Anthem Blue Cross California Docetaxel (Docefrez, Taxotere) Form

Overview Clinical criteria Overview Coding Document history References This document addresses the use of docetaxel (Taxotere). Docetaxel is a taxane derivative that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions. Docetaxel is used in the treatment of various types of cancer including breast cancer, lung cancer and head and neck cancer. The FDA approved indications for docetaxel include the following: • Breast cancer: locally advanced or metastatic breast cancer after failure of prior chemotherapy or in combination with doxorubicin and cyclophosphamide for the adjuvant treatment of those with operable node positive breast cancer • Non-small cell lung cancer (NSCLC): locally advanced or metastatic NSCLC after failure of prior platinum- based chemotherapy; in combination with cisplatin for unresectable, locally advanced or metastatic NSCLC in those who have not previously received chemotherapy • Prostate cancer: in combination with prednisone for metastatic castration-resistant prostate cancer • Gastric adenocarcinoma: in combination with cisplatin and fluorouracil for advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, in those who have not received prior chemotherapy for advanced disease • Head and neck cancer: In combination with cisplatin and fluoruracil for induction treatment of locally advanced squamous cell carcinoma of the head and neck (SCCHN) The National Comprehensive Cancer Network® (NCCN) provides additional recommendations with a category 2A level of evidence for the use of docetaxel: • Bladder cancer, including urothelial carcinoma of the bladder, primary carcinoma of the urethra, upper genitourinary (GU) tract tumors and urothelial carcinoma of the prostate • Bone cancer, including Ewing’s sarcoma and osteosarcoma • Esophageal and esophagogastric junction cancer • Small cell lung cancer (SCLC) • Occult primary tumors – adenocarcinoma and squamous cell carcinoma • Ovarian cancer, including fallopian tube cancer and primary peritoneal cancer • Small Bowel Adenocarcinoma • Soft tissue sarcoma • • Uterine neoplasms Thyroid carcinoma – anaplastic carcinoma in combination with doxorubicin Other Uses Docetaxel is also used in the treatment of penile cancer. Historic NCCN Penile Cancer Guidelines (V1.2014) stated “palliative options may include docetaxel as a single agent.” Current NCCN Penile Cancer Guidelines (V2.2018) report that no standard subsequent-line systemic therapy exists. NCCN recommends consideration of participation in a clinical trial as data are limited for second-line therapy. However, specialty consensus opinion suggests that docetaxel may be considered as a treatment option for penile cancer. NCCN also provides a 2A recommendation (formerly 2B) for second-line or subsequent therapy as a single agent for recurrent or metastatic cervical cancer. One phase II trial is cited which evaluated 23/27 enrolled (Garcia et.al. 2007). 2 individuals had a partial response, 8 had stable disease and 9 had increasing disease. The study concluded that docetaxel had minimal activity in refractory squamous cell carcinoma of the cervix. 1 Docetaxel has a black box warning regarding treatment mortality increases with abnormal liver function, at higher doses, and in those with NSCLC and prior platinum-based therapy receiving docetaxel at 100 mg/m2. Docetaxel should not be given if bilirubin is greater than upper limit of normal (ULN) or if AST and/or ALT are greater than 1.5 time ULN concomitant with alkaline phosphatase > 2.5 ULM. Liver function tests (LFTs) should be obtained before each treatment cycle. Docetaxel should not be given if neutrophil counts are less than 1,500 cells/mm3. The black box also includes warnings regarding severe hypersensitivity and fluid retention. Definitions and Measures Adenocarcinoma: Cancer originating in cells that line specific internal organs and that have gland-like (secretory) properties. Adjuvant therapy: Treatment given after the primary treatment to increase the chances of a cure; may include chemotherapy, radiation, hormone or biological therapy. Chemotherapy: Medical treatment of a disease, particularly cancer, with drugs or other chemicals. Line of Therapy: • First-line therapy: The first or primary treatment for the diagnosis, which may include surgery, chemotherapy, radiation therapy or a combination of these therapies. • Second-line therapy: Treatment given when initial treatment (first-line therapy) is not effective or there is disease progression. • Third-line therapy: Treatment given when both initial (first-line therapy) and subsequent treatment (second-line therapy) are not effective or there is disease progression. Locally advanced cancer: Cancer that has spread only to nearby tissues or lymph nodes. Malignant: Cancerous. Malignant cells can invade and destroy nearby tissue and spread to other parts of the body. Metastasis: The spread of cancer from one part of the body to another; a metastatic tumor contains cells that are like those in the original (primary) tumor and have spread. Microtubule inhibitors (MTI): A class of drugs including taxanes, vinca alkaloids, and epothilones that stabilize or destabilize microtubules, thereby suppressing microtubule dynamics required for proper mitotic function, effectively blocking cell cycle progression and resulting in cell death. Non-small cell lung cancer: A group of lung cancers that are named for the kinds of cells found in the cancer and how the cells look under a microscope. The