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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-J1000-52

Original Effective Date: 01/01/12

Reviewed: 11/09/16

Revised: 05/15/17

Subject: Temozolomide (Temodar®) Capsule and Injection

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Dosage/ Administration Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References Updates  
           

DESCRIPTION:

Temozolomide (Temodar®) is an alkylating agent that has advantages over other alkylating agents because of its unique chemical structure and pharmacokinetic properties. Temozolomide is rapidly and completely absorbed after oral administration and spontaneously converts into the active metabolite without the need for enzymatic demethylation in the liver. Additionally, it has a small molecular weight, is lipophilic and efficiently crosses the blood-brain barrier. Thus, it has demonstrated efficacy in the treatment of secondary central nervous system (CNS) malignancies including metastatic melanoma and low- and high-grade gliomas. Temozolomide has also demonstrated excellent penetration into other body tissues.

Temozolomide received accelerated Food and Drug Administration (FDA)-approval for the treatment of recurrent anaplastic astrocytoma in August 1999. This indication was based on response rates only and results are not available from randomized controlled trials of recurrent anaplastic astrocytoma to demonstrate a clinical benefit resulting from treatment (e.g., improvement in disease-related symptoms, delayed disease progression, or improved survival). The FDA approved oral temozolomide for the treatment of newly diagnosed glioblastoma multiforme in March 2005. In February 2009, the FDA approved temozolomide for intravenous injection. Temozolomide has an orphan drug designation for the treatment of recurrent malignant glioma (e.g., recurrent astrocytoma, recurrent gliobastoma).

The National Comprehensive Cancer Network (NCCN) guidelines provide recommendations for the use of temozolomide as a single agent or in combination with other therapy for various types of cancers. The guidelines currently recommend use in central nervous system cancers, dermatofibrosarcoma protuberans, Ewing’s sarcoma, lung neuroendocrine tumors, melanoma, mycosis fungoides/sezary syndrome, certain types of neuroendocrine tumors, small cell lung cancer, soft tissue sarcoma, and uterine sarcoma.

POSITION STATEMENT:

Comparative Effectiveness

The Food and Drug Administration has deemed the drug(s) or biological product(s) in this coverage policy to be appropriate for self-administration or administration by a caregiver (i.e., not a healthcare professional). Therefore, coverage (i.e., administration) in a provider-administered setting such as an outpatient hospital, ambulatory surgical suite, physician office, or emergency facility is not considered medically necessary.

I. Initiation of temozolomide (Temodar) meets the definition of medical necessity when administered for an indication listed in Table 1, ALL of the indication specific criteria are met, and member meets ALL criteria for requested formulation:

1. Temozolomide capsule (generic)

a. Dosage does not exceed 200 mg/m2/day using the fewest number of capsules per day

2. Temodar®

a. Member has failure, contraindication, or intolerance to generic temozolomide

b. Dosage does not exceed 200 mg/m2/day using the fewest number of capsules per day

3. Temodar® IV

a. Member has a contraindication or is temporarily unable to take oral temozolomide therapy

b. Dosage does not exceed 200 mg/m2/day

Table 1

Indications and Specific Criteria

Indication

Specific Criteria

CNS Cancer-Anaplastic gliomas (includes anaplastic astrocytoma, anaplastic oligoastrocytoma, anaplastic oligodendroglioma)

When either of the following is met:

1. Adjuvant treatment in members with good performance status (KPS greater than or equal to 60)

2. Single agent or in combination with bevacizumab (Avastin®) for treatment of recurrent disease

CNS Cancer-Glioblastoma

When ONE of the following is met:

1. Temozolomide is used in the adjuvant setting with or without carmustine wafer for ONE of the following:

a. In combination with radiotherapy

b. Post radiotherapy

c. Single agent use when tumor is methylguanine methyl transferase (MGMT) promoter methylated

2. Temozolomide is used for recurrent disease as a single agent or in combination with bevacizumab (Avastin®)

CNS Cancer- Intracranial and spinal ependymoma (excluding subependymoma)

