Subject:
Onivyde (Irinotecan 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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Onivyde (irinotecan liposome injection), is a topoisomerase inhibitor indicated, in combination with fluorouracil and leucovorin, for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. The FDA granted Priority Review and orphan drug designations for Onivyde.
The effectiveness for metastatic adenocarcinoma of the pancreas was based on a three-arm, randomized, open label study of 417 patients with metastatic pancreatic adenocarcinoma whose cancer had grown after receiving the chemotherapeutic drug gemcitabine or a gemcitabine-based therapy. The study was designed to determine whether patients receiving Onivyde plus fluorouracil/leucovorin or Onivyde alone lived longer than those receiving fluorouracil/leucovorin. Patients treated with Onivyde plus fluorouracil/leucovorin lived an average of 6.1 months, compared to 4.2 months for those treated with only fluorouracil/leucovorin. There was no survival improvement for those who received only Onivyde compared to those who received fluorouracil/leucovorin. In addition, patients receiving Onivyde plus fluorouracil/leucovorin had a delay in the amount of time to tumor growth compared to those who received fluorouracil/leucovorin. The average time for those receiving Onivyde plus fluorouracil/leucovorin was 3.1 months compared to 1.5 months for those receiving fluorouracil/leucovorin.
The safety of Onivyde was evaluated in 398 patients who received either Onivyde with fluorouracil/leucovorin, Onivyde alone or fluorouracil/leucovorin. The most common side effects of treatment with Onivyde included diarrhea, fatigue, vomiting, nausea, decreased appetite, inflammation in the mouth and fever. Onivyde was also found to result in low counts of infection-fighting cells (lymphopenia and neutropenia). Death due to sepsis following neutropenia has been reported in patients treated with Onivyde. The labeling for Onivyde includes a boxed warning to alert health care professionals about the risks of severe neutropenia and diarrhea. Onivyde is not approved for use as a single agent for the treatment of patients with metastatic pancreatic cancer.
[INFORMATIONAL NOTE: Based on animal studies and its mechanism of action, Onivyde can cause fetal harm when administered to a pregnant woman. Embryotoxicity and teratogenicity were observed following treatment, at doses resulting in irinotecan exposures lower than those achieved with Onivyde 70 mg/m2 in humans, administered to pregnant rats and rabbits during organogenesis. Pregnant women should be advised of the potential risk to a fetus. Females of reproductive potential should be advised to use effective contraception during treatment with Onivyde and for one month following the final dose.]
Policy:
(NOTE: For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance)
The requirements of the Horizon BCBSNJ Onivyde (Irinotecan 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. Onivyde (irinotecan liposome injection) is medically necessary for the treatment of metastatic adenocarcinoma of the pancreas in members that meet ALL of the following criteria:
a. Member is at least 18 years or older; AND
b. Onivyde will be used in combination with fluorouracil AND leucovorin; AND
c. Member has disease progression following gemcitabine-based therapy; AND
d. The member does not have any form of bowel obstruction; AND
e. Member has not previously received prior conventional irinotecan therapy; AND
f. 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. When Onivyde (irinotecan liposome injection) is medically necessary, initial therapy will be approved for 12 weeks until disease progression or unacceptable toxicity based on FDA recommendations:
a. Starting dose of 70 mg/m2 intravenous infusion every two weeks
b. Individuals homozygous for UGT1A1*28 should be initiated at a reduced dose of 50 mg/m2 every two weeks
c. Withhold Onivyde for diarrhea of Grade 2--4 severity
d. Withhold Onivyde for absolute neutrophil count below 1500/mm3 or neutropenic fever
[INFORMATIONAL NOTE: Based on the FDA approved package insert, blood cell counts should be monitored periodically during treatment.. Premedicate with a corticosteroid and an anti-emetic 30 minutes prior to Onivyde. ]
3. Continued therapy with Onivyde (irinotecan liposome injection) will be considered 6 months based on the following criteria:
a. Member continues to meet initial criteria, AND
b. Evidence of tumor response with stabilization of disease or decrease in size of tumor or tumor spread;, AND
c. Absence of unacceptable toxicity from Onivyde, including severe diarrhea, severe neutropenia, pulmonary toxicity (interstitial lung disease), or severe hypersensitivity reactions.
[INFORMATIONAL NOTE: The median duration of Onivyde exposure in the clinical study was 9 weeks.]
4. Onivyde (irinotecan 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 - irinotecan liposome. Available at: https://www.nccn.org/professionals/drug_compendium/content/
5. Onivyde is considered not medically necessary when used as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas
6. Onivyde (irinotecan liposome injection) for the treatment of other conditions/diseases is considered investigational, including, but not limited to small cell lung cancer, glioblastoma, gastroesophageal cancer, or breast cancer.
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:
Onivyde (Irinotecan Liposome Injection)
Irinotecan Liposome Injection (Onivyde)
References:
1. Onivyde® [package insert]. Merrimack Pharmaceuticals, Inc. Cambridge, MA. July 2017.
2. Von Hoff D, Li C, Wang-Gillam A, et. al. Napoli-1: Randomized Phase 3 Study of MM-398 (NAL-IRI), With or Without 5-Flurouracil and Leucovorin, In Metastatic Pancreatic Cancer Progressed On Or Following Gemcitabine-based therapy. Ann Oncol (2014) 25 (suppl 2): ii105-ii106. doi: 10.1093/annonc/mdu193.3
3. FDA News Release: FDA approves new treatment for advanced pancreatic cancer. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm468654.htm
4. ClinicalTrials.gov accessed January 2019 at https://clinicaltrials.gov/ct2/results?term=irinotecan+liposome&Search=Search
5. NCCN Clinical Practice Guidelines in Oncology. Pancreatic Adenocarcinoma v 1.2020. [cited 2/4/2020]. Available from: https://www.nccn.org/professionals/physician_gls/pdf/pancreatic.pdf
6. ClinicalTrials.gov accessed January 21, 2020 at https://clinicaltrials.gov/ct2/show/NCT00361842?term=irinotecan+liposome+injection&rank=2
7. FDA Approved Drugs: Irinotecan liposome injection. Available at: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm468728.htm
8. NCCN Drugs & Biologics Compendium. Irinotecan liposome. Available at: https://www.nccn.org/professionals/drug_compendium/content/. Accessed 2/4/2020.
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
J9205
* 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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