Print

Date Printed: July 29, 2016: 10:00 AM

Private Property of Blue Cross and Blue Shield of Florida.
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-J1000-02

Original Effective Date: 05/15/09

Reviewed: 08/12/15

Revised: 11/15/15

Subject: Topotecan HCl (Hycamtin®) Injection and Capsule

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.

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

DESCRIPTION:

Topotecan (Hycamtin®) is a type 1 DNA topoisomerase inhibitor and exerts its cytotoxic effects during the S-phase of DNA synthesis through an interaction with the DNA-DNA topoisomerase cleavable complex; ultimately, apoptosis occurs. Topotecan injection was initially approved by the Food and Drug Administration (FDA) in 1996 for the treatment of metastatic ovarian cancer. In 1998, the FDA approved topotecan for treatment of small cell lung and in 2006 in combination with cisplatin for advanced cervical cancer that cannot be treated with radiation therapy or surgery. In 2007, topotecan capsules were approved for the treatment of relapsed small cell lung cancer.

POSITION STATEMENT:

Topotecan (Hycamtin) meets the definition of medical necessity when administered for treatment of an indication listed in Table 1 and ALL of the indication specific criteria below are met:

Table 1

Indications and Specific Criteria

Indication

Specific Criteria

Oral Capsule

Relapsed small cell lung cancer (SCLC)

Subsequent chemotherapy as a single-agent 45 days or more from the end of first-line chemotherapy in members who are performance status 0-2 with ONE of the following:

  • Relapse within 6 months following complete or partial response with initial treatment
  • Relapse within 6 months following stable disease with initial treatment
  • Primary progressive disease

Small cell carcinoma histology (bladder cancer, prostate cancer, or neuroendocrine tumors)

Subsequent chemotherapy as a single-agent 45 days or more from the end of first-line chemotherapy in members who are performance status 0-2 with documentation of small cell carcinoma histology and ONE of the following:

  • Relapse within 6 months following complete or partial response with initial treatment
  • Relapse within 6 months following stable disease with initial treatment
  • Primary progressive disease

Injection

Acute Myeloid Leukemia (AML)

When ALL of the following are met:

  • Topotecan is used as induction therapy in combination with standard or high-dose cytarabine (i.e., cytarabine 100-200 mg/m2 or 2-3 g/m2)
  • Member is less than 60 years of age
  • Member has impaired cardiac function

Cervical Cancer

Topotecan is used in combination with cisplatin or paclitaxel (with or without bevacizumab) and ONE of the following is met:

  • Member has local/regional recurrence
  • Member has distant metastases
  • Member has stage IV-B cancer that is recurrent or persistent and is not a candidate for curative treatment with surgery and/or radiation therapy

Ovarian Cancer (Epithelial Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer)

Documented platinum resistant disease that is persistent or recurrent and ONE of the following is met:

  • Topotecan is used as a single-agent
  • Topotecan use is in combination with bevacizumab if bevacizumab not previously received

Small Cell Lung Cancer (SCLC)

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

  • Relapse within 6 months following complete or partial response
  • Relapse within 6 months following stable disease with initial treatment
  • Primary progressive disease

Small cell carcinoma histology (bladder cancer, prostate cancer, or neuroendocrine tumors)

Subsequent chemotherapy as a single-agent in members who are performance status 0-2 with documentation of small cell carcinoma histology for ONE of the following:

  • Relapse within 6 months following complete or partial response
  • Relapse within 6 months following stable disease with initial treatment
  • Primary progressive disease

Primary CNS Lymphoma

Topotecan is used as a single agent for progressive/ recurrent disease in members who meet ONE of the following:

  • Member has received prior whole brain radiation
  • Member has received prior methotrexate-based regimen without prior radiation
  • Member received prior high-dose chemotherapy with stem cell rescue with a previous response of 12 months

CNS Cancer-Leptomeningeal Metastases

Topotecan is used as a single agent and will be administered intrathecally in members who meet ONE of the following:

Used as induction therapy for member with good risk (KPS >60, no major neurologic deficits, minimal systemic disease) and normal CSF flow

Used as maintenance therapy for members with negative CSF cytology

Used as maintenance therapy for clinically stable members with positive CSF cytology

Used as postinduction therapy for members with positive CSF cytology

CNS Cancer- Metastatic Lesions due to small cell lung cancer

Single-agent treatment for recurrent brain metastases when topotecan was active against primary tumor.