When used a single-agent for disease progression

CNS Cancer- Low-grade infiltrative supratentorial astrocytoma/oligodendroglioma (excluding pilocytic astrocytoma)

When ALL of the following are met:

1. Temozolomide is used as single agent

2. Member has received prior radiation therapy

3. Member has recurrent or progressive disease

CNS Cancer-Medulloblastoma and supratentorial primitive neuroectodermal tumor

When used as a single agent for recurrent disease in member’s who have previously received chemotherapy

CNS Cancer- Metastatic Lesions in the brain

When temozolomide is used as a single agent if active against primary tumor in members with recurrent disease

CNS Cancer - Primary CNS Lymphoma

When either of the following is met:

1. Temozolomide is used as induction therapy when co-administered with high-dose methotrexate (8 g/m2) and rituximab

2. Temozolomide is used for recurrence or progressive disease as a single-agent or in combination with rituximab

Dermatofibrosarcoma Protuberans (non-melanoma skin cancer)

When used as a single agent for metastatic disease

Ewing’s Sarcoma

Used in combination with irinotecan (Camptosar®) with or without vincristine for ANY of the following:

1. Progressive disease following primary treatment

2. Relapsed disease

3. Metastatic disease when used in the second-line setting

Melanoma

Member meets ALL of the following:

1. Disease is unresectable or metastatic

2. Temozolomide is used as second-line or subsequent therapy for disease progression

3. Member’s performance status is 0-2

Mycosis Fungoides/Sézary Syndrome (MF/SS)

Second-line therapy and ONE of the following:

1. Stage IB-IIA with folliculotropic or large cell transformation

2. Stage IIB generalized extent tumor,transformed, or folliculotropic disease

3. Stage IV non-Sézary or visceral disease

4. Refractory or progressive stage III MF or SS

Neuroendocrine Tumor of the Lung

Member has ONE of the following:

1. Unresectable locoregional disease

2. Metastatic disease

Neuroendocrine Tumors of the Pancreas

When used as a single agent or in combination with capecitabine (Xeloda) in member’s with unresectable locoregional or distant metastatic disease and ONE of the following:

1. Progressive disease

2. Symptomatic disease

3. Significant tumor burden

Neuroendocrine tumors - Pheochromocytoma/Paraganglioma

When used as a single agent for distant metastatic disease

Neuroendocrine Tumor of the Thymus

Member has ONE of the following:

1. Unresectable locoregional disease

2. Metastatic disease

Small Cell Lung Cancer (SCLC)

Subsequent chemotherapy as a single-agent in members who are performance status 0-2 with either of the following:

1. Relapse within 6 months following complete response, partial response, or stable disease with initial treatment

2. Primary progressive disease

Soft tissue sarcoma:

Angiosarcoma

Extremity/trunk/head/neck

Retroperitoneal/intra-abdominal

Rhabdomyosarcoma

Solitary Fibrous Tumor/ Hemangiopericytoma

Member meets ONE of the following:

1. Temozolomide is used as a single agent as palliative therapy for ONE of the following:

a. Angiosarcoma

b. Metastatic disease of the extremity/trunk/head/neck

c. Unresectable or progressive disease of the retroperitoneal/intra-abdominal area

d. Pleomorphic rhabdomyosarcoma

2. Temozolomide is used for treatment of ONE of the following:

a. Non-pleomorphic rhabdomyosarcoma in combination with vincristine and irinotecan

b. Solitary fibrous tumor/hemangiopericytoma in combination with bevacizumab (Avastin)

Uterine Sarcoma

Temozolomide will be used as a single agent in member’s with ONE of the following:

1. Unresectable disease

2. Metastatic disease

3. Recurrent disease in the vagina or pelvis

4. Recurrent disease outside of the pelvis without receipt of prior radiation

5. Following total hysterectomy for stage II, III, or IV disease

Approval duration: 180 days (all indications)

