Takeda Patient Support | VPRIV® (velaglucerase alfa) for injection

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TAKEDA SUPPORT PROGRAMS

VPRIV can provide personalized product support through the different stages of your patients’ lives

Takeda Patient Support is designed for patients who have been prescribed VPRIV (velaglucerase alfa) and their caregivers. If English is not your patient’s preferred language, a support specialist can also communicate over the phone in a variety of languages—including Spanish, Yiddish, and more—using a translation service.

When you prescribe VPRIV (velaglucerase alfa) for your patient, Takeda Patient Support is here for them. Our support specialists can help with your patient’s questions and concerns, and provide them with the information they need.

For onboarding, access, and reimbursement assistance, some of our services may include:

Benefits investigation to help determine your patient’s insurance benefits and eligibility for certain services
Prior authorization (PA), reauthorization, and appeals information
Enrolling your patient in the Takeda Patient Support Co-Pay Assistance Program if they qualify*
Information about financial assistance options for your patient, if they’re eligible

Our additional services include:

Specialty pharmacy or site of care triage and coordination
Directing your patient to community support resources
Assistance during life transitions like relocation, moving to college, or changing jobs, and insurance changes
Coordination between your patient’s specialty pharmacy and your site of care, even if they are traveling out of town or relocating

To learn more about Takeda Patient Support, visit: www.TakedaPatientSupport.com/hcp

TO START YOUR PATIENTS ON VPRIV:

Complete a VPRIV Start Form via the portal or download one and fill it in with your patients
Our support specialists are never more than a tap or a call away

1-866-888-0660, Monday through Friday,
8:30 am to 8:00 pm ET

The Takeda Patient Support Co-Pay Assistance Program may help your patients save on their prescribed Takeda treatment.*

The program can cover up to 100% of your patient’s out-of-pocket co-pay costs, if they’re eligible.

*To be eligible, the patient must be enrolled in Takeda Patient Support, and have commercial insurance. Other terms and conditions apply. Call for more details.

IMPORTANT NOTICE: Takeda’s Co-pay Assistance Program ("the Program") provides financial support for commercially insured patients who qualify for the Program. Participation in the Program and provision of financial support is subject to all Program terms and conditions, including but not limited to eligibility requirements, the Program maximum benefit per claim and the annual calendar year Program maximum (“Annual Program Maximum”). The Annual Program Maximum for your prescribed Takeda product can be found by visiting: https://www.TakedaPatientSupport.com/copay

By enrolling in the Program, you agree that the Program is intended solely for the benefit of you—not health plans and/or their partners. Further, you agree to comply with all applicable requirements of your health plan. The Program cannot be used if the patient is a beneficiary of, or any part of the prescription is covered by: 1) any federal, state, or government-funded healthcare program (Medicare, Medicare Advantage, Medicaid, TRICARE, etc.), including a state pharmaceutical assistance program (the Federal Employees Health Benefit (FEHB) Program is not a government-funded healthcare program for the purpose of this offer), 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. No claim for reimbursement of the out-of-pocket expense amount covered by the Program shall be submitted to any third-party payer, whether public or private.

Some health plans have established programs referred to as ‘co-pay maximizer’ programs. A co-pay maximizer program is one in which the amount of a patient’s out-of-pocket costs is adjusted to reflect the availability of support offered by a manufacturer’s co-pay assistance program. If you are enrolled in a co-pay maximizer program, your Annual Program Maximum may vary over time to ensure the program funds are used for your benefit (for the benefit of the patient). Takeda also reserves the right to reduce or eliminate the co-pay assistance available to patients enrolled in an insurance plan that utilizes a co-pay maximizer program.

If you learn your health plan has implemented a co-pay maximizer program, you agree to notify the Program immediately by calling 1-866-888-0660. It may be possible that you are unaware whether you are subject to a co-pay maximizer program when you enroll or re-enroll in the Program. Takeda will monitor program utilization data and reserves the right to discontinue assistance under the Program at any time if Takeda determines that you are subject to a co-pay maximizer, or similar program.

The Program only applies in the United States, including Puerto Rico and other U.S. territories, and does not apply where prohibited by law, taxed, or restricted. This does not constitute health insurance. Void where use is prohibited by your insurance provider. If your insurance situation changes you must notify the Program immediately at 1-866-888-0660. Coverage of certain administration charges will not apply for patients residing in states where it is prohibited by law.

This Program offer is not transferable and is limited to one offer per person and may not be combined with any other coupon, discount, prescription savings card, rebate, free trial, patient assistance, co-pay maximizer, alternative funding program, co-pay accumulator, or other offer, including those from third parties and companies that help insurers or health plan manage costs. Not valid if reproduced.

By utilizing the Program, you hereby accept and agree to abide by these terms and conditions. Any individual or entity who enrolls or assists in the enrollment of a patient in the Program represents that the patient meets the eligibility criteria and other requirements described herein. You must meet the Program eligibility requirements every time you use the Program. Takeda reserves the right to rescind, revoke, or amend the Program at any time without notice, and other terms and conditions may apply.

For more information, please contact Takeda Patient Support — 1-866-888-0660, Monday through Friday, 8:30 am to 8:00 pm ET — or visit www.TakedaPatientSupport.com/hcp.

Streamline Treatment Initiation

Eligible patients can receive their infusion while their prior authorization is still being reviewed.

