Permanent J-Code for RYSTIGGO® (rozanolixizumab-noli): Available January 1, 2024 – 11/30/23

Effective for claims on or after January 1, 20241:

J9333

Injection, rozanolixizumab-noli, 1 mg

RYSTIGGO (rozanolixizumab-noli) is the first and only FDA-approved targeted treatment for both anti-acetylcholine receptor (AChR) and anti-muscle-specific tyrosine kinase (MuSK) antibody-positive (Ab+) adult patients with generalized myasthenia gravis (gMG).2

*Corrected WAC Pricing*

HCPCS Code1

J9333

HCPCS Code Descriptor1

Injection, rozanolixizumab-noli, 1 mg

NDC Codes2

50474-980-79

50474-0980-79*

Package Description2

Each carton of RYSTIGGO contains one single-dose glass vial containing 280 mg/2 mL (140 mg/mL)

WAC per HCPCS Unit3

$21.61

WAC per Package3

$6,050

ICD-10-CM Codes4,†

G70.00 Myasthenia gravis without (acute) exacerbation

G70.01 Myasthenia gravis with (acute) exacerbation

*For certain purposes, including the proper billing of drug products, an 11-digit NDC may be required.

These diagnosis codes are informational and not intended to be directive or a guarantee of reimbursement. They include potential codes for the FDA-approved indication for RYSTIGGO. Please consult the most recent version of the ICD-10-CM for a full list of myasthenia gravis (MG) codes.

FDA=Food and Drug Administration; HCPCS=Healthcare Common Procedure Coding System; ICD‑10‑CM=International Classification of Diseases, 10th Revision, Clinical Modification; NDC=National Drug Code; WAC=wholesale acquisition cost.

If you have questions on billing, coding, or reimbursement, or for more information, please contact your RRE.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Infections: RYSTIGGO may increase the risk of infection. Delay RYSTIGGO administration in patients with an active infection until the infection is resolved. During treatment with RYSTIGGO, monitor for clinical signs and symptoms of infection. If serious infection occurs, administer appropriate treatment and consider withholding RYSTIGGO until the infection has resolved.

 

Immunization

Immunization with vaccines during RYSTIGGO treatment has not been studied. The safety of immunization with live or live-attenuated vaccines and the response to immunization with any vaccine are unknown. Because RYSTIGGO causes a reduction in IgG levels, vaccination with live-attenuated or live vaccines is not recommended during treatment with RYSTIGGO. Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle with RYSTIGGO.

 

Aseptic Meningitis: Serious adverse reactions of aseptic meningitis (also called drug-induced aseptic meningitis) have been reported in patients treated with RYSTIGGO. If symptoms consistent with aseptic meningitis develop, diagnostic workup and treatment should be initiated according to the standard of care.

 

Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema and rash, were observed in patients treated with RYSTIGGO. Management of hypersensitivity reactions depends on the type and severity of the reaction. Monitor patients during treatment with RYSTIGGO and for 15 minutes after for clinical signs and symptoms of hypersensitivity reactions. If a reaction occurs, institute appropriate measures if needed.

 

ADVERSE REACTIONS

In a placebo-controlled study, the most common adverse reactions (reported in at least 10% of RYSTIGGO-treated patients) were headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea. Serious infections were reported in 4% of patients treated with RYSTIGGO. Three fatal cases of pneumonia were identified, caused by COVID-19 infection in two patients and an unknown pathogen in one patient. Six cases of infections led to discontinuation of RYSTIGGO.

 

Please refer to the full Prescribing Information or visit RYSTIGGOhcp.com.

For more information about RYSTIGGO, visit RYSTIGGOhcp.com.

For additional information, contact UCBCares® at 1-844-599-CARE (2273).

 

References: 1. Centers for Medicare & Medicaid Services. Third Quarter, 2023 HCPCS Coding Cycle. Accessed October 26, 2023. https://www.cms.gov/files/document/2023-hcpcs-application-summary-quarter-3-2023-drugs-and-biologicals.pdf. 2. RYSTIGGO [prescribing information]. Smyrna, GA: UCB, Inc. 3. Data on file. UCB, Inc., Smyrna, GA. 4. Centers for Medicare & Medicaid Services. ICD-10-CM tabular list of diseases and injuries. Updated June 29, 2023. Accessed October 26, 2023. https://www.cms.gov/files/zip/2024-code-tables-tabular-and-index-updated-06/29/2023.zip.

RYSTIGGO® and UCBCares® are registered trademarks of the UCB Group of Companies.

©2023 UCB, Inc., Smyrna, GA 30080. All rights reserved.

US-RZ-2300131 | November 2023