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Frequently Asked Questions

About Hizentra: Proven Efficacy and Safety

How effective is Hizentra at reducing infections in patients with PI?

Hizentra provides proven protection against infection, with over 70,000 patient-years of experience.3 In the US clinical trial,* the annual rate of serious bacterial infections (SBIs) was 0 per subject year, while the annual rate of any types of infections was 2.76 per subject year. This means that patients did not experience any serious infections (eg, bacterial pneumonia, sepsis, osteomyelitis, visceral abscess). On average, patients had fewer than 3 infections of any type per year.

In the long-term (1.7 years) extension study, Hizentra was demonstrated to provide safe, sustained, effective protection from infections. In this study, there were zero reported serious bacterial infections (per subject year, annualized rate), zero treatment-related serious adverse events, and zero subjects who discontinued because of treatment-related adverse events.

*Demonstrated in patients 2–65 years of age and older in the 12-month US phase 3 trial with Hizentra weekly. Hizentra was initiated at a weekly dose of 153% of the previous IVIg dose in the US study. Serious bacterial infections were defined as bacterial pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. During the US extension study, 2 SBIs (bacterial pneumonia) in 2 subjects were reported, giving an annualized rate of 0.06 infections per subject. Serious bacterial infections were defined as bacterial pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess.

What were the adverse reactions in the clinical trials of Hizentra and what adverse reactions can my patient expect from an infusion with Hizentra?

In the US clinical study, the most common adverse reactions (observed in 5% or more of study subjects receiving Hizentra) were local reactions (ie, swelling, redness, heat, pain, and itching at the injection site), headache, diarrhea, fatigue, back pain, nausea, extremity pain, cough, rash, pruritus, vomiting, upper abdominal pain, migraine and pain.

Local reactions were mostly mild (93.4%) or moderate (6.3%). Because Hizentra is infused under skin, local reactions are common and expected. Symptoms can include edema, erythema, local heat, local pain, and itching. Based on patient tolerability, the volume per infusion site and overall infusion rate should be adjusted. Please see the full Prescribing Information for a complete list of adverse reactions.

About Hizentra: Personalized Treatment

How are the trough IgG levels affected when switching a patient from IVIg to weekly or biweekly (every 2 weeks) dosing of Hizentra?

When switching from IVIg to weekly dosing of Hizentra, the target serum IgG trough level is projected to be approximately 16% higher than the last trough level during prior IVIg therapy. For biweekly (every 2 weeks) dosing of Hizentra, the trough IgG level is projected to be approximately 10% higher than the last IVIg trough level.*†

*No difference in the clinical benefit of SCIg and IVIg serum profiles has been demonstrated by substantial clinical evidence or experience. Weekly dose based on dose adjustment factor of 1.37 when switching from IVIg. Biweekly dosing = 2x weekly dose, based on adjustment factor of 1.37 when switching from IVIg.

How are the trough IgG levels affected when switching a patient from weekly dosing of Hizentra to biweekly (every 2 weeks) or more frequent (2 to 7 times per week) dosing?

When switching from weekly Hizentra dosing to biweekly dosing, the target trough is projected to be approximately 5% lower than the last trough level on weekly therapy. When switching from weekly dosing to more frequent Hizentra dosing, the target serum IgG trough level is projected to be approximately 3 to 4% higher than the last trough level on weekly therapy.*

*Weekly dose based on dose adjustment factor of 1.37 when switching from IVIg. Biweekly dosing = 2x weekly dose, based on adjustment factor of 1.37 when switching from IVIg.

Dosing and Administration

Can biweekly (every 2 weeks) and more frequent dosing be used in pediatric and geriatric populations?

Data from more than 150 unique subjects were analyzed, including a subset of pediatric (over age 2) and geriatric (over age 65) subjects.* No age-related effects were observed; thus, no specific dose adjustments for biweekly or more frequent dosing are needed for either pediatric or geriatric populations.

*Biweekly and frequent regimens are based on pharmacokinetic modeling and simulations.

When should I check IgG levels after changing a patient to Hizentra?

Over time, the dose may need to be adjusted to achieve the desired clinical response and serum IgG trough level, regardless of the frequency of administration. To determine if a dose adjustment should be considered, measure the patient's serum IgG trough level 2 to 3 months after switching to Hizentra.

What should patients do if they miss a dose?

Patients should contact their healthcare provider for further instructions and monitor for symptoms of infection.

How many infusion sites should be used for Hizentra?

A Hizentra dose can be infused into multiple sites, based on dose and tolerability. The number and location of infusion sites depends on the volume of the total dose. Use up to 4 sites simultaneously or up to 12 sites consecutively per infusion. Infusion sites should be at least 2 inches apart. Change the actual site of infusion with each administration. New sites should be at least 1 inch from previous site. Recommended infusion sites include the thighs, upper arms, stomach, and hips.

