Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Paclitaxel Protein-bound Particles for Injectable Suspension (Albumin-bound) / (Abraxane® for Injectable Suspension)

Policy #:08.00.90i

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

MEDICALLY NECESSARY

Paclitaxel protein-bound particles for injectable suspension (albumin-bound) (Abraxane® for injectable suspension) are considered medically necessary and, therefore, covered for any of the following indications:

AIDS-RELATED KAPOSI SARCOMA
Subsequent systemic therapy given with antiretroviral therapy (ART) for relapsed/refractory advanced, cutaneous, oral, visceral, or nodal disease that has progressed on or not responded to first-line systemic therapy, and progressed on alternate first-line systemic therapy

BLADDER CANCERS
  • Bladder Cancer
    • Single agent as subsequent systemic therapy post-platinum or post-checkpoint inhibitor for:
      • stage IIIB (cT1-T4a, N2,3) disease following partial response or progression after primary treatment with downstaging systemic therapy
      • stage IVA (cT4b, any N, M0) disease if tumor is present following reassessment of tumor status after primary treatment with systemic therapy
      • stage IVB (any T, any N, M1b) disease
      • metastatic or local recurrence post cystectomy
  • Upper Genitourinary Tract Tumors
Therapy for metastatic disease as a single agent for subsequent systemic therapy post-platinum or subsequent systemic therapy post-checkpoint inhibitor
  • Urothelial Carcinoma of the Prostate
Therapy for metastatic disease as a single agent for subsequent systemic therapy post-platinum or subsequent systemic therapy post-checkpoint inhibitor
  • Primary Carcinoma of the Urethra
    • Single agent for recurrent disease (excluding clinical stage T3-4 disease or palpable inguinal lymph nodes) or metastatic disease as:
      • subsequent systemic therapy post-platinum
      • subsequent systemic therapy post-checkpoint inhibitor

BREAST CANCER, INVASIVE
  • Single agent for recurrent Stage IV (M1) human epidermal growth factor receptor 2 (HER2) negative disease:
    • With symptomatic visceral disease or visceral crisis
    • That is hormone receptor-negative or hormone receptor-positive and endocrine therapy refractory
  • Therapy in combination with trastuzumab (Herceptin®) for HER2-positive recurrent Stage IV (M1) disease
    • With symptomatic visceral disease or visceral crisis
    • That is hormone receptor-negative or hormone receptor-positive and endocrine therapy refractory
  • As a substitute for paclitaxel (i.e., Taxol®, Onxol®) or docetaxel (i.e., Taxotere) for hypersensitivity reactions

Human Epidermal Growth Factor 2 (HER2) Testing For the Treatment of Breast Cancer

Paclitaxel protein-bound particles for injectable suspension (albumin-bound) (Abraxane® for injectable suspension) is considered medically necessary and, therefore, covered for the indication(s) identified above for individuals who meet the applicable criteria, and, whose results have been verified by one of the following US Food and Drug Administration (FDA)--approved diagnostic tests:
  • Immunohistochemical (IHC) assay with a result of 0 or 1+
  • Fluorescence in situ hybridization (FISH) test (ratio less than 1.8)
  • Single-probe in situ hybridization (ISH) test with average HER2 copy number less than 4.0 signals/cell
  • Dual-probe ISH test HER2/CEP17 (chromosome enumeration probe 17) ratio less than 4.0 signals/cell

Confirmatory tests should be performed for borderline results as follows:
  • If IHC assay has a result of 2+, confirm with ISH test of the same sample or a new test with IHC or ISH (if new sample available).
  • If FISH test has a HER2 gene/chromosome 17 ratio of 1.8-2.0, confirm with FISH re-test; additional cell counting and recalculation of the ratio; or IHC assay.
  • If single-probe ISH assay has an average HER2 copy number result of 4.0 to less than 6.0 signals/cell, confirm with dual-probe ISH or with IHC (if same sample), or with a new ISH or IHC (if new sample available).
  • If dual-probe ISH assay has a HER2/CEP17 ratio less than 2.0 and an average HER2 copy number result of 4.0 to less than 6.0 signals/cell, confirm with one of the following: IHC (if same sample), alternative ISH chromosome 17 probe, or order a new test with ISH or IHC (if new sample available).

BREAST CANCER, METASTATIC
Treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior chemotherapy must have included an anthracycline unless clinically contraindicated.

