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For adults with CIDP stabilized on IVIg Proven CIDP Control Greater Freedom for Everyday Living

Largest Study in CIDP 4,225 Total
Hizentra Infusions
n=172

CIDP indication and usage

Hizentra is indicated for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment.

Limitation of Use: Hizentra maintenance therapy in CIDP has been systematically studied for 6 months and for a further 12 months in a follow-up study. Maintenance therapy beyond these periods should be individualized based upon the patient's response and need for continued therapy.

Proven Control

In the PATH Study Relapse or withdrawal was significantly
reduced with Hizentra

KM replacement

Study design: Data from a randomized, multicenter, double-blind, placebo-controlled, parallel-group, phase III study of 2 doses of weekly Hizentra versus placebo for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP)—the PATH Study. Relapse was defined as a deterioration (increase) of at least 1 point in the total adjusted INCAT score.

*CIDP relapse was defined as a ≥ 1-point increase in adjusted INCAT score compared with baseline.
ARR=absolute risk reduction compared to placebo.

The recommended dose is 0.2 g/kg body weight per week. Both Hizentra doses demonstrated superiority over placebo for the primary endpoint.

body points

People on Hizentra maintained their:

  • Upper-body strength
  • Grip strength
  • Lower-body strength

Study design: Data from a randomized, multicenter, double-blind, placebo-controlled, parallel-group, phase III study of 2 doses of weekly Hizentra versus placebo for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP)—the PATH Study. Relapse was defined as a deterioration (increase) of at least 1 point in the total adjusted INCAT score.

*CIDP relapse was defined as a ≥ 1-point increase in adjusted INCAT score compared with baseline.
ARR=absolute risk reduction compared to placebo.

Demonstrated Tolerability

8 out of 10 patients

More than 7 of 10 patients on Hizentra did not report local reactions. Local reactions were the most commonly reported ARs

3.6x-fold lower

Patients on Hizentra reported a 3.6‑fold lower rate of systemic adverse reactions per infusion vs IVIg

Data represent systemic adverse reactions reported during the 13-week single-arm restabilization phase (9.8% of 956 total infusions) compared to those reported in the 2 Hizentra groups during the 24-week postrandomized phase (2.7% of 4,225 total infusions). However, there was no parallel group of subjects receiving placebo during the IVIg restabilization phase.

Patient Focused

88 percent

Most patients reported Hizentra easy to use9

§Based on last postdose observation (n=154). Exploratory endpoint, captured with the TSQM Treatment Satisfaction Questionnaire for Medication, version 1.4) on a 7-point scale, ranging from extremely difficult to extremely easy. This set was dichotomized into difficult for the categories: extremely difficult, very difficult, and difficult; and into easy for the categories: somewhat easy, easy, very easy, and extremely easy.

1 hour

In the PATH Study, the average infusion time was 1 hourװ

װHizentra may be administered in 1 or 2 infusions over 1 or 2 consecutive days.

How easy is self-administration with Hizentra?

Step-by-step instructions for self-administering Hizentra

Use this infusion guide when training patients to walk through each step of how to properly infuse Hizentra.

Self-administration guide
hizentra infusion guide

Convenient dosing

Hizentra is a ready-to-use 20% liquid SCIg with no warming or reconstitution necessary. See the calculator below to find dosing for your patient.

Your patients are all different and deserve a treatment with the flexibility to fit their individual needs and preferences. With the convenience of self-administration, most Hizentra patients can infuse in about 1 or 2 hours per week and fit their infusion into their normal routine.

CIDP administration: dosing and infusion rates

Patient Profile


1
lb
kg
2
0.2 g/kg
0.4 g/kg

Dosing Results


Your results are based on a patient weight of xxx and a dose of XXX g/kg

Weekly Dose: XXX g

Number of 10-g vials required: XXX

  • Initiate therapy with Hizentra 1 week after the last IVIg infusion
  • Recommended subcutaneous dose is 0.2 g/kg (1 mL/kg) body weight (BW) per week
    • In the clinical study after transitioning from IVIg to Hizentra, a dose of 0.4 g/kg (2 mL/kg) BW per week was also safe and effective to prevent CIDP relapse
  • If CIDP symptoms worsen, consider re-initiating treatment with an IVIg approved for the treatment of CIDP, while discontinuing Hizentra
    • If improvement and stabilization are observed during IVIg treatment, consider re-initiating Hizentra at 0.4 g/kg BW per week, while discontinuing IVIg
    • If CIDP symptoms worsen on 0.4 g/kg BW per week, consider re-initiating therapy with IVIg, while discontinuing Hizentra
  • Monitor patient’s clinical response and adjust duration of therapy based on patient need

Stay up-to-date about Hizentra for CIDP

To stay in touch for more information regarding CIDP treatment as it becomes available, register for updates by your preferred method of contact.

