ph-0111
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Sandostatin® LAR

Policy Number: PH-0111

octreotide suspension

 

Last Review Date: 04/06/2021

Date of Origin: 06/21/2011

Dates Reviewed: 09/2011, 12/2011, 03/2012, 06/2012, 09/2012, 12/2012, 03/2013, 06/2013, 09/2013, 12/2013, 03/2014, 06/2014, 09/2014, 01/2015, 03/2015, 05/2015, 08/2015, 11/2015, 02/2016, 05/2016, 08/2016, 11/2016, 02/2017, 05/2017, 08/2017, 11/2017, 02/2018, 05/2018, 04/2019, 04/2020, 05/2020, 04/2021

Precertification requirements do not apply for this policy. Pre-payment claim edits are applied to diagnosis criteria within this policy.

FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.

  1. Length of Authorization

Coverage is provided for six months and may be renewed.

  1. Dosing Limits

A.  Quantity Limit (max daily dose) [NDC Unit]:

  • 10 mg kit: 1 per 28 days
  • 20 mg kit: 2 per 28 days
  • 30 mg kit: 1 per 28 days

B.  Max Units (per dose and over time) [HCPCS Unit]:

  • Acromegaly: 40 units every 28 days
  • Carcinoid Tumors, Neuroendocrine Tumors, and VIPomas: 30 units every 28 days
  • Thymic Carcinoma/Thymoma: 20 units every 14 days
  1. Initial Approval Criteria 1

Coverage is provided in the following conditions:

  • Patient is at least 18 years of age; AND
  • Patient is being treated with octreotide acetate subcutaneously for at least 2 weeks and has shown a response and no adverse effects prior to starting therapy with the LAR formulation; AND

Carcinoid tumors/Neuroendocrine tumors (e.g., Gastrointestinal Tract, Lung, Thymus, Pancreas, Adrenal) † 1,4,6,9

  • Patient has severe diarrhea/flushing episodes (carcinoid syndrome) † Ф; OR
  • Used to treat symptoms related to hormone hypersecretion in neuroendocrine tumors of the pancreas; AND
    • Patient has a gastrinoma, glucagonoma, or VIPoma; OR
  • Use as primary treatment of unresected primary gastrinoma; OR
  • Used for locoregional unresectable bronchopulmonary or thymic disease as primary therapy or as subsequent therapy if progression on first-line therapy (including disease progression on prior treatment with octreotide LAR in patients with functional tumors); AND
    • Used for management of hormone symptoms and/or somatostatin receptor positive disease determined by imaging (i.e., 68Ga-dotatate imaging PET/CT or PET/MRI or somatostatin receptor scintigraphy [octreotide scan]); OR
  • Patient has distant metastatic bronchopulmonary or thymic disease; AND
    • Used for somatostatin receptor positive disease and/or symptomatic hormonal disease if clinically significant tumor burden and low grade (typical) histology OR evidence of progression OR intermediate grade (atypical histology); AND
      • Used as primary therapy or as subsequent therapy if progression on first-line therapy (including disease progression on prior treatment with octreotide LAR in patients with functional tumors); OR
    • Used for somatostatin receptor positive disease and/or hormonal symptoms if asymptomatic with low tumor burden and low grade (typical) histology; OR
    • Used for somatostatin receptor positive disease and/or chronic cough/dyspnea that is not responsive to inhalers with multiple lung nodules or tumorlets and evidence of diffuse idiopathic pulmonary neuroendocrine cell hyperplasia (DIPNECH); OR
  • Used for the management of locoregional advanced or distant metastatic disease of the gastrointestinal tract; AND
    • Patient is asymptomatic with a low tumor burden; OR
    • Patient with a clinically significant tumor burden; OR
    • Patient has disease progression and is not already receiving octreotide LAR; OR
    • Patient has disease progression with functional tumors and will be continuing treatment with octreotide LAR; OR
  • Used for tumor control of locoregional advanced and/or distant metastatic neuroendocrine tumors of the pancreas (***NOTE: for insulinoma ONLY, patient must have somatostatin-receptor positive disease); AND
    • Patient is asymptomatic with a low tumor burden and stable disease; OR
    • Patient is symptomatic; OR
    • Patient has a clinically significant tumor burden; OR
    • Patient has clinically significant progression and is not already receiving octreotide LAR; OR
  • Patient has pheochromocytoma or paraganglioma; AND
    •  Patient has symptomatic locally unresectable somatostatin receptor-positive disease; OR
    • Patient has distant metastatic disease