NON-SMALL-CELL LUNG CANCER (NSCLC)
  • First-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in individuals who are not candidates for curative surgery or radiation therapy
  • Treatment for recurrent, advanced, or metastatic disease as first-line therapy for PD-L1 expression positive (≥50%) tumors that are EGFR, ALK negative or unknown and no contraindications to the addition of pembrolizumab or atezolizumab and performance status 0-2 in combination with pembrolizumab and either carboplatin or cisplatin for squamous cell histology
  • Treatment for recurrent, advanced, or metastatic disease as a single agent for individuals with the Eastern Cooperative Oncology Group [ECOG] performance status (PS) 2, or in combination with carboplatin for PS 0-2 (if contraindications to the addition of pembrolizumab or atezolizumab and PS 0-1 for nonsquamous cell histology, or if contraindications to the addition of pembrolizumab and PS 0-1 for squamous cell histology), in combination with carboplatin and pembrolizumab (as a preferred regimen if no contraindications to the addition of pembrolizumab, squamous cell histology and PS 0-1), or in combination with cisplatin and pembrolizumab (if no contraindications to the addition of pembrolizumab, squamous cell histology and PS 0-1) as:
    • Initial systemic therapy for EGFR, ALK, ROS1, BRAF negative or unknown, and PD-L1 <50% or unknown
    • Subsequent therapy for sensitizing EGFR mutation-positive tumors and prior erlotinib, afatinib,gefitinib, or osimertinib, or dacomitinib therapy
    • First-line or subsequent therapy for BRAF V600E-mutation positive tumors
    • Subsequent therapy for ALK rearrangement-positive tumors and prior crizotinib, certinib, alectinib, or brigatinib therapy
    • Subsequent therapy for ROS1 rearrangement-positive tumors and prior crizotinib or ceritinib therapy
    • Subsequent therapy for PD-L1 expression-positive (50%) tumors and EGFR, ALK negative or unknown and no prior platinum-doublet chemotherapy
  • May be substituted for either paclitaxel or docetaxel in individuals who have experienced hypersensitivity reactions after receiving paclitaxel or docetaxel despite premedication, or for individuals in whom standard hypersensitivity premedication are contraindicated

OVARIAN CANCER-EPITHELIAL OVARIAN CANCER/FALLOPIAN TUBE CANCER/PRIMARY PERITONEAL CANCER
  • Therapy for persistent disease or recurrence
    • if platinum-sensitive, in combination with carboplatin for individuals with confirmed taxane hypersensitivity (excluding immediate treatment for biochemical relapse)
    • as a single agent (excluding immediate treatment for biochemical relapse)

PANCREATIC ADENOCARCINOMA
  • Neoadjuvant treatment (NCCN-preferred) in combination with gemcitabine, with or without subsequent chemoradiation for:
    • Resectable disease with high-risk features (i.e., very highly elevated CA 19-9, large primary tumors, large regional lymph nodes, excessive weight loss, extreme pain)
  • First-line chemotherapy, or induction therapy followed by chemoradiation in selected individuals, without systemic metastases, with locally advanced disease and good performance status (ECOG PS 0-2) in combination with gemcitabine (NCCN-preferred regimen)
  • NCCN-preferred first line therapy for metastatic disease in individuals with good performance status (ECOG PS 0-2), in combination with gemcitabine
  • Second-line treatment in combination with gemcitabine for locally advanced or metastatic disease for individuals with good performance status (ECOG PS 0-2), and disease progression who were previously treated with fluoropyrimidine-based therapy
  • Therapy with (if not previously done) or without chemoradiation in combination with gemcitabine for local recurrence in the pancreatic operative bed after resection or for metastatic disease with or without local recurrence if ≥6 months from completion of primary therapy in individuals with good performance status (ECOG PS 0-2)
  • Therapy in combination with gemcitabine for metastatic disease with or without local recurrence if less than 6 months from completion of primary therapy in individuals with good performance status (ECOG PS 0-2) previously treated with fluoropyrimidine-based therapy

MELANOMA, CUTANEOUS
Single-agent therapy for metastatic or resectable disease as second-line or subsequent therapy for disease progression or after maximum clinical benefit from BRAF targeted therapy

