CurrentColorado Rocky Mountain Health PlansPolicy CS2026D0036AB

Somatostatin Analogs Cs

Medical Benefit Drug Policy governing coverage and medical necessity criteria for specified somatostatin analogs (lanreotide, octreotide products, pasireotide) for non-oncology indications; oncology indications referred to separate oncology policy. Applies to Colorado Rocky Mountain Health Plans with state exceptions listed.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicySomatostatin Analogs Cs

Policy CodePolicy CS2026D0036AB

Change TypeClarified/Added/Removed updates (04/01/2026)

Effective DateApr 1, 2026

Next Review Date

Key ActionDocument diagnostic confirmation and prior treatment/candidacy per policy and report administrations using the listed J-codes; follow monitoring guidance (e.g., hyperglycemia monitoring with pasireotide).

SourceLink

POLICY UPDATE CHANGES

Removed content/language pertaining to the state of Louisiana.

Policy now explicitly refers to lanreotide injection, Sandostatin, Sandostatin LAR, Signifor LAR, and Somatuline Depot for non-oncology indications.

Added that Sandostatin and Sandostatin LAR are proven for severe diarrhea and flushing with metastatic carcinoid tumors and for profuse watery diarrhea with VIPomas.

Added that Somatuline Depot (lanreotide) is proven for unresectable/moderately-differentiated metastatic GEP-NETs in adults and for carcinoid syndrome in adults.

Removed language indicating Signifor is proven and medically necessary for treatment of Cushing's disease when inadequate response to pituitary surgery or not a candidate for surgery.

Added ICD-10 diagnosis codes C7A.023, C25.3, E24.8, and E24.9 to Applicable Codes.

Updated Background, Clinical Evidence, FDA, and References sections to reflect current information (July 2024 prescribing information and literature through 2025/2026 guidelines).

9Proven/medically necessary indications (listed non-oncology)

7Unproven / not medically necessary indications listed

5J-codes listed

5Somatostatin analogs referenced

4Added ICD-10 codes

Coverage Summary & Rationale

Scope: This Medical Benefit Drug Policy governs coverage and medical necessity criteria for specified somatostatin analogs for non-oncology indications and refers oncology indications to a separate oncology policy. Coverage stance: mixed — the policy lists proven/medically necessary indications for several non-oncology uses while designating other uses as unproven or not medically necessary. The policy explicitly refers to the following products for non-oncology indications: lanreotide injection, Sandostatin (octreotide), Sandostatin LAR (octreotide LAR), Signifor LAR (pasireotide), and Somatuline Depot (lanreotide). Oncology indications are handled under the Medical Benefit Drug Policy titled Oncology Medication Clinical Coverage (refer to the NCCN Drugs & Biologics Compendium for oncology use).

Coverage Rationale (as revised 04/01/2026)

Policy refers to specified somatostatin analog products for non-oncology indications and summarizes high-level approvals and recent revisions.

This policy refers to lanreotide injection, Sandostatin (octreotide acetate), Sandostatin LAR (octreotide acetate LAR), Signifor LAR (pasireotide), and Somatuline Depot (lanreotide).

Sandostatin approvals

Sandostatin (octreotide acetate) is indicated for severe diarrhea and flushing associated with metastatic carcinoid tumors.
Sandostatin (octreotide acetate) is indicated for profuse watery diarrhea associated with VIP-secreting tumors.

Somatuline / Lanreotide approvals

Somatuline Depot (lanreotide) is indicated for unresectable, well- or moderately-differentiated, locally advanced or metastatic GEP-NETs in adults to improve progression-free survival.
Somatuline Depot (lanreotide) is indicated for carcinoid syndrome in adults (reduces frequency of short-acting somatostatin analog rescue therapy).
Lanreotide Injection is indicated for unresectable, well- or moderately-differentiated, locally advanced or metastatic GEP-NETs in adults.

Removed prior policy language indicating Signifor LAR (pasireotide) was proven and medically necessary for Cushing's disease when inadequate response to pituitary surgery or not a candidate for surgery.

Initial Therapy Criteria

Cushing's disease - Signifor LAR (pasireotide diaspartate)

Covered when ALL of the following are met:

Diagnosis of Cushing's disease

Inadequate response or not a candidate for surgery

Inadequate response to pituitary surgery
Not a candidate for pituitary surgery

Somatuline Depot (lanreotide) - additional proven indications

Proven and medically necessary (no additional documented entry criteria in this part):

Continuation Therapy Criteria

Continuation: Where the policy notes maintenance or ongoing/long-term therapy (for example, long-term maintenance in acromegaly or GEP-NETs), continuation criteria mirror the initial entry criteria as specified for the indication. Monitoring thresholds referenced in the policy include: Serum GH > 1 ng/mL after a 2 hour oral glucose tolerance test (OGTT) and elevated serum IGF‑1 as above the age- and gender-adjusted normal range per the treating laboratory, which are used for diagnosis confirmation and ongoing assessment.