Diarrhea associated with Vasoactive Intestinal Peptide tumors (VIPomas) †

  • Patient has profuse watery diarrhea

Acromegaly † Ф 1,3,5

  • Patient diagnosis confirmed by elevated (age-adjusted) or equivocal serum IGF-1 as well as inadequate suppression of GH after a glucose load; AND
  • Patient has documented inadequate response to surgery and/or radiotherapy or it is not an option for the patient; AND
  • Used as long-term maintenance therapy; AND
  • Patient’s tumor has been visualized on imaging studies (i.e., MRI or CT-scan); AND
  • Baseline growth hormone (GH) and IGF-1 blood levels (renewal will require reporting of current levels)

Thymic Carcinomas/Thymomas ‡ 4,8

  • Used with or without prednisone therapy; AND
    • Used as first line therapy or postoperative treatment, in patients who are unable to tolerate first-line combination regimens; OR
    • Used as second-line therapy for unresectable or metastatic disease

FDA Approved Indication(s); Compendia recommended indication(s); Ф Orphan Drug

  1. Renewal Criteria 1,4-9

Coverage can be renewed based on the following criteria:

  • Patient continues to meet indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: cholelithiasis and complications of cholelithiasis (i.e. cholecystitis, cholangitis, pancreatitis), hyperglycemia, hypoglycemia, hypothyroidism, sinus bradycardia, cardiac arrhythmias, cardiac conduction abnormalities, depressed vitamin B12 levels, etc.; AND
  • Disease response with improvement in patient’s symptoms including reduction in symptomatic episodes (such as diarrhea, rapid gastric dumping, flushing, bleeding, etc.) and/or stabilization of glucose levels and/or decrease in size of tumor or tumor spread; OR
    • Acromegaly ONLY: Disease response as indicated by an improvement in signs and symptoms compared to baseline; AND
      • Reduction of growth hormone (GH) from pre-treatment baseline; OR
      • Age-adjusted normalization of serum IGF-1; OR
    • Neuroendocrine tumors (gastrointestinal tract, bronchopulmonary, thymus, or pancreas) ONLY: Patient has had disease progression and therapy will be continued in patients with functional tumors.

  1. Dosage/Administration1,7

Indication

Dose

Acromegaly

20 mg intramuscularly every 4 weeks for 3 months

  • After 3 months of therapy, doses may be adjusted as follows (not to exceed 40 mg every 4 weeks):
    • GH < 2.5 ng/mL, IGF-1 normal, and clinical symptoms controlled: maintain SANDOSTATIN LAR DEPOT dosage at 20 mg every 4 weeks; OR
    • GH > 2.5 ng/mL, IGF-1 elevated, and/or clinical symptoms uncontrolled, increase SANDOSTATIN LAR DEPOT dosage to 30 mg every 4 weeks; OR
    • GH < 1 ng/mL, IGF-1 normal, and clinical symptoms controlled, reduce SANDOSTATIN LAR DEPOT dosage to 10 mg every 4 weeks; OR
    • If GH, IGF-1, or symptoms are not adequately controlled at a dose of 30 mg, the dose may be increased to 40 mg every 4 weeks

Carcinoid Tumors, Neuroendocrine Tumors, and VIPomas

20 mg intramuscularly every 4 weeks for 2 months

  • After 2 months of therapy, doses may be adjusted as follows (not to exceed 30 mg every 4 weeks):
    • If symptoms are not adequately controlled, increase the dose to 30 mg every 4 weeks; OR
    • If good control has been achieved on a 20 mg dose, the dose may be lowered to 10 mg for a trial period; if symptoms recur, increase the dose to 20 mg every 4 weeks

