CMS Grants Fresenius Kabi COVID-19 Indication-Specific HCPCS Codes for Tyenne® (tocilizumab-aazg)

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LAKE ZURICH, Ill.--(BUSINESS WIRE)--Apr 9, 2026--

Fresenius Kabi, a part of Fresenius, and a leading provider of essential medicines and medical technologies, announced today that the Centers for Medicare & Medicaid Services has issued indication-specific Healthcare Common Procedure Coding System (HCPCS) codes for Tyenne ® (tocilizumab-aazg) for the treatment of COVID-19. The new codes will be effective for Medicare claims for eligible patients administered Tyenne on April 1, 2026.

These new COVID-19 HCPCS codes – Q0238 for injection, M0233 for intravenous infusion first-dose, and M0234 for intravenous infusion second-dose – will support billing and reimbursement for Tyenne when used in the treatment of COVID-19 in appropriate patients, consistent with its FDA-approved labeling.

“Fresenius Kabi’s indication-specific codes for COVID-19 represent an important step in supporting provider access and streamlined reimbursement for Tyenne,” said Molly Benson, senior vice president, Biopharma, at Fresenius Kabi USA. “Clear coding helps facilitate efficient claims processing and reinforces our commitment to ensuring patients have access to important treatment options.”

HCPCS codes are reimbursement codes used by healthcare providers and payers to process claims for drugs administered by injection, infusion, or other methods. These codes are used by Medicare, Medicaid, and commercial insurers to standardize claims submissions and reimbursement processes.

Tyenne previously received a permanent, product-specific Q-code for its approved autoimmune indications. These indication-specific COVID-19 codes further support appropriate coding and reimbursement pathways across care settings.

To learn more about how Fresenius Kabi provides comprehensive patient support, visit the KabiCare™ patient services hub. To learn more about Tyenne, please visit www.fresenius-kabi.com.

About Tyenne ®, a tocilizumab biosimilar

Tyenne ® (tocilizumab-aazg), a biosimilar to Actemra ® (tocilizumab), is a prescription medicine called an Interleukin-6 (IL-6) receptor antagonist. It was developed by Fresenius Kabi using advanced analytical and manufacturing technologies for use in the treatment of several autoimmune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. Serious infections leading to hospitalization or death including tuberculosis (TB), bacterial, invasive fungal, viral, and other opportunistic infections have occurred in patients receiving the product. Tyenne is contraindicated in patients with known hypersensitivity to tocilizumab products. For more information about Tyenne, please see the full prescribing information for the U.S. here, including Boxed Warning.

IMPORTANT SAFETY INFORMATION

RISK OF SERIOUS INFECTIONS

Patients treated with Tyenne ® (tocilizumab-aazg) are at increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis (TB), bacterial, invasive fungal, viral, or other opportunistic infections. If a serious infection develops, interrupt Tyenne until the infection is controlled.

Reported infections include:

• Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients, except those with COVID-19, should be tested for latent tuberculosis before Tyenne use and during therapy (except patients with COVID-19). Treatment for latent infection should be initiated prior to Tyenne use.
• Invasive fungal infections, including candidiasis, aspergillosis, and pneumocystis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
• Bacterial, viral and other infections due to opportunistic pathogens.

The risks and benefits of treatment with Tyenne should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Tyenne, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

CONTRAINDICATION

Tyenne is contraindicated in patients with known hypersensitivity to tocilizumab products.

WARNINGS AND PRECAUTIONS

COVID-19: Monitor for signs and symptoms of new infections during and after treatment with Tyenne in patients with COVID-19. Limited information is available regarding the use of Tyenne in patients with COVID-19 and concomitant serious active infections. The risks and benefits of treatment with Tyenne in patients with COVID-19 and other concurrent infections should be considered.