II. Continuation of temozolomide (Temodar®,) meets the definition of medical necessity for the indications in Table 1 when the following criteria are met:

A. The member’s disease has not progressed while receiving therapy with temozolomide

B. The member has been previously approved by Florida Blue or another health plan in the past 2 years, OR the member has previously met all indication-specific criteria for coverage

C. The member meets the following based on the requested dosage form:

1. Temozolomide capsule (generic)

a. Dosage does not exceed 200 mg/m2/day using the fewest number of capsules

2. Temodar®

a. Member has failure, contraindication, or intolerance to generic temozolomide

b. Dosage does not exceed 200 mg/m2/day using the fewest number of capsules

3. Temodar® IV

a. Member has a contraindication or is temporarily unable to take oral therapy

b. Dosage does not exceed 200 mg/m2/day

Approval duration: 1 year

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

FDA-approved: temozolomide is indicated for the treatment of individuals with newly diagnosed glioblastoma multiforme (GBM) concomitantly with radiotherapy and then as maintenance treatment and for the treatment of refractory anaplastic astrocytoma in individuals who have experienced disease progression on a drug regimen containing a nitrosurea and procarbazine. The recommended dosage is based on body surface area. Recommended dosing can be found in Table 2. The dose of the intravenous infusion and oral capsule formulation are equivalent. Antiemetic therapy may be administered prior to and/or following temozolomide administration.

• Capsules: To reduce nausea and vomiting, temozolomide should be taken on an empty stomach. Bedtime administration may be advised. Temozolomide capsules should not be opened or chewed and should be swallowed whole with a glass of water.

• Injection: Administer as an intravenous infusion over 90 minutes.

Table 2:

Indications and recommended dosing

CNS Cancer-Anaplastic astrocytoma

Initial dose: 150 mg/m2/day for days 1-5 of a 28 day cycle.

Subsequent doses: If both the nadir (Day 29) and day of dosing (Day 1 of next cycle) ANC are 1,500 cells/mm3 or greater and platelet counts are 100,000 cell/mm3 or greater, the dose may be increased to 200 mg/m2/day for days 1-5 of a 28 day cycle.

CNS Cancer-Glioblastoma

Concomitant phase: 75 mg/m2/day for 42 days

Maintenance phase:

• Cycle 1: 150 mg/m2/day for days 1-5 of a 28 day cycle

• Cycles 2-6: Dose can be escalated to 200 mg/m2/day if the CTC nonhematologic toxicity for cycle 1 is Grade 2 or less (except for alopecia, nausea, vomiting), ANC is 1,500 cell/mm3 or higher, and platelet count is 100,000 cell/mm3 or higher.

• The dose remains at the 200 mg/m2 per day for the first five days of each subsequent cycle except if toxicity occurs. If the dose was not escalated at cycle 2, escalation should not be done in subsequent cycles.

ANC, absolute neutrophil count

CTC, common toxicity criteria

Providers should refer to protocol by which member is being treated for off-label indications. Numerous dosing schedules exist and depend on disease, response and concomitant therapy.

Dosage Adjustments:

Renal/Hepatic Impairment: caution should be exercised when temozolomide is administered to members with severe renal or hepatic impairment.

Dose modifications

• During concomitant radiotherapy phase (treatment of high grade glioma): based on lowest weekly absolute neutrophil count (ANC) and/or platelet counts:

• ANC less than 500 cells/mm3, platelet count less than 10,000 cells/mm3, or CTC Grade 3 or 4 nonhematological toxicity (except alopecia, nausea, vomiting): Discontinue therapy until ANC is greater than 1500 cells/mm3 and platelet count is greater than 100,000 cells/mm3.

• ANC 500-1500 cells/mm3 , platelet count 10,000-100,000 cells/mm3, or CTC Grade 2 nonhematological toxicity (except alopecia, nausea, vomiting): interrupt therapy until ANC is greater than 1500 cells/mm3 and platelet count is greater than 100,000 cells/mm3.