Non-melanoma Skin Cancer

When BOTH of the following are met:

  • Member has Merkel cell carcinoma
  • Documented distant metastatic or disseminated recurrent disease

Bone Cancer-Ewing’s Sarcoma

Topotecan is used after primary treatment and BOTH of the following are met:

  • Topotecan is used in combination with cyclophosphamide and growth factor support
  • Documented relapsed, progressive, or metastatic disease

Bone Cancer-osteosarcoma

Second-line therapy in combination with cyclophosphamide and growth factor support

Soft-tissue sarcoma (Rhabdomyosarcoma)

BOTH of the following:

  • Member is diagnosed with a nonpleomorphic rhabdomyosarcoma
  • Topotecan will be used as a single agent or in combination with cyclophosphamide

Uterine Neoplasms - Endometrial Carcinoma

When used as a single agent and ONE of the following:

  • Primary treatment for extrauterine disease (e.g., abdomen, bladder, liver, ovary, pelvis, vagina, etc.)
  • Member has stage III or IV disease
  • Member has disseminated metastases
  • Member has local/regional recurrence
  • Member has serous carcinoma, clear cell carcinoma, or carcinosarcoma of the endometrium and stage I-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.

Table 2

FDA-approved Indications and Dosing

Indication

Dose

Comments

Oral capsule

Relapsed small cell lung cancer

2.3 mg/m2 orally once daily for 5 consecutive days repeated every 21 days

• Calculated dose should be rounded to the nearest 0.25 mg and prescribe the minimum number of 1- and 0.25 mg capsules. The same number of capsules should be prescribed for each of the five days

• May be taken with or without food

• Capsules should be swallowed whole and must not be chewed, crushed, or divided

• If member vomits following dose, member should NOT take a replacement dose

Injection

Ovarian Cancer

1.5 mg/m2 IV daily for 5 consecutive days, starting on day one of a 21-day course

Infuse over 30 minutes

Small Cell Lung Cancer

Cervical cancer

0.75 mg/m2 IV daily on days 1,2, and 3 followed by cisplatin 50 mg/m2 IV on day 1 repeated every 21 days

Dosage Adjustments:

Capsule

Renal Impairment:

Table 3

Recommended Dosage Adjustments for Adverse Reactions (Capsule)

Toxicity

Dosage Modification

Bone Marrow Suppression

Do no administer subsequent courses of therapy until all of the following:

ANC is greater than 1,000 cells/mm3

Platelet count greater than 100,000 cells/mm3

Hemoglobin is 9 mg/dL or greater

Severe neutropenia (ANC less than 500 cells/mm3 with fever or infection or lasting more than 7 days)

Reduce dose to 0.4 mg/m2/day for subsequent courses

Neutropenia (ANC 500-1000 cells/mm3 lasting beyond day 21 of treatment course

Platelet count less than 25,000 cells/mm3

ANC, absolute neutrophil count

Injection

Renal Impairment:

CrCl 20-39 ml/min: reduce dose to 0.75 mg/m2

CrCl less than 20 ml/min: insufficient data are available and the manufacturer does not provide a dosage recommendation

Table 4

Recommended Dosage Adjustments for Adverse Reaction (Injection)

Toxicity

Dosage Modification

Severe neutropenia (ANC less than 500 cells/mm3) during any course

Reduce dose to 1.25 mg/m2 for subsequent courses or administer G-CSF no sooner than 24 hours after completion of topotecan administration

Platelet count less than 25,000 cells/mm3

Reduce dose to 1.25 mg/m2 for subsequent courses

Combination use with cisplatin

Neutropenia (ANC less than 1000 cells/mm3) with temperature of 38.0°C (100.4°F) or greater)

Reduce dose to 0.60 mg/m2 and further to 0.45 mg/m2 if necessary or administer G-CSF no sooner than 24 hours after completion of topotecan administration

Platelet count less than 25,000 cells/mm3

Reduce dose to 0.60 mg/m2 and further to 0.45 mg/m2 if necessary

ANC, absolute neutrophil count; G-CSF, granulocyte colony stimulating factor

Drug Availability: topotecan is available as a 0.25- and 1 mg capsule and as a 4 mg single-dose vial for injection.

