|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)
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.
Lanreotide for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met: (See Medical Appropriateness below.)
Lanreotide for the treatment of other conditions/diseases is considered investigational.
Lanreotide is considered medically appropriate if ALL of the following:
Individual is 18 years of age or older
Individual has not received a long-acting somatostatin analogue (e.g., Octreotide LAR, Lanreotide SR, Lanreotide Autogel) within the last 4 weeks
Diagnosis of ANY ONE of the following:
Acromegaly with ALL of the following:
Diagnosis confirmed by elevated (age-adjusted) or equivocal serum IGF-1 as well as
inadequate suppression of GH after a glucose load
Prior treatment/assessment of inadequate response to surgery and/or radiotherapy OR surgery and/or radiotherapy is not an option
Baseline growth hormone (GH) and IGF-I blood levels (renewal will require reporting of current levels)
Tumor (i.e., growth hormone-secreting pituitary adenoma) is visualized on imaging studies (MRI or CT-scan)
Carcinoid Syndrome if documented neuroendocrine tumors with history of carcinoid syndrome used for ANY ONE of the following:
Reduce the frequency of short-acting somatostatin analog rescue therapy
Treatment and/or control of symptoms
Neuroendocrine Tumors of ANY ONE of the following types:
Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) if disease is ALL of the following:
Unresectable, locally advanced or metastatic
Non-functioning tumors without hormone-related symptoms
Well- or moderately differentiated
Tumors of the GI tract, Lung, and Thymus and Pancreas used for ANY ONE of the following:
Treatment of unresectable primary gastrinoma
Treatment of symptoms related to hormone hypersecretion and/or Carcinoid syndrome
Tumor control in individuals with unresectable and/or metastatic disease
Lanreotide is considered medically appropriate for approval renewal of therapy for 6 months after initial 3 months of therapy if ALL of the following:
Individual continues to meet initial approval criteria
Absence of unacceptable toxicity from the agent, including, but not limited to, formation of gallstones, cardiovascular abnormalities (bradycardia, sinus bradycardia, and hypertension), uncontrolled blood glucose abnormalities (hyperglycemia or hypoglycemia) or thyroid disorders (hypothyroidism)
Disease response is indicated with improvement in condition or disease-specific signs and/or symptoms for the following diagnoses:
Acromegaly with improvement in baseline if ANY ONE of the following:
Disease response with treatment as indicated by reduction in GH and/or IGF-1 levels when compared to baseline
Age-adjusted normalization of serum (GF-)
Carcinoid Syndrome if disease response with treatment as indicated by ALL of the following:
Reduction in use of short-acting somatostatin analog rescue medication (e.g., octreotide)
Decrease in the frequency of diarrhea ad flushing events, when compared to baseline
Neuroendocrine Tumors, treatment of and/or symptoms secondary to, if ALL of the following:
Disease response with treatment as indicated by an improvement in symptoms including, but not limited to, ANY ONE of the following:
Reduction in symptomatic episodes (e.g., diarrhea, rapid gastric dumping, flushing, bleeding, etc)
Stabilization of glucose levels
Decrease in size of tumor or tumor spread
|INDICATION(S)||DOSAGE & ADMINISTRATION|
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 weeksRenal 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||
All other indications
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.
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.
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).
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
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.
Maximum billable units per dose and over time by indication as a Medical Benefit; 1mg = 1 billable unit