• ANC > 1500 cells/mm3 , platelet count greater than 100,000 cells/mm3, or CTC Grade 1 or less nonhematological toxicity (except alopecia, nausea, vomiting): continue therapy as prescribed

• 28-day cycles: Based upon the lowest ANC and/or platelet counts on day 22 or day 29

• ANC less than 1000 cells/mm3 ,platelet count less than 50,000 cells/mm3 or CTC Grade 3 nonhematological toxicity (except alopecia, nausea, vomiting): delay therapy until ANC is greater than 1500 cells/mm3 and platelet count is greater than 100,000 cells/mm3 and the CTC is Grade 2 or less. Decrease dose by 50 mg/m2/day for subsequent cycle. Members who cannot tolerate 100 mg/m2/day or less should not receive further treatment.

• ANC 1000-1500 cells/mm3 or platelet count 50,000-100,000 cells/mm3: Delay therapy until ANC is greater than 1500 cells/mm3 and platelet count is greater than 100,000 cells/mm3. Continue current dosing regimen

Drug Availability

• Temozolomide capsules for oral administration: 5-, 20-, 100-, 140-, 180-, 250 mg

• Temozolomide injection: 100 mg/vial powder for injection

PRECAUTIONS:

CONTRAINDICATIONS

Temozolomide is contraindicated in members with a history of hypersensitivity reaction (e.g., urticaria, allergic reaction, including anaphylaxis, toxic epidermal necrolysis, and Stevens-Johnson syndrome) to any of its components. Temozolomide is also contraindicated in members who have a history of hypersensitivity to dacarbazine, since both drugs are metabolized to 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide (MTIC).

WARNINGS AND PRECAUTIONS

Bioequivalence: the oral and intravenous (IV) formulations have been found to be bioequivalent when the IV form is administered over 90 minutes. Shorter or longer administration times could result in suboptimal dosing or infusion reactions.

Hepatotoxicity: fatal and severe hepatotoxicity have been reported. Perform liver function tests at baseline, midway through the first cycle, prior to each subsequent cycle, and approximately two to four weeks after the last dose.

Laboratory tests: Complete blood counts should be obtained throughout the treatment course.

Pneumocystis Carinii Pneumonia: (PCP) prophylaxis is required for all members receiving concomitant temozolomide and radiotherapy for the 42-day regimen for the treatment of newly diagnosed glioblastoma multiforme. All patients, particularly those receiving steroids, should be monitored for the development of lymphopenia and PCP.

Pregnancy and Lactation:

• Temozolomide is classified as pregnancy category D. Pre-clinical studies have demonstrated fetal harm when temozolomide was administered to rats and rabbits. Women of childbearing potential should be advised to avoid becoming pregnant while taking temozolomide.

• It is unknown if temozolomide is excreted into breast milk. Breastfeeding should be avoided in women administered temozolomide.

Myelosuppression: Monitor complete blood count (CBC) (including ANC and platelet count) prior to temozolomide initiation and throughout treatment. Female and geriatric members are a higher risk for developing myelosuppression.

• Concomitant treatment phase with RT: CBC prior to initiation of treatment and weekly during treatment

• 28-day treatment cycles: CBC prior to treatment on Day1 and on Day 22 (21 days after the first dose) of each cycle. CBC should be performed weekly until recovery if ANC falls below 1,500 cells/mm3 and the platelet count falls below 100,000 cells/mm3.

Myelodysplastic Syndrome: Cases of myelodysplastic syndrome and secondary malignancies, including myeloid leukemia, have been observed.

