Print

Date Printed: June 28, 2017: 11:54 PM

Private Property of Blue Cross and Blue Shield of Florida.
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-J0000-93

Original Effective Date: 04/15/09

Reviewed: 01/15/14

Revised: 11/01/15

Subject: Carboplatin (Paraplatin®) 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.

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

DESCRIPTION:

Carboplatin (Paraplatin) was approved by the US Food and Drug Administration (FDA) in 1989 for the treatment of ovarian cancer. The efficacy and safety of carboplatin has been studied in a variety of other cancers and its use in treatment of other cancers is supported by referenced compendia.

Carboplatin is platinum compound related to cisplatin; however, carboplatin has a more favorable adverse effect profile, which has led to the investigation of the replacement of cisplatin with carboplatin in many regimens. The two agents share a similar mechanism of action and exert their cytotoxic activity by binding with DNA to form intrastrand crosslinks and adducts. This process changes the conformation of DNA and affects DNA replication and ultimately results in cell cycle arrest in the G2-phase and then programmed cell death, or apoptosis.

POSITION STATEMENT:

Carboplatin (Paraplatin®) IV meets the definition of medical necessity when administered for any of the following indications and the dosage does not exceed 360 mg/meter squared or alternately, dose derived from formula dosing (Total dose (mg) = (target AUC) × (GFR + 25):

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: carboplatin is indicated for initial treatment of advanced ovarian carcinoma and secondary treatment of advanced ovarian carcinoma. In addition, its use is supported by referenced compendium for several other off-label indications.

Single-Agent Therapy

Carboplatin, as a single agent, has been shown to be effective in individuals with recurrent ovarian cancer at a dosage of 360 mg/m2 IV on day 1 every 4 weeks. Combination Therapy with Cyclophosphamide

Intermittent courses of carboplatin, either as a single-agent or in combination with cyclophosphamide should not be repeated until the neutrophil count is at least 2,000 and the platelet count is at least 100,000.

Dose Adjustments

Table 1

Table 1: Dose modifications for bone marrow suppression

Platelet Count (cells/mm3)

Neutrophils ((cells/mm3)

Adjusted Dose† (From prior course)

Greater than 100,000

Greater than 2,000

125%

50-100,000

500 to 2,000

No adjustment

Less than 50,000

Less than 500

75%

† Percentages apply to carboplatin injection as a single agent or to both carboplatin and cyclophosphamide in combination.

Drug Availability: carboplatin is supplied as 600 mg/60 mL multi-dose vial.

PRECAUTIONS:

Boxed Warning:

Contraindications:

Warnings:

BILLING/CODING INFORMATION:

HCPCS Coding:

J9045

Injection, carboplatin, 50mg

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

C00.0 – C06.9

Malignant neoplasm of lip, base of tongue and other unspecified parts of the tongue, gum, floor of mouth, palate and other unspecified parts of mouth

C09.0

Malignant neoplasm of tonsillar fossa

C09.1

Malignant neoplasm of tonsillar pillar

C09.9

Malignant neoplasm of tonsil, unspecified

C10.3

Malignant neoplasm of posterior wall of oropharynx

C11.0 – C16.9

Malignant neoplasm of nasopharynx, pyriform sinus, hypopharynx, other and ill-defined sites in the lip, oral cavity and pharynx, esophagus and stomach

C31.0 – C31.1

Malignant neoplasm of maxillary sinus and ethmoidal sinus

C32.0 – C37

Malignant neoplasm of larynx, trachea, bronchus and lung and thymus

C38.4

Malignant neoplasm of pleura

C40.00 – C43.9

Malignant neoplasm of bone and articular cartilage of limbs, articular cartilage of other and unspecified sites, melanoma of skin, Merkel cell carcinoma and other malignant neoplasm of skin

