Centene Octreotide Acetate Coverage Update

Coverage Criteria

Initial Therapy — Acromegaly

Covered when ALL of the following are met

Acromegaly initial: 1) Diagnosis of acromegaly evidenced by one of the following: (a) pre-treatment IGF‑I above the reporting laboratory's upper limit of normal for age and gender; OR (b) serum GH ≥ 1 µg/mL after a 2‑hour oral glucose tolerance test; 2) Prescribed by or in consultation with an endocrinologist; 3) Age ≥ 18 years or, if younger, epiphyseal growth plates have closed; 4) Either (a) inadequate response to surgical resection or pituitary irradiation (unable to achieve normalization of GH and/or IGF‑I or adequately control tumor mass) OR (b) member is not a candidate for surgical resection or pituitary irradiation; 5) For Sandostatin Injection, member must use generic octreotide acetate unless contraindicated or clinically significant adverse effects occur; 6) For Sandostatin LAR Depot requests, both: (a) member will receive Sandostatin Injection for at least two weeks with improvement in GH or IGF‑I levels or tumor mass control; AND (b) member must use generic octreotide acetate LAR unless generic is unavailable due to shortage; 7) For Mycapssa requests, trial and failure of one of the alternatives listed in the policy is required unless contraindicated or adverse effects occur (see policy for specifics); 8) Requested dose does not exceed applicable maximums (Sandostatin Injection up to 1,500 mcg/day; Sandostatin LAR Depot up to 40 mg every 4 weeks; Mycapssa up to 80 mg/day).

Initial Therapy — Carcinoid Tumor / NET

Covered when ALL of the following are met

Carcinoid tumor initial: 1) Request is for Sandostatin Injection or Sandostatin LAR Depot; 2) Diagnosis of a carcinoid tumor AND one of the following: (a) request is for carcinoid syndrome (presence of diarrhea or flushing) OR (b) request is for advanced disease, with or without carcinoid syndrome; 3) Prescribed by or in consultation with an oncologist; 4) Age ≥ 18 years; 5) For Sandostatin Injection, member must use generic octreotide acetate unless contraindicated or clinically significant adverse effects occur; 6) For Sandostatin LAR Depot requests, both: (a) if request is for symptom management, member will receive Sandostatin Injection for at least two weeks with improvement in diarrhea or flushing; AND (b) member must use generic octreotide acetate LAR unless generic is unavailable due to shortage; 7) Dose does not exceed limits (Sandostatin Injection up to 1,500 mcg/day; Sandostatin LAR Depot up to 30 mg every 4 weeks) OR dose is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence).

Initial Therapy — Pancreatic NET / Adrenal Tumor

Covered when ALL of the following are met

Pancreatic NET/Adrenal initial: 1) Request is for Sandostatin Injection or Sandostatin LAR Depot; 2) Diagnosis of pancreatic neuroendocrine tumor (including VIPoma, gastrinoma, insulinoma, glucagonoma) with one of: (i) request for symptom management of hormonal hypersecretion (e.g., diarrhea); (ii) request for treatment of a gastrinoma with or without symptoms; (iii) request for other pancreatic NET for advanced disease with or without symptoms; OR (b) advanced adrenal pheochromocytoma/paraganglioma; 3) Prescribed by or in consultation with an oncologist; 4) Age ≥ 18 years; 5) For Sandostatin Injection, member must use generic octreotide acetate unless contraindicated or clinically significant adverse effects occur; 6) For Sandostatin LAR Depot requests, both: (a) if request is for symptom management, member will receive Sandostatin Injection for at least two weeks with improvement in symptoms; AND (b) member must use generic octreotide acetate LAR unless generic is unavailable due to shortage; 7) Dose does not exceed limits (Sandostatin Injection up to 750 mcg/day for pancreatic NET; Sandostatin LAR Depot up to 30 mg every 4 weeks) OR dose is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence).