PRECAUTIONS:

CONTRAINDICATIONS

Topotecan is contraindicated in members with a history of severe hypersensitivity reactions (e.g., anaphylactoid reactions) to topotecan or any of its ingredients.

BOXED WARNING:

Topotecan can cause severe myelosuppression and should not be administered to members with baseline neutrophil counts less than 1,500 cells/mm3 or platelet counts <100,000 cells/mm3. Complete blood counts and platelets should be monitored frequently in all members administered topotecan.

WARNINGS

Capsules and Parenteral administration

Bone Marrow Suppression: Bone marrow suppression is a dose-limiting toxicity. Neutropenia, thrombocytopenia, and anemia can occur. Monitor CBC, temperature and adjust dose if needed.

Neutropenia: Topotecan-induced neutropenia can lead to fatal typhlitis (neutropenic colitis).

Interstitial Lung Disease: Fatal cases have occurred, monitor for symptoms and discontinue topotecan if diagnosis is confirmed.

Pregnancy and Lactation:

Gastrointestinal (capsules only): Severe diarrhea requiring hospitalization may occur; do not administer capsules to patients with grade 3 or 4 diarrhea. Reduce dose after recovery to Grade 1 or less.

Extravasation and tissue injury (parenteral administration only): Severe cases have been reported. Immediately stop and initiate treatment if extravasation occurs.

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding:

J8705

Topotecan, Oral, 0.25 mg

J9351

Injection, topotecan, 0.1 mg

ICD-10 Diagnoses Codes That Support Medical Necessity for Hycamtin® Oral: (Effective 10/01/15)

C33

Malignant neoplasm of trachea

C34.00

Malignant neoplasm of unspecified main bronchus

C34.01

Malignant neoplasm of right main bronchus

C34.02

Malignant neoplasm of left main bronchus

C34.10

Malignant neoplasm of upper lobe, unspecified bronchus or lung

C34.11

Malignant neoplasm of upper lobe, right bronchus or lung

C34.12

Malignant neoplasm of upper lobe, left bronchus or lung

C34.2

Malignant neoplasm of middle lobe, bronchus or lung

C34.30

Malignant neoplasm of lower lobe, unspecified bronchus or lung

C34.31

Malignant neoplasm of lower lobe, right bronchus or lung

C34.32

Malignant neoplasm of lower lobe, left bronchus or lung

C34.80

Malignant neoplasm of overlapping sites of unspecified bronchus and lung

C34.81

Malignant neoplasm of overlapping sites of right bronchus and lung

C34.82

Malignant neoplasm of overlapping sites of left bronchus and lung

C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

C61

Malignant neoplasm of prostate

C65.1 – C65.2,

C65.9

Malignant neoplasm of renal pelvis, unspecified

C66.1-C66.2,

C66.9

Malignant neoplasm of ureter, unspecified

C67.0 – C67.9

Malignant neoplasm of bladder

C68.0

Malignant neoplasm of urethra

C68.1

Malignant neoplasm of paraurethral glands

C68.8

Malignant neoplasm of overlapping sites of urinary organs

C68.9

Malignant neoplasm of urinary organ, unspecified

C7A.1

Malignant poorly differentiated neuroendocrine carcinoma

C7A.8

Other malignant neuroendocrine tumors

C7B.00C7B.09

Secondary carcinoid tumors, unspecified site

C7B.8

Other secondary neuroendocrine tumors

C78.00

Secondary malignant neoplasm of unspecified lung

C78.01

Secondary malignant neoplasm of right lung

C78.02

Secondary malignant neoplasm of left lung

C79.31

Secondary malignant neoplasm of brain

C79.51

Secondary malignant neoplasm of bone

C79.52

Secondary malignant neoplasm of bone marrow

D09.0

Carcinoma in situ of bladder

ICD-10 Diagnoses Codes That Support Medical Necessity for Hycamtin® IV: (Effective 10/01/15)

