Subject:
Sacituzumab govitecan-hziy (Trodelvy)
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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According to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines, triple-negative breast cancer (TNBC) is a term that has historically been applied to cancers that lack expression of the estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2). Hence, medications that target those receptors do not work in TNBC. In addition, TNBC is usually more aggressive, harder to treat, and there are fewer medications with which to treat. Unlike other breast cancer subtypes (ER-positive, HER2-positive subtypes), there are no approved targeted treatments available, although immunotherapy (in combination with chemotherapy) is available for those with advanced TNBC that expresses programmed cell death ligand 1 (PD-L1). Although the basic principles of diagnosis and management of TNBC are similar to those of breast cancer in general, many aspects, including risk factors, molecular and pathologic characteristics, natural history, and chemotherapy sensitivity, are unique to TNBC.
TNBC accounts for approximately 15% of breast cancers diagnosed worldwide, which amounts to almost 200,000 cases each year. Compared with hormone receptor-positive breast cancer, TNBC is more commonly diagnosed in women younger than 40 years. Risk factors associated with the diagnosis of TNBC include positive BRCA mutation status, African American race, and premenopausal status. Chemotherapy has been the mainstay of systemic treatment for TNBC, as endocrine therapy and HER2-directed therapies are ineffective. However, several trials have suggested a role for targeted therapies in TNBC including inhibitors of polyadenosine diphosphate-ribose polymerase (PARP) and immune checkpoints.
On April 22, 2020, the Food and Drug Administration granted accelerated approval to Trodelvy (sacituzumab govitecan-hziy) for adult patients with metastatic triple-negative breast cancer (mTNBC) who received at least two prior therapies for metastatic disease. Trodelvy (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate that attaches to the Trop-2 protein found on the surface of many types of solid tumors, including breast tumors. Once attached to tumors, the antibody-conjugate induces apoptosis. This indication was approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Efficacy was demonstrated in IMMU-132-01 (NCT 01631552), a multicenter, single-arm, trial enrolling 108 patients with metastatic triple negative breast cancer who received at least two prior treatments for metastatic disease. Patients received sacituzumab govitecan-hziy 10 mg/kg intravenously on days 1 and 8 every 21 days. Tumor imaging was obtained every 8 weeks, and patients were treated until disease progression or intolerance to therapy. The primary efficacy outcome measures were investigator assessed overall response rate (ORR) using RECIST 1.1 and response duration. The ORR was 33.3% (95% CI: 24.6, 43.1). The median response duration was 7.7 months (95% CI: 4.9, 10.8).
The most common adverse reactions (≥25% of patients) were nausea, neutropenia, diarrhea, fatigue, anemia, vomiting, alopecia, constipation, rash, decreased appetite, and abdominal pain. Trodelvy (sacituzumab govitecan-hziy) can also cause severe neutropenia and diarrhea. The prescribing information for Trodelvy (sacituzumab govitecan-hziy) includes a Boxed Warning to advise health care professionals and patients about the risk of severe neutropenia (abnormally low levels of white blood cells) and severe diarrhea. Trodelvy (sacituzumab govitecan-hziy) may need to be withheld, dose reduced or permanently discontinued for neutropenia or diarrhea.
Trodelvy (sacituzumab govitecan-hziy) is an injection. It is given directly into the vein (intravenous infusion) by a healthcare provider once weekly on Days 1 and 8 of 21-day treatment cycles.