Diagnostic thresholds for acromegaly

Serum GH after OGTT> 1 ng/mL after a 2 hour oral glucose tolerance test (OGTT) at time of diagnosis

IGF-1Elevated serum IGF1 levels (above the age and gender adjusted normal range as provided by the physician's lab) at time of diagnosis

Not Medically Necessary / Unproven Indications

Not medically necessary / Unproven indications

Somatostatin analogs are unproven and not medically necessary for:

HIV-AIDS-related diarrhea

Chylothorax

Dumping syndrome

Pancreatitis

Persistent hyperinsulinemic hypoglycemia of infancy

Prevention of postoperative complications following pancreatic surgery

Provider Actions & Billing

Documentation / Clinical notes

Billing / Prior authorization notes

Applicable Codes

HCPCS J-codes (drugs)HCPCS

J1930	Injection, lanreotide, 1 mg
J1932	Injection, lanreotide, (cipla), 1 mg
J2353	Injection, octreotide, depot form for intramuscular injection, 1 mg
J2354	Injection, octreotide, non-depot form for subcutaneous or intravenous injection, 25 mcg
J2502	Injection, pasireotide long acting, 1 mg

ICD-10 Diagnosis codes mapped to J-codesICD-10

C7A.010	Malignant carcinoid tumor of the duodenum (mapped to J1930, J1932, J2353/J2354)
C7A.011	Malignant carcinoid tumor of the jejunum (mapped to J1930, J1932, J2353/J2354)
C7A.012	Malignant carcinoid tumor of the ileum (mapped to J1930, J1932, J2353/J2354)
C7A.019	Malignant carcinoid tumor of the small intestine, unspecified portion (mapped to J1930, J1932, J2353/J2354)
C7A.020	Malignant carcinoid tumor of the appendix (mapped to J1930, J1932, J2353/J2354)
C7A.021	Malignant carcinoid tumor of the cecum (mapped to J1930, J1932, J2353/J2354)
C7A.022	Malignant carcinoid tumor of the ascending colon (mapped to J1930, J1932, J2353/J2354)
C7A.023	Malignant carcinoid tumor of the transverse colon (mapped to J1930, J1932, J2353/J2354)
C7A.024	Malignant carcinoid tumor of the descending colon (mapped to J1930, J1932, J2353/J2354)
C7A.025	Malignant carcinoid tumor of the sigmoid colon (mapped to J1930, J1932, J2353/J2354)

1–10 of 24

1/3

Added ICD-10 diagnosis codes (per 04/01/2026 revision)ICD-10

[See policy notes]

Providers: verify diagnosis coding aligns with federal/state/contractual benefit terms and submit the applicable ICD-10 code(s) when billing J-codes above. Ensure documentation confirms diagnosis (e.g., acromegaly diagnostic criteria) and adjunct use for variceal bleeding as applicable.

Note

Clinical Evidence Summaries

Evidence sources: The policy summarizes evidence from randomized trials, phase 3 studies, meta‑analyses, registries, and clinical practice guidelines. The detailed, indication‑specific summaries below reflect those sources reported in the brief (trials and extensions for octreotide/lanreotide/pasireotide in acromegaly, pasireotide trials in Cushing's disease, RCTs and meta-analyses for variceal bleeding, randomized data for radiation‑induced diarrhea, and systematic reviews/observational data for malignant bowel obstruction and other indications).

15%Pasireotide LAR biochemical control at 24 wks (40 mg)

20%Pasireotide LAR biochemical control at 24 wks (60 mg)

0%Active control (continued octreotide/lanreotide) biochemical control at 24 wks

57%Hyperglycemia-related AEs with pasireotide in PAOLA (common)

Clinical Evidence Summaries (select indications)

Evidence findings summarized by indication from trials, meta-analyses, registries, and guidelines:

Background & Definitions

Background: Octreotide, lanreotide, and pasireotide are synthetic somatostatin analogs. Octreotide (Sandostatin) is a cyclic octapeptide that inhibits GH, glucagon, insulin and various gastrointestinal hormones and is available as an immediate‑release injection and as a long‑acting release (LAR) depot formulation that provides slow release from the injection site. Lanreotide (Somatuline Depot/Lanreotide Injection) is a prolonged‑release formulation for deep subcutaneous injection with biological activity similar to somatostatin and reduces GH and IGF‑1 in acromegaly. Pasireotide (Signifor LAR) is a long‑acting release formulation that binds multiple somatostatin receptor subtypes (SSTR1–5), including SSTR5 which is often overexpressed in corticotroph tumors, and its activation inhibits ACTH secretion leading to decreased cortisol in Cushing's disease.

