Access and Support

Together, we got this

Get support and resources to help your patients every step of the way

Your patient with primary immunodeficiency (PI) may have questions regarding cost and coverage.

We are here to help. In this section, we have several resources to help your patient along the insurance journey.

CUVITRU is covered similarly to other treatments for PI, but requirements may vary by plan 

The first question your patients may have is whether their health insurance covers CUVITRU and how much it will cost.

Benefits investigation

benefits investigation can uncover these answers. Call the patient’s health plan on their behalf to determine coverage and out-of-pocket costs. Be sure to have your patient’s full insurance information to get the process started.

Dual Benefit brochure PDF thumbnail.

Download the Dual Benefit Brochure

There are some health plans that cover CUVITRU under the medical benefit, the pharmacy benefit, or both. This dual benefit design can impact how CUVITRU is acquired and reimbursed.

A basic overview and comparison of the 2 benefit designs is detailed here. 

Coverage lookup tool

Use this lookup tool to determine your patient’s coverage information for CUVITRU in your area. Search for local coverage by entering a ZIP code.

Clarify a health plan’s prior authorization requirements and prevent any treatment access delays

Depending on a patient’s medical or prescription drug benefit, you may be required to submit a prior authorization (PA) before your patient can receive treatment with CUVITRU. Each health plan has different requirements, so it’s always good to call and confirm their policy. 

Appeals process

Sometimes PAs do get denied. You and your patient are able to appeal the decision and it’s important to understand why it was denied in the first place. Some common reasons for denial:

  • Missing or inaccurate information
  • Step-edit requirement
  • Incorrect diagnosis code(s) submitted
  • Billed to the wrong benefit (ie, medical vs pharmacy)
  • Site of care for infusion is not preferred/not covered
  • Not covered on the formulary

These resources are at your disposal to support the PA process for CUVITRU 

PA checklist

Be prepared for every PA submission

Appeals checklist

Appealing a denial requires organized paperwork and information

Denials and appeals resource

Understand the appeals and denials process for both pharmacy and medical benefits

Sample letter of medical necessity (LMN)

An LMN supports the PA process by explaining the clinical rationale for CUVITRU

Sample letter of appeal

Each appeal needs to clearly answer the reason for denial and the HCP’s clinical rationale

CUVITRU Prescribing Information

Please click for Full Prescribing Information, including Black Box Warning

Takeda Patient Support* Co-Pay Assistance Program

If a patient is prescribed CUVITRU and needs co-pay assistance, you can direct the patient to enroll in Takeda Patient Support. The co-pay assistance program can cover up to 100% of your patient’s out-of-pocket co-pay costs, if they’re eligible.*† A support specialist can review your patient’s coverage and determine eligibility.

ELIGIBILITY*:

  • Be prescribed CUVITRU for primary immunodeficiency (PI)
  • Have commercial insurance. This includes Health Insurance Marketplace plans
  • See below for terms and conditions.

 

If your patient has government insurance, Takeda Patient Support can help answer questions about their prescribed Takeda treatment coverage. This includes federal or state insurance such as Medicare, Medicare Advantage, or Medicaid.

If your patient can’t afford treatment, Takeda Patient Support may be able to connect them to programs that may help.

Enroll patients today 

Complete the Start Form and fax to 1-855-268-1826.

*Must meet eligibility requirements.

IMPORTANT NOTICE: The Takeda Patient Support Co-Pay Assistance Program (the Program) is not valid for prescriptions eligible to be reimbursed, in whole or in part, by Medicaid, Medicare (including Medicare Part D), Tricare, Medigap, VA, DoD, or other federal or state programs (including any medical or state prescription drug assistance programs). 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. The Program cannot be combined with any other rebate/coupon, free trial, or similar offer. Co-payment assistance under the Program is not transferable.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 patient’s insurance provider. If your patient’s insurance situation changes, they must notify the Program immediately at 1-855-268-1825. Coverage of certain administration charges will not apply for patients residing in states where it is prohibited by law. Takeda reserves the right to rescind, revoke, or amend the Program at any time without notice.

Reimbursement support

CUVITRU offers helpful resources so that your office can sort through the complexities of the reimbursement process. Find downloadable resources and information needed to process billing and diagnostic codes and claim forms.

CUVITRU billing and coding guide

This guide contains information necessary to bill health plans for CUVITRU. This guide contains common administrative and diagnosis codes related to CUVITRU. 

The codes are provided for informational purposes and may not include all necessary codes.

CMS-1500 claim form

The CMS-1500 claim form is the standard claim form used to bill many government and private insurers. This sample is intended to assist you with completing the form for billing CUVITRU and associated services.

Review safety information

Review Important Safety Information, including contraindications and other specific warnings and precautions to consider when prescribing and monitoring patients treated with CUVITRU.

Patient resources

HelloCUVITRU logo.

HelloCUVITRU Free Trial Program

Learn if CUVITRU is right for your patients with the HelloCUVITRU Free Trial Program.

This free trial offer is solely intended to allow new patients to try CUVITRU and help determine, along with their HCP, if it is right for them.

With the HelloCUVITRU program, the entire cost of their first 4 infusions of CUVITRU, along with ancillary supplies, pump, and administration are all covered.