MELANOMA, UVEAL
Single agent therapy for metastatic or resectable disease

UTERINE NEOPLASMS
  • Primary treatment of endometrial carcinoma as a single agent:
    • For select individuals with disease limited to the uterus that is not suitable for primary surgery
    • With sequential external beam radiation therapy (EBRT) and brachytherapy for disease not suitable for primary surgery in individuals with suspected or gross cervical involvement
    • Preoperatively for individuals presenting with abdominal/pelvic confined disease that is suitable for primary surgery
    • With or without sequential EBRT and/or brachytherapy for extrauterine disease that is not suitable for primary surgery
    • With or without EBRT and/or hormonal therapy for distant metastases
  • Single-agent adjuvant treatment for endometrial carcinoma in surgically staged individuals:
    • With sequential EBRT and/or vaginal brachytherapy, for stage IB disease and histologic grade 3 tumors
    • With sequential EBRT with or without vaginal brachytherapy for stage IIIA-IVA disease
    • With or without vaginal brachytherapy for stage IIIA-IVA disease
    • With or without sequential EBRT and vaginal brachytherapy for stage IVB disease
  • Single-agent therapy for treatment of endometrial carcinoma:
    • Disseminated metastases that have progressed on hormonal therapy
    • With or without sequential palliative EBRT for symptomatic, grade 2, 3, or large volume disseminated metastases or for local/regional recurrence in individuals with gross upper abdominal residual disease
    • With sequential EBRT with or without brachytherapy for local/regional recurrence in individuals with disease confined to the vagina or in pelvic lymph nodes
    • With sequential EBRT for local/regional recurrence in individuals with disease in para-aortic or common iliac lymph nodes
    • With or without sequential tumor-directed EBRT for local/regional recurrence in individuals with microscopic residual upper abdominal or peritoneal disease
    • With or without sequential palliative EBRT for local/regional recurrence in individuals who have received prior EBRT to site of recurrence
  • Single-agent therapy for endometrial carcinoma
    • for disease suitable for primary surgery as additional treatment with vaginal brachytherapy for stage IA disease (NCCN-preferred)
    • for disease suitable for primary surgery as additional treatment with or without sequential external beam radiation therapy (EBRT) with or without vaginal brachytherapy for stage IB-IV disease
    • for disease not suitable for primary surgery as primary treatment with or without sequential EBRT and with or without brachytherapy

EXPERIMENTAL/INVESTIGATIONAL

All other uses for paclitaxel protein-bound particles for injectable suspension (albumin-bound) (Abraxane® for injectable suspension) are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the medical policy on off-label coverage for prescription drugs and biologics.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug.
Guidelines

BLACK BOX WARNINGS

Refer to the specific manufacturer's prescribing information for any applicable Black Box Warnings.

THE EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) PERFORMANCE STATUS

The ECOG Performance Status was originally published in 1982 in the American Journal of Clinical Oncology*. ECOG states: "These scales and criteria are used by doctors and researchers to assess how an individual's disease is progressing, assess how the disease affects the daily living abilities of the individual, and determine appropriate treatment and prognosis. They are included here for health care professionals to access."

KARNOFSKY PERFORMANCE STATUS

The Karnofsky Performance Status is a method to assess the ability of an individual with cancer to perform ordinary tasks. This method is used to score functional impairment, compare the effectiveness of therapies, and assess the prognosis of a patient. The Karnofsky index ranges between 100 and 0.

Karnofsky Performance Status
ECOG Performance Status
100- Normal; no evidence of disease0- Fully active, able to carry on all pre-disease performance without restriction
90- Minor signs or symptoms of disease
80- Normal activity with effort; some signs or
symptoms
1- Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
70- Cares for self; unable to carry on normal
activity
60- Occasional assistance required; capable of most
self-care
2- Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50 percent of waking hours
50- Requires assistance, frequent medical care
40- Disabled; requires special care/assistance
3- Capable of only limited self care, confined to bed or chair more than 50 percent of waking hours
30- Severely disabled; hospitalization indicated
20- Hospitalization necessary; requires active
supportive care
10- Moribund; progressing rapidly
4- Completely disabled. Cannot carry on any self care: totally confined to bed or chair
0- Dead5- Dead

*Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol.1982;5(6):649-655.

*Karnofsky DA, Burchenal JH. The clinical evaluation of chemotherapeutic agents in cancer. In: Macleod CM, ed. Evaluation of Chemotherapeutic Agents in Cancer. New York: Columbia University Press; 1949:191-205.


BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, paclitaxel protein-bound particles for injectable suspension (albumin-bound) (Abraxane® for injectable suspension) are covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Paclitaxel protein-bound particles for injectable suspension (albumin-bound) (Abraxane® for injectable suspension) was approved by the FDA on January 7, 2005, for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.

