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Date Printed: October 23, 2017: 02:17 AM

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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-J0000-97

Original Effective Date: 04/15/09

Reviewed: 08/09/17

Revised: 10/15/17

Subject: Granisetron (Sustol®) 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:

Chemotherapy induced (or radiation therapy induced) vomiting and nausea can significantly affect a patient’s quality of life, leading to poor compliance with further chemotherapy or radiation therapy treatment. The severity and incidence of chemotherapy or radiation therapy induced nausea and vomiting are affected by factors such as the selected agent and dose of chemotherapy, route of administration, location of radiation therapy, prior chemotherapy use, and patient age and sex.

In general, to provide maximal protection against chemotherapy induced nausea and vomiting, antiemetic therapy should be initiated before chemotherapy. The antiemetic therapy should also be continued for the same length of time as the duration of the emetic activity of the chemotherapeutic agent being used. However, daily use of antiemetics is not recommended for some therapeutic agents that are taken long term (e.g., imatinib, erlotinib). Antiemetic agents can be administered by the oral, rectal, IV, intramuscular, subcutaneous or transdermal route.

Granisetron (Kytril) injection was approved by the U.S. Food and Drug Administration (FDA) in December 1993 for prevention of nausea and vomiting associated with cancer chemotherapy. Granisetron selectively blocks serotonin 5-HT3 receptors to prevent emesis. A subcutaneous formulation of granisetron (Sustol) was FDA approved in August 2016 for use in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. In a randomized, multicenter, double-blind study of patients receiving moderately emetogenic chemotherapy, a 10 mg granisetron delayed-release subcutaneous injection was noninferior to palonosetron 0.25 mg IV regarding a complete response (no emetic episodes and no rescue therapy needed). Granisetron delayed-release subcutaneous injection also demonstrated noninferiority to palonosetron regarding a complete response in patients receiving chemotherapy regimens with an anthracycline plus cyclophosphamide.

National Comprehensive Cancer Network (NCCN) Guidelines for antiemesis recommend granisetron subcutaneous injection for acute and delayed emesis prevention in combination with an NK1 antagonist (e.g., aprepitant, fosaprepitant, rolapitant) and dexamethasone before intravenous antineoplastic therapy with high or moderate emetic risk. It is also recommended in combination with dexamethasone without an NK1 antagonist for chemotherapy with moderate emetic risk. It is also recommended in combination with either aprepitant or fosaprepitant, olanzapine, and dexamethasone for high risk antineoplastic therapy.

POSITION STATEMENT:

Granisetron (Sustol®) subcutaneous meets the definition of medical necessity for members meeting ALL of the following criteria:

1. Use is for ONE of the following:

a. Prevention of acute or delayed chemotherapy induced nausea and vomiting associated with initial or repeat courses of moderately emetogenic chemotherapy (see Table 1)

b. Prevention of acute or delayed chemotherapy induced nausea and vomiting associated with initial or repeat courses of highly emetogenic chemotherapy (see Table 1) and use is in combination with an NK1 antagonist (e.g., fosaprepitant, aprepitant, rolapitant) or the member has a contraindication or intolerance to an NK1 antagonist

c. Prevention of acute or delayed chemotherapy induced nausea and vomiting associated with initial or repeat courses of low emetogenic chemotherapy (Table 1) and the member had an inadequate response or contraindication to use of an alternative formulation of a serotonin antagonist (e.g., oral ondansetron, dolasetron, granisetron) to prevent chemotherapy-induced nausea and vomiting with the current regimen

2. Use is in combination with dexamethasone or the member has a contraindication or intolerance to dexamethasone

3. Member is not receiving an additional serotonin antagonist (e.g., palonosetron, granisetron transdermal)

4.Dose does not exceed 10 mg every 7 days

Duration of approval: 6 months

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

Granisetron SQ: 10 mg administered subcutaneously in combination with dexamethasone at least 30 minutes before the initiation of MEC or AC combination chemotherapy. Administer on Day 1 of chemotherapy and not more frequently than once every 7 days because of the extended-release properties of the formulation. See the prescribing information for the recommended administration technique and dexamethasone dosage.

Dose Adjustments

Granisetron SQ:

• Moderate renal impairment (CrCl 30 to 59 mL/min): administer on Day 1 of chemotherapy and not more frequently than once every 14 days.

• Severe renal impairment (CrCl less than 30 mL/min): avoid use

Drug Availability

Granisetron SQ:

• Extended-Release Injection: 10 mg/0.4 mL in a single-dose pre-filled syringe

PRECAUTIONS:

Contraindications:

• Granisetron SQ: Hypersensitivity to granisetron, any of the components of the formulation, or to any of the other 5-HT receptor antagonists

Precautions/Warnings:

Granisetron SQ:

• Injection site reactions, including infection, bleeding, pain, nodules, swelling and induration may occur. Note that some may occur 2 weeks or more after administration.

• Increased risk of bruising or severe hematoma in patients receiving anticoagulants or antiplatelet agents.

• Gastrointestinal disorders: Monitor for constipation or decreased bowel activity, and signs and symptoms of ileus.

• Hypersensitivity reactions: Serious reactions have been reported and may occur up to 7 days or longer following administration. Serotonin syndrome may occur particularly with concomitant use of serotonergic drugs.

