Viva Health lanreotide prior auth policy

Coverage Criteria for Lanreotide (Somatuline Depot)

Initial Therapy — Prior authorization validity is provided when ALL of the following universal and indication-specific criteria are met.

Prior authorization validity is provided when ALL of the following universal and indication-specific criteria are met:

Initial universal

Acromegaly-specific: Diagnosis confirmed by either unequivocally elevated age-adjusted serum IGF-1 OR equivocal IGF-1 with inadequate suppression of GH after a glucose load; AND documented inadequate response to surgery and/or radiotherapy or those are not options; AND baseline GH and IGF-1 blood levels have been obtained (renewal will require reporting of current levels); AND will not be used in combination with oral octreotide.
(FDA indication)
Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs): Patient has unresectable, locally advanced or metastatic disease; AND non-functioning tumors without hormone-related symptoms; AND well or moderately differentiated disease.
(FDA indication)
Carcinoid Syndrome: Documented neuroendocrine tumors with history of carcinoid syndrome (flushing and/or diarrhea); AND used to reduce frequency of short-acting somatostatin analog rescue therapy OR used for treatment and/or control of symptoms.
(Compendia approved)
Neuroendocrine and Adrenal Tumors: Used for symptom and/or tumor control (lung, thymic, gastrointestinal, pancreatic, pheochromocytoma/paraganglioma, etc.) with SSTR-positive disease and/or hormonal symptoms; AND used in one of the following settings: first-line therapy OR subsequent therapy after progression on first-line; AND patient meets tumor burden/grade/progression or symptomatic criteria as specified in policy (e.g., recurrent/locoregional unresectable disease, distant metastatic disease, clinically significant tumor burden, evidence of progression, intermediate grade histology, DIPNECH with symptomatic disease, well-differentiated grade 3 NETs with favorable biology, or secreting pheochromocytoma/paraganglioma with unresectable disease).
(Compendia approved; multiple sub-criteria)

Continuation/Renewal Therapy — Renewal is allowed when ALL the following are met.

Renewal is allowed when ALL the following are met.

Universal renewal: Patient continues to meet the universal and relevant indication-specific criteria identified in Initial Approval (section III), including concomitant therapy requirements and performance status; AND absence of unacceptable toxicity from the drug.

Examples of unacceptable toxicity include cholelithiasis with complications, cardiovascular abnormalities, uncontrolled blood glucose abnormalities, thyroid disorders, malabsorption, etc.

Response criteria by indication: Acromegaly: improvement in signs and symptoms compared to baseline AND either reduction of GH from pre-treatment baseline OR age-adjusted normalization of serum IGF-1; GEP-NETs and other neuroendocrine/adrenal tumors: improvement in symptoms (e.g., reduced diarrheal or flushing episodes) and/or stabilization or decrease in tumor size or spread; Carcinoid syndrome: reduction in use of short-acting somatostatin analog rescue medication and decreased frequency of diarrhea and/or flushing compared to baseline.

Covered indications (diagnosis-based) — Covered when the member has a diagnosis listed in Appendix 1 and medical necessity documentation is provided.

Covered when the member has a diagnosis listed in Appendix 1 and medical necessity documentation is provided

Diagnosis requirement: Member has one of the ICD-10 diagnosis codes listed in Appendix 1.

See Appendix 1 code list

For the treatment of acromegaly, lanreotide must not be administered in combination with oral octreotide. This exclusion is part of the indication-specific requirements for acromegaly and applies when confirming eligibility for initial authorization or renewal.

Medicare (Part B) coverage determinations may differ from this policy. National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) or Local Coverage Articles (LCAs) can supersede or modify applicability for Medicare members; compliance with applicable CMS documents is required. Use the CMS Medicare Coverage Database to identify any Medicare-specific guidance that may apply.

