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This medical policy (medical coverage guideline) is Copyright 2015, 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 2015 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: 11/12/14

Revised: 07/15/15

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

Decision Tree

Previous Version

           

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 malignant glioma (e.g., recurrent astrocytoma, recurrent gliobastoma) and advanced metastatic melanoma.

Then NCCN CNS Cancers guidelines focus on management of adult CNS cancers: anaplastic gliomas and glioblastoma multiforme, low-grade infiltrative astrocytomas, oligodendrogliomas, ependymomas, brain metastases, leptomeningeal metastases, primary CNS lymphomas (non-AIDS), and metastatic spinal tumors. Diffusely infiltrative low-grade gliomas (i.e., astrocytomas, oligodendrogliomas, and mixed gliomas) are a diverse group of relatively uncommon malignancies. When possible, maximal safe resection is recommended for low-grade infiltrative astrocytomas and oligodendrogliomas. Chemotherapy is not a traditional mainstay of upfront treatment for low-grade gliomas. There is some data that support temozolomide as adjuvant therapy and it is included as a category 2B recommendation based on non-uniform panel consensus. At the time of recurrence, surgery is recommended (if resectable) followed by chemotherapy if the individual has previously received fractionated external beam radiation therapy (EBRT). Diffusely infiltrative high-grade gliomas (e.g., anaplastic astrocytomas and glioblastomas) are the most common primary brain tumors in adults and account for 7% and 54% of all gliomas, respectively. Following surgical intervention, the choice of adjuvant therapy is based on tumor pathology and performance status of the individual. In the case of anaplastic gliomas (i.e., anaplastic astrocytoma), fractionated EBRT is the historical standard for individuals with a good Karnofsky performance score (KPS); however, chemotherapy may be an option for specific individuals. Temozolomide or PCV (carmustine, procarbazine, and vincristine) with deferred radiotherapy are category 2A recommendations. If gliobastoma is diagnosed, the adjuvant options mainly depend on the individual’s performance status. For those with KPS below 70, options include EBRT, chemotherapy, combined treatment, or palliative/best supportive care. Individuals aged 70 years or under with KPS 70 or above should undergo radiation plus current and adjuvant temozolomide (Category 1 recommendation). Those greater than 70 years with a KPS of 70 or above can receive standard or hypofractionated EBRT with or without temozolomide. In the setting of recurrence, temozolomide as a single agent or in combination with bevacizumab (Avastin®) is a category 2A recommendation for the treatment of anaplastic gliomas or gliobastoma. The guidelines also recommend several other chemotherapies for the treatment of recurrent anaplastic gliomas.

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.

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

2. Temodar®

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

b. Dosage does not exceed 200 mg/m2/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

Ewing’s Sarcoma

Used in combination with irinotecan (Camptosar®) and ANY of the following:

1. Progressive disease following primary treatment

2. Relapse therapy

3. Second-line for metastatic disease

CNS Cancer-Anaplastic astrocytoma

When either of the following is met:

1. Single agent as adjuvant treatment

2. Single agent or in combination with bevacizumab (Avastin®) as salvage therapy/treatment of recurrent disease

CNS Cancer-Glioblastoma

When ONE of the following is met:

1. Temozolomide is used in the adjuvant setting for either of the following:

a. In combination with radiotherapy

b. Post radiotherapy

2. Temozolomide is used for recurrence/salvage therapy as a single agent or in combination with bevacizumab (Avastin®)

CNS Cancer- Low-grade infiltrative supratentorial astrocytoma/oligodendroglioma

When BOTH of the following are met:

1. Temozolomide is used as single agent

2. Member has received prior radiation therapy

CNS Cancer-Medulloblastoma and supratentorial primitive neuroectodermal tumor

Second-line therapy as a single agent and ONE of the following:

1. Member has progression of localized brain recurrence

2. Member has disseminated disease

CNS Cancer- Metastatic Lesions due to small cell lung cancer

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

Lung Neuroendocrine Tumor

Member has low/intermediate-grade neuroendocrine tumor that is either stage IIIb or stage IV

Metastatic Melanoma

Temozolomide is used as a single agent for any of the following:

