Sandoz Zarxio® demonstrates cost-effectiveness for breast cancer patients at intermediate risk when used as primary prophylaxis to decrease the incidence of febrile neutropenia following first-round of chemotherapy

Princeton, New Jersey, October 6, 2020 — Sandoz Inc. announced that in addition to being safe and effective, new data shows Zarxio^® (filgrastim-sndz) is cost-effective as primary prophylaxis to decrease the incidence of chemotherapy-induced febrile neutropenia (FN) in early-stage breast cancer patients receiving curative chemotherapy who are at intermediate risk for febrile neutropenia.

The study, released by the American Society of Clinical Oncology (“ASCO”) Quality Care Symposium, demonstrates that using Zarxio after the first cycle of docetaxel chemotherapy rather than waiting until the patient develops FN, is cost-effective based on a willingness to pay (WTP) threshold of $50,000 per quality adjusted life year (QALY). Historically, due to the high cost of reference medicines, patients at intermediate risk are monitored for development of FN before receiving a granulocyte colony-stimulating factor (G-CSF). 

“These data add to the growing body of evidence on the cost-effectiveness of Zarxio as primary prophylaxis in cancer patients, including similar findings in patients with non-Hodgkin’s lymphoma and lung cancer, and support the recent NCCN recommendations during the COVID-19 pandemic,” said study author Edward Li, Pharm.D., Director, Health Economics and Outcomes Research at Sandoz. “Sandoz is committed to supporting strategies to improve patient care and enhance sustainability for overburdened health systems, including the greater adoption of biosimilars.”

These findings align with the recent National Comprehensive Cancer Network (NCCN) recommendations for FN prevention1, which have been expanded in response to the potential higher risk of COVID-19 infection among cancer patients due to compromised immune systems. NCCN now recommends administration of G-CSF as primary prophylaxis treatment for FN for both intermediate and high-risk patients after their first cycle of chemotherapy, with the goal of reducing emergency room and hospital visits. Before the pandemic, the guidelines only recommended routine primary prophylaxis for high-risk and selected intermediate-risk patients.

The study abstract, Cost-effectiveness of filgrastim-sndz as primary prophylaxis (PP) versus secondary prophylaxis (SP) to prevent chemotherapy-induced febrile neutropenia (FN) in breast cancer patients at intermediate risk, is now available on the ASCO website at meetinglibrary.asco.org.

Zarxio® Indication and Important Safety Information²

Indication

ZARXIO is a man-made form of granulocyte colony-stimulating factor (GCSF). G-CSF is a substance produced by the body. It stimulates the growth of neutrophils, a type of white blood cell important in the body’s fight against infection.

Important Safety Information

Contraindications

Do not take ZARXIO if you have had a serious allergic reaction to human G-CSFs such as filgrastim or pegfilgrastim products.

Warnings and Precautions

Before you take ZARXIO, tell your doctor about all of your medical conditions, including if you:

• have a sickle cell disorder.
• have a problem with your kidneys, as you may need more frequent urine tests.
• are receiving radiation therapy.
• are allergic to latex. The needle cap on the prefilled syringe contains natural rubber (derived from latex). Do not handle the prefilled syringe if you are allergic to latex.
• are pregnant or plan to become pregnant. It is not known if ZARXIO will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if ZARXIO passes into your breast milk.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of ZARXIO?

ZARXIO may cause serious side effects, including:

• Spleen rupture. Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Call your doctor right away if you have pain in the left upper stomach (abdomen) area or your left shoulder.
• A serious lung problem called acute respiratory distress syndrome (ARDS). Call your doctor or get emergency medical help right away if you have shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing.
• Serious allergic reactions. ZARXIO can cause serious allergic reactions. These reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate, and sweating. If you have any of these symptoms, stop using ZARXIO, and call your doctor or get emergency help right away.
• Sickle cell crises. You may have a serious sickle cell crisis if you have a sickle cell disorder and take ZARXIO. Serious sickle cell crisis has happened in people with sickle cell disorders receiving filgrastim that has sometimes led to death. Call your doctor right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.
• Kidney injury (glomerulonephritis). Kidney injury has been seen in patients who received filgrastim products. Call your doctor right away if you experience puffiness in your face or ankles, blood in your urine or brown-colored urine or you notice you urinate less than usual.
• Capillary leak syndrome. ZARXIO can cause fluid to leak from blood vessels into your body’s tissues. This condition is called “Capillary Leak Syndrome” (CLS). CLS can quickly cause you to have symptoms that may become life-threatening. Get emergency medical help right away if you develop any of the following symptoms:
  • • swelling or puffiness and are urinating less often.
    • trouble breathing.
    • swelling of your stomach-area (abdomen) and feeling of fullness.
    • dizziness or feeling faint.
    • a general feeling of tiredness.
• Decreased platelet count (thrombocytopenia). Your doctor will check your blood during treatment with ZARXIO. Tell your doctor if you have unusual bleeding or bruising while taking ZARXIO. This could mean a decrease of platelets, which reduces the ability of blood to clot.
• Increased white blood cell count (leukocytosis). Your doctor will check your blood during treatment with ZARXIO.
• Inflammation of your blood vessels (cutaneous vasculitis). Tell your doctor if you develop purple spots or redness of your skin.
• Inflammation of the aorta (aortitis). Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported in patients who received filgrastim products. Symptoms may include fever, abdominal pain, feeling tired, and back pain. Call your healthcare provider if you experience these symptoms.

The most common side effects of ZARXIO include aching in the bones and muscles.

These are not all the possible side effects of ZARXIO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Informationfor ZARXIO.

Disclaimer

This media update contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this media update, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this media update will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that, if approved, such generic or biosimilar products will be approved for all indications included in the reference product’s label. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional generic or biosimilar versions of such products; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling its products; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this media update as of this date and does not undertake any obligation to update any forward-looking statements contained in this media update as a result of new information, future events or otherwise.

About Sandoz

Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical needs. Our ambition is to be the world’s leading and most valued generics company. Our broad portfolio of high-quality medicines, covering all major therapeutic areas, accounted for 2019 sales of USD 9.7 billion. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area.

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References

1. National Comprehensive Cancer Network. Coronavirus Disease 2019 (COVID-19) Resources for the Cancer Care Community. Hematopoietic Growth Factors. Available at: https://www.nccn.org/covid-19/pdf/HGF_COVID-19.pdf. Accessed September 21, 2020.
2. Zarxio. Prescribing Information. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c0d1c22b-566b-4776-bdbf-00f96dad0cae. Accessed September 22, 2020.

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