Gastrointestinal Perforations: Events of gastrointestinal (GI) perforation have been reported in clinical trials, primarily as complications of diverticulitis in RA patients. Use Tyenne with caution in patients who may be at increased risk for GI perforation. Promptly evaluate patients presenting with new-onset abdominal symptoms for early identification of GI perforation.

Hepatotoxicity: Serious cases of hepatic injury have been observed in patients taking intravenous or subcutaneous tocilizumab. Some of these cases have resulted in liver transplant or death. Time to onset for cases ranged from months to years after treatment initiation. Most cases presented with marked elevations of transaminases (> 5 times ULN), and some cases presented with signs or symptoms of liver dysfunction and only mildly elevated transaminases.

Treatment with Tocilizumab was associated with a higher incidence of transaminase elevations; increased frequency and magnitude of these elevations were observed when tocilizumab was used in combination with potentially hepatotoxic drugs (e.g., methotrexate).

It is not recommended to initiate Tyenne treatment in RA, GCA, PJIA, and SJIA patients with elevated transaminases ALT or AST greater than 1.5x ULN. In patients who develop elevated ALT or AST greater than 5x ULN discontinue Tyenne.

Patients who are hospitalized with COVID-19 may have elevated AST or ALT levels. Multiorgan failure with involvement of the liver is recognized as a complication of severe COVID-19. The decision to administer Tyenne should balance the potential risks of acute treatment with Tyenne against the potential benefit of treating COVID-19. It is not recommended to initiate TYENNE treatment in COVID-19 patients with elevated ALT or AST above 10x ULN. Monitor ALT and AST during treatment.

Measure liver tests promptly in patients who report symptoms that may indicate liver injury. If the patient is found to have abnormal liver tests, Tyenne treatment should be interrupted. Tyenne should only be restarted in patients with another explanation for the liver test abnormalities after normalization of the liver tests.

Laboratory Parameters: Laboratory monitoring is recommended due to potential consequences of treatment-related laboratory abnormalities in neutrophils, platelets, lipids, and liver function tests. Dosage modifications may be required.

Neutropenia: Treatment with tocilizumab products was associated with a higher incidence of neutropenia. It is not recommended to initiate Tyenne treatment in RA, GCA, PJIA, and SJIA patients with a low neutrophil count i.e., absolute neutrophil count (ANC) less than 2000 per mm 3. In patients who develop an ANC less than 500 per mm 3 treatment is not recommended.

It is not recommended to initiate Tyenne treatment in COVID-19 patients with an ANC less than 1000 per mm 3. Neutrophils should be monitored.

Thrombocytopenia: Treatment with tocilizumab products was associated with a reduction in platelet counts. It is not recommended to initiate Tyenne in RA, GCA, PJIA, and SJIA patients with a platelet count below 100,000 per mm 3. In patients who develop a platelet count less than 50,000 per mm 3, treatment is not recommended.

It is not recommended to initiate Tyenne treatment in COVID-19 patients with a platelet count less than 50000 per mm 3. Platelets should be monitored.

Elevated Liver Enzymes: It is not recommended to initiate Tyenne treatment in patients with elevated transaminases ALT or AST >1.5x ULN. In patients who develop elevated ALT or AST >5x ULN, treatment is not recommended.

Lipid Abnormalities: Treatment with tocilizumab products was associated with increases in lipid parameters such as total cholesterol, triglycerides, LDL cholesterols, and/or HDL cholesterol.

Immunosuppression: The impact of treatment with tocilizumab products on the development of malignancies is not known, but malignancies were observed in clinical studies with tocilizumab. Tyenne is an immunosuppressant, and treatment with immunosuppressants may result in an increased risk of malignancies.

Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis, have been reported in association with tocilizumab and anaphylactic events with a fatal outcome have been reported with intravenous infusion of Tocilizumab. Additionally, serious cutaneous reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported in patients with autoinflammatory conditions treated with Tocilizumab products. Tyenne for intravenous use should only be infused by a healthcare professional with appropriate medical support to manage anaphylaxis. For Tyenne subcutaneous injection, advise patients to seek immediate medical attention if they experience any symptoms of a hypersensitivity reaction. If anaphylaxis or other hypersensitivity reaction occurs, stop administration of Tyenne immediately and discontinue Tyenne permanently. Do not administer Tyenne to patients with known hypersensitivity to Tyenne.