1. Unresectable stage III metastases

2. Local/satellite and/or unresectable recurrence

3. Incompletely resected nodal recurrence

4. Recurrent or metastatic disease

Mycosis Fungoides/Sézary Syndrome (MF/SS)

Second-line therapy and ONE of the following:

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

2. Stage IIB generalized/transformed/folliculotropic disease

3. Stage IV non-Sézary or visceral disease

4. Refractory or progressive stage III MF or SS

Neuroendocrine Tumors of the Pancreas-Islet Cell Tumors

When ONE or more of the following is met:

1. Member has unresectable locoregional disease

2. Member has distant metastases

Primary CNS Lymphoma

When either of the following is met:

1. Temozolomide is used as primary 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

Small Cell Lung Cancer (SCLC)

Second-line 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 or partial response with initial treatment

2. Primary progressive disease

Soft-Tissue Sarcoma, angiosarcoma

Temozolomide will be used as a single agent

Soft Tissue Sarcoma, extremity/trunk

Temozolomide is used as single agent palliative therapy for either of the following:

1. Synchronous stage IV disease

2. Recurrent disease with disseminated metastases

Soft Tissue Sarcoma, Solitary Fibrous Tumor/ Hemangiopericytoma

Temozolomide is used in combination with bevacizumab (Avastin)

Soft Tissue Sarcoma, retroperitoneal/intra-abdominal

Temozolomide is used as single agent palliative chemotherapy for unresectable or progressive disease

Soft-tissue Sarcoma, rhabdomyosarcoma

EITHER of the following:

1. Member is diagnosed with a pleomorphic rhabdomyosarcoma and temozolomide will be used as a single agent

2. Member is diagnosed with a non-pleomorphic rhabdomyosarcoma and temozolomide will be used in combination with vincristine and irinotecan

Uterine Sarcoma

Temozolomide will be used as a single agent for stage II, III, or IV disease.

Approval duration: 180 days (all indications)

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.

Melanoma

150 – 200 mg/m2/day for days 1-5 of a 28 day cycle.

ANC, absolute neutrophil count

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 anaplastic astrocytoma): based on lowest weekly absolute neutrophil count (ANC) and/or platelet counts

• ANC less than 500 cells/mm3 or platelet count less than 10,000 cells/mm3: 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 or platelet count 10,000-100,000 cells/mm3: interrupt therapy until ANC is greater than 1500 cells/mm3 and platelet count is greater than 100,000 cells/mm3.

• ANC > 1500 cells/mm3 or platelet count greater than 100,000 cells/mm3: 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 or platelet count less than 50,000 cells/mm3: delay therapy until ANC is greater than 1500 cells/mm3 and platelet count is greater than 100,000 cells/mm3. 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

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.

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.

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.

BILLING/CODING INFORMATION:

HCPCS Coding

J8700

Temozolomide, oral, 5 mg

J9328

Injection, temozolomide, 1 mg

ICD-9 Diagnoses Codes That Support Medical Necessity

157.4

Malignant neoplasm of islets of Langerhans

158.0

Malignant neoplasm of retroperitoneum

158.8

Malignant neoplasm of specified parts of peritoneum

158.9

Malignant neoplasm of peritoneum, unspecified

162.0 – 162.9

Malignant neoplasm of trachea bronchus and lung

170.0 – 170.9

Malignant neoplasm of bones

171.0 – 171.9

Malignant neoplasm of connective and other soft tissue

172.0 – 172.9

Malignant melanoma

179

Malignant neoplasm of uterus, part unspecified

180.0

Malignant neoplasm of endocervix

182.0-182.1

Malignant neoplasm of corpus uteri, isthmus

182.8

Malignant neoplasm of other specified sites of body of uterus

191.0 – 191.9

Malignant neoplasm of brain

192.8

Malignant neoplasm of other specified sites of nervous system

192.9

Malignant neoplasm of nervous system, part unspecified

197.0

Secondary malignant neoplasm of lung

198.3

Secondary malignant neoplasm of brain and spinal cord

198.5

Secondary malignant neoplasm of bone and bone marrow

199.0

Disseminated malignant neoplasm

199.1

Other malignant neoplasm of unspecified site

200.50

Primary central nervous system lymphoma, unspecified site, extranodal and solid organ sites