Some insurance plans may require additional paperwork, called a prior authorization, before treatment can be initiated, which can cause delays
QuickStart allows eligible patients to receive up to two free VPRIV infusions while the prior authorization is still being reviewed
Additional terms and conditions apply

TO BE ELIGIBLE FOR QUICKSTART, PATIENTS MUST BE ENROLLED IN Takeda Patient Support:

Complete a VPRIV Start Form via the portal or download the form here. When filling in the Start Form with your patients, check mark the QuickStart box in Section 6 to enroll your patients in the QuickStart program

Expedite Infusion Preparation

Expedite infusion preparation with PreppedAhead so your patient can save time before their infusions:

VPRIV is a 60-minute infusion, administered once every other week¹
It takes a site of care time to prepare this infusion for patients
PreppedAhead provides patients with the option of having the infusion center prepare the treatment before they arrive to save time
PreppedAhead is only available to eligible patients enrolled in Takeda Patient Support, and whose site of care is enrolled in the PreppedAhead program

TO ENROLL YOUR PATIENTS IN THE PREPPEDAHEAD PROGRAM:

Download and complete the sign-up form

VPRIV BILLING & REIMBURSEMENT

Billing and reimbursement for VPRIV require appropriate codes.

Completing forms with the appropriate codes is a necessary part of the billing and reimbursement process, and is the responsibility of the healthcare providers who are administering VPRIV.

Download the coding guide for
more information

IMPORTANT SAFETY INFORMATION

WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS

Patients treated with enzyme replacement therapies have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy.

Initiate VPRIV in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment.

INDICATION

VPRIV® (velaglucerase alfa) for injection is indicated for long-term enzyme replacement therapy (ERT) for patients with type 1 Gaucher disease.

IMPORTANT SAFETY INFORMATION

WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS

Initiate VPRIV in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment.

If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue VPRIV and immediately initiate appropriate medical treatment, including use of epinephrine. Inform patients of the symptoms of life-threatening hypersensitivity reactions, including anaphylaxis and to seek immediate medical care should symptoms occur.

Life-threatening hypersensitivity reactions, including anaphylaxis, have occurred in patients treated with enzyme replacement therapies, including VPRIV. VPRIV-treated patients have had these reactions occur in clinical studies and postmarketing experience.

Hypersensitivity reactions were the most commonly observed adverse reactions in patients treated with VPRIV in clinical studies. Patients were not routinely pre-medicated prior to infusion of VPRIV. The most commonly observed symptoms of hypersensitivity reactions were: headache, dizziness, hypotension, hypertension, nausea, fatigue/asthenia, and pyrexia. Hypersensitivity reactions in the clinical trials include any event considered related to and occurring within up to 24 hours of VPRIV infusion, including one case of anaphylaxis. Generally the reactions were mild and, in treatment-naïve patients, onset occurred mostly during the first 6 months of treatment and tended to occur less frequently with time. Additional hypersensitivity reactions of chest discomfort, dyspnea, pruritus and vomiting have been reported in post-marketing experience. In some cases vomiting can be serious, requiring hospitalization and/or drug discontinuation.

Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. Administration of VPRIV should be supervised by a healthcare provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis. Initiate VPRIV in a healthcare setting with appropriate medical monitoring and support measures including access to cardiopulmonary resuscitation equipment.

Management of hypersensitivity reactions should be based on severity of the reaction, such as slowing the infusion rate, treatment with medications such as antihistamines, antipyretics and/or corticosteroids, and/or stopping and resuming treatment with increased infusion time. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue VPRIV and immediately initiate appropriate medical treatment, including use of epinephrine. In cases where patients have exhibited symptoms of hypersensitivity to velaglucerase alfa or excipients in the drug product or to other enzyme replacement therapy, pre-treatment with antihistamines and/or corticosteroids may prevent subsequent reactions. Inform patients of the symptoms of life-threatening hypersensitivity reactions, including anaphylaxis and to seek immediate medical care should symptoms occur.

The most common adverse reactions during clinical studies (in ≥10% of patients) were hypersensitivity reactions, headache, dizziness, abdominal pain, nausea, back pain, joint pain, prolonged activated partial thromboplastin time (aPTT), fatigue/asthenia, and pyrexia. In clinical studies, the overall frequency of adverse events was generally higher in the population naïve to enzyme replacement therapy (ERT) than in the population switched from imiglucerase to VPRIV.

The safety and efficacy profiles were similar in pediatric (ages 4 to 17) and adult patients. The safety of VPRIV has not been established in patients under 4 years of age. Adverse reactions more commonly seen in pediatric patients compared to adult patients include (>10% difference): rash, prolonged aPTT, and pyrexia. The adverse reaction profile in elderly patients was consistent with that previously observed across pediatric and adult patients. In general, dose selection for an elderly patient should be approached cautiously, considering comorbid conditions.

As with all therapeutic proteins, there is a potential for immunogenicity. In clinical studies, 1 of 54 (2%) enzyme treatment-naïve patients treated with VPRIV developed IgG class antibodies (neutralizing in an in vitro assay). One additional patient developed IgG antibodies to VPRIV during an extension study. It is unknown if the presence of IgG antibodies to VPRIV is associated with a higher risk of infusion reactions. Patients with an immune response to other ERTs who are switching to VPRIV should continue to be monitored for antibodies to VPRIV.

To report SUSPECTED ADVERSE REACTIONS, contact Medical Information at 1-866-888-0660, option 2 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please click here for Full Prescribing Information, including Boxed WARNING for Risk of Anaphylaxis.

For more information, contact Takeda at 1-877-TAKEDA-7 (1-877-825-3327), or by email at medinfous@takeda.com