Thymic Carcinoma/Thymoma

20 mg intramuscularly every 14 days

*Renal impairment (patients on dialysis) and hepatic impairment (patients with cirrhosis):  starting dose of 10mg every 4 weeks

  1. Billing Code/Availability Information

HCPCS Code:

  • J2353- Injection, octreotide, depot form for intramuscular injection, 1 mg: 1 mg = 1 billable unit

NDC:

  • 10 mg single-use kit: 00078-0811-XX
  • 20 mg single-use kit: 00078-0818-XX
  • 30 mg single-use kit: 00078-0825-XX
  1. References
  1. Sandostatin LAR [package insert]. East Hanover, NJ; Novartis Pharmaceuticals Corporation; April 2019. Accessed March 2021.
  2. Giustina A, Chanson P, Kleinberg D, et al. Expert consensus document: A consensus on the medical treatment of acromegaly. Nat Rev Endocrinol. 2014 Apr; 10(4):243-8. doi: 10.1038/nrendo.2014.21. Epub 2014 Feb 25.
  3. Katznelson L, Laws ER Jr, Melmed S, et al. Acromegaly: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2014 Nov; 99(11):3933-51. doi: 10.1210/jc.2014-2700. Epub 2014 Oct 30.
  4. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for Octreotide acetate (LAR). National Comprehensive Cancer Network, 2021. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed March 2021.
  5. Lancranjan I, Atkinson AB & Sandostatin® LAR® Group#. Results of a European Multicentre Study with Sandostatin® LAR® in Acromegalic Patients. Pituitary 1, 105–114; Published: June 1999. https://doi.org/10.1023/A:1009980404404.
  6. Rubin J, Ajani J, Schirmer W, et al. Octreotide Acetate Long-Acting Formulation Versus Open-Label Subcutaneous Octreotide Acetate in Malignant Carcinoid Syndrome. J Clin Oncol, 17 (2), 600-6; Feb 1999. PMID: 10080605. DOI: 10.1200/JCO.1999.17.2.600.
  7. Longo F, De Filippis L, Zivi A, et al. Efficacy and Tolerability of Long-Acting Octreotide in the Treatment of Thymic Tumors: Results of a Pilot Trial. Am J Clin Oncol, 35 (2), 105-9; April 2012. PMID: 21325939. DOI: 10.1097/COC.0b013e318209a8f8.
  8. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Thymomas and Thymic Carcinomas. Version 1.2021.  National Comprehensive Cancer Network, 2021. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed March 2021.
  9. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Neuroendocrine and Adrenal Tumors. Version 2.2020.  National Comprehensive Cancer Network, 2021. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed March 2021.
  10. Palmetto GBA. Local Coverage Article: Billing and Coding: Octreotide Acetate for Injectable Suspension (Sandostatin LAR® depot) (A56531). Centers for Medicare & Medicaid Services, Inc. Updated on 09/09/2020 with effective date 10/01/2020. Accessed March 2021.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

