BlueCross BlueShield of Tennessee Medical Policy Manual

Lanreotide

NDC CODE(S)

15054-1090-xx Somatuline Depot 90 mg/0.5mL Ipsen

 

15054-0090-xx Somatuline Depot 90 mg/0.5mL Ipsen

 

15054-0060-xx Somatuline Depot 60 mg/0.5mL Ipsen

 

15054-1120-xx Somatuline Depot 120 mg/0.5mL Ipsen

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 andparacrine 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.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
All indications

Dose range of 60 mg to 120 mg every 4 weeks

Recommended dose is 90 mg every 4 weeks for 3 months, then adjust thereafter based on GH and/or IGF-1 levels.

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 (See Renewal Criteria).

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 dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., The American Hospital Formulary Service Drug Information).

No controlled studies were found in the published literature that validate the use of lanreotide for the treatment of other conditions or diseases.

SOURCES

Lexi-Comp Online. (2016, March). AHFS Dl. Lanreotide acetate. Retrieved June 22, 2016 from Lexi­ Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2016, June). Lanreotide. Retrieved June 22, 2016 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2016). NCCN Drugs & Biologics Compendium™. Lanreotide. Retrieved June 22, 2016 from the National Comprehensive Cancer Network .

U.S. Food and Drug Administration.  (2014, December). Center for Drug Evaluation and Research. Somatuline® Depot (Lanreotide). Retrieved June 22, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022074s010lbl.pdf.

ORIGINAL EFFECTIVE DATE:  12/1/2016

MOST RECENT REVIEW DATE:  12/1/2016

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.

Pharmaceutical Decision Support Tree

Lanreotide (Somatuline® Depot)

  1. Is this the initial for treatment with lanreotide?

If yes, go to question #2

If no, go to question #12

  1. Is the individual 18 years of age or older with a diagnosis of acromegaly with baseline growth hormone (GH) and IGF-I blood levels (renewal will require reporting of current levels) and ANY ONE of the following?

If yes, go to question #9

If no, go to question #3

  1. Does the individual, 18 years of age or older, have a diagnosis of a neuroendocrine tumor?

If yes, go to question #4

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the tumor further diagnosed as a lung neuroendocrine tumor, stage IIIb-IV, low- or moderate-grade neuroendocrine carcinoma with ANY ONE of the following?

If yes, go to question #9

If no, go to question #5

  1. Is the tumor further diagnosed as an adrenal gland tumor for symptom control with positive somatostatin scintigraphy in an individual with ALL of the following?

If yes, go to question #9

If no, go to question #6

  1. Are the tumors further diagnosed as tumors of the GI tract, lung and/or thymus if ANY ONE of the following?

If yes, go to question #9

If no, go to question #7

  1. Are the tumors further diagnosed as tumors of the pancreas with ANY ONE of the following?

If yes, go to question #9

If no, go to question #7

  1. Are the tumors poorly differentiated (high grade)/large or small cell tumors for symptom control if the somatostatin scintigraphy is positive?

If yes, go to question #9

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the dosage requested 60 mg, 90 mg or 120 mg every 28 days, and for renal and hepatic impairment initial dose is 60 mg every 4 weeks for 3 months in moderate and severe renal or hepatic impairment?

If yes, go to question #10

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Are the requested billable units (1 billable unit = 1 mg) 120 units for 28 days or less?

If yes, go to question #11

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the length of authorization requested for the initial trial for 90 days?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. For renewal of the agent, does the individual have a diagnosis of acromegaly with ANY ONE of the following results in the first 90 days after the initial trial of the agent or later?

If yes, go to question #13

If no, go to question #2

  1. For renewal of the agent, does the individual continue to meet medically appropriate criteria for ANY ONE of the neuroendocrine tumors in questions 2 through 7 above?

If yes, go to question #14

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual show evidence of disease response with treatment as indicated by an improvement in symptoms including, but not limited to, ANY ONE of the following?

If yes, go to question #15

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is there absence of unacceptable toxicity from the drug, including, but not limited to, ANY ONE of the following?

If yes, go to question #16

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Are the requested billable units 120 or less (1 billable unit = 1 mg) every 28 days?

If yes, go to question #17

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the length of the authorization requested for 6 months with possible renewal?

If yes, go to question #18

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the dosage range fall within 60 mg to 120 mg every 4 weeks with consideration for renal and hepatic impairment?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.