Coding Information-ZARXIO

Billing codes

For your convenience, the billing codes for ZARXIO are as follows:

HCPCS Codes¹

Five-digit alpha-numeric codes used to report drugs and other supplies

Physician Office or Hospital Outpatient Setting²:

Q5101 Injection, filgrastim-sndz, biosimilar, (zarxio), 1 microgram¹

CPT Codes³

Five-digit codes that describe procedures and services performed by physicians and other healthcare providers

Physician Office or Hospital Outpatient Setting⁴:

96372—Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular

Diagnosis Codes

Numeric classification descriptive of patient conditions accepted by all payers

Physician Office or Hospital Outpatient Setting:

Appropriate ICD-9-CM or ICD-10-CM diagnosis code for the patient’s condition

Allowable diagnosis codes vary by payer. Report the appropriate diagnosis code(s) to describe the patient’s condition. Primary and secondary diagnosis codes may be required.

Use ICD-9-CM code(s) for dates of service prior to October 1, 2015
Use ICD-10-CM code(s) for dates of service on and after October 1, 2015

NDCs*

Universal 11-digit product identifier for human drugs; each NDC identifies the labeler, product, and trade package size

Physician Office or Hospital Outpatient Setting:

ZARXIO single-dose pre-filled syringe (PFS), pack of 1 PFS:
61314-0318-01 (300 mcg filgrastim-sndz PFS)
61314-0326-01 (480 mcg filgrastim-sndz PFS)
ZARXIO single-dose PFS, pack of 10 PFS:
61314-0318-10 (300 mcg filgrastim-sndz PFS)
61314-0326-10 (480 mcg filgrastim-sndz PFS)

Sandoz One Source co-pay details

*When reporting the NDC on claims, use the 5-4-2 digit format. Insert a leading zero in the appropriate section to complete the 5-4-2 digit format. Remove the dashes prior to entering the NDC on the claim form.

References: 1. US Centers for Medicare & Medicaid Services. Pub 100-04 Medicare Claims Processing: HCPCS Drug/Biological Code Changes. https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R3966CP.pdf. Published February 2, 2018. Effective April 1, 2018. Accessed February 21, 2018. 2. Centers for Medicare & Medicaid Services. Part B biosimilar biological product payment and required modifiers. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/Part-B-Biosimilar-Biological-Product-Payment.html. Accessed May 3, 2017. 3. American Medical Association. CPT^®process - how a code becomes a code. http://www.ama-assn.org/ama/pub/physician-resources/solutions-managing-your-practice/coding-billing-insurance/cpt/cpt-process-faq/code-becomes-cpt.page. Accessed May 3, 2017. 4. Centers for Medicare & Medicaid Services. CMS’ preliminary decisions on the recommendations of the hospital outpatient payment panel on supervision levels for select services. https://www.cms.gov/regulations-and-guidance/guidance/faca/downloads/prelim-supervision-decisions092412.pdf. Accessed May 3, 2017.

Please see information on ZARXIO administration on the next page.

ZARXIO is a registered trademark of Novartis AG.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ZARXIO is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim or pegfilgrastim products.

WARNINGS AND PRECAUTIONS

Splenic rupture, including fatal cases, has been reported following the administration of filgrastim products. Patients who report left upper abdominal or shoulder pain should be evaluated.

Acute respiratory distress syndrome (ARDS) has been reported in patients receiving filgrastim products. Patients who develop fever and lung infiltrates or respiratory distress should be evaluated. Discontinue ZARXIO in patients with ARDS.

Serious allergic reactions, including anaphylaxis, have been reported in patients receiving filgrastim products. The majority of reported events occurred upon initial exposure. Provide symptomatic treatment for allergic reactions. Allergic reactions, including anaphylaxis, in patients receiving filgrastim products can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue ZARXIO in patients with serious allergic reactions.

Sickle cell crisis, in some cases fatal, has been reported with the use of filgrastim products in patients with sickle cell trait or sickle cell disease.

Glomerulonephritis has occurred in patients receiving filgrastim products. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after dose reduction or discontinuation of filgrastim products. If glomerulonephritis is suspected, evaluate for cause. If causality is likely, consider dose-reduction or interruption of ZARXIO.