How long does it take to infuse?

In the US clinical trial, the median duration of a weekly infusion ranged from 1.6 to 2 hours. Your patient's experience may vary, depending on a number of factors, including dosing schedule, number of infusion sites used, type of tubing, and patient tolerability.

What volume should be used per infusion site?

For the first infusion of Hizentra, do not exceed a volume of 15 mL per injection site. The volume may be increased to 20 mL per site after the fourth infusion and then to 25 mL per site as tolerated.

At what rate do you infuse?

For the first infusion of Hizentra, the recommended maximum flow rate is 15 mL per hour per site. For subsequent infusions, the flow rate may be increased to a maximum of 25 mL per hour per site as tolerated.

Does the infusion rate or volume administered per site change depending on the dosing schedule of Hizentra?

No. The maximum volume per infusion site is the same with any of the dosing regimens and is based on patient tolerability. Depending on several factors, the infusion rate might be the same.

Example based on a 10-g dose. To determine your patient's specific dose per his or her dosing regimen, use the Dosing Calculator.

Hizentra dosing chart

How long can Hizentra be stored at room temperature?

Hizentra can be stored at room temperature (up to 77°F [25°C]), for its entire shelf life, up to 30 months. Because Hizentra is stored at room temperature, there is no need to refrigerate. Room-temperature storage enables patients to infuse when they are ready, without waiting to bring the product to room temperature before use.

Starting Patients on Hizentra: Access and Billing Codes

How do I bill for Hizentra?

The treating physician is solely responsible for diagnosis coding and determination of the appropriate ICD-10-CM codes that describe the patient's condition and are supported by the medical record. The billing party is solely responsible for coding of services (eg, CPT Coding). The Hizentra Coding Guide can be found here. All codes listed in this guide are for informational purposes and are not an exhaustive list. The CPT, HCPCS, and ICD-10-CM codes provided are based on AMA and CMS guidelines. Because government and other third-party payer coding requirements change periodically, please verify current coding requirements directly with the payer being billed.

Medicare, Medicaid, and most insurers will cover Hizentra for the treatment of patients with primary immunodeficiency disease. Hizentra is covered as a Medicare Part B benefit with claims considered for payment by the 4 regional Durable Medical Equipment Medicare Administrative Contractors (DME MACs). Medicaid coverage policy varies by state. Coverage by other payers varies by payer and provider contract.

Filling each section of the claim entirely and including all of the requested documentation is the best way to avoid payment delays.

How much does Hizentra cost? Will biweekly (every 2 weeks) or more frequent dosing for Hizentra cost the same or more or less than weekly dosing?

The cost of any treatment, including Hizentra, depends on a number of factors, including insurance status and the insurers' co-pay/coinsurance policy. The actual out-of-pocket cost to a patient will depend on their individual prescription or medical coverage.

To help those who cannot afford their treatment, CSL Behring is committed to providing appropriate resources to ensure patients can begin and/or remain on their therapy. These include:

  • Hizentra Co-Pay Relief Program, for those who need assistance with copays, deductibles or coinsurance specifically related to the product. Eligible patients can receive up to $5,000 annually of assistance, with no monthly cap.
  • Hizentra Ancillary Supplies Program, for financially qualified individuals, helps cover the cost (up to $300 per month) of ancillary supplies associated with the administration of Hizentra.
  • Patient Assistance ProgramSM, which helps patients gain access to Hizentra if uninsured, underinsured, or unable to afford it.
  • CSL Behring AssuranceSM program, which is designed to help ensure that people who rely on CSL Behring therapies can continue to receive treatment even if they experience a lapse in third-party, private health insurance.

For more information, call the IgIQ Resource Center, CSL Behring's single source for information about immunoglobulin therapies, at 1-877-355-IGIQ (4447), Monday–Friday, 8 AM to 8 PM ET.

Does CSL Behring provide assistance with Hizentra billing information?

Yes, IgIQSM Support Services can provide coding, billing, and reimbursement information, as well as assistance with insurance verifications and prior authorizations.

For more information, call the IgIQ Resource Center, CSL Behring's single source for information about immunoglobulin therapies, at 1-877-355-IGIQ (4447), Monday–Friday, 8 AM to 8 PM ET.

Starting Patients on Hizentra: Patient Resources

Can my patients self-administer Hizentra?

Most patients/caregivers can be trained to infuse. However, patients should self-administer only after they have gone through training and performed a successful return demonstration in front of a healthcare professional. It might be a good idea to periodically ask your patients about their self-administration technique, especially if their infusion regimen has recently changed. See Patient Resources for more information.