Policy:
(NOTE: For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance)
I. Trodelvy (sacituzumab govitecan-hziy) is medically necessary for adults with metastatic triple-negative breast cancer when ALL of the following criteria are met:
a. 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
b. Member is 18 years and older
c. Member has stage IV (metastatic) disease
d. Member is refractory to or relapsed after at least two prior therapies for metastatic disease (e.g. taxanes, anthracyclines, cyclophosphamide, platinum agents, gemcitabine, fluoropyrimidine agents, eribulin, vinorelbine)
e. Member has an ECOG performance score of 0 or 1
f. Member is not pregnant
[INFORMATIONAL NOTE: As per NCCN Guidelines Version 3.2020 - Invasive Breast Cancer, systemic therapy regimens for recurrent or stage IV (M1) disease HER2-negative include:
- Single-agent preferred regimens
- Anthracyclines (doxorubicin, liposomal doxorubicin)
- Taxanes (paclitaxel)
- Anti-metabolites (capecitabine, gemcitabine)
- Microtubule inhibitors (vinorelbine, eribulin)
- For germline BRAC1/2 mutations: PARP inhibitors (olaparib, talazoparib)
- Platinum (option for patients with triple-negative tumors and germline BRAC1/2 mutations; carboplatin, cisplatin)
- For PD-L1-positive TNBC: atezolizumab plus albumin-bound paclitaxel
- Other recommended regimens
- Cyclophosphamide
- Docetaxel
- Cisplatin
- Epirubicin
- Ixabepilone
- Useful in certain circumstances
- AC (doxorubicin/cyclophosphamide)
- EC (epirubicin/cyclophosphamide)
- CMF (cyclophosphamide/methotrexate/fluorouracil)
- Docetaxel/capecitabine
- GT (gemcitabine/paclitaxel)
- Gemcitabine/carboplatin
- Paclitaxel/bevacizumab
- Carboplatin/albumin-bound paclitaxel
- Carboplatin/paclitaxel]
II. When considered medically necessary, Trodelvy (sacituzumab govitecan-hziy) will be approved for 6 months at the following FDA approved dosing:
a. 10 mg/kg administered as an intravenous infusion once weekly on Days 1 and 8 of 21-day treatment cycles
[INFORMATIONAL NOTE: As per the FDA labeled package insert dosing section, continue treatment until disease progression or unacceptable toxicity. Do not administer Trodelvy at doses greater than 10 mg/kg.]
III. Continued therapy of Trodelvy (sacituzumab govitecan-hziy) will be approved for 12 months when ALL of the following are met:
a. Tumor response with stabilization of disease or decrease in size of tumor
b. Absence of unacceptable toxicity from the drug (e.g. hypersensitivity, severe neutropenia, severe diarrhea, etc.)
IV. Trodelvy (sacituzumab govitecan-hziy) is considered medically necessary for the following off-label uses:
- Breast Cancer - Invasive Breast Cancer
- Treatment of recurrent or stage IV (M1) triple-negative disease in patients who received at least two prior therapies for metastatic disease
V. Other uses of Trodelvy (sacituzumab govitecan-hziy) 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
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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:
Sacituzumab govitecan-hziy (Trodelvy)
Trodelvy (Sacituzumab govitecan-hziy)
References:
1. Hammond ME, Hayes DF, Dowsett M, et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer (unabridged version). Arch Pathol Lab Med 2010; 134:e48.
2. Wolff AC, Hammond ME, Hicks DG, et al. Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update. J Clin Oncol 2013; 31:3997.
3. Swain S. Triple-Negative Breast Cancer: Metastatic Risk and Role of Platinum Agents 2008 ASCO Clinical Science Symposium, 2008. June 3, 2008.
4. Trivers KF, Lund MJ, Porter PL, et al. The epidemiology of triple-negative breast cancer, including race. Cancer Causes Control 2009; 20:1071.
5. FDA grants accelerated approval to sacituzumab govitecan-hziy for metastaic triple negative breast cancer. U.S. Food & Drug Administration. April 22, 2020. Available at: https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-sacituzumab-govitecan-hziy-metastatic-triple-negative-breast-cancer
6. Trodelvy (sacituzumab govitecan-hziy) [package insert]. Immunomedics, Inc. Morris Plains, NJ. April 2020.
7. UpToDate. ER/PR negative, HER2-negative (triple-negative) breast cancer. Accessed May 7, 2020. https://www.uptodate.com
8. Phase I/II Study of IMMU-132 in Patients With Epithelial Cancers. ClinicalTrials.gov. NCT01631552. Available at:https://clinicaltrials.gov/ct2/show/NCT01631552
9. Bardia A, Mayer IA, et al. Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer. N Engl J Med 2019; 380:741-751. Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa1814213?url_ver=Z39.88-2003&rfr_id=ori%3Arid%3Acrossref.org&rfr_dat=cr_pub%3Dpubmed
10. National Comprehensive Cancer Network. NCCN Guidelines Version 3.2020. Invasive Breast Cancer. Systemic therapy regiments for recurrent or stage IV (M1) disease. Available at: https://www.nccn.org/professionals/physician_gls/pdf/breast_blocks.pdf
11. National Comprehensive Cancer Network. NCCN Drugs & Biologics Compendium. Trodelvy. Available at: https://www.nccn.org/professionals/drug_compendium/content/. Accessed 5/11/2020.
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
* 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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