Alveolar hemorrhage manifesting as pulmonary infiltrates and hemoptysis requiring hospitalization have been reported in healthy donors treated with filgrastim products undergoing peripheral blood progenitor cell (PBPC) collection mobilization. Hemoptysis resolved with discontinuation of filgrastim. The use of ZARXIO for PBPC mobilization in healthy donors is not an approved indication.

Capillary leak syndrome (CLS) has been reported after G-CSF administration, including filgrastim products, and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive appropriate treatment.

Confirm the diagnosis of severe chronic neutropenia (SCN) before initiating ZARXIO therapy. Myelodysplastic syndrome (MDS) and acute myelogenous leukemia (AML) have been reported to occur in the natural history of congenital neutropenia without cytokine therapy. Cytogenetic abnormalities, transformation to MDS, and AML have also been observed in patients treated with filgrastim products for SCN. Abnormal cytogenetics and MDS have been associated with the eventual development of myeloid leukemia. The effect of filgrastim products on the development of abnormal cytogenetics and the effect of continued filgrastim administration in patients with abnormal cytogenetics or MDS are unknown. If a patient with SCN develops abnormal cytogenetics or myelodysplasia‚ the risks and benefits of continuing ZARXIO should be carefully considered.

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

Leukocytosis:

Patients with Cancer Receiving Myelosuppressive Chemotherapy: White blood cell counts of 100‚000/mm³ or greater were observed in approximately 2% of patients receiving filgrastim at dosages above 5 mcg/kg/day. In patients with cancer receiving ZARXIO as an adjunct to myelosuppressive chemotherapy‚ to avoid the potential risks of excessive leukocytosis‚ it is recommended that ZARXIO therapy be discontinued if the ANC surpasses 10‚000/mm³ after the chemotherapy-induced ANC nadir has occurred. Monitor CBCs at least twice weekly during therapy.
Peripheral Blood Progenitor Cell (PBPC) Collection and Therapy: During the period of administration of ZARXIO for PBPC mobilization in patients with cancer, discontinue ZARXIO if the leukocyte count rises to >100,000/mm³.

Cutaneous vasculitis has been reported in patients treated with filgrastim products. In most cases‚ the severity of cutaneous vasculitis was moderate or severe. Most of the reports involved patients with SCN receiving long-term filgrastim therapy. Hold ZARXIO therapy in patients with cutaneous vasculitis. ZARXIO may be started at a reduced dose when the symptoms resolve and the ANC has decreased.

The possibility that ZARXIO acts as a growth factor for any tumor type cannot be excluded. The safety of filgrastim products in chronic myeloid leukemia (CML) and myelodysplasia has not been established. When ZARXIO is used to mobilize PBPC‚ tumor cells may be released from the marrow and subsequently collected in the leukapheresis product. Available data is limited and inconclusive.

The safety and efficacy of ZARXIO given simultaneously with cytotoxic chemotherapy have not been established. Do not use ZARXIO in the period 24 hours before through 24 hours after the administration of cytotoxic chemotherapy. The safety and efficacy of ZARXIO have not been evaluated in patients receiving concurrent radiation therapy. Avoid the simultaneous use of ZARXIO with chemotherapy and radiation therapy.

Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone-imaging changes on nuclear imaging.

Aortitis has been reported in patients receiving filgrastim 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 ZARXIO if aortitis is suspected.

ADVERSE REACTIONS

Most common adverse reactions in patients:

With nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs (≥ 5% difference in incidence compared to placebo) are thrombocytopenia, nausea, pyrexia, chest pain, pain, fatigue, back pain, arthralgia, bone pain, pain in extremity, dizziness, cough, dyspnea, rash, blood lactate dehydrogenase increased and blood alkaline phosphatase increased

With AML (≥ 2% difference in incidence) are epistaxis, back pain, pain in extremity, erythema, and rash maculo-papular

With nonmyeloid malignancies undergoing myeloablative chemotherapy followed by BMT (≥ 5% difference in incidence) are rash and hypersensitivity

Undergoing peripheral blood progenitor cell mobilization and collection (≥ 5% incidence) are bone pain, pyrexia, blood alkaline phosphatase increased and headache

With severe chronic neutropenia (SCN) (≥ 5% difference in incidence) are arthralgia, bone pain, back pain, muscle spasms, musculoskeletal pain, pain in extremity, splenomegaly, anemia, upper respiratory tract infection, urinary tract infection, epistaxis, chest pain, diarrhea, hypoesthesia, and alopecia

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

CODING INFORMATION