Subject:
Marqibo (Vincristine Sulfate Liposome Injection)
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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Marqibo (vincristine sulfate liposome injection) is vincristine encapsulated in sphingomyelin/cholesterol liposomes for intravenous administration. Vincristine sulfate is a vinca alkaloid that binds to tubulin, altering the tubulin polymerization equilibrium, resulting in altered microtubule structure and function. Vincristine sulfate stabilizes the spindle apparatus, preventing chromosome segregation, triggering metaphase arrest and inhibition of mitosis.
Marqibo is indicated for the treatment of adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies.
Acute lymphoblastic leukemia (ALL) is a malignant disorder that originates in a single B- or T-lymphocyte progenitor. Proliferation and accumulation of blast cells in the marrow result in suppression of hematopoiesis and, thereafter, anemia, thrombocytopenia, and neutropenia. Adult ALL is one of the rarest malignancies, with only approximately 2,000 new cases diagnosed annually in the United States. Of these, approximately 1,400 are Ph- Adult ALL. Based on published treatment response rates and treatment-related mortality rates, each year in the United States approximately 840 patients relapse from a first remission or are refractory to front-line therapy. Fifty-five percent of these will relapse a second time or be refractory to second-line therapy, with worsening prognosis, decreased survival, and a need for a third line of therapy.
Marqibo gained U.S. Food and Drug Administration (FDA) approval based on HBS407, a phase 2 single arm, international, multi-center, open-label trial that evaluated the effect of vincristine sulfate liposomal injection in adult patients with Ph- ALL in second or greater relapse, or Ph-ALL who failed two or greater number of treatment lines of anti-leukemia chemotherapy. The primary efficacy endpoint was the combined proportion of patients who achieved complete remission (CR) and complete remission with incomplete blood count recovery (CRi). In the trial, 65 patients received at least 1 dose of Marqibo, 10 patients (15.4%) achieved CR + CRi with a (95% confidence interval, 7.6-26.5). In the 10 patients achieving CR or CRi, the median duration of documented remission was 28 days. The median duration of CR or CRi based on the first date of CR or CRi to date of documented relapse, death, or subsequent chemotherapies including hematopoietic stem cell transplant was 56 days (95% CI, 9-36). Marqibo’s safety was evaluated in two single arm trials of 83 patients, HBS407 and VSLI-06. Overall, 80 out of 83 patients (96.4%) reported adverse events of Grade 3 or higher such as neuropathy, febrile neutropenia, thrombocytopenia, anemia, and infections. The most common side effects observed included constipation, nausea, fever, nerve damage, fatigue, diarrhea, decreased appetite, and insomnia.
In order for patients to be eligible for HBS407 they had to be 18 years or older with Ph1 ALL in second or greater relapse or have disease progression after two or greater treatment lines of anti-leukemia therapy. Patients had to have achieved a complete remission to at least one prior anti-leukemia chemotherapy, defined by a leukemia-free interval of equal or more than 90 days. Patients were not eligible for immediate hematopoietic stem cell transplantation at time of screening and enrollment. All treated patients had received prior vincristine sulfate and 80% had evidence of residual neuropathy at study baseline.
Vincristine sulfate liposome injection is marketed as Marqibo by Talon Therapeutics Inc., based in South San Francisco, CA. Marqibo was approved by the FDA on August 9, 2012.
Marqibo is contraindicated in patients with demyelinating conditions including Charcot-Marie-Tooth syndrome, in patients with hypersensitivity to vincristine sulfate or any other component of Marqibo, and for intrathecal administration. Marqibo has different dosage recommendations than vincristine sulfate injection; dosages are not interchangeable between products.
Policy:
(NOTE: For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance)
The requirements of the Horizon BCBSNJ Marqibo (Vincristine Sulfate Liposome Injection) Program may require a precertification/prior authorization via MagellanRx Management. These requirements are member-specific: please verify member eligibility and requirements through the Horizon Provider Portal (www.horizonblue.com/provider). Ordering clinicians should request pre-certification from MagellanRx Management at ih.magellanrx.com or call 1-800-424-4508 (when applicable).
1. Marqibo (vincristine sulfate liposome injection) is considered medically necessary when ALL of the following criteria are met:
- Member has a diagnosis of Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL) that
- is in second or greater relapse, OR
- has progressed following two or more anti-leukemia therapies, AND
- Member is 18 years or older, AND
- Member does not have any FDA labeled contraindications (e.g. demyelinating conditions including Charcot-Marie-Tooth syndrome, hypersensitivity to vincristine sulfate or any of the other components of Marqibo, and intrathecal administration of Marqibo) AND
- Marqibo is used as a single agent AND
- 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.
