Somatuline® Depot; Lanreotide may be considered medically necessary in patients 18 years of age or older and patient has not received a long-acting somatostatin analogue (e.g., Octreotide LAR depot, Lanreotide SR, Lanreotide auto-gel, pasireotide LAR depot, etc.) within the last 4 weeks; AND
Universal Criteria
Patient has not received a long-acting somatostatin analogue (e.g., Octreotide LAR depot, Lanreotide SR, Lanreotide auto-gel, pasireotide LAR depot, etc.) within the last 4 weeks; AND
Acromegaly1,2,5,6
Patient’s diagnosis is confirmed by elevated (age-adjusted) or equivocal serum IGF-1 as well as inadequate suppression of growth hormone (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
Patient’s tumor has been visualized on imaging studies (i.e., MRI or CT-scan); AND
Baseline GH and IGF-1 blood levels (renewal will require reporting of current levels); AND
Will not be used in combination with oral octreotide
Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) 1,2
Patient has unresectable, locally advanced or metastatic disease; AND
Patient has non-functioning tumors without hormone-related symptoms; AND
Patient has well or moderately differentiated disease
Carcinoid Syndrome1,2,3
Patient has documented neuroendocrine tumors with a history of carcinoid syndrome
(flushing and/or diarrhea); AND
Used to reduce the frequency of short-acting somatostatin analog rescue therapy; OR
Used for treatment and/or control of symptoms
Neuroendocrine and Adrenal Tumors (e.g., GI Tract, Lung, Thymus, Pancreas, and Pheochromocytoma/Paraganglioma) 1,2,3,8
Used as primary treatment for 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 lanreotide in patients with functional tumors); AND
Used for management of hormone symptoms and/or somatostatin receptor positivedisease determined by imaging (i.e., 68Ga-dotatate imaging PET/CT or PET/MRI or somatostatin receptor scintigraphy); 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 lanreotide 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 notresponsive 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 lanreotide; OR
Patient has disease progression with functional tumors and will be continuing treatment with lanreotide; OR
Used to manage symptoms related to hormone hypersecretion of locoregional neuroendocrine tumors of the pancreas (well differentiated grade 1/2); AND
Patient has gastrinoma, glucagonoma, or VIPoma; OR
Used for tumor control of locoregional advanced and/or distant metastatic neuroendocrine tumors of the pancreas (well differentiated grade 1/2 – Gastrinoma, Glucagonoma, Insulinoma, VIPoma ) [***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 lanreotide; OR
Patient has unresectable locally advanced or metastatic neuroendocrine tumors (well differentiated grade 3); AND
Patient has favorable biology (e.g., relatively low Ki-67 [<55%], somatostatin receptorpositive disease); OR Patient has pheochromocytoma or paraganglioma; AND Patient has symptomatic locally unresectable somatostatin receptor-positive disease; OR Patient has distant metastatic disease