C33

Malignant neoplasm of trachea

C34.00

Malignant neoplasm of main bronchus, unspecified side

C34.01

Malignant neoplasm of right main bronchus

C34.02

Malignant neoplasm of left main bronchus

C34.10

Malignant neoplasm of upper lobe, bronchus or lung, unspecified side

C34.11

Malignant neoplasm of upper lobe, right bronchus or lung

C34.12

Malignant neoplasm of upper lobe, left bronchus or lung

C34.2

Malignant neoplasm of middle lobe, right bronchus or lung

C34.30

Malignant neoplasm of lower lobe, bronchus or lung, unspecified side

C34.31

Malignant neoplasm of lower lobe, right bronchus or lung

C34.32

Malignant neoplasm of lower lobe, left bronchus or lung

C34.80

Malignant neoplasm of overlapping sites of bronchus and lung, unspecified side

C34.81

Malignant neoplasm of overlapping sites of right bronchus and lung

C34.82

Malignant neoplasm of overlapping sites of left bronchus and lung

C34.90

Malignant neoplasm of bronchus or lung, unspecified, unspecified side

C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

C40.00

Malignant neoplasm of scapula and long bones of upper limb, unspecified side

C40.01

Malignant neoplasm of scapula and long bones of right upper limb

C40.02

Malignant neoplasm of scapula and long bones of left upper limb

C40.10

Malignant neoplasm of short bones of upper limb, unspecified side

C40.11

Malignant neoplasm of short bones of right upper limb

C40.12

Malignant neoplasm of short bones of left upper limb

C40.20

Malignant neoplasm of long bones of lower limb, unspecified side

C40.21

Malignant neoplasm of long bones of right lower limb

C40.22

Malignant neoplasm of long bones of left lower limb

C40.30

Malignant neoplasm of short bones of lower limb, unspecified side

C40.31

Malignant neoplasm of short bones of right lower limb

C40.32

Malignant neoplasm of short bones of left lower limb

C40.80

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

C40.81

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

C40.82

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

C40.90

Malignant neoplasm of unspecified bone and articular cartilage of unspecified limb