three main types of non-small cell lung cancer are squamous cell carcinoma, large cell carcinoma, and adenocarcinoma. Primary treatment: The first treatment given for a disease. It is often part of a standard set of treatments, such as surgery followed by chemotherapy and radiation. Also called first-line therapy, induction therapy, and primary therapy. Relapse or recurrence: After a period of improvement, during which time a disease (for example, cancer) could not be detected, the return of signs and symptoms of illness or disease. For cancer, it may come back to the same place as the original (primary) tumor or to another place in the body. Taxane: A type of mitotic inhibitor and antimicrotubule drug used to treat cancer that blocks cell growth by stopping mitosis (cell division). Clinical Criteria When a drug is being reviewed for coverage under a member’s medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose. Docetaxel (Taxotere) Requests for docetaxel (Taxotere, Docefrez) may be approved if the individual has any of the following conditions: I. II. Bladder cancer (NCCN 2A); OR Bone cancer (NCCN 2A): A. Used in combination with gemcitabine with or without vincristine as second-line therapy for Ewing’s sarcoma; OR B. Used in combination with gemcitabine as second-line therapy for Osteosarcoma; OR III. IV. V. Breast cancer (Label, NCCN 1, 2A); OR Esophageal and esophagogastric junction cancers (NCCN 2A); OR Gastric (stomach) adenocarcinoma; OR 2 VI. VII. VIII. Head and neck cancer (Label, NCCN 1, 2A); OR Lung cancer (non-small cell lung cancer [Label, NCCN 1, 2A], and small cell lung cancer (NCCN 2A); OR Occult primary tumors (cancer of unknown primary) (NCCN 2A): A. Adenocarcinoma; OR B. Squamous cell carcinoma; OR IX. X. XI. XII. XIII. XIV. Ovarian cancer, including fallopian tube cancer and primary peritoneal cancer (NCCN 1, 2A); OR Penile cancer; OR Prostate cancer (Label, NCCN 2A); OR Small Bowel Adenocarcinoma (NCCN 2A); OR Soft tissue sarcoma (NCCN 2A); OR Thyroid Carcinoma - Anaplastic Carcinoma: A. Used in combination with doxorubicin (NCCN 2A); OR B. Used as a single agent with concurrent radiation (NCCN 2A); XV. Uterine neoplasms (NCCN 2A). Requests for docetaxel (Taxotere) may not be approved when the above criteria are not met and for all other indications Coding The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member. HCPCS J9171 J9172 ICD-10 Diagnosis C00.0-C14.8 C15.30-C16.9 C17.0-C17.9 C30.0-C32.9 C33-C34.92 C40.00-C41.9 C44.02 C44.121-C44.129 C44.221-C44.229 C44.320-C44.329 C44.42 C48.0-C48.8 C49.0-C49.9 Injection, docetaxel, 1 mg [Docefrez, Taxotere] Injection, docetaxel (ingenus) not therapeutically equivalent to j9171, 1 mg Malignant neoplasm of lip, oral cavity, and pharynx Malignant neoplasm of esophagus, stomach Malignant neoplasm of small intestine Malignant neoplasm of nasal cavities, ear, sinuses, larynx Malignant neoplasm of trachea, bronchus and lung Malignant neoplasm of bone and articular cartilage of limbs, other and unspecified sites Squamous cell carcinoma of skin of lip Squamous cell carcinoma of skin of eyelid, including canthus Squamous cell carcinoma of skin of ear and external auditory canal Squamous cell carcinoma of skin of other and unspecified parts of face Squamous cell carcinoma of skin of scalp and neck Malignant neoplasm of retroperitoneum and peritoneum Malignant neoplasm of other connective and soft tissue C50.011-C50.929 Malignant neoplasm of breast C53.0-C53.9 C54.0-C55 C56.1-C57.9 C60.0-C60.9 C61 C64.1-C66.9 C67.0-C67.9 C68.0 C73 Malignant neoplasm of endocervix Malignant neoplasm of corpus uteri, uterus part unspecified Malignant neoplasm of ovary, other and unspecified female genital organs Malignant neoplasm of penis Malignant neoplasm of prostate Malignant neoplasm of kidney, renal pelvis, ureter Malignant neoplasm of bladder Malignant neoplasm of urethra Malignant neoplasm of thyroid gland 3 C76.0 C77.0 Malignant neoplasm of head, face and neck Secondary and unspecified malignant neoplasm of lymph nodes of head, face and neck C78.00-C78.02 Secondary malignant neoplasm of lung C79.81 C79.82 C79.89 C80.0-C80.1 D00.00-D00.2 D02.0 D02.20-D02.22 D05.00-D05.92 D07.39 D09.0 D09.3 Z85.01 Z85.028 Z85.118 Z85.21-Z85.22 Z85.3 Z85.43 Z85.46 Z85.51 Z85.59 Secondary malignant neoplasm of breast Secondary malignant neoplasm of genital organs Secondary malignant neoplasm of other specified sites [thyroid] Malignant neoplasm without specification of site Carcinoma in situ of lip, oral cavity, pharynx, esophagus, stomach Carcinoma in situ of larynx Carcinoma in situ of bronchus and lung Carcinoma in situ of breast Carcinoma in situ of other female genital organs Carcinoma in situ of bladder Carcinoma in situ of thyroid and other endocrine glands Personal history of malignant neoplasm of esophagus Personal history of other malignant neoplasm of stomach Personal history of other malignant neoplasm of bronchus and lung Personal history of malignant neoplasm of larynx, nasal cavities, middle ear, and accessory sinuses Personal history of malignant neoplasm of breast Personal history of malignant neoplasm of ovary Personal history of malignant neoplasm of prostate Personal history of malignant neoplasm of bladder Personal history of malignant neoplasm of other urinary tract organ [urethra] Z85.810-Z85.819 Personal history of malignant neoplasm of lip, oral cavity, and pharynx Z85.830 Z85.850 Personal history of malignant neoplasm of bone Personal history of malignant neoplasm of thyroid Document History Revised: 02/24/2023