C44.01

Basal cell carcinoma of skin of lip

C44.111

Basal cell carcinoma of skin of unspecified eyelid, including canthus

C44.211

Basal cell carcinoma of skin of unspecified ear and external auricular canal

C44.310

Basal cell carcinoma of skin of unspecified parts of face

C44.311

Basal cell carcinoma of skin of nose

C44.319

Basal cell carcinoma of skin of other parts of face

C44.41

Basal cell carcinoma of skin of scalp and neck

C44.510

Basal cell carcinoma of anal skin

C44.511

Basal cell carcinoma of skin of breast

C44.519

Basal cell carcinoma of skin of other part of trunk

C44.611

Basal cell carcinoma of skin of unspecified upper limb, including shoulder

C44.711

Basal cell carcinoma of skin of unspecified lower limb, including hip

C44.81

Basal cell carcinoma of overlapping sites of skin

C44.91

Basal cell carcinoma of skin, unspecified

C48.0 – C48.8

Malignant neoplasm of retroperitoneum and peritoneum

C49.9

Malignant neoplasm of connective and soft tissue, unspecified

C50.011 – C50.929

Malignant neoplasm of breast

C53.0 – C54.9

Malignant neoplasm of cervix uteri and corpus uteri

C56.0 – C57.4

Malignant neoplasm of fallopian tube, broad ligament, round ligament, parametrium and uterine adnexa, unspecified

C60.0

Malignant neoplasm of prepuce

C60.1

Malignant neoplasm of glans penis

C60.2

Malignant neoplasm of body of penis

C60.8

Malignant neoplasm of overlapping sites of penis

C60.9

Malignant neoplasm of penis, unspecified

C61 – C62.92

Malignant neoplasm of prostate and testis

C63.7

Malignant neoplasm of other specified male genital organs

C63.8

Malignant neoplasm of overlapping sites of male genital organs

C65.0 – C67.9

Malignant neoplasm of renal pelvis, ureter and bladder

C7A.1

Malignant poorly differentiated neuroendocrine tumors

C7B.1

Secondary Merkel cell carcinoma

C71.0 – C71.9

Malignant neoplasm of brain

C72.9

Malignant neoplasm of central nervous system, unspecified

C74.90 – C74.92

Malignant neoplasm of adrenal gland, unspecified

C7A.091

Malignant carcinoid tumor of the thymus

C7A.1

Malignant poorly differentiated neuroendocrine tumors

C7B.00

Secondary carcinoid tumors, unspecified site

C7B.1

Secondary Merkel cell carcinoma

C73

Malignant neoplasm of thyroid gland

C76.0

Malignant neoplasm of head, face and neck

C77.0

Secondary and unspecified malignant neoplasm of lymph nodes of head, face and neck

C78.00 – C78.02

Secondary malignant neoplasm of lung

C78.7

Secondary malignant neoplasm of liver and intrahepatic bile duct

C79.51

Secondary malignant neoplasm of bone

C79.52

Secondary malignant neoplasm of bone marrow

C79.70 – C79.72

Secondary malignant neoplasm of unspecified adrenal gland

C79.89

Secondary malignant neoplasm of other specified sites

C80.0

Disseminated malignant neoplasm, unspecified

C80.1

Malignant (primary) neoplasm, unspecified

C81.00 – C81.49

Hodgkin lymphoma

C81.90 – C81.99

Hodgkin lymphoma, unspecified

C82.90 – C82.99

Follicular lymphoma, unspecified

C83.10 – C83.39

Mantle cell lymphoma and diffuse large B-cell lymphoma

C83.70 – C83.79

Burkitt lymphoma

C83.80 – C84.09

Other follicular and non-follicular and mycosis fungoides

C84.40 – C84.79

Peripheral T-cell lymphoma, not classified, Anaplastic large cell lymphoma, ALK-positive and anaplastic large cell lymphoma, ALK-negative