Authorization renewal may be denied if the member demonstrates unacceptable toxicitycholelithiasis with complications (e.g., cholecystitis, cholangitis, pancreatitis), significant cardiovascular abnormalities (such as bradycardia or hypertension), uncontrolled blood glucose abnormalities (hyper- or hypoglycemia), thyroid disorders (e.g., hypothyroidism), and symptoms of fat malabsorption (steatorrhea, stool discoloration, loose stools).

Coding, Units, and Billing Rules

HCPCS CodesHCPCS

J1930	Injection, lanreotide, 1 mg; 1 billable unit = 1 mg (Somatuline Depot only)
J1932	Injection, lanreotide (cipla), 1 mg; 1 billable unit = 1 mg (Lanreotide branded product only)

NDCsNDC

15054-1060-xx	Somatuline Depot 60 mg/0.2 mL prefilled syringe
15054-1090-xx	Somatuline Depot 90 mg/0.3 mL prefilled syringe
15054-1120-xx	Somatuline Depot 120 mg/0.5 mL prefilled syringe
69097-0880-xx	Lanreotide Depot 60 mg/0.2 mL prefilled syringe
69097-0890-xx	Lanreotide Depot 90 mg/0.3 mL prefilled syringe
69097-0870-xx	Lanreotide Depot 120 mg/0.5 mL prefilled syringe

Covered ICD-10 Diagnosis CodesICD-10Covered

C25.4	Malignant neoplasm of endocrine pancreas.
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.

1–10 of 72

1/8

Max units per dosing interval

Acromegaly120 billable units every 28 days

All other indications120 billable units every 14 days

HCPCS unit definition1 billable unit = 1 mg (see HCPCS codes J1930/J1932 for product-specific billing)

NQTL considerations

IndicationYes — considered for prior authorization (PA)

Safety and efficacyNo — PA not prioritized for safety/efficacy

Provider Requirements, Documentation, and Renewal Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial approvals are valid for 6 months. Renewal frequency depends on indication: Acromegaly renewals may be authorized every 12 months; all other indications may be authorized every 6 months.

Prior authorization required
Initial approval: 6 months
Renewal: Acromegaly — every 12 months
Renewal: Other indications — every 6 months

Prior Authorization

Prior Authorization Consideration

Prior authorization is considered based on the clinical indication and drug cost; documentation supporting the diagnosis and medical necessity must be submitted with the PA request. See NQTL checklist for rationale behind utilization management decisions.

PA consideration: indication and cost
Submit documentation supporting diagnosis and medical necessity

Definitions and Referenced Products

SSTR-positive

DefinitionTumors that demonstrate somatostatin receptor (SSTR) positivity, often determined by SSTR-based PET imaging

Clinical requirementSSTR-positive status is required for certain neuroendocrine and adrenal tumor indications (e.g., unresectable, locally advanced or metastatic disease)

Imaging correlatePositive SSTR-based PET imaging is cited as evidence of SSTR-positive disease

Drug references

Somatuline Depot (Ipsen) package insertSomatuline Depot [package insert]. Ipsen Pharma Biotech; July 2024

Lanreotide (Cipla) package insertLanreotide [package insert]. Cipla USA Inc.; September 2024

Background

Lanreotide (Somatuline Depot) is a long-acting somatostatin analog used to control hormone-secreting tumors and tumor growth in conditions such as acromegaly and various gastroenteropancreatic and other neuroendocrine tumors. For acromegaly, the policy requires biochemical confirmation (elevated age-adjusted IGF-1 or equivocal IGF-1 with inadequate GH suppression), documentation of prior inadequate response to surgery and/or radiotherapy or that those options are not appropriate, and baseline GH and IGF-1 measurements prior to therapy initiation. Indications include FDA-approved uses and compendium-supported neuroendocrine tumor indications where somatostatin receptor expression and symptom or tumor control are relevant.

OpenPayer

Lanreotide (Somatuline Depot) coverage

Coverage Criteria for Lanreotide (Somatuline Depot)

Coding, Units, and Billing Rules

Provider Requirements, Documentation, and Renewal Actions

Definitions and Referenced Products

Background