Initial Therapy — Off-label oncologic indications

Covered when ALL of the following are met

Meningioma off-label: 1) Request is for Sandostatin Injection or Sandostatin LAR Depot; 2) Diagnosis of meningioma; 3) Prescribed by or in consultation with an oncologist; 4) Age ≥ 18 years; 5) For Sandostatin Injection, member must use generic octreotide acetate unless contraindicated or clinically significant adverse effects occur; 6) For Sandostatin LAR Depot requests, member must use generic octreotide acetate LAR unless generic is unavailable due to shortage; 7) Disease is not amenable to surgery or radiation; 8) Octreotide scan is positive; 9) Dose is within FDA maximum for any FDA‑approved indication OR supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence).

Thymoma/thymic carcinoma off-label: 1) Request is for Sandostatin Injection or Sandostatin LAR Depot; 2) Diagnosis of thymoma or thymic carcinoma; 3) Prescribed by or in consultation with an oncologist; 4) Age ≥ 18 years; 5) For Sandostatin Injection, member must use generic octreotide acetate unless contraindicated or clinically significant adverse effects occur; 6) For Sandostatin LAR Depot requests, member must use generic octreotide acetate LAR unless generic is unavailable due to shortage; 7) Octreotide scan or dotatate PET/CT is positive per NCCN; 8) Dose is within FDA maximum for any FDA‑approved indication OR supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence).

Merkel cell carcinoma off-label:

Continued Therapy — Acromegaly

Covered when ALL of the following are met

Acromegaly continued: 1) Member meets one of the following: (a) currently receiving medication via Centene benefit OR member has previously met initial approval criteria; OR (b) member is receiving medication and is enrolled in a state/product with continuity of care regulations; 2) Member is responding positively to therapy (e.g., improvement in GH or IGF‑1 serum concentrations or tumor mass control since initiation); 3) For Sandostatin Injection, member must use generic octreotide acetate unless contraindicated or clinically significant adverse effects occur; 4) For Sandostatin LAR Depot requests, member must use generic octreotide acetate LAR unless generic is unavailable due to shortage; 5) If request is for a dose increase, new dose does not exceed any of the following: (a) Sandostatin Injection 1,500 mcg/day in divided doses; (b) Sandostatin LAR Depot 40 mg every 4 weeks; (c) Mycapssa 80 mg (4 capsules) per day.

Continued Therapy — Acromegaly (alternate/expanded criteria)

Covered when ALL of the following are met

Acromegaly continued therapy: 1) Member is currently receiving medication via Centene benefit or previously met initial approval, or is in a continuity of care state/product; 2) Member is responding positively to therapy (e.g., improvement in GH or IGF‑1 serum concentrations or tumor mass control); 3) For Sandostatin Injection, member must use generic octreotide acetate unless contraindicated or clinically significant adverse effects occur; 4) For Sandostatin LAR Depot, member must use generic octreotide acetate LAR unless generic is unavailable due to shortage; 5) If a dose increase is requested, the new dose must not exceed: Sandostatin Injection 1,500 mcg/day OR Sandostatin LAR Depot 40 mg every 4 weeks OR Mycapssa 80 mg/day.

Continued Therapy — Carcinoid and NET

Covered when ALL of the following are met

Carcinoid/NET continued therapy: 1) Member is currently receiving medication via Centene benefit or documentation supports member has received Sandostatin Injection or LAR for at least 30 days; 2) Request is for Sandostatin Injection or Sandostatin LAR Depot; 3) Member is responding positively to therapy; 4) For Sandostatin Injection, member must use generic octreotide acetate unless contraindicated or clinically significant adverse effects occur; 5) For Sandostatin LAR Depot requests, member must use generic octreotide acetate LAR unless generic is unavailable due to shortage; 6) If request is for a dose increase, new dose must meet one of the following: (a) does not exceed the listed maximums: (i) Sandostatin Injection — carcinoid tumors: 1,500 mcg/day (divided) OR VIPomas: 750 mcg/day; OR (ii) Sandostatin LAR Depot — 30 mg every 4 weeks; OR (b) dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence).

