CurrentColorado Rocky Mountain Health PlansPolicy 2026D0036W

Somatostatin Analogs – Commercial and Individual Exchange Medical Benefit Drug Policy

UnitedHealthcare Medical Drug Policy for Commercial and Individual Exchange plans describing coverage rationale, indications, background, evidence, applicable procedure and diagnosis codes, and revision history for somatostatin analogs used for non-oncology indications (e.g., acromegaly, carcinoid syndrome, VIPomas, Cushing's disease for pasireotide).

Policy Summary

PayerUnitedHealthcare Commercial; Individual Exchange

PolicySomatostatin Analogs – Commercial and Individual Exchange Medical Benefit Drug Policy

Policy CodePolicy 2026D0036W

Change TypeCoverage criteria and code updates

Effective DateApr 1, 2026

Next Review Date

Key ActionDocument the FDA-indicated diagnosis/clinical rationale when requesting coverage (e.g., acromegaly after inadequate response to surgery/radiotherapy or bromocriptine mesylate at maximally tolerated doses; carcinoid syndrome or VIPoma symptoms; Cushing's disease when surgery is not an option for pasireotide).

SourceLink

POLICY UPDATE CHANGES

Transferred content to shared policy template and applied to both UnitedHealthcare Commercial and Individual Exchange plans.

Coverage Rationale updated to list specific somatostatin analogs for non-oncology indications.

Removed previous language that Signifor is proven for Cushing's disease patients for whom pituitary surgery is not an option or has not been curative.

Removed multiple previously listed unproven indications (HIV-AIDS-related diarrhea, chylothorax, dumping syndrome, pancreatitis, prevention of postoperative complications following pancreatic surgery, short bowel syndrome, chemotherapy/radiation-induced diarrhea, malignant bowel disease).

Revised Sandostatin and Sandostatin LAR acromegaly criteria to reference specific comparator treatments: replaced broader dopamine agonist language with 'bromocriptine mesylate at maximally tolerated doses' for Sandostatin and with 'surgery and/or radiotherapy' for Sandostatin LAR.

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 current information.

Removed criterion requiring bleeding gastroesphoageal varices associated with liver disease.

Replaced acromegaly criterion referencing requirement to try dopamine agonist therapy with wording requiring inadequate response to or inability to be treated with surgery and/or radiotherapy.

Removed ICD-10 diagnosis codes I85.01 and I85.11 from Applicable Codes.

Archived previous policy versions 2025D0036V and IEXD0036.09.

Coverage Summary & Rationale

Policy-level stance: covered_with_criteria. Scope summary: UnitedHealthcare Medical Drug Policy for Commercial and Individual Exchange plans covering somatostatin analogs for non-oncology indications, including acromegaly, carcinoid syndrome, vasoactive intestinal peptide (VIP) tumors, and Cushing's disease (for pasireotide). Referenced products include octreotide/Sandostatin, Sandostatin LAR, pasireotide/Signifor LAR, lanreotide/Somatuline Depot/Lanreotide Injection and Lanreotide Injection.

Coverage Rationale / Proven Indications

Policy refers to the following somatostatin analogs for non-oncology indications and lists proven treatment indications:

Sandostatin (octreotide acetate): Acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, or bromocriptine mesylate at maximally tolerated doses; Severe diarrhea and flushing episodes associated with metastatic carcinoid tumors; Profuse watery diarrhea associated with vasoactive intestinal peptide (VIP)-secreting tumors
Sandostatin LAR (octreotide acetate LAR): Acromegaly patients who have had inadequate response to or cannot be treated with surgery and/or radiotherapy; Severe diarrhea and flushing episodes associated with metastatic carcinoid tumors; Profuse watery diarrhea associated with VIP-secreting tumors
Signifor LAR (pasireotide): Acromegaly patients who have had an inadequate response to surgery and/or for whom surgery is not an option; Cushing's disease in patients for whom pituitary surgery is not an option or has not been curative
Somatuline Depot (lanreotide) and Lanreotide Injection: Acromegaly patients who have had an inadequate response to surgery and/or radiotherapy or for whom surgery and/or radiotherapy is not an option

Initial Therapy Criteria

Sandostatin LAR (octreotide acetate LAR) - revised coverage criteria highlights

Policy revisions affecting clinical criteria for coverage:

Sandostatin LAR (octreotide acetate LAR) - revised coverage criteria highlights: Summary of revisions to clinical coverage criteria for Sandostatin LAR: removed prior requirement for bleeding gastroesophageal varices associated with liver disease; replaced prior wording referencing dopamine-agonist therapy with updated prior-treatment language requiring inadequate response to or inability to be treated with surgery and/or radiotherapy (applies to acromegaly criteria).

Replaced wording now requires 'acromegaly patients who have had inadequate response to or cannot be treated with surgery and/or radiotherapy'. Also removed varices requirement and other deleted prior criteria per policy history.

This policy requires documentation of the specific FDA-indicated diagnosis or clinical rationale when requesting coverage (see provider actions for required documentation). Effective date: April 1, 2026. Providers should follow the policy's documentation items (e.g., indication, prior treatment history) when submitting requests.