C40.91

Malignant neoplasm of unspecified bone and articular cartilage of right limb

C40.92

Malignant neoplasm of unspecified bone and articular cartilage of left limb

C41.0

Malignant neoplasm of bones of skull and face

C41.1

Malignant neoplasm of mandible

C41.2

Malignant neoplasm of vertebral column

C41.3

Malignant neoplasm of ribs, sternum and clavicle

C41.4

Malignant neoplasm of pelvic bones, sacrum and coccyx

C41.9

Malignant neoplasm of bone and articular cartilage, unspecified

C48.1

Malignant neoplasm of specified parts of peritoneum

C48.2

Malignant neoplasm of peritoneum, unspecified

C48.8

Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum

C49.9

Malignant neoplasm of connective and soft tissue, unspecified

C4A.0

Merkel cell carcinoma of lip

C4A.10

Merkel cell carcinoma of eyelid, including canthus, unspecified side

C4A.11

Merkel cell carcinoma of right eyelid, including canthus

C4A.12

Merkel cell carcinoma of left eyelid, including canthus

C4A.20

Merkel cell carcinoma of ear and external auricular canal, unspecified side

C4A.21

Merkel cell carcinoma of right ear and external auricular canal

C4A.22

Merkel cell carcinoma of left ear and external auricular canal

C4A.30

Merkel cell carcinoma of unspecified part of face

C4A.31

Merkel cell carcinoma of nose

C4A.39

Merkel cell carcinoma of other parts of face

C4A.4

Merkel cell carcinoma of scalp and neck

C4A.51

Merkel cell carcinoma of anal skin

C4A.52

Merkel cell carcinoma of skin of breast

C4A.59

Merkel cell carcinoma of other part of trunk

C4A.60

Merkel cell carcinoma of upper limb, including shoulder, unspecified side

C4A.61

Merkel cell carcinoma of right upper limb, including shoulder

C4A.62

Merkel cell carcinoma of left upper limb, including shoulder

C4A.70

Merkel cell carcinoma of lower limb, including hip, unspecified side

C4A.71

Merkel cell carcinoma of right lower limb, including hip

C4A.72

Merkel cell carcinoma of left lower limb, including hip

C4A.8

Merkel cell carcinoma of overlapping sites

C4A.9

Merkel cell carcinoma, unspecified

C53.0

Malignant neoplasm of endocervix

C53.1

Malignant neoplasm of exocervix

C53.8

Malignant neoplasm of overlapping sites of cervix uteri

C53.9

Malignant neoplasm of cervix uteri, unspecified

C54.0

Malignant neoplasm of isthmus uteri

C54.1

Malignant neoplasm of endometrium

C54.2

Malignant neoplasm of myometrium

C54.3

Malignant neoplasm of fundus uteri

C54.8

Malignant neoplasm of overlapping sites of corpus uteri

C54.9

Malignant neoplasm of corpus uteri, unspecified

C56.1

Malignant neoplasm of right ovary

C56.2

Malignant neoplasm of left ovary

C56.9

Malignant neoplasm of ovary, unspecified side

C57.00

Malignant neoplasm of fallopian tube, unspecified side

C57.01

Malignant neoplasm of right fallopian tube

C57.02

Malignant neoplasm of left fallopian tube

C57.10

Malignant neoplasm of broad ligament, unspecified side

C57.11

Malignant neoplasm of right broad ligament

C57.12

Malignant neoplasm of left broad ligament

C57.20

Malignant neoplasm of round ligament, unspecified side

C57.21

Malignant neoplasm of right round ligament

C57.22

Malignant neoplasm of left round ligament

C57.3

Malignant neoplasm of parametrium

C57.4

Malignant neoplasm of uterine adnexa, unspecified

C61

Malignant neoplasm of prostate

C65.1 – C65.2,

C65.9

Malignant neoplasm of renal pelvis, unspecified

C66.1-C66.2,

C66.9

Malignant neoplasm of ureter, unspecified

C67.0 – C67.9

Malignant neoplasm of bladder

C68.0

Malignant neoplasm of urethra

C68.1

Malignant neoplasm of paraurethral glands

C68.8

Malignant neoplasm of overlapping sites of urinary organs

C68.9

Malignant neoplasm of urinary organ, unspecified

C7A.1

Malignant poorly differentiated neuroendocrine carcinoma

C7A.8

Other malignant neuroendocrine tumors

C7B.00 – C7B.09

Secondary carcinoid tumors, unspecified site

C7B.1

Secondary Merkel cell carcinoma

C7B.8

Other secondary neuroendocrine tumors

C78.00

Secondary malignant neoplasm of lung, unspecified side

C78.01

Secondary malignant neoplasm of right lung

C78.02

Secondary malignant neoplasm of left lung

C79.31

Secondary malignant neoplasm of brain

C79.32

Secondary malignant neoplasm of cerebral meninges

C79.40

Secondary malignant neoplasm of unspecified part of nervous system

C79.49

Secondary malignant neoplasm of other parts of nervous system

C79.51

Secondary malignant neoplasm of brain

C79.52

Secondary malignant neoplasm of bone marrow

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

C92.00

Acute myeloblastic leukemia, not having achieved remission

C92.40

Acute promyelocytic leukemia, not having achieved remission

C92.50

Acute myelomonocytic leukemia, not having achieved remission

C92.60

Acute myeloid leukemia with 11q23-abnormality, not having achieved remission

C92.A0

Acute myeloid leukemia with multilineage dysplasia, not having achieved remission

C93.00

Acute monoblastic/monocytic leukemia, not having achieved remission

C94.00

Acute erythroid leukemia, not having achieved remission

C94.02

Acute erythroid leukemia, in relapse

D09.0

Carcinoma in situ of bladder

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) was identified during the last review. The following Local Coverage Determination (LCD) located at www.fcso.com was reviewed on the last guideline revised date: Topotecan hydrochloride (Hycamtin), (L33752)

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

DEFINITIONS:

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

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

RELATED GUIDELINES:

Oprelvekin; Interleukin 11 (Neumega®), 09-J0000-63
Romiplostim Injection (Nplate™), 09-J0000-88

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

Carboplatin (Paraplatin®) IV, 09-J0000-93

Docetaxel (Taxotere®) IV, 09-J0000-95

Gemcitbine (Gemzar®), 09-J0000-96

Irinotecan HCl (Camptosar®) IV, 09-J0000-99

OTHER:

None applicable.

