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Horizon BCBSNJ
Uniform Medical Policy ManualSection:Drugs
Policy Number:197
Effective Date: 04/10/2020
Original Policy Date:12/17/2019
Last Review Date:03/10/2020
Date Published to Web: 12/18/2019
Subject:
Gemcitabine in sodium chloride injection (Infugem)

Description:
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IMPORTANT NOTE:

The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.

Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.

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Gemcitabine is a nucleoside metabolic inhibitor indicated for the following: (1) in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy; (2) in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated; (3) in combination with cisplatin for the treatment of non-small cell lung cancer; and (4) as a single agent for the treatment of pancreatic cancer.

On July 18, 2018, Sun Pharma announced the FDA approval of Infugem (gemcitabine in sodium chloride injection). Infugem (gemcitabine in sodium chloride injection) uses proprietary technology which allows cytotoxic oncology products to be premixed in a sterile environment and supplied to the prescribers in ready-to-administer infusion bags. Gemcitabine is available generically as a powder for intravenous (IV) injection and a solution for IV infusion. Infugem is gemcitabine in a sodium chloride injection. It is the first chemotherapy product in a pre-mixed, ready-to-infuse formulation. The ready-to-infuse agent was launched to eliminate steps in the chemotherapy preparation process therefore reducing exposure and mitigating inherent provider and patient safety risks.

Infugem is an alcohol-free, clear, colorless, sterile solution of 10mg/mL gemcitabine in 0.9% sodium chloride that is supplied to pharmacists in ready-to-infuse bags as a Spike & Go™ package. It involves dose banding practice, whereby standardized doses of intravenous cytotoxic drugs are used for ranges (or “bands”) of doses calculated for individual patients. Infugem is the only available gemcitabine formulation that does not require reconstitution and syringe withdrawal prior to intravenous administration. Eliminating these steps reduces complexity and minimizes the inherent risks of hazardous drug exposure, contamination, and medication errors. The product is stable when stored at room temperature for 2 years compared with other gemcitabine products that require reconstitution and/or dilution and are only stable at room temperature for 24 hours.

New clinical studies, including bioequivalence studies, were not needed to support the U.S. Food & Drug Administration (FDA) approval of Infugem (gemcitabine in sodium chloride injection). Infugem (gemcitabine in sodium chloride injection) approval was based on the safety and efficacy data that were used to approve Gemzar (gemcitabine for injection), as well as supportive literature data. A virtual 2-way crossover clinical trial provided additional evidence of bioequivalence between the 2 formulations.

The indication, dose, route, and duration of administration of Infugem (gemcitabine in sodium chloride injection) will be the same as those of the reference product, Gemzar (gemcitabine for injection) which was initially approved in 1996. As with Gemzar (gemcitabine for injection), Infugem (gemcitabine in sodium chloride injection) is intended solely for administration by intravenous injection over 30 minutes. At the fixed concentration of 10 mg/ mL, the product requires no dilution and is ready to use. The Infugem (gemcitabine in sodium chloride injection) premixed bag(s) should be selected based on the patient’s body surface area range as outlined in the FDA approved package insert.

Warnings and precautions of Infugem (gemcitabine in sodium chloride injection) are the same as the reference product Gemzar (gemtcitabine for injection) and they include schedule-dependent toxicity, myelosuppression, pulmonary toxicity and respiratory failure, hemolytic-uremic syndrome, hepatic toxicity, embryo-fetal toxicity, exacerbation of radiation therapy toxicity, capillary leak syndrome, and posterior reversible encephalopathy syndrome. The most common adverse reactions (≥ 20%) with Infugem (gemcitabine in sodium chloride injection) use as a single agent are the same as the reference product Gemzar (gemtcitabine for injection) use as a single agent and they include nausea/vomiting, anemia, hepatic transaminitis, neutropenia, increased alkaline phosphatase, proteinuria, fever, hematuria, rash, thrombocytopenia, dyspnea, and peripheral edema.


Policy:
(NOTE: For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance.)

I. Infugem (gemcitabine in sodium chloride injection) is medically necessary when the member meets ALL of the following criteria:

    A. Confirmed diagnosis of one of the following FDA approved indications for gemcitabine
        1. Ovarian cancer
            a. Used in combination with carboplatin in patients who are platinum-sensitive; AND
            b. Patient has advanced disease that has relapsed at least 6 months after completion of a platinum-based regimen
        2. Breast cancer
            a. Patient has metastatic disease; AND
            b. Used in combination with paclitaxel as first-line treatment; AND
            c. Patient has previous failure on an anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated
        3. Non-small cell lung cancer
            a. Used as first-line treatment in combination with cisplatin; AND
            b. Patient has unresectable, locally advanced (Stage IIIA or IIIB), or metastatic (Stage IV) disease
        4. Pancreatic cancer
            a. Used as first-line treatment or patient was previously treated with fluorouracil; AND
            b. Patients has locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) disease
      [INFORMATIONAL NOTE: As per the FDA approved package, based on animal data and its mechanism of action, Infugem (gemcitabine in sodium chloride injection) can cause fetal harm when administered to a pregnant woman. There are no available data on the use of gemcitabine in pregnant women. In animal reproductive studies, gemcitabine was teratogenic, embryotoxic, and fetotoxic in mice and rabbits. Advise pregnant women of the potential risk to a fetus.]

