ModifiedUnitedHealthcarePolicy CSLA2025D0036V

Somatostatin Analogs (for Louisiana Only)

Medical benefit drug policy governing coverage and medical necessity criteria for somatostatin analogs (e.g., octreotide, lanreotide, pasireotide) for UnitedHealthcare Community Plan members in Louisiana.

Policy Summary

PayerUnitedHealthcare Community Plan

PolicySomatostatin Analogs (for Louisiana Only)

Policy CodePolicy CSLA2025D0036V

Change TypeCoverage rationale revisedcoding and exclusions updated

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis confirmation and prior therapy (e.g., GH/IGF‑1 levels, prior short‑acting octreotide trial for LAR formulations) when seeking coverage.

SourceLink

POLICY UPDATE CHANGES

Added language to indicate Somatostatin analogs are unproven and not medically necessary for treating HIV‑AIDS‑related diarrhea.

Removed language indicating Sandostatin and Sandostatin LAR were proven for the treatment of refractory HIV‑AIDS‑related diarrhea.

Removed medical necessity criteria for the treatment of refractory HIV‑AIDS‑related diarrhea.

Reformatted list of applicable ICD‑10 diagnosis codes to reflect/include the corresponding HCPCS codes and removed ICD‑10 diagnosis codes B20 and R19.7.

Updated Clinical Evidence, FDA, and References sections to reflect the most current information.

Archived previous policy version CSLA2024D0036U.

06/01/2025policy effective

Yesmaterial changes

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

7excluded indications count

62%pediatric chylothorax resolution

Coverage Criteria and Indications

inv-01: Covered Indications and Required Criteria

Covered when ALL of the following are met (per indication):

Bleeding gastroesophageal varices (octreotide/Sandostatin): Diagnosis of bleeding esophageal varices associated with liver disease AND octreotide acetate will be used as an adjunct to endoscopic therapy.

Chemotherapy- and/or radiation-induced diarrhea: Use of Sandostatin (octreotide) or Sandostatin LAR for chemotherapy- and/or radiation-induced diarrhea.

Malignant bowel disease: Use of Sandostatin (octreotide) or Sandostatin LAR for malignant bowel disease.

Acromegaly — immediate release (IR): Diagnosis of acromegaly AND diagnosis confirmed by either serum GH > 1 ng/mL after a 2-hour OGTT at time of diagnosis OR elevated age- and gender-adjusted serum IGF-1.GH > 1 ng/mL after 2-hour OGTT OR elevated IGF-1

Acromegaly — long-acting formulations (Sandostatin LAR, Somatuline Depot, Signifor LAR): Diagnosis of acromegaly AND biochemical confirmation (GH > 1 ng/mL after 2-hour OGTT OR elevated age- and gender-adjusted IGF-1) AND inadequate response to or not a candidate for surgery/radiotherapy/dopamine agonist AND for Sandostatin LAR initial treatment with octreotide IR has been shown to be effective and tolerated.GH > 1 ng/mL after 2-hour OGTT OR elevated IGF-1

Cushing's disease (Signifor/Signifor LAR): Diagnosis of Cushing's disease AND either inadequate response to pituitary surgery OR not a candidate for pituitary surgery.

inv-02: Bleeding gastroesophageal varices (adjunctive use)

Bleeding gastroesophageal varices

Use for acute variceal bleeding as adjunct to endoscopic therapy: Octreotide improves initial control of esophageal variceal hemorrhage and 5-day hemostasis when used with endoscopic therapy; meta-analyses favor octreotide over vasopressin/terlipressin for control of bleeding. Trials are needed to determine optimal dose, route, and duration.

inv-03: Chemotherapy/radiation-induced diarrhea

Chemotherapy- and radiation-induced diarrhea

Second-line therapy for chemotherapy-induced diarrhea: If mild to moderate chemotherapy-induced diarrhea persists for more than 48 hours despite loperamide, consider octreotide as a second-line antidiarrheal agent. Aggressive or complicated cases may require IV fluids, octreotide, and antibiotics.>48 hours despite loperamide

Radiation-induced diarrhea is less consistently responsive to octreotide; consider inpatient management for complicated radiation enteritis.

inv-04: Malignant bowel obstruction

Malignant bowel obstruction

Use in malignant bowel obstruction: Octreotide administration is recommended early in malignant bowel obstruction due to high efficacy and tolerability; systematic reviews report therapeutic success rates between approximately 60% and 90%. Consider immediate‑release IV or SC administration and adjunctive steroids as reported in trials.