Get your eligible* patients started today by following the process below.

1

Download and complete

Download and complete the HelloCUVITRU Free Trial Request Form (see link below) and fax to 866-861-1752.

HCP can check a box on the form if they want to have the pharmacist determine ramp-up dosing.

Please note that the pharmacist will call the HCP’s office to clarify ramp-up dosing if it is not written or the box isn’t checked.

2

Receive a welcome call

Patients will receive a welcome call from a HelloCUVITRU Free Trial Case Manager.

The Case Manager will:

  • Ensure that the patient has signed the HelloCUVITRU Free Trial Request Form
  • Connect the patient with the specialty pharmacy that will coordinate medication shipment
  • Connect the patient with a nurse who will help schedule administration training

3

Begin CUVITRU treatment

The patient will receive their CUVITRU infusions either at home or in the office, depending on what you choose. After completion of the program, communication will be sent to the physician documenting the infusion rate and patient training.

*Eligible patients must have an ICD-10 code verifying diagnosis of PI, be a new patient not currently using CUVITRU, and not have previously enrolled in the HelloCUVITRU Program. Additional terms apply.

There is no obligation for the patient to continue use of CUVITRU after the free trial has been completed. HelloCUVITRU is not meant to induce or require future or continuing prescriptions of CUVITRU.

HelloCUVITRU Free Trial Request Form

See how CUVITRU is administered

tru1 logo.

Get organized

tru2 logo.

Prep and draw CUVITRU

tru3 logo.

Start infusion

tru4 logo.

Remove needle(s) and wrap up

The infusion process is broken up into four sections to help make it easier for you to remember. You may remember the “ABCs to infuse.” TRU4 replaces those! Why? Because we wanted to get more descriptive with the sections to make the process easier to remember. Learn more on our FAQ page.

Watch the video to learn more about CUVITRU administration

Find comprehensive resources that provide support for your patients. 

Explore comprehensive resources for your patients to help support them with their CUVITRU treatment.

Why CUVITRU brochure

Help patients learn if CUVITRU is right for them, while encouraging them to take the next step in their treatment journey.

Why CUVITRU brochure PDF thumbnail.

Patient Starter Kit 

The CUVITRU Patient Starter Kit contains educational resources and materials to help facilitate their PI treatment.

To order starter kits, contact your specialty pharmacy or visit TakedaPatientSupport.com.

Step-by-Step Infusion Guide

If your patient needs to learn how to infuse CUVITRU using a syringe driver pump, this step-by-step guide helps you walk them through all the necessary steps.

Step-by-Step Infusion Guide PDF thumbnail.
MyIgSource logo.

Find strong community support and educational
resources for your patients with PI

Support from the start with resources throughout their journey

MyIgSource is committed to helping your patients manage a life with primary immunodeficiency at diagnosis and throughout their PI journey. From advocacy to learning about diagnosis, management, and living with PI, your patients and their caregivers, regardless of treatment, have access to:

  1. Learn more about PI and managing their condition
  2. Sign up to receive educational materials that can help them, and their loved ones, better understand PI
  3. Connect by phone or online with patient advocates that have PI or have loved ones living with the condition
  4. Register for events focusing on disease education related to PI

Have your patients connect at
MyIgSource.com or call 1-855-250-5111.

For patients prescribed CUVITRU, Takeda Patient Support is here for them

Welcome to Takeda Patient Support

When your patient enrolls, we’re here to help them gain access to their prescribed Takeda medication. Our dedicated specialists provide several services, including:

  • Benefits investigation to help determine your patient’s insurance benefits
  • Prior authorization (PA), reauthorization, and appeals information in coordination with your patient’s insurance company to determine any requirements
  • Financial assistance options including the Takeda Patient Support Co-Pay Assistance Program. The program may cover up to 100% of your patient’s out-of-pocket co-pay costs, if they’re eligible
  • Education and training about their prescribed Takeda treatment or condition from nursing professionals. Our nurses cannot provide medical advice
  • Specialty pharmacy triage and coordination, and more*

If English is not your patient’s preferred language, we can assist them in a language of their choosing.

*If your patients’ medication is dispensed by specialty pharmacy.

Must meet eligibility requirements. IMPORTANT NOTICE: The Takeda Patient Support Co-Pay Assistance Program (the Program) is not valid for prescriptions eligible to be reimbursed, in whole or in part, by Medicaid, Medicare (including Medicare Part D), Tricare, Medigap, VA, DoD, or other federal or state programs (including any medical or state prescription drug assistance programs). 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. The Program cannot be combined with any other rebate/coupon, free trial, or similar offer. Copayment assistance under the Program is not transferable. 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 patient’s insurance provider. If your patient’s insurance situation changes, they must notify the Program immediately at 1-866-861-1750. Coverage of certain administration charges will not apply for patients residing in states where it is prohibited by law. Takeda reserves the right to rescind, revoke, or amend the Program at any time without notice.

TAKEDA Patient Support for CUVITRU® logo.

Need to enroll your patient?

Visit our convenient online enrollment portal at TakedaPatientSupport.com/hcp/
cuvitru/enroll_your_patient
. You can also enroll your patient by faxing the completed Start Form to 1-866-861-1752.