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Help patients start Hizentra with confidence

Find information regarding self-infusion training to help your patients get started on Hizentra.

Patient resources

Diagnostic and billing codes for Hizentra therapy

Medicare, Medicaid, and most insurers cover Hizentra for the treatment of patients with primary immunodeficiency disease. All codes provided here are for informational purposes and are not an exhaustive list. The CPT, HCPCS, and ICD-10-CM codes provided are based on AMA or CMS guidelines. 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). Because government and other third-party payer coding requirements change periodically, please verify current coding requirements directly with the payer being billed.

Hizentra is covered as a Medicare Part B benefit with claims considered for payment by the four 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.

ICD-10-CM Diagnosis Codes5

G61.81 Chronic inflammatory demyelinating polyneuritis
Chronic inflammatory demyelinating polyneuropathy
Chronic inflammatory demyelinating polyradiculoneuropathy
Polyneuropathy (multiple nerve disorder)
Polyneuropathy, chronic inflammatory demyelinating
Polyradiculoneuropathy, chronic inflammatory demyelinating
Polyradiculoneuropathy, inflammatory demyelination

HCPCS Billing Codes6,7

The following HCPCS codes describe supplies (including drugs) rendered by the billing provider. CMS publishes and maintains the HCPCS code set.

These codes are entered to paper claim for CMS-1500 in Field 24; or to electronic claim form ASC 837P in Loop 2400, Segment SV101-2, with the Qualifier “HC” entered to Segment SV101-1, unless otherwise directed by the payer.

Hizentra: Immune Globulin Subcutaneous (Human), 20% liquid
HCPCS Code Description
J1559 Injection, immune globulin (Hizentra), 100 mg

Certain payers may require the entry of NDC information to the claim form, as directed by the payer.

Ready-to-Use Hizentra Vial Sizes
Grams Protein Fill Size NDC Number to Use on All Claim Forms
1 g 5 mL 44206-0451-01
2 g 10 mL 44206-0452-02
4 g 20 mL 44206-0454-04
10 g 50 mL 44206-0455-10

If the billing provider performs administration services in conjunction with a patient's infusion, the following administration codes may be used to bill for this service if the service meets the requirements of the code description.

CPT Code Description
96369 Subcutaneous injection for therapy or prophylaxis; initial, up to 1 hour, including pump setup and establishment of subcutaneous infusion site(s)
96370 Each additional hour
96371 Additional pump setup with establishment of new subcutaneous infusion site(s)

Billing for Medicare DME MACs7

The medicare benefit for subcutaneous immune globulin administered by DME MACs applies only to those products that are specifically labeled as subcutaneous administration products. Intravenous immune globulin products administered via the subcutaneous route are not covered by Medicare DME MACs (refer to Local Coverage Decision for External Pumps, effective 2/4/2011).

Billing for External Pumps and Supplies

When the billing provider furnishes an external infusion pump for patient use, the following code may be used to bill for the pump if it meets the requirements of the code description.

External Infusion Pump
HCPCS Code Description
E0779 Ambulatory infusion pump, mechanical, reusable, for infusion 8 hours or greater

Only an E0779 infusion pump is covered by Medicare for the administration of Hizentra.

Other pump codes may be used to bill other payers, depending on the pump that is used and the payer's pump coverage policy. The codes below are not covered by Medicare. Other pump codes may include:

E0781 Ambulatory infusion pump, single or multiple channels, electric or battery operated, with administrative equipment, worn by patient
E0791 Parenteral infusion pump, stationary, single or multichannel

When the billing provider furnishes supplies for the patient's use with the external infusion pump, the following codes may be appropriate for the supplies if they meet the requirements of the code description and payer coverage policies.

External Infusion Pump Supplies
K0552 Supplies for external drug infusion pump, syringe-type cartridge, sterile, each
A4221 Supplies for maintenance of drug infusion catheter, per week
A4222 Infusion supplies for external drug infusion pump, per cassette or bag

Medicare requires the addition of Modifier -JB (administered subcutaneously) to the HCPCS code for Hizentra (J1559) to confirm subcutaneous administration. Example: J1559-JB. Modifier -JB should also be added to the HCPCS code for the covered infusion pump (E0779) following the modifier that indicates whether the pump is being rented (RR) or purchased (NU). Example: E0779-RR-JB or E0779-NU-JB.

ICD = International Classification of Diseases.
HCPCS = Healthcare Common Procedure Coding System.
CPT = Current Procedural Terminology.

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