Some trials of long-acting formulations show mixed results; assess functional status (e.g., Karnofsky) when interpreting trial outcomes.

inv-05: Refractory HIV/AIDS-related diarrhea

Refractory HIV/AIDS-related diarrhea

Historical evidence and current policy stance: Small studies and case reports previously described decreases in stool frequency and volume with octreotide in refractory AIDS-related diarrhea, with mixed results across trials and response influenced by baseline stool weight; however, the policy now states somatostatin analogs are unproven and not medically necessary for treating HIV-AIDS-related diarrhea.

Updated policy language removes prior medical necessity criteria for this indication.

inv-06: Chylothorax

Chylothorax (neonates, children, adults)

Octreotide/somatostatin as potential therapy for chylothorax: Evidence consists of case reports, small series, and retrospective reviews with no randomized controlled trials; some reports show resolution (often after failure of nutritional measures) with dosing and duration varying (IV infusions or SC, typical treatment durations 1–2 weeks in reported successful cases), while other series report limited benefit.

Caution in patients at increased risk of vascular compromise; randomized controlled trials are needed to define efficacy and safe protocols.

inv-07: Indication-specific coverage considerations

Coverage considerations by indication (evidence summary and typical treatment context):

Chylothorax: Somatostatin or octreotide has case-series and retrospective evidence of benefit in pediatric and adult chylothorax, often initiated after failure of nutritional/first-line measures with observed reduction in chest tube drainage within days; dosing varied (IV infusion or SC) and duration typically 1–2 weeks; randomized trials lacking.

Evidence limited to case series and small retrospective cohorts; randomized trials lacking.

Dumping syndrome: Octreotide provides effective short-term symptomatic relief for severe dumping syndrome in reported series; long-term use is limited by adverse effects and loss of efficacy in some patients.

High discontinuation rates due to side effects reported in long-term follow-up.

Post-ERCP pancreatitis prophylaxis: Meta-analyses report conflicting results: some analyses indicate somatostatin or high-dose octreotide (total dose ≥ 0.5 mg) or somatostatin 12-hour infusion may reduce post-ERCP pancreatitis in selected settings; other large trials/meta-analyses do not support routine prophylactic use.

inv-08: Coverage criteria for initiation of long-acting SRLs

Coverage aligns with FDA-indicated uses and trial populations where documented biochemical control or intolerance to other options exists. Consider therapy when ALL of the following apply:

FDA-aligned indication: Patient has an FDA-indicated condition for the requested agent (examples: acromegaly inadequately controlled by or unsuitable for surgery/radiotherapy; unresectable/metastatic GEP‑NETs for lanreotide/octreotide; carcinoid syndrome or VIPoma symptoms for octreotide; Cushing's disease for pasireotide when surgery is not an option).

Biochemical criteria or documented prior therapy: Either documented inadequate response to prior definitive therapy (surgery/radiation) or prior medical therapy, or biochemical evidence of active disease consistent with trial enrollment (eg, elevated age‑adjusted IGF‑1 and elevated mean GH as used in trials).GH thresholds reported in trials (eg, >5 ng/mL for treatment‑naïve entry; >3 ng/mL for prior‑treated after washout)

Safety and monitoring considerations: Documentation of a monitoring plan for known adverse effects (eg, GI side effects; hyperglycemia risk with pasireotide) and rationale for agent selection based on comorbidities (eg, diabetes) and tumor characteristics.

inv-09: HIV-AIDS-related diarrhea coverage change

Policy-level coverage statement (excerpted from Summary of Changes):

Not medically necessary for HIV-AIDS-related diarrhea: Somatostatin analogs are unproven and not medically necessary for treating HIV‑AIDS‑related diarrhea.

This revision replaces prior language that indicated Sandostatin and Sandostatin LAR were proven for refractory HIV‑AIDS‑related diarrhea and removes medical necessity criteria for that indication.

Somatostatin analogs are considered unproven and not medically necessary for the following conditions due to insufficient published clinical evidence: HIV-AIDS-related diarrhea, chylothorax, dumping syndrome, pancreatitis, persistent hyperinsulinemic hypoglycemia of infancy, prevention of postoperative complications following pancreatic surgery, and short bowel syndrome.