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding:

C9486

Injection, granisetron extended release, 0.1 mg (hospital outpatient use ONLY)

J3490

Unclassified drugs

ICD-10 Diagnoses Codes That Support Medical Necessity for granisetron SQ (Sustol)(C9399, J3490):

R11.0

Nausea

R11.10 – R11.12

Vomiting, unspecified

R11.2

Nausea with vomiting, unspecified

T45.1X5A

Adverse effect of antineoplastic and immunosuppressive drugs, initial encounter

T45.1X5D

Adverse effect of antineoplastic and immunosuppressive drugs, subsequent encounter

T45.1X5S

Adverse effect of antineoplastic and immunosuppressive drugs, sequela

T45.95XA

Adverse effect of unspecified primarily systemic and hematological agent, initial encounter

T50.905A

Adverse effect of unspecified drugs, medicaments and biological substances

Z51.11

Encounter for antineoplastic chemotherapy

Z51.12

Encounter for antineoplastic immunotherapy

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:

No guideline specific definitions apply.

RELATED GUIDELINES:

Oral Antiemetic Agents, 09-J0000-55
Palonosetron Hydrochloride (Aloxi®), 09-J0000-87

Ondansetron HCl (Zofran®) IV, 09-J0000-98

OTHER:

Table 1

Emetogenic Potential of Antineoplastic Agents

 

High emetic risk

(>90% frequency of emesis)

Moderate emetic risk

(30-90% frequency of emesis)

IV

AC combination (doxorubicin or epirubicin with cyclophosphamide)

Carboplatin AUC > 4

Carmustine (>250 mg/m2)

Cisplatin

Cyclophosphamide (> 1500 mg/m2)

Dacarbazine

Doxorubicin (>60 mg/m2)

Epirubicin (>90 mg/ m2)

Ifosfamide (≥2 g/ m2)

Mechlorethamine

Streptozocin

Aldesleukin (>12-15 million IU/m2)

Amifostine (>300 mg/m2)

Arsenic trioxide

Azacitidine

Bendamustine

Busulfan

Carboplatin AUC < 4

Carmustine (≤250 mg/m2)

Clofarabine

Cyclophosphamide (≤1500 mg/m2)

Cytarabine (>200 mg/m2)

Dactinomycin

Daunorubicin

Dinutuximab

Doxorubicin (<60 mg/m2)

Epirubicin (≤90 mg/m2)

Idarubicin

Ifosfamide (< 2g/m2)

Interferon alfa (≥10 million IU/m2)

Irinotecan

Melphalan

Methotrexate (≥250 mg/m2)

Oxaliplatin

Temozolomide

Trabectedin

IV

Low emetic risk (10 – 30% frequency of emesis)

 

Ado-trastuzumab emtansine

Aldesleukin < 12 million international units/m2

Amifostine <300 mg/m2

Atezolizumab

Belinostat

Blinatumomab

Brentuximab vedotin

Cabazitaxel

Carfilzomib

Cytarabine (low dose) 100 – 200 mg/m2

Docetaxel

Doxorubicin (liposomal)

Eribulin

Etoposide

5-FU

Floxuridine

Gemcitabine

Interferon alfa >5 -<10 million international units/m2

Irinotecan (liposomal)

Ixabepilone

Methotrexate > 50 mg/m2 - <250 mg/m2

Mitomycin

Mitoxantrone

Necitumumab

Omacetaxine

Paclitaxel

Paclitaxel-albumin

Pemetrexed

Pentostatin

Pralatrexate

Romidepsin

Talimogene laherparepvec

Thiotepa

Topotecan

Ziv-aflibercept

REFERENCES:

  1. AHFS Drug Information. Bethesda (MD): American Society of Health-System Pharmacists, Inc; 2013 [cited 2016 Sept 27]. In: STAT!Ref Online Electronic Medical Library [Internet]. Available from: http://online.statref.com/.
  2. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2016 [cited 2016 Sept 27]. Available from: http://www.clinicalpharmacology.com/.
  3. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 2016 Sept 27]. Available from: http://www.thomsonhc.com/.
  4. Fresenius Kabi USA, LLC. Granisetron (granisetron hydrochloride) injection. 2016 [cited 2016 Oct 5]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=dddc8714-383f-4bc5-a468-ae89dbc802b4/.
  5. NCCN Drugs & Biologics Compendium [Internet]. Fort Washington (PA): National Comprehensive Cancer Network; 2017 [cited 2017 July 28]. Available from: http://www.nccn.org/professionals/drug_compendium/content/contents.asp/.
  6. NCCN Clinical practice guidelines in oncology (NCCN Guidelines®). Antiemesis, v. 2.2017 [cited 2017-09-13]. Available from: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp.
  7. Sustol [prescribing information]. Heron Therapeutics. Redwood City, CA. November 2016.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 08/09/17.

GUIDELINE UPDATE INFORMATION:

04/15/09

New Medical Coverage Guideline.

10/15/09

Revision; consisting of clarifying dosage.

01/01/10

Revision; consisting of adding fixed dosing as an alternative in position statement.

09/15/10

Review and revision; consisting of updating references.

01/15/11

Revision to guideline; consisting of adding ICD-10 codes.

09/15/11

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

09/15/12

Review and revision to guideline; consisting of removing postanesthetic shivering indication, reformatting position statement, updating coding and references.

08/15/13

Review and revision to guideline; consisting of description, position statement, dosage/administration, precautions, program exceptions, and references.

11/01/15

Revision: ICD-9 Codes deleted.

11/15/16

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

12/15/16

Revision to guideline; consisting of updating position statement, description, dosage/administration, precautions, coding and references.

04/01/17

Revision to guideline consisting of adding HCPCS code C9486.

09/15/17

Review and revision to guideline; consisting of updating position statement, description, and references.

10/15/17

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

Date Printed: October 23, 2017: 02:17 AM