BlueCross BlueShield of Tennessee Medical Policy Manual

Lanreotide

NDC CODE(S)

15054-1060-xx Somatuline Depot 60 MG/0.2ML SOLN (IPSEN BIOPHARMACEUTICALS)

 

15054-1090-xx Somatuline Depot 90 MG/0.3ML SOLN (IPSEN BIOPHARMACEUTICALS)

 

15054-1120-XX Somatuline Depot 120 MG/0.5 ML SOLN (IPSEN BIOPHARMACEUTICALS)

DESCRIPTION

Lanreotide is an octapeptide analog of the natural hormone somatostatin. Its biological activity is similar to naturally occurring somatostatin, inhibiting various endocrine, neuroendocrine, exocrine and paracrine functions.  It is believed to be responsible for growth hormone inhibition and sustained injection schedules allow elevated growth hormone (GH) and/or insulin growth factor-1 (IGF-1) levels to normalize.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
Acromegaly

Recommended starting dose is 90 mg by deep subcutaneous injection every 4 weeks for 3 months, adjusted thereafter based on GH and/or IGF-1 levels:

·       GH >1 to ≤ 2.5 ng/mL, IGF-1 normal and clinical symptoms controlled: maintain Somatuline Depot dose at 90 mg every 4 weeks

·       GH > 2.5 ng/mL, IGF-1 elevated and/or clinical symptoms uncontrolled, increase Somatuline Depot dose to 120 mg every 4 weeks

·       GH ≤ 1 ng/mL, IGF-1 normal and clinical symptoms controlled: reduce Somatuline Depot dose to 60 mg every 4 weeks

Renal and Hepatic Impairment: Initial dose is 60 mg every 4 weeks for 3 months in moderate and severe renal or hepatic impairment, then adjust thereafter based on GH and/or IGF-1 levels.
GEP-NETs; Carcinoid Syndrome
  • 120 mg administered every 4 weeks by deep subcutaneous injection

All other indications

  •  Dose range of 60 mg to 120 mg every 4 weeks

LENGTH OF AUTHORIZATION

Initial coverage will be provided for three months and is eligible for renewal for six months.

Refer to DOSAGE LIMITS below

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION 

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

SOURCES

Lexi-Comp Online. (2018). AHFS Dl. Lanreotide acetate. Retrieved September 24, 2018 from Lexi­ Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, February). Lanreotide. Retrieved September 24, 2018 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium™. Lanreotide. Retrieved September 24, 2018 from the National Comprehensive Cancer Network.

U.S. Food and Drug Administration.  (2018, February). Center for Drug Evaluation and Research. Somatuline® Depot (Lanreotide). Retrieved September 24, 2018 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022074s018lbl.pdf.

ORIGINAL EFFECTIVE DATE:  12/1/2016

MOST RECENT REVIEW DATE:  1/31/2019

ID_MRx

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

This document has been classified as public information.

 

 

 

 

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit; 1mg = 1 billable unit

DIAGNOSIS

MAXIMUM UNITS

All indications 120 billable units every 28 days