CMS grants Fresenius Kabi permanent, product-specific Q-Code for Stimufend® (pegfilgrastim-fpgk)

Effective for Medicare claims as of April 1, 2023

LAKE ZURICH, Ill.–(BUSINESS WIRE)–#FreseniusKabi–Fresenius Kabi announced today that the Centers for Medicare and Medicaid Services (CMS) issued a permanent product-specific Q-code for Stimufend^® (pegfilgrastim-fpgk). Under the Healthcare Common Procedure Coding System (HCPCS), the Q-code assigned to Stimufend is effective for patients administered Stimufend on and after April 1, 2023. The KABICARE™ patient services hub is available to facilitate successful access and reimbursement.

“Now physicians will be able to use a new permanent, product-specific Q-code for Stimufend,” said Ali Ahmed, senior vice president, Biosimilars, at Fresenius Kabi USA. “This marks a critical milestone in the launch of Stimufend and represents our commitment to making advanced, life-changing biologic medicines more accessible to more patients.”

The new code for Stimufend is Q 5127. To learn more about Stimufend, visit https://www.stimufendhcp.com/.

Stimufend is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Limitations of Use: Stimufend is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

About Q-Codes

Q-codes are permanent reimbursement codes granted to biosimilars and used by commercial insurance plans, Medicare, Medicare Advantage, and other government payers for Medicare Part B drugs like Stimufend that are administered by a physician. Claims submission and documentation are simplified with a permanent Q-code, facilitating and streamlining the billing and reimbursement process.

IMPORTANT SAFETY INFORMATION

Contraindication

• Stimufend (pegfilgrastim-fpgk) is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products

Contraindication

• Reactions have included anaphylaxis

Splenic Rupture

• Splenic rupture, including fatal cases, can occur following the administration of pegfilgrastim products
• Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain

Acute Respiratory Distress Syndrome (ARDS)

• ARDS can occur in patients receiving pegfilgrastim products
• Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving Stimufend
• Discontinue Stimufend in patients with ARDS

Serious Allergic Reactions

• Serious allergic reactions, including anaphylaxis, can occur in patients receiving pegfilgrastim products
• The majority of reported events occurred upon initial exposure and can recur within days after the discontinuation of initial anti-allergic treatment
• Permanently discontinue Stimufend in patients with serious allergic reactions

Use in Patients with Sickle Cell Disorders

• In patients with sickle cell trait or disease, severe and sometimes fatal sickle cell crises can occur in patients receiving pegfilgrastim products
• Discontinue Stimufend if sickle cell crisis occurs

Glomerulonephritis

• Has occurred in patients receiving pegfilgrastim products
• Diagnoses based on azotemia, hematuria, proteinuria, and renal biopsy
• Generally, events resolved after dose-reduction or discontinuation of pegfilgrastim products
• If suspected, evaluate for cause and if cause is likely, consider dose-reduction or interruption of Stimufend

Leukocytosis

• Increased white blood cell counts of 100 x 10⁹/L have been observed
• Monitoring of complete blood count (CBC) during Stimufend therapy is recommended

Thrombocytopenia

• Thrombocytopenia has been reported in patients receiving pegfilgrastim products. Monitor platelet counts

Capillary Leak Syndrome (CLS)

• CLS has been reported after G-CSF administration, including pegfilgrastim products
• Characterized by hypotension, hypoalbuminemia, edema and hemoconcentration

Capillary Leak Syndrome (CLS)

• Episodes vary in frequency, severity and may be life-threatening if treatment is delayed
• Patients with symptoms should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care

Potential for Tumor Growth Stimulatory Effects on Malignant Cells

• G-CSF receptor has been found on tumor cell lines
• The possibility that pegfilgrastim products act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim products are not approved, cannot be excluded.

Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer

• MDS and AML have been associated with the use of pegfilgrastim products in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings.

Aortitis

• Aortitis has been reported in patients receiving pegfilgrastim products. It may occur as early as the first week after start of therapy
• Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count)
• Consider aortitis in patients who develop these signs and symptoms without known etiology. Discontinue Stimufend if aortitis is suspected

Nuclear Imaging

• Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. This should be considered when interpreting bone imaging results

Most common adverse reactions

• Bone pain
• Pain in extremity

This Important Safety Information does not include all the information needed to use Stimufend (pegfilgrastim-fpgk) Injection safely and effectively. Please see Stimufend Full Prescribing Information here.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

About Fresenius Kabi

Fresenius Kabi (www.fresenius-kabi.com/us) is a global health care company that specializes in medicines and technologies for infusion, transfusion, and clinical nutrition. The company’s products and services are used to help care for patients with critical and chronic conditions. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany. To learn about U.S. career opportunities at Fresenius Kabi, visit us at http://www.fresenius-kabi.com/us/join-us and follow us on LinkedIn.

For more information Fresenius Kabi Biosimilars in the U.S., please visit https://biospecialized.com/.

Contacts

Media contact
Matt Kuhn (847) 220-3033

[email protected]