Sandostatin LAR is a long-acting intramuscular formulation of octreotide intended for administration every 4 weeks and is indicated only in patients in whom initial treatment with Sandostatin (immediate-release octreotide) has been shown to be effective and tolerated. Prior documentation of a successful and tolerated trial of the short‑acting formulation is required before initiating the LAR product.

Current literature does not support routine prophylactic use of somatostatin or protease inhibitors for prevention of post-ERCP pancreatitis. Although some early studies suggested benefit with certain agents, larger contemporary trials and meta-analyses indicate inconsistent effects and do not endorse routine prophylactic administration of somatostatin or octreotide for ERCP-related pancreatic damage.

Routine use of somatostatin or octreotide for the management of acute pancreatitis is not recommended. Guideline and pooled-trial data report insufficient and conflicting evidence: the largest randomized trial showed no effect on mortality or organ failure, and technical reviews conclude the data are not convincing to support routine therapy.

UnitedHealthcare policy explicitly states that somatostatin analogs are unproven and not medically necessary for HIV-AIDS-related diarrhea. This is a formal exclusion from coverage reflecting the lack of high-quality evidence to support routine use for this indication.

Uses listed in the exclusions section are considered unproven and not medically necessary because published peer‑reviewed clinical evidence of safety and efficacy is lacking. Requests for somatostatin analog therapy for these indications are therefore subject to denial in the absence of robust supporting documentation.

For radiation-induced diarrhea, octreotide may not be sufficiently effective for the majority of mild to moderate cases. The policy notes that octreotide is more consistently effective for chemotherapy-induced diarrhea persisting >48 hours despite loperamide, whereas radiation-induced cases respond less reliably and often do not require octreotide.

Routine prophylactic administration of somatostatin analogs following pancreatic surgery for non-malignant indications is not supported by consistent evidence. Although some meta-analyses report benefit in malignancy-related resections, the literature is mixed and routine use for non‑malignant indications lacks sufficient supportive data.

FDA approval or prescribing information is provided for informational purposes only; FDA approval alone is not sufficient documentation to establish medical necessity. Coverage decisions require supporting clinical documentation consistent with the policy's criteria.

The policy revision clarifies that the prior statements indicating Sandostatin or Sandostatin LAR as proven treatments for refractory HIV/AIDS‑related diarrhea have been removed. Consequently, use of Sandostatin and Sandostatin LAR for refractory HIV/AIDS-related diarrhea is not medically necessary under the updated coverage rationale.

Applicable Codes and Diagnostic Mapping

Applicable HCPCS/J CodesHCPCS

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

No codes listed

Applicable ICD-10 Codes (examples shown)ICD-10

C17.0	Malignant neoplasm of duodenum.
C17.1	Malignant neoplasm of jejunum.
C17.2	Malignant neoplasm of ileum.
C17.3	Meckel's diverticulum, malignant.
C17.8	Malignant neoplasm of overlapping sites of small intestine.
C17.9	Malignant neoplasm of small intestine, unspecified.
C18.0	Malignant neoplasm of cecum.
C18.1	Malignant neoplasm of appendix.
C18.2	Malignant neoplasm of ascending colon.
C18.3	Malignant neoplasm of hepatic flexure.

1–10 of 14

1/2

No codes listed

Applicable ICD-10 Diagnosis CodesICD-10

C17.0	Malignant neoplasm of duodenum
C17.1	Malignant neoplasm of jejunum
C17.2	Malignant neoplasm of ileum
C17.3	Meckel's diverticulum, malignant
C17.8	Malignant neoplasm of overlapping sites of small intestine
C17.9	Malignant neoplasm of small intestine, unspecified
C18.0	Malignant neoplasm of cecum
C18.1	Malignant neoplasm of appendix
C18.2	Malignant neoplasm of ascending colon
C18.3	Malignant neoplasm of hepatic flexure

1–10 of 55

1/6

No codes listed

Applicable J-codes / HCPCS referencedHCPCS

J1930	Octreotide acetate, non-chemotherapeutic, 1 mg
J1932	Octreotide acetate, long-acting, per 1 mg
J2502	Pasireotide (description blank in doc)
J2353	Lanreotide (description blank in doc)
J2354	Lanreotide sustained-release (description blank in doc)