2. Marqibo (vincristine sulfate liposome injection) is considered medically necessary initially for 6 months at the FDA approved dose of 2.25 mg/m2 intravenously over 1 hour once every 7 days.
[INFORMATIONAL NOTE: Patients with preexisting severe neuropathy should be treated with Marqibo only after careful risk-benefit assessment. Dose and schedule modification guidelines for patients who experience peripheral neuropathy are included in the prescribing information for Marqibo.]
3. Marqibo (vincristine sulfate liposome injection) is considered medically necessary for continued therapy annually if ALL of the following criteria are met:
- Member continues to meet the initial criteria; AND
- There is stabilization of disease and/or absence of progression of disease; AND
- There is absence of unacceptable toxicity from the drug (e.g. peripheral motor and sensory neuropathy, central and autonomic neuropathy, myelosuppression
, (neutropenia, thrombocytopenia, anemia), tumor lysis syndrome, elevated liver function tests (ALT, AST, and bilirubin)).
4. Marqibo (vincristine sulfate liposome injection) is considered medically necessary for off-label indications that have in effect a rating of 'Category 1' or 'Category 2A' in the current recommendations in the National Comprehensive Cancer Network (NCCN) compendium. Refer to National Comprehensive Cancer Network: Drugs and Biologics Compendium - vincristine sulfate liposome. Available at: https://www.nccn.org/professionals/drug_compendium/content/.
5. Other uses of Marqibo (vincristine sulfdate liposome injection) are considered investigational.
Medicare Coverage
There is no National Coverage Determination (NCD or Local Coverage Determination (LCD) for jurisdiction JL for this service. Therefore, Medicare Advantage will follow the Horizon Policy. See generally: Local Coverage Article: Approved Drugs and Biologicals; Includes Cancer Chemotherapeutic Agents (A53049). Available at: https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=53049&ver=44&name=314*1&UpdatePeriod=711&bc=AQAAEAAAAAAAAA%3d%3d&
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:
Marqibo (Vincristine Sulfate Liposome Injection)
Vincristine Sulfate Liposome Injection (Marqibo)
Acute Lymphoblastic Leukemia, Marqibo for
ALL, Marqibo for
References:
1. Marqibo (vincristine sulfate liposome injection) Prescribing Information. Talon Therapeutics, Inc. South San Francisco, CA. September 2019.
2. Pui C. Chapter 93. Acute Lymphoblastic Leukemia. In: Prchal JT, Kaushansky K, Lichtman MA, Kipps TJ, Seligsohn U, eds. Williams Hematology. 8th ed. New York: McGraw-Hill; 2010. http://www.accessmedicine.com/content.aspx?aID=6127146. Accessed August 14, 2012.
3. American Cancer Society. Cancer Facts & Figures 2010. Atlanta: American Cancer Society; 2010.
4. Tavemier E, Boiron JM, Hugue F, et al. Outcome of treatment after first relapse in adults with acute lymphoblastic leukemia initially treated by the LALA-94 trial. Leukemia. 2007;21(9):1907-14.
5. Thomas DA, Kantarjian H, Smith TL, et al. Primary refractory and relapsed adult acute lymphoblastic leukemia: characteristics, treatment results, and prognosis with salvage therapy. Cancer. 1999;86(7):1216-30.
6. O’Brien S, Thomas D, Ravandi F, et al. Outcome of adults with acute lymphocytic leukemia after second salvage therapy. Cancer. 2008;113(11):3186-91.
7. National Comprehensive Cancer Network: Drugs and Biologics Compendium. Vincristine 2016. Available at http://www.nccn.org/professionals/drug_compendium/MatrixGenerator/Matrix.aspx?AID=68. [Accessed 2/26/2019]
8. MICROMEDEX® 1.0 (Healthcare Series). DRUGDEX® Evaluations. Vincristine. Available at: http://www.thomsonhc.com. Accessed April 30, 2016.
9. National Cancer Institute (NCI). To evaluate the safety, activity and pharmacokinetics of Marqibo in children and adolescents with refractory cancer. Available from: https://clinicaltrials.gov/ct2/show/NCT01222780?term=marqibo&rank=2. NLM identifier: NCT01222780. Accessed April 28, 2015
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
* 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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