C85.80 – C85.89

Other specified types of non-Hodgkin lymphoma

C91.10

Chronic lymphocytic leukemia of B-cell type not having achieved remission

C91.12

Chronic lymphocytic leukemia of B-cell in relapse

C91.90

Lymphoid leukemia, unspecified not having achieved remission

C91.92

Lymphoid leukemia, unspecified, in relapse

D03.0 – D03.9

Melanoma in situ

D09.9

Carcinoma in situ, unspecified

D15.0

Benign neoplasm of thymus

D37.01

Neoplasm of uncertain behavior of lip

D37.02

Neoplasm of uncertain behavior of tongue

D37.04

Neoplasm of uncertain behavior of the minor salivary glands

D37.05

Neoplasm of uncertain behavior of pharynx

D37.1

Neoplasm of uncertain behavior of stomach

D37.2

Neoplasm of uncertain behavior of small intestines

D37.4

Neoplasm of uncertain behavior of colon

D37.5

Neoplasm of uncertain behavior of rectum

D37.8

Neoplasm of uncertain behavior of other specified digestive organs

D37.9

Neoplasm of uncertain behavior of digestive organ, unspecified

D38.0

Neoplasm of uncertain behavior of larynx

D43.2

Neoplasm of uncertain behavior of brain, unspecified

D43.4

Neoplasm of uncertain behavior of spinal cord

G73.1

Lambert-Eaton syndrome

Z80.49

Family history of malignant neoplasm of other genital organs

Z85.00

Personal history of malignant neoplasm of unspecified digestive organ

Z85.020

Personal history of malignant carcinoid tumor of stomach

Z85.028

Personal history of other malignant neoplasm of stomach

Z85.030

Personal history of malignant carcinoid tumor of large intestine

Z85.040

Personal history of malignant carcinoid tumor of rectum

Z85.060

Personal history of malignant carcinoid tumor of small intestine

Z85.110

Personal history of malignant carcinoid tumor of bronchus and lung

Z85.118

Personal history of other malignant neoplasm of bronchus and lung

Z85.230

Personal history of malignant carcinoid tumor of thymus

Z85.3

Personal history of malignant neoplasm of breast

Z85.43

Personal history of malignant neoplasm of ovary

Z85.46

Personal history of malignant neoplasm of prostate

Z85.47

Personal history of malignant neoplasm of testis

Z85.520

Personal history of malignant carcinoid tumor of kidney

Z85.71

Personal history of Hodgkin lymphoma

Z85.79

Personal history of other malignant neoplasms of lymphoid, hematopoietic and related tissues

Z85.821

Personal history of Merkel cell carcinoma

Z85.828

Personal history of other malignant neoplasm of skin

Z85.830

Personal history of malignant neoplasm of bone

Z85.841

Personal history of malignant neoplasm of brain

Z85.858

Personal history of malignant neoplasm of other endocrine glands

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 found at the time of the last guideline revised date. The following Local Coverage Determination (LCD) was reviewed on the last guideline revised date: Carboplatin (Paraplatin, Paraplatin-AQ), (L33275) located at fcso.com.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

Rituximab (Rituxan®), 09-J0000-59
Off-Label Use of FDA Approved Drugs, 09-J0000-68

Azacitidine (Vidaza®) Injection, 09-J0000-84

Trastuzumab (Herceptin®) Injection, 09-J0000-86

Octreotide Acetate (Sandostatin LAR® Depot) Injection, 09-J0000-90

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

Bortezomib (Velcade®) IV, 09-J0000-92

Docetaxel (Taxotere®) IV, 09-J0000-95

Gemcitabine (Gemzar®), 09-J0000-96

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

Oxaliplatin (Eloxatin®) IV, 09-J1000-00

Pemetrexed (Alimta®) IV, 09-J1000-01

Topotecan HCl (Hycamtin®) IV, 09-J1000-02

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

Fulvestrant (Faslodex®) IM, 09-J1000-04

OTHER:

None applicable.

REFERENCES:

  1. Clinical Pharmacology. Copyright® 2012 Elsevier. Accessed 01/30/13.
  2. DRUGDEX®. Accessed 01/30/13.
  3. Facts & Comparisons® E Answers. Accessed 02/02/12.
  4. Ingenix, HCPCS Level II, Expert 2011.
  5. Ingenix, ICD-9-CM for Physicians-Volumes 1 & 2, Expert, 2011.
  6. NCCN Drugs & Biologics Compendium™. Accessed 01/30/13.
  7. Paraplatin® Prescribing Information. Revised August 2012.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 01/15/14.

GUIDELINE UPDATE INFORMATION:

04/15/09

New Medical Coverage Guideline.

10/01/09

Revision; consisting of modifying maximum dosage.

10/15/09

Revision; consisting of adding 2 new indications and updating coding.

01/15/10

Revision; consisting of updating coding.

04/15/10

Review and revision; consisting of updating codes and references.

08/01/10

Revision; consisting of updating coding.

04/15/11

Review and revision to guideline; consisting of updating references.

04/15/12

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

10/15/12

Revision to guideline; consisting of removing melanoma indication and adding penile cancer indication.

12/15/12

Revision to guideline; consisting of updating coding.

04/15/13

Review and revision to guideline; consisting of revising position statement to include treatment of gastric cancer, kidney cancer, and thymomas and thymic cancers as medically necessary; revised and reformatted description, dosage/administration, and precautions section; updated coding and references.

12/15/13

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

02/15/14

Revision to guideline; consisting of adding and removing neuroendocrine tumor codes.

10/01/15

Revision consisting of update to Program Exceptions section.

Date Printed: June 28, 2017: 11:54 PM