response, achieving clinical remission, and achieving corticosteroid‐free remission.

Please see full Prescribing Information, including Medication Guide.

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