No codes listed

Applicable codes reformatted (ICD-10/HCPCS)mixed

No codes listed

Acromegaly biochemical thresholds

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

IGF-1Elevated serum IGF‑1 above the age- and gender-adjusted normal range as provided by the physician's laboratory

ApplicationRequired for biochemical confirmation of acromegaly prior to initiating immediate‑release or long‑acting somatostatin analog therapy

Octreotide infusion duration

Key trial resultRandomized trial (n=124) found no significant difference in early rebleeding when octreotide continuous infusion was given for 2 days versus 5 days (4.8% vs 8.6%)

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior Authorization Required — Code & Diagnosis Linkage

Prior authorization is required for long-acting somatostatin analog administrations billed with the listed HCPCS/J‑codes. Requests must include the diagnosis code that links to the specific J‑code billed; absence of an allowed diagnosis-to-code linkage may result in denial or request for additional documentation.

PA applies to administrations billed with listed J‑codes (e.g., J2353, J2354, J1930/J1932, J2502)
Ensure submitted ICD-10 corresponds to one of the diagnoses mapped to the billed J‑code

Prior Authorization

Pasireotide LAR (Signifor LAR) — Acromegaly Authorization Considerations

Pasireotide LAR (Signifor LAR) requires documentation supporting use in acromegaly that aligns with trial populations and FDA‑labeled indications. For acromegaly, demonstrate inadequate response to or unsuitability for surgery and/or radiotherapy and confirm diagnostic biochemical criteria. Be aware that clinical trials often enrolled patients inadequately controlled on octreotide/lanreotide, which may affect sequencing/step requirements.

Document prior medical therapy and response (including prior octreotide or lanreotide doses and duration)

Clinical Background and Drug Class Information

Somatostatin analogs (including octreotide, lanreotide and pasireotide) are synthetic peptides that mimic native somatostatin activity. They are used clinically to reduce hormone secretion in endocrine disorders (for example, acromegaly and Cushing's disease), to control symptoms of hormone‑secreting neuroendocrine tumors (eg, carcinoid syndrome), and as adjunctive therapy for complications such as variceal bleeding and treatment‑related secretory diarrhea. Long‑acting formulations reduce dosing frequency but generally require prior demonstration of efficacy or intolerance to short‑acting agents for some products.

Definitions and Key Terms

Biochemical confirmation of acromegaly

Diagnostic definitionBiochemical confirmation of acromegaly is met by serum GH > 1 ng/mL after a 2‑hour OGTT or elevated age‑ and gender‑adjusted serum IGF‑1 at time of diagnosis

Use for IR and LAR agentsSame biochemical confirmation criteria apply for immediate‑release octreotide and long‑acting SRL formulations (Sandostatin LAR, Signifor LAR, Somatuline Depot) per coverage criteria

Documentation requirementProvider documentation should include the specific GH and/or IGF‑1 values and reference ranges used to confirm diagnosis

Sandostatin LAR

DefinitionSandostatin LAR is a long‑acting intramuscular octreotide formulation designed for intragluteal injection once every 4 weeks

Indication note

Policy Revision History

2025-06-01policy_revisionLatest

Added language that Somatostatin analogs are unproven and not medically necessary for treating HIV-AIDS-related diarrhea; removed prior medical necessity language and medical necessity criteria for refractory HIV/AIDS-related diarrhea.

2025-06-01coding_update

Reformatted applicable ICD-10 diagnosis code list to align with HCPCS codes and removed ICD-10 codes B20 and R19.7.

2025-06-01supporting_information_update

Policy Summary

PayerUnitedHealthcare Community Plan

PolicySomatostatin Analogs (for Louisiana Only)

Policy CodePolicy CSLA2025D0036V

Change TypeCoverage rationale revisedcoding and exclusions updated

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis confirmation and prior therapy (e.g., GH/IGF‑1 levels, prior short‑acting octreotide trial for LAR formulations) when seeking coverage.

SourceLink

On This Page

octreotide total dose >= 0.5 mg noted in some analyses

Insufficient consensus to mandate routine prophylactic use.