On October 11, 2012, the FDA granted paclitaxel protein-bound particles for injectable suspension (albumin-bound) (Abraxane® for injectable suspension), a supplemental approval for use in combination with carboplatin for the initial treatment of individuals with locally advanced or metastatic non-small-cell lung cancer who are not candidates for curative surgery or radiation therapy.

On September 6, 2013, the FDA approved paclitaxel protein-bound particles for injectable suspension (albumin-bound) (Abraxane® for injectable suspension), a supplemental approval for use in combination with gemcitabine for the first-line treatment of adults with metastatic adenocarcinoma of the pancreas.

PEDIATRIC USE

The safety and effectiveness of paclitaxel protein-bound particles for injectable suspension (albumin-bound) (Abraxane® for injectable suspension) in the pediatric population have not been evaluated.

Description

Paclitaxel protein-bound particles for injectable suspension (albumin-bound) (Abraxane® for injectable suspension) is an antimicrotubule agent that promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depolymerization. This stability results in the inhibition of the normal dynamic reorganization of the microtubule network that is essential for vital interphase and mitotic cellular functions. Abraxane® is an albumin-bound form of paclitaxel, a natural product with antitumor activity. In contrast to solvent-based paclitaxel, which requires premedication to decrease the risks of hypersensitivity reactions (e.g., difficulty breathing, hives, swollen eyes and lips), Abraxane® requires no premedication.

Paclitaxel protein-bound particles for injectable suspension (albumin-bound) (Abraxane® for injectable suspension) was approved by the US Food and Drug Administration (FDA) on January 7, 2005, for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or after relapse within 6 months of adjuvant chemotherapy. Per the FDA label, prior therapy should include an anthracycline unless clinically contraindicated.

The FDA approval was based on a randomized, comparative, multicenter study of 460 individuals that compared standard paclitaxel with premedication to Abraxane® without premedication in individuals with metastatic breast cancer. Individuals on the Abraxane® treatment had a statistically significantly higher reconciled target lesion response rate of 21.5% compared to 11.1% for individuals on the standard paclitaxel therapy. There was no significant difference in overall survival between the two groups.

On October 11, 2012, the FDA approved paclitaxel protein-bound particles for injectable suspension (albumin- bound) (Abraxane® for injectable suspension) for use in combination with carboplatin for the initial treatment of individuals with locally advanced or metastatic non-small-cell lung cancer who are not candidates for curative surgery or radiation therapy. The FDA approval was based on a multicenter, randomized, open-label study that was conducted comparing Abraxane® in combination with carboplatin to paclitaxel injection in combination with carboplatin as first-line treatment in 1052 chemo-naive individuals with advanced non-small-cell lung cancer. Paclitaxel injection was administered as an intravenous infusion following premedication. In both treatment arms, carboplatin was administered intravenously on Day 1 of each 21-day cycle after completion of Abraxane®/paclitaxel infusion. Treatment was administered until disease progression or development of an unacceptable toxicity. Individuals in the Abraxane®/carboplatin arm had a statistically significantly higher overall response rate compared to individuals in the paclitaxel injection/carboplatin arm (33% versus 25%). There was no statistically significant difference in overall survival between the two study arms.

On September 6, 2013, the FDA approved paclitaxel protein-bound particles for injectable suspension (albumin bound) (Abraxane® for injectable suspension) as first-line treatment for use to treat individuals with metastatic adenocarcinoma of the pancreas in combination with gemcitabine. The FDA approval was based on a multicenter, multinational, open-label study, conducted in individuals with metastatic adenocarcinoma of the pancreas (n=861). Abraxane® in combination with gemcitabine were compared with gemcitabine monotherapy as first-line treatment. Individuals in the Abraxane®/gemcitabine arm, on average, lived 1.8 months longer than those in the gemcitabine monotherapy arm. Additionally, individuals in the Abraxane®/gemcitabine arm also experienced longer median progression-free survival (delay in tumor growth) than those in the gemcitabine monotherapy arm (5.5 months versus 3.7 months).