Infusion Resources: Managing Therapy

How are infusion issues managed?

See the Managing Infusion Issues page for a detailed list of troubleshooting suggestions.

Infusion Resources: SHARE Nurse Training Center

Why do I need to register for the online SHARE training program?

Registration is required so we can help you keep track of your progress in each module and provide certification once you've passed the exam.

How do I access SHARE training materials?

You can access SHARE training through the SHARE page of this site. Registration is required.

What if my staff has already been trained on administration of other SCIg therapies?

SHARE training is specific to Hizentra administration. While your staff may be familiar with certain aspects of SCIg administration, there are specific clinical and administrative aspects that are unique to Hizentra and this is necessary for proper education.

How long does SHARE training take?

It's hard to say exactly how long training will take because you will be able to move at your own pace. However, most people are able to finish in less than an hour.

Will my staff have to be retrained in the future?

It is recommended that your staff go through training regularly, especially if they don't train patients on a frequent basis.

What happens when someone completes training?

After training, you can take the exam to test your knowledge of Hizentra administration. Upon passing, you will receive a certificate and be provided the option to add your organization to the nurse locator.

I have taken the SHARE training. How do I take the exam?

To take the exam, visit the SHARE page and select the option to take the exam. You will need to log in using your email and password used when registering for a SHARE Nurse Training account.

I am having problems logging into SHARE, or viewing/printing my certificate, what can I do?

If you have forgotten your password, you can have the password sent to your registered email address by completing the "Forgot Password" form. For any other technical issues, please contact IgIQ at 1-877-355-IGIQ (4447), Monday–Friday, 8 AM to 8 PM ET.

Problems viewing your certificate are commonly caused by the Adobe® Reader application. Ensure your Adobe® Reader is up-to-date.

IgIQ Support

Where can my patients get more information about financial and co-pay assistance?

IgIQSM Support Services can provide information on programs designed to help patients with access to Hizentra therapy. They can also answer other related financial assistance questions.

Hizentra Co-Pay Relief Program – The Hizentra Co-Pay Relief program helps eligible patients with out-of-pocket expenses for Hizentra (up to $5,000 for one year).*

To be eligible:

  • Prescription must be for primary immunodeficiency diagnosis
  • Patients must be at least 2 years of age
  • Patient must be receiving Hizentra through a specialty pharmacy or physician office
  • Patient must express financial need
  • Patient must have coverage for the product under a private US insurance plan. Not valid for prescriptions eligible for reimbursement by any federal or state healthcare program, such as Medicare, Medicare advantage plans, Medicaid, PCIP, Champus, TriCare, Veterans Administration (VA), or any other state or federal program
  • Patients whose insurance policy prohibits co-pay assistance are not eligible
  • This program is subject to change or discontinuation by CSL Behring at any time, for any reason, with or without prior notice

Hizentra Co-Pay Relief program is administered by Medmonk Inc. Terms and conditions apply.

To enroll, the patient must contact his or her Specialty Pharmacy and express a financial need for Hizentra Co-Pay Assistance. The Specialty Pharmacy will verify the patient's eligibility and process the request through Medmonk. The patient can access his or her account anytime at the secure online patient portal: Hizentra.medmonk.com.

Hizentra Ancillary Supplies Program – For financially qualified individuals, this program helps cover the cost (up to $300 per month) of ancillary supplies associated with the administration of Hizentra.

CSL Behring Patient Assistance ProgramSM – The CSL Behring Patient Assistance Program may help if your patients are uninsured or underinsured, or otherwise can't afford SCIg therapy. If they qualify, they may receive up to a 3-month supply of a SCIg therapy. At the end of 3 months, eligibility is re-evaluated for continued participation. If your patients have an emergency need for SCIg therapy, it will be addressed under a separate process when the call is received within 24 hours of the emergency.

CSL Behring AssuranceSM – The CSL Behring Assurance Program is free and features simple enrollment and participation. The program allows your patients to earn CSL Behring Assurance points for every month of continuous Ig product use. The points are redeemable for Ig therapy in the event that patients lose insurance.

*This program applies to product costs only; however, assistance for infusion-related costs may be available through a non-profit patient support organization. Contact IgIQ to learn more. Prior to enrolling in this CSL Behring program, participants are responsible for checking with their insurance carrier to confirm that their participation is not inconsistent with their insurance carrier's requirements.

For more information, call the IgIQ Resource Center, CSL Behring's single source for information about immunoglobulin therapies, at 1-877-355-IGIQ (4447), Monday–Friday, 8 AM to 8 PM ET.

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