C25.4

Malignant neoplasm of endocrine pancreas

C37

Malignant neoplasm of thymus

C74.10

Malignant neoplasm of medulla of unspecified adrenal gland

C74.11

Malignant neoplasm of medulla of right adrenal gland

C74.12

Malignant neoplasm of medulla of left adrenal gland

C74.90

Malignant neoplasm of unspecified part of unspecified adrenal gland

C74.91

Malignant neoplasm of unspecified part of right adrenal gland

Malignant neoplasm of unspecified part of right adrenal gland

C74.92

Malignant neoplasm of unspecified part of left adrenal gland

C75.5

Malignant neoplasm of aortic body and other paraganglia

C7A.00

Malignant carcinoid tumor of unspecified site

C7A.010

Malignant carcinoid tumor of the duodenum

C7A.011

Malignant carcinoid tumor of the jejunum

C7A.012

Malignant carcinoid tumor of the ileum

C7A.019

Malignant carcinoid tumor of the small intestine, unspecified portion

C7A.020

Malignant carcinoid tumor of the appendix

C7A.021

Malignant carcinoid tumor of the cecum

C7A.022

Malignant carcinoid tumor of the ascending colon

C7A.023

Malignant carcinoid tumor of the transverse colon

C7A.024

Malignant carcinoid tumor of the descending colon

C7A.025

Malignant carcinoid tumor of the sigmoid colon

C7A.026

Malignant carcinoid tumor of the rectum

C7A.029

Malignant carcinoid tumor of the large intestine, unspecified portion

C7A.090

Malignant carcinoid tumor of the bronchus and lung

C7A.091

Malignant carcinoid tumor of the thymus

C7A.092

Malignant carcinoid tumor of the stomach

C7A.093

Malignant carcinoid tumor of the kidney

C7A.094

Malignant carcinoid tumor of the foregut, unspecified

C7A.095

Malignant carcinoid tumor of the midgut, unspecified

C7A.096

Malignant carcinoid tumor of the hindgut, unspecified

C7A.098

Malignant carcinoid tumors of other sites

C7A.1

Malignant poorly differentiated neuroendocrine tumors

C7A.8

Other malignant neuroendocrine tumors

C7B.00

Secondary carcinoid tumors, unspecified site

C7B.01

Secondary carcinoid tumors of distant lymph nodes

C7B.02

Secondary carcinoid tumors of liver

C7B.03

Secondary carcinoid tumors of bone

C7B.04

Secondary carcinoid tumors of peritoneum

C7B.09

Secondary carcinoid tumors of other sites

C7B.8

Other secondary neuroendocrine tumors

D15.0

Benign neoplasm of thymus

D3A.00

Benign carcinoid tumor of unspecified site

D3A.010

Benign carcinoid tumor of the duodenum

D3A.011

Benign carcinoid tumor of the jejunum

D3A.012

Benign carcinoid tumor of the ileum

D3A.019

Benign carcinoid tumor of the small intestine, unspecified portion

D3A.020

Benign carcinoid tumor of the appendix

D3A.021

Benign carcinoid tumor of the cecum

D3A.022

Benign carcinoid tumor of the ascending colon

D3A.023

Benign carcinoid tumor of the transverse colon

D3A.024

Benign carcinoid tumor of the descending colon

D3A.025

Benign carcinoid tumor of the sigmoid tumor

D3A.026

Benign carcinoid tumor of the rectum

D3A.029

Benign carcinoid tumor of the large intestine, unspecified portion

D3A.090

Benign carcinoid tumor of the bronchus and lung

D3A.091

Benign carcinoid tumor of the thymus

D3A.092

Benign carcinoid tumor of the stomach

D3A.094

Benign carcinoid tumor of the foregut, unspecified

D3A.095

Benign carcinoid tumor of the midgut, unspecified

D3A.096

Benign carcinoid tumor of the hindgut, unspecified

D3A.098

Benign carcinoid tumors of other sites

E16.1

Other hypoglycemia

E16.3

Increased secretion of glucagon

E16.4

Increased secretion of gastrin

E16.8

Other specified disorders of pancreatic internal secretion

E22.0

Acromegaly and pituitary gigantism

E34.0

Carcinoid syndrome

Z85.020

Personal history of malignant carcinoid tumor 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

Z85.07

Personal history of malignant neoplasm of pancreas

Z85.110

Personal history of malignant carcinoid tumor of bronchus and lung

Z85.230

Personal history of malignant carcinoid tumor of thymus

Z85.858

Personal history of malignant neoplasm of other endocrine glands

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA):

Jurisdiction(s): J, M

NCD/LCD Document (s): A56531

https://www.cms.gov/medicare-coverage-database/search/article-date-search.aspx?DocID=A56531&bc=gAAAAAAAAAAAAA==  

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC

 

 

SANDOSTATIN® LAR (octreotide) Prior Auth Criteria
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