Continued Therapy — Specified off‑label oncology indications

Covered when ALL of the following are met

Off-label oncology continued therapy: 1) Member is currently receiving medication via Centene benefit or documentation supports member has received Sandostatin Injection or LAR for at least 30 days; 2) Request is for Sandostatin Injection or Sandostatin LAR Depot; 3) For Sandostatin Injection, member must use generic octreotide acetate unless contraindicated or clinically significant adverse effects occur; 4) For Sandostatin LAR Depot requests, member must use generic octreotide acetate LAR unless generic is unavailable due to shortage; 5) Member is responding positively to therapy; 6) If request is for a dose increase, new dose is within FDA maximum for any FDA‑approved indication OR is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence); prescribed regimen must be FDA‑approved or recommended by NCCN.

Continued Therapy — Other indications (ONE of the following)

Covered when ONE of the following is met

Other diagnoses: 1) If the drug has undergone a label change within the last 6 months that is not yet reflected in this policy, follow the applicable formulary/no‑coverage or non‑formulary policies for the relevant line of business (referenced policies listed in the clinical policy); OR 2) If the requested use is not specifically listed under section III and criterion 1 does not apply, follow the off‑label use policy for the relevant line of business (prescriber must follow referenced policies).

Policy updates and coverage rules

Policy updates and coverage-related rules added or revised in annual reviews include:

Off-label/additional indication: Merkel cell carcinoma criteria added per NCCN

Added 1Q 2026

Diagnostic confirmation for acromegaly: Added requirement for confirmatory diagnostic testing (IGF‑I or GH) per professional society guidelines

Added in prior review

Imaging requirement for thymoma/thymic carcinoma: Octreotide scan or dotatate PET/CT must be positive per NCCN for relevant indications

Added 1Q 2024

Product redirection for Mycapssa: Mycapssa requests redirected to lanreotide or generic octreotide acetate LAR; brand Sandostatin LAR Depot allowed only if generic is unavailable due to shortage; Mycapssa removed from non‑formulary list

If the drug label has changed within the last 6 months and that change is not reflected in this policy, follow the referenced formulary/no‑coverage or non‑formulary policies for the applicable line of business. Specifically, use the formulary/no‑coverage policy for drugs on the formulary or PDL (e.g., CP.CPA.190 for commercial, HIM.PA.33 for marketplace, CP.PMN.255 for Medicaid) or the non‑formulary policy for drugs not on the formulary or PDL (e.g., CP.CPA.190 for commercial, HIM.PA.103 for marketplace, CP.PMN.16 for Medicaid).

Non‑FDA approved indications that are not specifically addressed in this clinical policy are excluded from coverage unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy (CP.CPA.09 for commercial, HIM.PA.154 for marketplace, CP.PMN.53 for Medicaid) or other evidence-of-coverage documentation.

References to the discontinued product Bynfezia have been removed from this policy due to product discontinuation.

For any requested use not listed under Section III (Diagnoses/Indications for which coverage is NOT authorized) and where a recent label change does not apply, refer the request to the applicable off‑label use policy for that line of business (CP.CPA.09 for commercial, HIM.PA.154 for marketplace, CP.PMN.53 for Medicaid) for evaluation of medical necessity.

Uses that are not FDA‑approved and are not supported by sufficient evidence per the referenced off‑label use policies will be considered not medically necessary and are not authorized for coverage.

Inclusion or exclusion of procedure or diagnosis codes in this clinical policy is for informational purposes only and does not guarantee coverage. The absence of a code in this policy is not an assertion that the service or drug is not covered; providers must reference current professional coding guidance and applicable coverage policies when submitting claims.

Coding and Dose Limits

Coding implications / affected codesmixed

affected codes

placeholder for codes referenced in coding implications revision log

Referenced HCPCS CodesHCPCS

J2353	Injection, octreotide, depot form for intramuscular injection, 1 mg.
J2354	Injection, octreotide, nondepot form for subcutaneous or intravenous injection, 25 mcg

Referenced HCPCS CodesHCPCS

J2353	Injection, octreotide, depot form for intramuscular injection, 1 mg.
J2354	Injection, octreotide, nondepot form for subcutaneous or intravenous injection, 25 mcg

GH/IGF-I diagnostic thresholds

Acromegaly diagnostic criteriaPre-treatment IGF‑I above the laboratory age-/gender‑specific upper limit of normal (ULN) or serum GH ≥ 1 µg/mL after a 2‑hour oral glucose tolerance test (OGTT).