BILLING/CODING INFORMATION:

HCPCS Coding

J8700

Temozolomide, oral, 5 mg

J9328

Injection, temozolomide, 1 mg

ICD-10 Diagnoses Codes That Support Medical Necessity (Effective 10/01/15)

C25.4

Malignant neoplasm of endocrine pancreas

C33

Malignant neoplasm of trachea

C34.00 – C34.02

Malignant neoplasm of unspecified main bronchus

C34.10 – C34.12

Malignant neoplasm of upper lobe, unspecified bronchus or lung

C34.2

Malignant neoplasm of middle lobe, bronchus or lung

C34.30 – C34.32

Malignant neoplasm of lower lobe, unspecified bronchus or lung

C34.80 – C34.82

Malignant neoplasm of overlapping sites of unspecified bronchus and lung

C34.90 – C34.92

Malignant neoplasm of unspecified part of unspecified bronchus or lung

C40.00 – C40.02

Malignant neoplasm of scapula and long bones of unspecified upper limb

C40.10 – C40.12

Malignant neoplasm of short bones of unspecified upper limb

C40.20 – C40.22

Malignant neoplasm of long bones of unspecified lower limb

C40.30 – C40.32

Malignant neoplasm of short bones of unspecified lower limb

C40.80 – C40.82

Malignant neoplasm of overlapping sites of bone and articular cartilage of limb

C40.90 – C40.92

Malignant neoplasm of unspecified sites of bone and articular cartilage of limb

C41.0 – C41.9

Malignant neoplasm of bone

C43.0 – C43.9

Malignant melanoma

C44.90

Unspecified malignant neoplasm of skin, unspecified

C47.8

Malignant neoplasm of overlapping sites of peripheral nerves and autonomic nervous system

C48.0 – C48.8

Malignant neoplasm of retroperitoneum and peritoneum

C49.0 – C49.9

Malignant neoplasm of connective and soft tissue

C53.0

Malignant neoplasm of endocervix

C54.0-54.3

Malignant neoplasm of , isthmus uteri, endometrium, myometrium, fundus uteri

C54.8

Malignant neoplasm of overlapping sites of corpus uteri

C54.9

Malignant neoplasm of corpus uteri, unspecified

C55

Malignant neoplasm of uterus, part unspecified

C71.0 – C71.9

Malignant neoplasm of brain

C72.9

Malignant neoplasm of central nervous system, unspecified

C74.10 – C74.12

Malignant neoplasm of medulla of adrenal gland

C74.90 -- C74.92

Malignant neoplasm of unspecified part of adrenal gland

C7A.090

Malignant carcinoid tumor of the bronchus and lung

C7A.091

Malignant carcinoid tumor of thymus

C7B.00 – C7B.09

Secondary neuroendocrine carcinoid tumors

C78.00 – C78.02

Secondary malignant neoplasm of unspecified lung

C79.31

Secondary malignant neoplasm of brain

C79.51

Secondary malignant neoplasm of bone

C79.52

Secondary malignant neoplasm of bone marrow

C80.0

Disseminated malignant neoplasm, unspecified

C80.1

Malignant (primary) neoplasm, unspecified

C83.31

Diffuse large B-cell lymphoma, lymph nodes of head, face, and neck

C83.39

Diffuse large B-cell lymphoma, extranodal and solid organ sites

C83.80

Other non-follicular lymphoma, unspecified site

C83.81

Other non-follicular lymphoma, lymph nodes of head, face, and neck

C83.89

Other non-follicular lymphoma, extranodal and solid organ sites

C84.00 – C84.09

Mycosis fungoides

C84.10 – C84.19

Sézary disease

D43.0 – C43.9

Neoplasm of uncertain behavior of brain and autonomic nervous system

E16.1

Hypoglycemia, other

E16.3

Increased secretion of glucagon

E16.8

Other specified disorders of pancreatic internal secretion

E34.0

Carcinoid syndrome

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage Products: No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline revised date.

Medicare Part D: Florida Blue has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline.

DEFINITIONS:

Adjuvant Treatment: Additional cancer treatment given after the primary treatment to lower the risk that the cancer will return. Adjuvant therapy may include chemotherapy, radiation therapy, hormone therapy, targeted therapy, or biologic therapy. Adjuvant therapy can be used after or in combination with another form of cancer therapy and is commonly used following removal of a cancerous tumor to further help in treatment.