Term	Definition
LAR
Long-acting release (depot) formulation: a prolonged-release dosage form that slowly releases the somatostatin analog from the injection site, reducing the need for frequent administration (e.g., Sandostatin LAR, Signifor LAR, Somatuline Depot).
IR
Immediate release formulation: the short-acting formulation administered subcutaneously or intravenously for rapid onset (e.g., Sandostatin injection).
SSAs
Somatostatin analogs (e.g., octreotide, lanreotide, pasireotide).
GEP-NETs
Gastroenteropancreatic neuroendocrine tumors.
POPF
Postoperative pancreatic fistula.

Revision History

04/01/2026revisedLatest

Removed content/language pertaining to the state of Louisiana.

04/01/2026clarifiedLatest

Policy explicitly refers to lanreotide injection, Sandostatin, Sandostatin LAR, Signifor LAR, and Somatuline Depot for non-oncology indications.

04/01/2026added

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicySomatostatin Analogs Cs

Policy CodePolicy CS2026D0036AB

Change TypeClarified/Added/Removed updates (04/01/2026)

Effective DateApr 1, 2026

Next Review Date

SourceLink

On This Page

Unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults

Carcinoid syndrome in adults

Lanreotide Injection - additional proven indication

Proven and medically necessary (no additional documented entry criteria in this part):

Unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults

Short bowel syndrome

Other conditions not listed as proven due to lack of published clinical evidence

Pancreatic surgery / postoperative complications: Cochrane review: SSAs reduce perioperative complications but not mortality; recommended for routine use in pancreatic resection for malignancy, not for other indications (need adequately powered trials). Meta-analyses (Zeng et al.): somatostatin/analogs did not significantly reduce pancreatic fistula, pancreas-specific complications, delayed gastric emptying, total complications, mortality, or length of stay after pancreaticoduodenectomy. Individual study: prophylactic depot octreotide in high-risk patients did not reduce POPF incidence; duct size impacts POPF occurrence.

Short bowel syndrome: Small open-label study (Nehra et al.): octreotide acetate depot increased small bowel transit time over 15 weeks; other clinical measures variable; larger multicenter studies needed.

Acromegaly: Multiple trials show octreotide LAR, lanreotide Autogel/Depot, and pasireotide LAR achieve GH and IGF-1 control comparable or superior to subcutaneous octreotide or between agents; response rates and adverse events (notably pasireotide-associated hyperglycemia) summarized. Lanreotide studies: various trials with titrated dosing show normalized IGF-1 in ~43% (Chanson) and sustained GH reductions; SODA registry shows IGF-1 < ULN achieved in ~71% at 12 months and 74% at 24 months with general tolerability. Pasireotide trials (PAOLA, head-to-head): pasireotide LAR showed superior biochemical control vs octreotide/lanreotide in some trials but higher rates of hyperglycemia/diabetes. Endocrine Society (2014) and Pituitary Society (2021) guideline recommendations: SRLs as medical therapy post-surgery or as primary therapy when surgery not feasible; dosing, predictors of response, and combination strategies (pegvisomant ± SRL) described.

Cushing's disease: Phase 3 trial of subcutaneous pasireotide showed urinary free cortisol control (15% for 600 µg bid; 26% for 900 µg bid at month 6 without dose increase); high rates of hyperglycemia-related AEs (73% overall), with 6% discontinuation for hyperglycemia. Endocrine Society guideline (2015): pituitary-directed medical treatments including pasireotide may be used for patients not surgical candidates or with persistent disease after surgery (weak recommendation).

Bleeding gastroesophageal varices / malignant bowel obstruction: Guidelines (AASLD/ACG 2007): octreotide (or somatostatin) recommended as adjunct to endoscopic therapy for variceal hemorrhage, initiated as soon as suspected and continued 3-5 days (Class I, Level A). NCCN Palliative Care (2026): somatostatin analogs can be considered for grade 3-4 diarrhea and malignant bowel obstruction.

Added that Sandostatin and Sandostatin LAR are proven for severe diarrhea and flushing with metastatic carcinoid tumors and for profuse watery diarrhea associated with VIP-secreting tumors.

04/01/2026addedLatest

Added that Somatuline Depot (lanreotide) is proven for unresectable, well- or moderately-differentiated, locally advanced or metastatic GEP-NETs in adults and for carcinoid syndrome in adults.

04/01/2026removedLatest

Removed prior policy language indicating Signifor (pasireotide LAR) was proven and medically necessary for treatment of Cushing's disease when inadequate response to pituitary surgery or not a candidate for pituitary surgery.

04/01/2026addedLatest

Added ICD-10 diagnosis codes C7A.023, C25.3, E24.8, and E24.9 to the Applicable Codes list.

04/01/2026revisedLatest

Updated Background, Clinical Evidence, FDA, and References sections to reflect current information (July 2024 prescribing information and literature through 2025/2026 guidelines).