Subject:
Lurbinectedin (Zepzelca)
Description:
_______________________________________________________________________________________
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.
__________________________________________________________________________________________________________________________
Small cell lung cancer (SCLC) accounts for approximately 15% of all lung cancers, or roughly 30,000 new patients in the United States annually. While it is generally more responsive to chemotherapy and radiation than other types of lung cancer, the disease often is widely disseminated by the time of diagnosis. Standard of care first-line chemotherapy for both limited- and extensive-stage disease is a platinum doublet, and, in the case of extensive stage SCLC, in combination with a checkpoint inhibitor. SCLC is sensitive to platinum-based chemotherapy in the first-line setting but almost universally relapses, requiring subsequent lines of therapy. Of patients diagnosed with SCLC, approximately 55% to 90% will receive first-line treatment; of these, approximately 20% to 40% will receive second-line treatment, and approximately 10% to 18% will receive third-line therapy.
On June 15, 2020, the Food and Drug Administration granted accelerated approval to lurbinectedin (ZEPZELCA, Pharma Mar S.A.) for adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. Efficacy was demonstrated in the PM1183-B-005-14 trial (Study B-005; NCT02454972), a multicenter open-label, multi-cohort study enrolling 105 patients with metastatic SCLC who had disease progression on or after platinum-based chemotherapy. Patients received lurbinectedin 3.2 mg/m2 by intravenous infusion every 21 days until disease progression or unacceptable toxicity.
The main efficacy outcome measures were confirmed overall response rate (ORR) determined by investigator assessment using RECIST 1.1 and response duration. Among the 105 patients, the ORR was 35% (95% CI: 26%, 45%), with a median response duration of 5.3 months (95% CI: 4.1, 6.4). The ORR as per independent review committee was 30% (95% CI: 22%, 40%) with a median response duration of 5.1 months (95% CI: 4.9, 6.4).
The most common adverse reactions (≥20%), including laboratory abnormalities, were myelosuppression, fatigue, increased creatinine, increased alanine aminotransferase, increased glucose, nausea, decreased appetite, musculoskeletal pain, decreased albumin, constipation, dyspnea, decreased sodium, increased aspartate aminotransferase, vomiting, cough, decreased magnesium and diarrhea.
The recommended lurbinectedin dose is 3.2 mg/m2 every 21 days.
This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Policy:
(NOTE: For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance.)
I. 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. Lurbinectedin (Zepzelca) is medically necessary for adult patients with the FDA labeled indication of metastatic small cell lung cancer (SCLC) when all of the following criteria are met:
A. Member has an ECOG performance score of ≤2
B. Member has advanced or metastatic disease
C. Member has disease progression on or after at least one line of platinum-based chemotherapy
[INFORMATIONAL NOTE: As per the FDA labeled package insert, Zepzelca can cause fetal harm. Advise females and males of reproductive potential the potential risk to a fetus and to use an effective method of contraception.]
III. When lurbinectedin (Zepzelca) is medically necessary, therapy will be approved for 6 months at the following FDA approved recommended doses:
A. 3.2 mg/m2 every 21 days over a 60 minute intravenous infusion until disease progression or unacceptable toxicity
[INFORMATIONAL NOTE: As per the FDA labeled package insert, consider premedication with corticosteroids and serotonin antagonists for antiemetic prophylaxis. Initiate treatment with Zepzelca only if absolute neutrophil count (ANC) is at least 1,500 cells/mm3 and platelet count is at least 100,000/mm3.]
IV. Continuation of lurbinectedin (Zepzelca) will be approved every 6 months if the following criteria are met:
A. Member shows treatment response (e.g. decrease in tumor progression, partial or complete response to therapy)
B. There is absence of intolerable adverse effects (e.g.: severe myelosuppression, hepatoxicity, leukopenia, lymphophenia, etc.)
V. Lurbinectedin (Zepzelca) is considered medically necessary for the following off-label indications:
A. Subsequent systemic therapy for patients with performance status 0-2 as a single agent
1. for relapse within 6 months following complete or partial response or stable disease with initial treatment (preferred)
2. for relapse occurring more than 6 months following complete or partial response or stable disease with initial treatment
3. for primary progressive disease
VI. Other uses of lurbinectedin (Zepzelca) 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 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
________________________________________________________________________________________
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.
___________________________________________________________________________________________________________________________
Index:
Lurbinectedin (Zepzelca)
Zepzelca (Lurbinectedin)
References:
1. Zepzelca (lurbinectedin) [package insert]. Pharma Mar, S.A. & Jazz Pharmaceuticals, Inc. Palo Alto, CA. June 2020.
2. Lurbinectedin. Unapproved Product Dossier. Jazz Pharmaceuticals, Inc. May 19, 2020.
3. FDA grants accelerated approval to lurbinectedin for metastatic small cell lung cancer. FDA Drug Approvals and Databases. June 16, 2020. Available at: https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-lurbinectedin-metastatic-small-cell-lung-cancer
4. National Comprehensive Cancer Network: Drugs and Biologics Compendium. Available at https://www.nccn.org/professionals/drug_compendium/content/.
5. ClinicalTrials.gov. Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors. NCT02454972. Available at: https://clinicaltrials.gov/ct2/show/NCT02454972
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.
_________________________________________________________________________________________
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
____________________________________________________________________________________________________________________________ |