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Date Printed: October 23, 2017: 07:32 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-J1000-51

Original Effective Date: 01/01/12

Reviewed: 11/09/16

Revised: 12/15/16

Subject: Sunitinib Malate (Sutent®) Capsules

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:

Sunitinib (Sutent®) is an oral multikinase inhibitor that acts by inhibiting tumor growth and disrupting tumor microvasculature through antiproliferative, anti-angiogenic and proapoptotic effects. It exerts these effects via inhibition of multiple targets including vascular endothelial growth factor receptor (VEGFR) tyrosine kinases; VEGFR-1, VEGRF-2, VEGRF-3 and platelet-derived growth factor receptor beta. In 2006, the Food and Drug Administration (FDA) approved sunitinib for the treatment of advanced renal cell carcinoma and treatment of gastrointestinal stromal tumor after disease progression on or intolerance to imatinib (Gleevec). In May 2011, sunitinib was FDA-approved for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors in adults with unresectable locally advanced or metastatic disease.

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 sunitinib (Sutent) meets the definition of medical necessity when the dose does not exceed 50 mg once daily* using the fewest number of capsules, it is administered for an indication in Table 1, and all of the indication specific criteria are met:

Table 1

Indication

Specific Criteria

Chordoma

Sunitinib will be used as a single agent for the treatment of recurrent chordoma

Kidney cancer*

When used as a single agent in member’s with relapsed or surgically unresectable stage IV disease meeting ONE of the following:

1. Sunitinib is used as first line or subsequent therapy for disease with predominant clear cell histology

2. Sunitinib is used for treatment of disease with non-clear cell histology

Lung neuroendocrine tumor

When ONE of the following are met:

1. Member has stage IIIb low- or intermediate-grade neuroendocrine tumor

2. Member has stage IV low- or intermediate-grade neuroendocrine tumor

Pancreatic neuroendocrine tumor (pNET)*

When used as a single agent 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

Soft tissue sarcoma:

Alveolar soft part sarcoma

Angiosarcoma

Gastrointestinal stromal tumor (GIST)*

Solitary Fibrous Tumor/Hemangiopericytoma

Sunitinib is used as a single agent and will be used to treat ONE of the following:

1. Alveolar soft part sarcoma

2. Angiosarcoma

3. Gastrointestinal stromal tumor (GIST) in member’s who had disease progression on or intolerable side effects to imatinib (Gleevec)

4. Solitary Fibrous Tumor/Hemangiopericytoma

Thymic carcinoma

Sunitinib is used as a single agent as second-line therapy

Thyroid cancer:

Follicular carcinoma

Hurthle cell carcinoma

Papillary carcinoma

Medullary carcinoma

When the member meets all criteria for treatment of ONE of the following:

1. Follicular carcinoma, Hurthle cell carcinoma, or Papillary carcinoma of the thyroid when used as a single agent for iodine-refractory symptomatic or progressive disease classified as ONE of the following:

a. Unresectable locoregional disease that is recurrent or persistent

b. Distant metastatic disease

2. Medullary carcinoma of the thyroid when used as a single agent for progressive or symptomatic distant metastatic disease and member meets ONE of the following:

a. Disease is refractory to vandetanib (Caprelsa) or cabozantinib (Cometriq)

b. Member is unable to tolerate or has a contraindication to vandetanib (Caprelsa) or cabozantinib (Cometriq)

Approval Duration: 180 days (all indications)

II. Continuation of sunitinib (Sutent®) 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 treatment with sunitinib

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 dose does not exceed 50 mg once daily* and will be provided using the fewest number of capsules

Approval duration: 1 year

*NOTE: Avoid use with strong CYP3A4 inhibitors or inducers. Selection of an alternate concomitant medication with no or minimal enzyme interference potential is recommended. If coadministration of a strong CYP3A4 inducer (e.g., carbamazepine, dexamethasone, phenobarbital, phenytoin, rifabutin, rifampin, rifapentin) cannot be avoided, a dose greater than 50 mg daily will be permitted for FDA-approved indications. Per FDA- labeling, the dose maximum of 87.5 mg (GIST and RCC) or 62.5 mg (pNET) daily with coadministration of a strong CYP3A4 inducer may be considered. If the dose is increased, the patient should be monitored carefully for toxicity. A dose reduction should be considered if coadministration with strong CYP3A4 inhibitors cannot be avoided.