Acute pancreatitis treatment: Randomized trials and meta-analyses show octreotide does not significantly reduce short-term mortality but may reduce some complications in select studies; overall guideline-level recommendations are uncertain and routine use is not supported.

Heterogeneous study designs and outcomes.

Pancreatic surgery (prophylaxis for POPF): Evidence is mixed: some meta-analyses report reduced pancreatic fistula incidence with perioperative octreotide, while other reviews and trials find no significant benefit; somatostatin analogs may reduce perioperative complications in malignancy and shorten hospital stay per some reviews but are not recommended routinely for non-malignant indications.

Consider selective use in malignancy or high-risk subgroups; document duct size and risk status.

Short bowel syndrome: Limited open-label data show octreotide depot can prolong small bowel transit time; clinical effects variable with small sample sizes and uncertain impact on key clinical endpoints.

Further multicenter trials needed.

Acromegaly and Cushing's disease (long-acting agents): Pasireotide LAR has demonstrated superior biochemical control versus octreotide/lanreotide in some trials but with higher rates of hyperglycemia; lanreotide autogel and lanreotide injection achieve substantial biochemical control in trials and registries; safety monitoring for hyperglycemia and other AEs should inform agent selection.GH < 2.5 µg/L and normalized IGF-1 common endpoints

Prior therapy and baseline glucose/HbA1c should be considered when selecting pasireotide due to hyperglycemia risk.

ConclusionStudy concluded 2 days of octreotide infusion following endoscopic therapy is as effective as 5 days for preventing early rebleed

ContextPatients had cirrhosis and acute variceal bleeding and received concurrent endoscopic therapy

Biochemical thresholds reported in trials

IGF‑I endpointTrials report normalized age‑adjusted IGF‑I (i.e., IGF‑I within the age‑adjusted reference range) as a primary/secondary outcome

GH thresholdsCommon trial thresholds: GH ≤ 2.5 μg/L (biochemical control) and GH < 1 μg/L reported in some studies

Enrollment GH criteriaEligibility examples include mean GH > 5 ng/mL for treatment‑naïve subgroups and >3 ng/mL for previously treated patients after washout periods

Removed ICD-10 codes

Removed ICD-10 codesICD-10 codes B20 and R19.7 were removed from the applicable diagnosis list in the policy update effective 06/01/2025

Coding reformattingApplicable ICD-10 diagnosis lists were reformatted to reflect corresponding HCPCS codes as part of the revision

Include baseline and screening GH and IGF‑1 levels and prior treatment history showing inadequate control where applicable

Monitor and document glucose control due to high rates of hyperglycemia with pasireotide

Prior Authorization

PA for FDA‑Indicated Uses — FDA Approval Informational Only

Prior authorization is required for FDA‑indicated uses. Approval alone by the FDA is informational; coverage decisions also require that clinical documentation meets the policy’s medical necessity criteria and any applicable federal/state/contractual plan terms.

Provide documentation that the requested use matches an FDA‑labeled indication and meets the policy’s detailed clinical criteria
Federal, state, or contractual requirements may supersede this policy and must be supplied if applicable

Prior Authorization

Prior Authorization Guidance — Process and Documentation

Follow UnitedHealthcare’s prior authorization processes and submit complete clinical documentation with the request. Policy updates have revised coverage rationale and how ICD‑10 to HCPCS/J‑code mappings are presented; verify current code lists and submitors should expect benefit‑administration checks.

Use the current policy version (effective 2025-06-01) when preparing requests
UnitedHealthcare may use external decision‑support tools (e.g., InterQual) to assist in reviews

Billing Rule

Diagnosis‑Code Linkage Required

A diagnosis code that matches the listed, allowable ICD‑10 diagnoses must be submitted and clearly linked to the J‑code billed. Coverage is contingent on an appropriate diagnosis-to-code linkage; missing or non‑mapped diagnosis codes may delay or deny payment.

Confirm the ICD‑10 is one of the diagnoses listed in the policy and that it is valid for the billed HCPCS J‑code
Do not bill J‑codes without a corresponding allowed diagnosis on the claim

Documentation Required

Postoperative Pancreatic Surgery — Variable Evidence; Documentation Required

Evidence for prophylactic somatostatin analog use to prevent postoperative complications after pancreatic surgery is mixed. When requesting coverage for this use, include specific patient‑risk factors, indication (e.g., malignancy), and relevant trial/meta‑analysis data supporting benefit in the submitted case.