REFERENCES:

  1. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.;2012. URL www.clinicalpharmacilogy-ip.com Accessed July 9, 2015.
  2. Hycamtin (topotecan) capsules [package insert]. GlaxoSmithKline. Research Triangle Park (NC): June 2014.
  3. Hycamtin (topotecan) injection [package insert]. GlaxoSmithKline. Research Triangle Park (NC): June 2015.
  4. Ingenix HCPCS Level II, Expert 2013
  5. Ingenix ICD-9-CM for Physicians-Volumes 1 & 2, Expert 2013.
  6. Micromedex® Healthcare Series [Internet Database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed July 9, 2015.
  7. National Comprehensive Cancer Network. Cancer Guidelines. Cancer Guidelines and Drugs and Biologics Compendium. Accessed July 10, 2015.
  8. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 1.2015. Acute Myeloid Leukemia. Available at http://www.nccn.org/professionals/physician_gls/PDF/aml.pdf
  9. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 1.2015. Bone Cancer. Available from http://www.nccn.org/professionals/physician_gls/PDF/bone.pdf
  10. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 1.2015. Central Nervous System Cancers. Available from http://www.nccn.org/professionals/physician_gls/PDF/cns.pdf
  11. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 2.2015. Cervical Cancer. Available from: http://www.nccn.org/professionals/physician_gls/PDF/cervical.pdf
  12. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 2.2015. Epithelial Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer. Available from: http://www.nccn.org/professionals/physician_gls/PDF/ovarian.pdf
  13. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 2.2015. Merkel Cell Carcinoma. Available from http://www.nccn.org/professionals/physician_gls/PDF/mcc.pdf
  14. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 7.2015. Non-Small Cell Lung Cancer. Available from http://www.nccn.org/professionals/physician_gls/PDF/nscl.pdf
  15. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 1.2015. Neuroendocrine Tumors. Available from http://www.nccn.org/professionals/physician_gls/PDF/neuroendocrine.pdf
  16. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 1.2015. Prostate cancer. Available from http://www.nccn.org/professionals/physician_gls/PDF/prostate.pdf
  17. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 1.2016. Small Cell Lung Cancer. Available from http://www.nccn.org/professionals/physician_gls/PDF/sclc.pdf
  18. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 1.2015. Soft tissue sarcoma. Available from http://www.nccn.org/professionals/physician_gls/PDF/sarcoma.pdf
  19. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 2.2015. Uterine neoplasms.. Available from: http://www.nccn.org/professionals/physician_gls/PDF/uterine.pdf
  20. Topotecan. In McEvoy GK, editor. AHFS drug information 2015 [monograph on the internet]. Bethesda (MD): American Society of Health-System Pharmacists; 2015 [cited July 8, 2015].

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 08/12/15.

GUIDELINE UPDATE INFORMATION:

05/15/09

New Medical Coverage Guideline.

10/15/09

Revision to guideline; consisting of clarifying dosage and updating coding.

01/01/10

Revision to guideline; consisting of updating coding and alternate dosing regimen.

04/15/10

Revision to guideline; consisting of updating coding.

08/01/10

Revision to guideline; consisting of updating coding.

01/01/11

Review and revision to guideline; consisting of updating coding, related guidelines and references.

10/01/11

Revision to guideline; consisting of updating coding.

01/01/12

Review and revision to guideline; consisting of adding oral formulation and updating references.

12/15/12

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

02/15/13

Revision to guideline; consisting of adding new indication and updating coding.

04/15/13

Revision to guideline; consisting of adding new indication and updating coding.

12/15/13

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

09/15/15

Review and revision to guideline; consisting of updating position statement, dosage/administration, warnings/precautions, definitions, coding and references.

10/01/15

Revision consisting of update to Program Exceptions section.

11/01/15

Revision: ICD-9 Codes deleted.

11/15/15

Revision to guideline; consisting of updating position statement and 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.

Internet Privacy Statement   |   Terms of Use
 

Date Printed: July 29, 2016: 10:00 AM