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: sunitinib is indicated for the treatment of gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib (Gleevec), advanced renal cell carcinoma (RCC), and progressive, well-differentiated pancreatic neuroendocrine (pNET) in members with unresectable locally advanced or metastatic disease. The recommended dose for the treatment of GIST and advanced RCC is 50 mg orally once daily for 4 weeks followed by 2 weeks off. The recommended dose for treatment of pNET is 37.5 mg orally once daily continuously without a scheduled off-treatment period. Sunitinib can be taken with or without food.

Dosage Adjustments

Hepatic Impairment: Initiation dose adjustments are not required for members with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. Sunitinib was not evaluated in subjects with severe (Child-Pugh Class C) hepatic impairment.

Renal Impairment: Initiation dose adjustments are not required for members with mild, moderate, and severe renal impairment. In clinical studies, subjects with end-stage renal disease (ESRD) on dialysis had a 47% lower exposure when compared to subjects with normal renal function. As such, subsequent doses may be increased gradually up to 2 fold based on safety and tolerability.

Adverse reactions: dose interruption and/or dose modification in 12.5 mg increments or decrements is recommended based on individual safety and tolerability.

Drug Interactions

• Strong CYP3A4 inhibitors (e.g., ketoconazole): If coadministration cannot be avoided, consider reducing dose to 37.5 mg (GIST and RCC) and 25 mg (pNET) daily.

• Strong CYP3A4 inducers (e.g., rifampin): If coadministration cannot be avoided, consider increasing dose to a maximum of 87.5 mg (GIST and RCC) or 62.5 mg (pNET) daily.

Drug Availability: sunitinib is available as 12.5-, 25-, 37.5-, and 50 mg hard gelatin capsules.

PRECAUTIONS:

Boxed Warning: hepatotoxicity has been observed in clinical trials and post-marketing experience. Hepatotoxicity may be severe and deaths have been reported.

Hepatotoxicity: Liver failure has been observed. Monitor liver function tests (ALT, AST, and bilirubin) before initiation of treatment, during each treatment cycle, and as clinically indicated. Sunitinib therapy should be interrupted for Grade 3 or 4 drug-related hepatic related events and discontinued if there is no resolution.

Cardiac Toxicity: cardiac toxicity, including myocardial ischemia, myocardial infarction, left ventricular ejection fraction declines to below the lower limit of normal and cardiac failure including death have occurred. Monitor members for signs and symptoms of congestive heart failure.

Prolonged QT and Torsade de Pointes: use with caution in members at higher risk for developing QT interval prolongation. Monitoring with on-treatment electrocardiograms and electrolytes should be considered.

Hypertension: monitor blood pressure and treat as needed.

Hemorrhagic events: Monitor complete blood counts (CBC) and assess for signs and symptoms.

Osteonecrosis of the Jaw: consider preventative dentistry prior to treatment with sunitinib. If possible, avoid invasive dental procedures, particularly in members receiving intravenous bisphosphonate therapy.

Tumor lysis syndrome (TLS): primarily reported in individuals with RCC and GIST with a high tumor burden; monitor these members closely and treat as clinically indicated.

Thrombotic microangiopathy: thrombotic thrombocytopenic purpura and hemolytic uremic syndrome sometimes leading to renal failure or a fatal outcome has been reported.

Thyroid dysfunction: Monitor thyroid function members with signs/symptoms suggestive of hypo- or hyperthyroidism; manage per standard medical practice.

Hypoglycemia: Check blood glucose levels regularly and adjust anti-diabetic medications as necessary.

Major surgical procedures: temporary interruption of sunitinib therapy is recommended due to impaired wound healing.

Proteinuria: Monitor urine protein and interrupt therapy for 24 hour urine protein > 3 grams. Discontinue for repeat episodes of protein > 3 grams despite dose reductions or nephrotic syndrome

Severe skin reaction: discontinue if necrotizing fasciitis, erythema multiforme, Stevens-Johnson syndrome or toxic epidermal necrolysis occur.

Adrenal hemorrhage: monitor adrenal function in case of stress such as surgery, trauma or severe infection.

Pregnancy and Lactation:

• Sunitinib is classified as pregnancy category D and can cause fetal harm when administered to pregnant women.

• Although it is unknown whether sunitinib is excreted into human milk, sunitinib and its metabolites are excreted in rat milk.