DIAGNOSTIC TESTS FOR HER2 PROTEIN OVEREXPRESSION

HER2 protein overexpression is detected either by immunohistochemical (IHC) assay or with a type of in situ hybridization (ISH) test for gene amplification (e.g., fluorescence in situ hybridization [FISH], chromogenic in situ hybridization [CISH], dual in situ hybridization [DISH]. Each technique has its own advantages and disadvantages, such as accuracy of results, timeliness of results, and whether the sample will fade over time. The FDA has approved several commercially available tests to aid in the selection of breast cancer patients for Abraxane® therapy. The NCCN and American Society of Clinical Oncology (ASCO) guidelines further recommend that IHC assay and ISH testing should only be done at laboratories that are accredited to perform HER2 testing.
  • An IHC test result is reported as 0 or 1+ (negative), 2+ (borderline), or 3+ (positive).
  • A FISH test result is reported as a HER2 gene/chromosome 17 ratio less than 1.8 (negative), a ratio of 1.8 to less than 2.0 (borderline), or a ratio of 2.0 or greater (positive).
  • A single-probe ISH test result is reported as: average HER2 copy number less than 4.0 signals/cell (negative); 4.0 to less than 6.0 signals/cell (borderline); 6.0 or greater signals/cell (positive).
  • A dual-probe ISH test result is reported as HER2/CEP17 (chromosome enumeration probe 17) ratio 2.0 or greater (positive); HER2/CEP17 ratio less than 2.0 AND average HER2 copy number less than 4.0 signals/cell (negative); HER2/CEP17 ratio less than 2.0 AND average HER2 copy number 4.0 to less than 6.0 signals/cell (borderline); HER2/CEP17 ratio less than 2.0 AND average HER2 copy number 6.0 signals/cell or greater (positive).

The NCCN and ASCO both have issued guidelines for HER2 testing in invasive breast cancer that call for confirming a borderline or equivocal result:
  • IHC assay result of 2+: confirm with ISH test (if same sample), or with a new IHC or ISH test (if new sample available).
  • FISH assay: confirm with either a repeat FISH test or an additional cell counting and recalculation of the ratio. If a repeat FISH test remains equivocal, then an IHC assay is recommended for confirmation.
  • Single-probe ISH assay: confirm with dual-probe ISH or with IHC (if same sample), or with a new ISH or IHC (if new sample available).
  • Dual-probe ISH assay: confirm with one of the following: IHC (if same sample), alternative ISH chromosome 17 probe, or order a new test with ISH or IHC (if new sample available).

OFF-LABEL INDICATIONS

There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company’s off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.
References


Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound). [prescribing information]. Summit, NJ: Celgene Corporation: August 2018. Available at: https://www.abraxane.com/ . Accessed November 14, 2018.

American Hospital Formulary Service (AHFS). Drug Info 2018. Abraxane. [Lexi-Comp website]. 08/10/2017. Available at: http://online.lexi.com/lco/action/home# [via subscription only]. Accessed November 15, 2018.

Elsevier Gold's Standard Clinical Pharmacology Compendium. Nanoparticle Albumin-Bound Paclitaxel. [ClinicalKey Web site]. 11/14/2018. Available at: https://www.clinicalkey.com/pharmacology/ [via subscription only]. Accessed November 15, 2018.

Giordano SH, Temin S, Kirshner JJ, et al. Systemic therapy for patients with advanced human epidermal growth factor receptor 2-positive breast cancer: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2014;May 5.

Gradishar W, Tjulandin S, Davidson N, et al. Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer. J Clin Oncol. 2002;23(31):7794-7803 [via subscription only].

Hammond MEH, Hayes DF, Dowsett M, et al. ASCO-CAP guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer. J Clin Oncol. 2010;28(16):2784-2795.

Harris L, Fritsche H, Mennel R, et al. American Society of Clinical Oncology 2007 update of recommendations for the use of tumor markers in breast cancer. J Clin Oncol. 2007; 25(33):5287-5312.

Hersh Evan M, et al. A phase 2 clinical trial of nab–paclitaxel in previously treated and chemotherapy–naive patients with metastatic melanoma. Cancer.2010;116(1):155-63.

Karnofsky DA, Burchenal JH. The clinical evaluation of chemotherapeutic agents in cancer. In: Macleod CM, ed. Evaluation of Chemotherapeutic Agents in Cancer. New York: Columbia University Press; 1949:191-205.

Kottschade Lisa A, et al. A phase II trial of nab–paclitaxel (ABI–007) and carboplatin in patients with unresectable stage IV melanoma. Cancer. 2011;117(8):1704-10.