Provide rationale referencing duct size, malignancy status, or high‑risk features when claiming prophylactic use
Be aware that guidelines differ — routine use is supported for pancreatic surgery for malignancy but not for other indications

Note

FDA Approval Alone Is Not a Basis for Coverage

FDA approval is informational and is not, by itself, sufficient to establish medical necessity for coverage. Requests must include supporting clinical evidence that the patient meets the policy’s coverage criteria and any applicable plan requirements.

Include clinical findings, prior treatments, and objective laboratory/imaging data that meet the policy’s criteria
When federal/state/contractual rules require coverage despite policy, include those references in the request

Step Therapy

Step Requirement for Sandostatin LAR — Prior Short‑Acting Trial Needed

For Sandostatin LAR, demonstrate prior successful use of short‑acting octreotide immediate release (IR) with effectiveness and tolerance before authorizing long‑acting depot therapy. This step is an FDA‑stated requirement and part of the medical necessity criteria in this policy.

Document dose, duration, response, and any adverse effects from prior octreotide IR therapy
If prior short‑acting trial was not given, provide clinical justification for bypassing the trial

Step Therapy

Short‑Acting Trial Before Long‑Acting Formulations

Short‑acting somatostatin analog trial (octreotide IR) should precede long‑acting formulations to demonstrate efficacy and tolerability unless there is a documented contraindication or clinical justification. Include details of the trial in the PA submission.

Record start/stop dates, dosing, objective response (GH/IGF‑1), and adverse events during the IR trial
If exempting the short‑acting trial, provide rationale (e.g., intolerance to injections, prior documented efficacy)

Step Therapy

Step Therapy Implication for Pasireotide — Prior SRL Use and Inadequate Control

Because pasireotide trials often enrolled patients inadequately controlled on octreotide or lanreotide, prior step‑therapy with those agents and documentation of inadequate control may be required before pasireotide is authorized. Provide prior dosing, duration, and biochemical response data.

Include prior SRL agent, dose, duration, and evidence of inadequate biochemical control (GH, IGF‑1)
Document any contraindications or intolerance to prior SRLs if claiming exemption from step therapy

Documentation Required

Therapy Sequencing Considerations — Document Clinical Rationale

Therapy sequencing should follow guideline‑based and evidence‑based recommendations. Consider patient factors (age, tumor characteristics, comorbid diabetes) and the relative risks/benefits of SRLs, pegvisomant, and combination approaches when proposing treatment sequencing in the PA.

Address selection rationale for lanreotide, octreotide, pasireotide, pegvisomant, or combination therapy with respect to prior response and comorbidities
If requesting a nonstandard sequence, include evidence or rationale (e.g., tumor responsiveness, prior adverse events)

Documentation Required

Chylothorax — Conservative Therapy Tried First; Dosing & Duration Required

For chylothorax requests, document failure of conservative first‑line measures (nutritional interventions, drainage) and provide dosing/timing details for octreotide or somatostatin trials. Include patient weight‑based dosing and duration used, as the literature reports variable dosing regimens and durations.

Specify prior conservative therapy attempted and dates of failure before initiating somatostatin analogs
Provide initial and maximum doses used (e.g., IV infusion mcg/kg/day or continuous mcg/kg/hr), route, and duration, and response to therapy

Documentation Required

Required Clinical Documentation for PA Requests

Required clinical documentation for prior authorization must include diagnostic confirmation (GH and/or IGF‑1 criteria for acromegaly), prior therapy history, objective response measures, and relevant imaging or laboratory results. For continued/renewal requests, include prior treatment response and plans for monitoring.

Diagnostic tests: OGTT GH results and/or age/gender‑adjusted IGF‑1 with lab reference ranges
Prior therapy: dates, agents, doses, response, and intolerances
Objective measures: serial GH and IGF‑1 values, tumor imaging when relevant
For renewals: documentation of ongoing benefit and monitoring for adverse events (e.g., hyperglycemia with pasireotide)

Documentation Required

Instructions for Use / Documentation Requirements

Include the manufacturer’s Instructions for Use and any applicable patient‑specific instructions as part of the submission when federal/state/contractual rules require them. UnitedHealthcare may request additional documentation per plan terms.