BILLING/CODING INFORMATION:

HCPCS Coding

C9399

Unclassified drugs or biologicals

J8999

Prescription drug, oral, chemotherapeutic, NOS

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

C25.4

Malignant neoplasm of endocrine pancreas

C37

Malignant neoplasm of thymus

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

C64.1 – C64.9

Malignant neoplasm of unspecified kidney, except renal pelvis

C65.1 – C65.9

Malignant neoplasm of unspecified renal pelvis

C72.0

Malignant neoplasm of spinal cord

C72.1

Malignant neoplasm of cauda equina

C73

Malignant neoplasm of thyroid gland

C7A.090

Malignant carcinoid tumor of the bronchus and lung

C7B.00 – C7B.09

Secondary neuroendocrine carcinoid tumors

D15.0

Benign neoplasm of thymus

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

DEFINITIONS:

None

RELATED GUIDELINES:

Cabozantinib (Cometriq™) Capsules, 09-J1000-88
Imatinib Mesylate (Gleevec®) Tablets, 09-J1000-46

Pazopanib (Votrient™) Tablets, 09-J1000-49

Sorafenib (Nexavar®) Tablets, 09-J1000-50

Vandetanib (Caprelsa®) Tablets, 09-J1000-38

OTHER:

TABLE 1: Stages of Renal Cell Cancer

Stage I

The tumor is 7 centimeters or smaller and is found only in the kidney.

Stage II

The tumor is larger than 7 centimeters and is found only in the kidney.

Stage III

The tumor is any size and cancer is found only in the kidney and in 1 or more nearby lymph nodes; or cancer is found in the main blood vessels of the kidney or in the layer of fatty tissue around the kidney. Cancer may be found in 1 or more nearby lymph nodes.

Stage IV

Cancer has spread beyond the layer of fatty tissue around the kidney and may be found in the adrenal gland above the kidney with cancer, or in nearby lymph nodes; or to other organs, such as the lungs, liver, bones, or brain, and may have spread to lymph nodes.

TABLE 2: Child-Pugh Score and Classification

 

1 point

2 points

3 points

Total bilirubin

< 2

2-3

> 3

Serum albumin

> 3.5

2.8-3.5

< 2.8

INR

> 1.7

1.71-2.20

< 2.20

Ascites

None

Mild

Severe

Hepatic encephalopathy

None

Grade I-II

Grade III-IV

Classification of Result:
Class A: 5-6 points
Class B: 7-9 points
Class C: 10-15 points

REFERENCES:

  1. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.;2016. URL www.clinicalpharmacilogy-ip.com Accessed 10/20/16.
  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 0/20/16.
  5. National Comprehensive Cancer Network. Cancer Guidelines. Cancer Guidelines and Drugs and Biologics Compendium. Accessed 10/20/16.
  6. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 1.2017 Bone Cancer. Available at http://www.nccn.org/professionals/physician_gls/PDF/bone.pdf Accessed 10/25/16.
  7. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 1.2016 Central Nervous System Cancer. Available at http://www.nccn.org/professionals/physician_gls/PDF/CNS.pdf Accessed 10/25/16.
  8. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 1.2017 Kidney Cancer. Available at http://www.nccn.org/professionals/physician_gls/PDF/kidney.pdf Accessed 10/20/16.
  9. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 2.2016 Neuroendocrine Tumors. Available at http://www.nccn.org/professionals/physician_gls/PDF/neuroendocrine.pdf Accessed 10/24/16.
  10. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 2.2016. Pancreatic adenocarcinoma. Available at http://www.nccn.org/professionals/physician_gls/PDF/pancreatic.pdf Accessed 10/25/16.
  11. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 2.2017 Small Cell Lung Cancer. Available at http://www.nccn.org/professionals/physician_gls/PDF/sclc.pdf Accessed 10/24/16.
  12. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 2.2016. Soft Tissue Sarcoma. Available at http://www.nccn.org/professionals/physician_gls/PDF/sarcoma.pdf Accessed 10/24/16.
  13. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 3.2016 Thymoma and Thymic Carcinoma. Available at http://www.nccn.org/professionals/physician_gls/PDF/thymic.pdf Accessed 10/24/16.
  14. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 1/2016. Thyroid Carcinoma. Available at http://www.nccn.org/professionals/physician_gls/PDF/thyroid.pdf Accessed 10/20/16.
  15. Sunitinib. In McEvoy GK, editor. AHFS drug information 2016 [monograph on the internet]. Bethesda (MD): American Society of Health-System Pharmacists; 2016 [cited 2016 October 20]. Available from http://online.statref.com Subscription required to review.
  16. Sutent (sunitinib) [package insert]. Pfizer Inc. New York (NY): January 2016.

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 and reformatting position statement; revising description section, dosage/administration, and precaution section; updating references and coding.

12/15/13

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

12/15/14

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

12/15/15

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

12/15/16

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

Date Printed: October 23, 2017: 07:32 AM