Lexi-Drugs Compendium. Abraxane. 10/31/18. [Lexicomp Online Web site]. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed November 14, 2018.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - AIDS-related Kaposi Sarcoma. V1.2019. [NCCN Web site]. 10/19/2018. Available at:http://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed November 15, 2018.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Bladder cancer. V5.2018. [NCCN Web site]. 07/03/2018. Available at:https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf. Accessed November 14, 2018.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Breast cancer.V3.2018. [NCCN Web site]. 10/25/2018. Available at:http://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed November 15, 2018.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Cutaneous Melanoma V1.2019. [NCCN Web site]. 11/01/2018. Available at: http://www.nccn.org/professionals/physician_gls/pdf/melanoma.pdf. Accessed November 14, 2018.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Non-small cell lung cancer. V1.2019. [NCCN Web site]. 10/19/2018. Available at: https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed November 15, 2018.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Ovarian Cancer. V2.2018. [NCCN Web site]. 03/09/2018. Available at:http://www.nccn.org/professionals/physician_gls/pdf/ovarian.pdf. Accessed November 15, 2018.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Pancreatic adenocarcinoma. V1.2019. [NCCN Web site]. 11/08/2018. Available at: http://www.nccn.org/professionals/physician_gls/pdf/pancreatic.pdf. Accessed November 15, 2018.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Uterine Neoplasms. V1.2019. [NCCN Web site]. 10/17/2018. Available at: https://www.nccn.org/professionals/physician_gls/pdf/uterine.pdf. Accessed November 15, 2018.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Uveal Melanoma. V1.2018. [NCCN Web site]. 03/15/2018. Available at: https://www.nccn.org/professionals/physician_gls/pdf/uterine.pdf. Accessed November 14, 2018.

National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium.Paclitaxel, albumin bound. [NCCN Web site]. Available at: https://www.nccn.org/professionals/drug_compendium/content/ [via subscription only]. Accessed November 8, 2018.

Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol.1982;5(6):649-655.

Truven Health Analytics. Micromedex® DrugDex® Compendium. Paclitaxel protein-bound. 10/31/2018. Greenwood Village, CO. [Micromedex® Solutions Web site]. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed November 14, 2018.

US Food and Drug Administration (FDA). Center for Biologics Evaluation and Research. Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound). Approval letter. [FDA Web site]. 01/07/2005. Available at:http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021660ltr.pdf. Accessed November 8, 2018.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Drugs@FDA. Drug details: Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound). [FDA Web site]. Original: 01/07/05. (Revised: 08/16/18). Available at: https://www.accessdata.fda.gov/scripts/cder/daf/ . Accessed November 8, 2018.





Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

See Attachment A


HCPCS Level II Code Number(s)

J9264 Injection, paclitaxel protein-bound particles, 1 mg


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References

Attachment A: Paclitaxel Protein-bound Particles for Injectable Suspension (Albumin-bound) / (Abraxane® for Injectable Suspension)
Description: ICD-10 codes




Policy History

Revisions from 08.00.90i
12/31/2018This policy has been updated to be consistent with the US Food and Drug Administration (FDA) labeling and NCCN compendia, including the additional indication of Kaposi sarcoma.


Revisions from 08.00.90h
10/01/2018This policy has been identified for the ICD-10 CM code update, effective 10/01/2018.

The following CD-10 CM codes have been termed from this policy:
C43.11 Malignant melanoma of right eyelid, including canthus
C43.12 Malignant melanoma of left eyelid, including canthus

The following ICD-10 CM codes have been added to to the attachment A:
C43.111 Malignant melanoma of right upper eyelid, including canthus
C43.112 Malignant melanoma of right lower eyelid, including canthus
C43.121 Malignant melanoma of left upper eyelid, including canthus
C43.122 Malignant melanoma of left lower eyelid, including canthus


Policy 08.00.90g
12/27/2017This version of the policy will become effective 12/27/2017.

This policy has been updated to be consistent with the US Food and Drug Administration (FDA) labeling and NCCN compendia.

Policy criteria was updated to include new recommendations from NCCN:
  • Criteria were updated for Primary Cancers of the Urinary tract
  • Criteria were updated for Invasive Breast Cancer
  • Criteria were updated for Non-Small Cell Lung Cancer
  • Criteria were updated for Ovarian Cancer
  • Criteria were updated for Pancreatic Adenocarcinoma
  • Criteria were updated for Melanoma
  • Uterine neoplasm was added as a new indication

Description of Karnofsky Performance Scores added.

The following codes were added: C54.0, C54.1, C54.2, C54.3, C54.8, C54.9, C55, C57.9.

The following codes were removed: C45.1, Z17.0, Z17.1.


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 12/31/2018
Version Issued Date: 12/31/2018
Version Reissued Date: N/A

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