Methylguanine methyl transferase (MGMT): a gene that encodes a DNA repair enzyme that can cause resistance to DNA-alkylating agents. When MGMT is methylated at the promoter region, the MGMT gene is inactivated and there is enhanced chemosensitivity to alkylating agents.

Visceral Disease: disease of the viscera, which are the soft internal organs of the body including the lungs, the heart, and the organs of the digestive, excretory, reproductive, and circulatory systems. Typically used when an individual has lymphangitic lung metastases, liver metastases, or carcinomatous meningitis.

RELATED GUIDELINES:

Allogeneic Bone Marrow and Stem Cell Transplantation, 02-38240-01
Carboplatin (Paraplatin®) IV, 09-J0000-93

Dermatoscopy, 02-10000-17

Doxorubicin HCl Liposome (Doxil®) IV, 09-J0000-91

Gemcitabine (Gemzar®), 09-J0000-96

H.P. Acthar® Gel, 09-J1000-15

Intensity-Modulated Radiation Therapy (IMRT), 04-77260-22

Ipilimumab (Yervoy™) IV, 09-J1000-34

Positron Emission Tomography (PET Scan) Miscellaneous Applications, 04-78000-18

Proton Beam Therapy, 04-77260-18

Stereotactic Radiosurgery (Intracranial), 02-77371-01

Transpupillary Thermotherapy (TTT), 01-92000-20

Vemurafenib (Zelboraf™), 09-J1000-40

Vinorelbine Tartrate (Navelbine®) IV, 09-J1000-03

Whole Body Photography for Early Detection of Malignant Melanoma, 01-96900-03

OTHER:

TABLE 2: ECOG Performance Status

Grade

ECOG

0

Fully active, able to carry on all pre-disease performance without restriction

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

2

Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours

3

Capable of only limited self-care, confined to bed or chair more than 50% of waking hours

4

Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair

5

Dead

TABLE 3: Karnofsky Performance Status (KPS)

Karnofsky Performance Status (KPS) (%)

Able to carry on normal activity and to work; no special care needed.

  100  

Normal no complaints; no evidence of disease.

90

Able to carry on normal activity; minor signs or symptoms of disease.

80

Normal activity with effort; some signs or symptoms of disease.

Unable to work; able to live at home and care for most personal needs; varying amount of assistance needed.

70

Cares for self; unable to carry on normal activity or to do active work.

60

Requires occasional assistance, but is able to care for most of his personal needs.

50

Requires considerable assistance and frequent medical care.

Unable to care for self; requires equivalent of institutional or hospital care; disease may be progressing rapidly.

40

Disabled; requires special care and assistance.

30

Severely disabled; hospital admission is indicated although death not imminent.

20

Very sick; hospital admission necessary; active supportive treatment necessary.

10

Moribund; fatal processes progressing rapidly.

0

Dead

TABLE 4: International Federation of Obstetrics and Gynecology (FIGO) Surgical Staging System of Uterine Sarcoma

Stage I

The tumor is found only in the uterus

Stage II

The tumor extends beyond the uterus, within the pelvis (adenexa and other pelvic tissues may be involved)

Stage III

The tumor infiltrates abdominal tissues in one or more sites (not just protruding into the abdomen) and regional lymph node metastasis may be present

Stage IV

The tumor invades the bladder or rectum and other distant metastasis may be present (excluding adnexa, pelvic, and abdominal tissues)

REFERENCES:

  1. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.;2016. URL www.clinicalpharmacilogy-ip.com Accessed10/20/16.
  2. INGENIX HCPCS LEVEL II, EXPERT 2013.
  3. INGENIX ICD-9-CM FOR PHYSICIANS-VOLUMES 1 & 2, EXPERT 2013.
  4. Micromedex® Healthcare Series [Internet Database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed 10/20/16.
  5. National Comprehensive Cancer Network. Cancer Guidelines. Cancer Guidelines and Drugs and Biologics Compendium. Accessed 04/10/17..
  6. National Comprehensive Cancer Network Cancer Guidelines. Bone Cancer. Version1.2017. Available at http://www.nccn.org/professionals/physician_gls/PDF/bone.pdf Accessed.10/25/16.
  7. National Comprehensive Cancer Network Cancer Guidelines. Central Nervous System Cancers. Version1.2016. Available at http://www.nccn.org/professionals/physician_gls/PDF/cns.pdf Accessed. 10/25/16.
  8. National Comprehensive Cancer Network Cancer Guidelines. Dermatofibrosarcoma Protuberans. Version 1.2017. Available at http://www.nccn.org/professionals/physician_gls/PDF/dfsp.pdf Accessed.10/20/16.
  9. National Comprehensive Cancer Network Cancer Guidelines. Melanoma. Version 1.2017. Available at http://www.nccn.org/professionals/physician_gls/PDF/melanoma.pdf Accessed 04/10/17.
  10. National Comprehensive Cancer Network Cancer Guidelines. Neuroendocrine Tumor. Version 2.2017. Available at http://www.nccn.org/professionals/physician_gls/PDF/neuroendocrine.pdf Accessed 04/10/17.
  11. National Comprehensive Cancer Network Cancer Guidelines. Non-Hodgkin’s Lymphomas. Version 3.2016. Available at http://www.nccn.org/professionals/physician_gls/PDF/nhl.pdf Accessed 10/25/16.
  12. National Comprehensive Cancer Network Cancer Guidelines. Small Cell Lung Cancer. Version 2.2017. Available at http://www.nccn.org/professionals/physician_gls/PDF/sclc.pdf Accessed 10/24/16.
  13. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version2.2016. Soft Tissue Sarcoma. Available at http://www.nccn.org/professionals/physician_gls/PDF/sarcoma.pdf Accessed 10/24/16.
  14. National Comprehensive Cancer Network Cancer Guidelines. Uterine Cancer. Version 2.2016. Available at http://www.nccn.org/professionals/physician_gls/PDF/uterine.pdf Accessed 10/24/16.
  15. Temodar (temozolomide) [package insert]. Merck Sharp & Dohme Corp. . Whitehouse Station (NJ): December 2015.
  16. Temozolomide. In McEvoy GK, editor. AHFS drug information 2016 [monograph on the internet]. Bethesda (MD): American Society of Health-System Pharmacists; 2016 [cited 2016 Oct 20]. Available from http://online.statref.com Subscription required to review.
  17. Wick W, Hartmann C, Engel C, et al. NOA-04 Randomized phase III trial of sequential radiochemotherapy of anaplastic glioma with procarbazine, lomustine, and vincristine or temozolomide. J Clin Oncol 2009;27(35):5874-80.
  18. Wick W, Platten M, Meisner C, et al. Temozolomide chemotherapy alone versus radiotherapy alone for malignant astrocytoma in the elderly: the NOA-08 randomized, phase 3 trial. Lancet 2012;13:707-15.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 11/09/16.

GUIDELINE UPDATE INFORMATION:

01/01/12

New Medical Coverage Guideline.

12/15/12

Review and revision to guideline; consisting of revising, reformatting, updating position statement; revising dosage/administration, precautions section; updating references and coding.

12/15/13

Review and revision to guideline; consisting of revising position statement, updating references, coding, and program exceptions.

07/15/14

Revision to guideline; consisting of adding in language requiring failure of generic temozolomide.

12/15/14

Review and revision to guideline; consisting of reformatting the position statement, updating references and coding.

07/15/15

Review and revision to guideline; consisting of updating coding.

12/15/15

Review and revision to guideline; consisting of updating the position statement, dosage, precautions, references and coding.

12/15/16

Review and revision to guideline; consisting of updating the position statement, precautions, coding and references.

05/15/17

Revision to guideline; consisting of updating the position statement, coding and references.

Date Printed: June 24, 2017: 11:33 AM