AND

    B. Inadequate documented response or documented infusion reaction to generic gemcitabine injection AND

    C. The prescriber is a specialist in the area of the patient’s diagnosis (e.g. oncologist) or has consulted with a specialist in the area of the patient’s diagnosis.

II. When Infugem (gemcitabine in sodium chloride injection) is considered medically necessary initial therapy will be approved for 6 months at the following indication specific dose:
    A. Ovarian Cancer: 1000 mg/m2 days 1 and 8; repeat cycle every 21 days
    B. Breast Cancer: 1250 mg/m2 days 1 and 8; repeat cycle every 21 days
    C. Non-small Cell Lung Cancer: 1000 mg/m2 days 1, 8, and 15; repeat cycle every 28 days OR 1250 mg/m2 days 1 and 8; repeat cycle every 21 days
    D. Pancreatic Cancer: 1000 mg/m2 weekly for weeks 1-7, followed by 1 week of rest, then 1000 mg/m2 days 1, 8, and 15 of a 28 day cycle

III. Continued therapy of Infugem (gemcitabine in sodium chloride injection) will be approved annually at the FDA-approved dosing if the member meets the following criteria:
    • Member continues to meet initial criteria; AND
    • Tumor response with stabilization of disease or decrease in tumor size or tumor spread; AND
    • Absence of unacceptable toxicity from the drug (e.g. severe myelosuppression, pulmonary toxicity and respiratory failure, hemolytic-uremic syndrome, hepatic toxicity, capillary leak syndrome, exacerbation of radiation therapy toxicity, posterior reversible encephalopathy syndrome (PRES), etc.)
IV. Infugem (gemcitabine in sodium chloride injection) is considered medically necessary for the off-label indications that are 2A or better recommendations on National Comprehensive Cancer Network (NCCN) compendium. Refer to National Comprehensive Cancer Network: Drugs and Biologics Compendium - Infugem (gemcitabine in sodium chloride injection). Available at: https://www.nccn.org/professionals/drug_compendium/content/.

V. Infugem (gemcitabine in sodium chloride injection) is considered investigational for all other indications.


Medicare Coverage:

There is no National Coverage Determination (NCD) or Local Coverage Determination (LCD) for jurisdiction JL for this service. Therefore, Medicare Advantage Products will follow the Horizon BCBSNJ Medical Policy.

Medicaid Coverage:

For Horizon NJ Health members, please follow this link for the corresponding HNJH drug policy https://services3.horizon-bcbsnj.com/ddn/NJhealthWeb.nsf

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Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

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Index:
Gemcitabine in sodium chloride injection (Infugem)
Infugem (gemcitabine in sodium chloride injection)

References:
1. Infugem (gemcitabine in sodium chloride injection). [Package insert] Sun Pharmaceuticals. July 2018.

2. Gemzar (gemcitabine). [Pacakge insert] Lilly USA, LLC. May 2019.

3. Sun Pharma Announces U.S. FDA Approval of INFUGEM™ Injection. Sun Pharmaceutical Industries Ltd. https://www.sunpharma.com/media/press-releases. July 2019.

4. National Comprehensive Cancer Network. NCCN Drugs & Biologics Compendium. Gemcitabine. Available at https://www.nccn.org/professionals/drug_compendium/content/. Accessed February 2020.

5. Sun Pharma Launches Ready-to-Infuse INFUGEM in the U.S. Sun Pharma. April 8, 2019. Available at: https://www.biospace.com/article/releases/sun-pharma-launches-ready-to-infuse-infugem-in-the-u-s-/

6. Raedler, LA. Infugem (Gemcitabine) First Formulation of Premixed, Ready-to-Administer Intravenous Chemotherapy Approved for Several Tumor Types. Journal of Hematology Oncology Pharmacy. 2019. Available at: http://jhoponline.com/2019-fourth-annual-oncology-guide-to-new-fda-approvals/17773-infugem-gemcitabine-first-formulation-of-premixed-ready-to-administer-intravenous-chemotherapy-approved-for-several-tumor-types

7. Center for Drug Evaluation and Research, Application Number: 208313Orig1s000. Clinical Pharmacology and Biopharmaceuticals Review. Available at:https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208313Orig1s000ClinPharmR.pdf

Codes:

(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

HCPCS
J9199
J9198

* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.

The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy

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