Attach relevant product labeling or Instructions for Use when requested
Provide any state or contractual coverage mandates that affect decision making

Indicated for acromegaly in patients in whom initial treatment with Sandostatin (immediate‑release octreotide) has been shown to be effective and tolerated

AdministrationMust be administered under the supervision of a physician

Signifor LAR / Pasireotide

DefinitionSignifor LAR (pasireotide) is a long‑acting release formulation of pasireotide, a somatostatin analog that binds multiple SSTR subtypes including SSTR5

Receptor activityPasireotide binds and activates SSTR1–5; corticotroph tumors frequently overexpress SSTR5 and pasireotide inhibits ACTH secretion leading to decreased cortisol

Clinical notePasireotide LAR demonstrated superior biochemical control versus octreotide/lanreotide in trials but with higher rates of hyperglycemia—monitor glucose/HbA1c

Somatuline Depot / Lanreotide

DefinitionSomatuline Depot (lanreotide) is a prolonged‑release lanreotide formulation for deep subcutaneous injection with somatostatin‑like activity

Administration and dosingGiven as deep subcutaneous injections at ~4‑week intervals; trials used titrated dosing (60–120 mg) with dose adjustments based on GH and IGF‑1

Clinical effectLanreotide reduces GH and IGF‑1 levels; trials report normalized IGF‑1 in ~43% at 48 weeks and substantial proportions achieving GH ≤2.5 μg/L

chylothorax

DefinitionChylothorax is accumulation of lymphatic (chyle) fluid in the pleural space

Therapeutic rationaleSomatostatin/octreotide may reduce lymph flow and promote leak closure, with reported reduction in chest‑tube drainage within days and typical treatment durations of 1–2 weeks in successful cases

Evidence noteEvidence consists of case reports, small series, and retrospective reviews; randomized controlled trials are lacking and caution is advised in patients at risk for vascular compromise

biochemical control (acromegaly)

Policy definitionBiochemical control in acromegaly is achievement of growth hormone below commonly used thresholds (e.g., < 2.5 μg/L) together with age‑adjusted normalized IGF‑1

Monitoring implicationTrials and coverage criteria use GH and IGF‑1 targets to define response and continuation of long‑acting SRL therapy

Safety implicationAgent selection and monitoring should consider comorbidities (e.g., diabetes risk with pasireotide) when assessing biochemical control goals

Biochemical control — trial‑reported thresholds

Trial definitionsClinical trials define biochemical control as GH < 2.5 μg/L plus normalized IGF‑1 (age‑adjusted); some trials also report GH < 1 μg/L as a stricter endpoint

Reported outcomesExamples: pasireotide LAR extension study reported biochemical control (GH < 2.5 μg/L and normal IGF‑1) at month 25 in 48.6% (pasireotide) vs 45.7% (octreotide); lanreotide trials reported ~43% normalized IGF‑1 at 48 weeks and 85% with GH ≤2.5 μg/L

Enrollment thresholdsSome trials enrolled patients with mean GH > 5 ng/mL (treatment‑naïve) or >3 ng/mL (previously treated after washout) as eligibility criteria

Somatostatin analogs — agents in class

Included agentsClass includes octreotide (Sandostatin, Sandostatin LAR), lanreotide (Somatuline Depot/lanreotide injection), and pasireotide (Signifor/Signifor LAR)

Formulation examplesShort‑acting (octreotide SC/IV), long‑acting intramuscular (Sandostatin LAR, Signifor LAR) and deep subcutaneous depot (Somatuline Depot/lanreotide Autogel)

Clinical usesUsed across GI and endocrine indications such as variceal bleeding adjunct, malignant bowel obstruction, acromegaly, NETs, and some palliative indications per prescribing information and trials

Updated Clinical Evidence, FDA, and References sections to reflect current information and archived previous policy version CSLA2024D0036U.

Material changes effective 06/01/2025: the policy now specifies that somatostatin analogs are unproven and not medically necessary for HIV‑AIDS‑related diarrhea, removes prior medical necessity criteria that previously supported Sandostatin/Sandostatin LAR for that indication, and reformats applicable ICD‑10/HCPCS coding lists (with removal of ICD‑10 codes B20 and R19.7). Providers should follow the payer's current prior authorization processes in light of these revisions.