Prescriber requirementDiagnosis must be established and therapy prescribed by or in consultation with an endocrinologist.

Age requirementAge ≥ 18 years or epiphyseal growth plates closed for younger patients.

Dose maximums (per formulation summaries)

Sandostatin Injection (short‑acting)Maximum: 1,500 mcg per day (divided doses) for acromegaly and carcinoid; 750 mcg/day for VIPoma indications.

Sandostatin LAR Depot (IM)

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization and Coding

Prior authorization is required for requests for Sandostatin Injection, Sandostatin LAR Depot, Mycapssa, octreotide acetate LAR, Somatuline (lanreotide) and other related products. Providers must include appropriate coding on the PA request; referenced HCPCS codes (for informational purposes) include J2353 (octreotide depot, 1 mg) and J2354 (octreotide non-depot, 25 mcg). Inclusion of codes does not guarantee coverage — verify coding guidance prior to claim submission.

Prior authorization required for Sandostatin Injection, Sandostatin LAR Depot, Mycapssa, octreotide acetate LAR, and Somatuline (lanreotide).
Reference HCPCS: J2353 (depot 1 mg), J2354 (non-depot 25 mcg) — informational only.

Prior Authorization

Prior Authorization and Product Redirection

Requests may be redirected to preferred products as part of formulary or step-therapy requirements. For Mycapssa (oral octreotide) requests, step therapy/redirection to lanreotide (Somatuline Depot) or to generic octreotide acetate LAR is required unless contraindicated or shortages prevent use of the generic LAR; if generic octreotide acetate LAR is unavailable due to shortage, redirection to brand Sandostatin LAR Depot may be required. For Sandostatin Injection and Sandostatin LAR Depot requests, members are expected to use generic octreotide acetate (or generic octreotide acetate LAR) unless contraindicated or shortage exists.

Background

Octreotide acetate is a synthetic somatostatin analog that inhibits secretion of several peptide hormones. It is used clinically to reduce growth hormone and IGF‑I levels in acromegaly and to control hormone-mediated symptoms (e.g., diarrhea and flushing) of carcinoid syndrome and other neuroendocrine tumors. Formulations include short‑acting injection (Sandostatin Injection), long‑acting release depot (Sandostatin LAR Depot or generic octreotide acetate LAR), and an oral maintenance capsule (Mycapssa) for responders; policy criteria distinguish initial versus continued therapy and require specialty prescribing and objective evidence of disease or treatment response.

Definitions and Diagnostic Criteria

Responder to therapy (LAR depot conversion) — definition/criteria

Definition — responder to LAR conversionDocumented improvement in GH or IGF‑I levels or tumor mass control after at least two weeks of Sandostatin Injection prior to converting to Sandostatin LAR Depot.

Symptom responseFor symptom management (e.g., carcinoid syndrome), responder defined as improvement in diarrhea or flushing after ≥2 weeks of Sandostatin Injection.

Documentation requiredResponse/tolerance must be documented in provider records to support LAR depot conversion or continued therapy.

insulin growth factor I (IGF‑I) definition/reference

TermInsulin‑like growth factor I (IGF‑I), also referred to as somatomedin C.

Role in acromegalyIGF‑I is a key biochemical marker used to diagnose and monitor acromegaly; pre‑treatment IGF‑I above lab‑specific ULN supports diagnosis.

OpenPayer

Octreotide Acetate (Sandostatin, Sandostatin LAR Depot, Mycapssa) coverage

Coverage Criteria

Coding and Dose Limits

Provider Actions and Authorization Requirements

Background

Definitions and Diagnostic Criteria