200.51

Primary central nervous system lymphoma, lymph nodes of head, face, and neck

202.10 – 202.18

Mycosis fungoides

202.20 – 202.28

Sézary disease

209.21

Malignant carcinoid tumor of the bronchus and lung

237.5

Neoplasm of uncertain behavior of brain and spinal cord

251.1

Hypoglycemia, other specified

251.4

Abnormality of secretion of glucagon

251.8

Other specified disorders of pancreatic internal secretion

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

Malignant neoplasm of unspecified main bronchus

C34.10

Malignant neoplasm of upper lobe, unspecified bronchus or lung

C34.2

Malignant neoplasm of middle lobe, bronchus or lung

C34.3

Malignant neoplasm of lower lobe, unspecified bronchus or lung

C34.80

Malignant neoplasm of overlapping sites of unspecified bronchus and lung

C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

C40.00

Malignant neoplasm of scapula and long bones of unspecified upper limb

C40.10

Malignant neoplasm of short bones of unspecified upper limb

C40.20

Malignant neoplasm of long bones of unspecified lower limb

C40.30

Malignant neoplasm of short bones of unspecified lower limb

C41.0 – C41.9

Malignant neoplasm of bone

C43.0 – C43.9

Malignant melanoma

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 – C49.22

Malignant neoplasm of connective and soft tissue of head, face, neck, upper limb including shoulder and lower limb including hip

C49.3

Malignant neoplasm of connective and soft tissue of thorax

C49.4

Malignant neoplasm of connective and soft tissue of abdomen

C49.6

Malignant neoplasm of connective and soft tissue of trunk, unspecified

C49.8

Malignant neoplasm of overlapping sites of connective and soft tissue

C49.9

Malignant neoplasm of connective and soft tissue, unspecified

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

C78.0

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 – C84.18

Sézary disease

C7A.090

Malignant carcinoid tumor of the bronchus and lung

D43.2

Neoplasm of uncertain behavior of brain, unspecified

D43.4

Neoplasm of uncertain behavior of spinal cord

E16.0

Drug-induced hypoglycemia without coma

E16.1

Hypoglycemia, other

E16.3

Increased secretion of glucagon

E16.8

Other specified disorders of pancreatic internal secretion

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.

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.

Salvage Therapy: treatment that is administered after the cancer has not responded to other treatments.

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

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

Interferon alfa-n3 (Alferon N Injection®), 09-J0000-33

Interferons for Oncology Use, 09-J1000-37

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:

None

REFERENCES:

  1. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.;2012. URL www.clinicalpharmacilogy-ip.com Accessed 8/25/14.
  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 8/25/14.
  5. National Comprehensive Cancer Network. Cancer Guidelines. Cancer Guidelines and Drugs and Biologics Compendium. Accessed 8/25/14.
  6. National Comprehensive Cancer Network Cancer Guidelines. Central Nervous System Cancers. Version 2.2012. Available at http://www.nccn.org/professionals/physician_gls/PDF/cns.pdf Accessed 10/16/2012.
  7. National Comprehensive Cancer Network Cancer Guidelines. Melanoma. Version 2.2013. Available at http://www.nccn.org/professionals/physician_gls/PDF/melanoma.pdf Accessed 10/17/2012.
  8. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 2.2012. Soft Tissue Sarcoma. Available at http://www.nccn.org/professionals/physician_gls/PDF/sarcoma.pdf Accessed 10/16/12
  9. Temodar (temozolomide) [package insert]. Schering Corporation. Whitehouse Station (NJ): June 2013.
  10. Temozolomide. In McEvoy GK, editor. AHFS drug information 2014 [monograph on the internet]. Bethesda (MD): American Society of Health-System Pharmacists; 2014 [cited 2014 Aug 25]. Available from http://online.statref.com Subscription required to review.
  11. 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.
  12. 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 11/12/14.

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.

Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is copyright 2013, 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 2013 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.

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Date Printed: July 28, 2015: 08:33 PM