Continuation Therapy Criteria

Continuation — clinical benefit / biochemical control

Continuation therapy requires documentation of ongoing clinical benefit or biochemical control consistent with trial-defined thresholds.

Continuation criteria (acromegaly): Continuation of somatostatin analog therapy requires demonstration of clinical benefit or biochemical control as defined in cited trials.Biochemical control in acromegaly: mean GH < 2.5 μg/L and normalized IGF-1 concentration

Biochemical control definition per trial definitions (used to evaluate continued benefit).

Unproven Indications & Exclusions

The policy removed multiple previously listed unproven indications. Conditions that are no longer labeled as proven and were removed from the policy include: HIV‑AIDS‑related diarrhea, chylothorax, dumping syndrome, pancreatitis, prevention of postoperative complications following pancreatic surgery, short bowel syndrome, chemotherapy- or radiation-induced diarrhea, and malignant bowel disease.

Applicable Codes

HCPCS J-codes (drug administration billing)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

Applicable ICD-10 diagnosis codes (listed in policy)ICD-10

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
C7A.024	Malignant carcinoid tumor of the descending colon
C7A.025	Malignant carcinoid tumor of the sigmoid colon

1–10 of 57

1/6

Added ICD-10 diagnosis codesICD-10Covered

C7A.023
C25.3
E24.8
E24.9

Provider Actions & Billing Rules

Documentation Required

Indication documentation

Document the specific FDA-indicated diagnosis/clinical rationale (e.g., acromegaly with inadequate response to surgery/radiotherapy or bromocriptine mesylate at maximally tolerated doses; carcinoid syndrome with severe diarrhea/flushing; VIPoma with watery diarrhea; Cushing's disease when surgery not an option for pasireotide).

Documentation Required

Apply updated acromegaly coverage wording

When requesting coverage for Sandostatin LAR for acromegaly, document that the patient has had inadequate response to or cannot be treated with surgery and/or radiotherapy (replacing older requirement referencing specific dopamine agonist trial).

Clinical Evidence Summary

15%Pasireotide 40 mg: biochemical control at 24 weeks (GH <2.5 μg/L and normalized IGF‑1)

20%Pasireotide 60 mg: biochemical control at 24 weeks (GH <2.5 μg/L and normalized IGF‑1)

48.6%Pasireotide LAR: biochemical control at month 25 in extension study

43%Lanreotide titrated dosing: normalized IGF‑1 ~43% at 48 weeks

PAOLA trial: In a randomized phase 3 trial of pasireotide LAR 40 mg and 60 mg versus continued octreotide or lanreotide, biochemical control at 24 weeks (mean GH < 2.5 μg/L and normalized IGF‑1) was achieved by 15% and 20% of patients in the pasireotide 40 mg and 60 mg groups, respectively, versus 0% in the active control; the most common adverse events were hyperglycemia, diabetes, and diarrhea.

Sheppard extension: In the double‑blind extension (up to 26 months) comparing pasireotide LAR and octreotide LAR, biochemical control at month 25 was achieved in 48.6% and 45.7% of patients, respectively; hyperglycemia‑related adverse events were higher with pasireotide LAR (62.9%) versus octreotide LAR (25.0%).

Lanreotide trials: Titrated dosing (Autogel/Depot) produced normalization of age‑adjusted IGF‑1 in approximately 43% of patients in a 48‑week study, with marked GH reductions; adverse events were predominantly gastrointestinal.

Background & Drug Information

Background: Octreotide, lanreotide, and pasireotide are somatostatin analogs that bind somatostatin receptors (SSTRs) to inhibit secretion of hormones such as GH/IGF‑1 and ACTH. Formulations include immediate‑release and long‑acting release (LAR/Depot) products administered by subcutaneous (SC), deep subcutaneous (deep SC), or intramuscular (IM) injection. Pasireotide preferentially binds SSTR subtypes (including SSTR5) and inhibits ACTH secretion in corticotroph tumors.

Clinical evidence: Long‑acting octreotide (LAR), lanreotide Depot/Autogel, and pasireotide LAR are supported by randomized and long‑term trials demonstrating biochemical control in acromegaly and symptom control in carcinoid syndrome and VIPomas; pasireotide has demonstrated efficacy in some patients with Cushing's disease. Prescribing information and trial summaries have been updated through 2024/2025 sources and are reflected in the policy's background and references.

Revision History

04/01/2026template update (policy change)Latest

Transferred content to a shared policy template and added Application section indicating the policy applies to UnitedHealthcare Commercial and Individual Exchange plans; updated Background, Clinical Evidence, FDA, and References sections.

04/01/2026coverage rationale updated (material change)Latest

Coverage Rationale updated to explicitly list somatostatin analogs for non‑oncology indications: Lanreotide Injection, Sandostatin (octreotide), Sandostatin LAR (octreotide LAR), Signifor LAR (pasireotide), and Somatostatin Depot (lanreotide).