Demyelinating Disorders: The impact of treatment with tocilizumab products on demyelinating disorders is not known, but multiple sclerosis and chronic inflammatory demyelinating polyneuropathy were reported rarely in clinical studies. Monitor patients for signs and symptoms of demyelinating disorders. Prescribers should exercise caution in considering the use of Tyenne in patients with preexisting or recent-onset demyelinating disorders.

Active Hepatic Disease and Hepatic Impairment: Treatment with Tyenne is not recommended in patients with active hepatic disease or hepatic impairment.

Vaccinations: Avoid use of live vaccines concurrently with Tyenne. No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving Tyenne or on the effectiveness of vaccination in patients receiving Tyenne. Patients should be brought up to date on all recommended vaccinations prior to initiation of Tyenne therapy, if possible.

ADVERSE REACTIONS

Most common adverse reactions (incidence of at least 5%): upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, injection site reactions.

DRUG INTERACTIONS

In GCA patients, no effect of concomitant corticosteroid on tocilizumab exposure was Observed. Cytochrome P450s in the liver are down-regulated by infection and inflammation stimuli including cytokines such as IL-6. Inhibition of IL-6 signaling in RA patients treated with Tyenne may restore CYP450 activities to higher levels than those in the absence of Tyenne leading to increased metabolism of drugs that are CYP450 substrates. Exercise caution when co-administering Tyenne with CYP3A4 substrate drugs where decrease in effectiveness is undesirable, e.g., oral contraceptives, lovastatin, atorvastatin, Etc.

USE IN PREGNANCY

The limited available data with tocilizumab products in pregnant women are not sufficient to determine whether there is a drug-associated risk for major birth defects and miscarriage, or other adverse maternal or fetal outcomes.

You may report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program. You may also report side effects to Fresenius Kabi at (800) 551-7176.

INDICATIONS

Tyenne is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs).

Tyenne is indicated for the treatment of giant cell arteritis (GCA) in adult patients.

Tyenne is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older.

Tyenne is indicated for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients 2 years of age and older.

Tyenne is indicated for the treatment of chimeric antigen receptor (CAR)-T cell-induced severe or life-threatening cytokine release syndrome in adults and pediatric patients 2 years of age and older.

Tyenne is indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adult patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Please see additional Important Safety Information in full Prescribing Information, including BOXED WARNING.

About Fresenius Kabi

As a global healthcare company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of patients with critical and chronic conditions. With more than 41,000 employees and present in more than 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to essential medicines and technologies.

In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients’ nutritional status. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is a global leader in supplying blood collection bags and devices, supporting blood banks and health care facilities worldwide. The company’s I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care.

Fresenius Kabi takes a holistic approach to health care and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of 450 million patients annually. With the #FutureFresenius strategy, the company is developing, producing, and selling new products and technologies and aspires to expand its position as a leading global provider of therapies, improve patient care, generate sustainable value for stakeholders – shaping the future of healthcare.

Fresenius Kabi is part of the Fresenius Group, founded in 1912, along with Helios and Quirónsalud. As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing healthcare solutions on a global scale.

For more information, please visit www.fresenius-kabi.com/us. To learn about U.S. career opportunities at Fresenius Kabi, visit us at www.fresenius-kabi.com/us/join-us and follow us on LinkedIn and Facebook.

This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g., changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius Kabi does not undertake any responsibility to update the forward-looking statements in this release.

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KEYWORD: ILLINOIS UNITED STATES NORTH AMERICA

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SOURCE: Fresenius Kabi

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PUB: 04/09/2026 08:00 AM/DISC: 04/09/2026 08:00 AM

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