mhn octreotide acetate Coverage & Prior Auth Update

Coverage and Medical Necessity Criteria

Initial Therapy – Acromegaly

Covered when ALL of the following are met:

Acromegaly initial criteria: 1) Diagnosis of acromegaly as evidenced by one of the following: (a) pre-treatment IGF‑I above the laboratory upper limit of normal for age/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) One of the following: (a) inadequate response to surgical resection or pituitary irradiation (unable to normalize GH and/or IGF‑I or control tumor mass), OR (b) 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 2 weeks with improvement in GH or IGF‑I levels or tumor control, AND (b) member must use generic octreotide acetate LAR unless unavailable due to shortage; 7) For Mycapssa requests, failure of lanreotide (Somatuline Depot) or generic octreotide acetate LAR is required unless contraindicated or clinically adverse effects occur (Illinois HIM requests exempt per IL HB 5395); 8) Dose limits must be respected (Injection ≤ 1,500 mcg/day; LAR ≤ 40 mg every 4 weeks; Mycapssa ≤ 80 mg/day).as stated

Also contains step therapy requirements for Mycapssa and IL exception (see step_therapy).

Initial Therapy – Carcinoid Tumor

Covered when ALL of the following are met:

Carcinoid tumor initial criteria: 1) Request is for Sandostatin Injection or Sandostatin LAR Depot; 2) Diagnosis of a carcinoid tumor and either (a) carcinoid syndrome (diarrhea or flushing), OR (b) 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 for symptom management, member will receive Sandostatin Injection for at least 2 weeks with improvement in diarrhea or flushing, AND (b) member must use generic octreotide acetate LAR unless unavailable due to shortage; 7) Dose either does not exceed stated maxima (Injection up to 1,500 mcg/day; LAR 30 mg every 4 weeks) OR dose is supported by practice guidelines/peer‑reviewed literature with prescriber evidence submission. Prescribed regimen must be FDA‑approved or recommended by NCCN.

Initial Therapy – Pancreatic NET / Adrenal Tumor

Covered when ALL of the following are met:

Pancreatic NET/Adrenal tumor initial criteria: 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) symptom management for hormonal hypersecretion (e.g., diarrhea), (ii) treatment of gastrinoma with or without symptoms, (iii) advanced disease for other pancreatic NETs, OR (iv) if insulinoma, tumor is somatostatin receptor positive on imaging; OR diagnosis of 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 for symptom management, member will receive Sandostatin Injection for at least 2 weeks with improvement in symptoms, AND (b) member must use generic octreotide acetate LAR unless unavailable due to shortage; 7) Dose either does not exceed stated maxima (Injection up to 750 mcg/day for VIPoma; LAR 30 mg every 4 weeks) OR dose is supported by practice guidelines/peer‑reviewed literature with prescriber evidence submission. Prescribed regimen must be FDA‑approved or recommended by NCCN.

Initial Therapy – Meningioma (off-label)

Covered when ALL of the following are met:

Meningioma initial criteria: 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 unavailable due to shortage; 7) Disease is not amenable to surgery or radiation; 8) Octreotide scan is positive; 9) Dose is within FDA maximum limit for any FDA‑approved indication or is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence). Prescribed regimen must be FDA‑approved or recommended by NCCN.

Initial Therapy – Thymoma/Thymic Carcinoma (off-label)

Covered when ALL of the following are met:

Thymoma/thymic carcinoma initial criteria: 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 unavailable due to shortage; 7) Octreotide scan or DOTATATE PET/CT is positive; 8) Dose is within FDA maximum limit for any FDA‑approved indication or is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence). Prescribed regimen must be FDA‑approved or recommended by NCCN.

Initial Therapy – Merkel Cell Carcinoma (off-label)

Covered when ALL of the following are met:

Merkel cell carcinoma initial criteria: 1) Request is for Sandostatin LAR Depot; 2) Diagnosis of Merkel cell carcinoma; 3) Prescribed by or in consultation with an oncologist; 4) Age ≥ 18 years; 5) For Sandostatin LAR Depot requests, member must use generic octreotide acetate LAR unless unavailable due to shortage; 6) Prescribed as a single agent; 7) One of the following: (a) disease progressed after anti‑PD‑1/PD‑L1 therapy, OR (b) anti‑PD‑1/PD‑L1 therapy is contraindicated; 8) Dose is within FDA maximum limit for any FDA‑approved indication or is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence). Prescribed regimen must be FDA‑approved or recommended by NCCN.

Continued Therapy – Acromegaly

Covered when ALL of the following are met:

Acromegaly continued therapy: 1) Member meets one of the following: (a) currently receiving medication via the Centene benefit or previously met initial approval criteria, OR (b) member is currently receiving medication and continuity of care regulations apply; 2) Member is responding positively to therapy (e.g., improvement in GH or IGF‑1 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 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, (b) Sandostatin LAR Depot 40 mg every 4 weeks, OR (c) Mycapssa 80 mg (4 capsules) per day.

Continued Therapy — Acromegaly

Covered when ALL of the following are met:

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

Continued Therapy — Carcinoid and Neuroendocrine Tumors

Covered when ALL of the following are met:

Carcinoid/NET continued therapy: 1) Currently receiving medication via Centene benefit, or documentation supports current receipt of Sandostatin Injection or Sandostatin LAR Depot for a covered indication 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 unavailable due to shortage; 6) If request is for a dose increase, either: (a) new dose does not exceed stated maximums (Carcinoid tumors: Injection up to 1,500 mcg/day; VIPomas: Injection up to 750 mcg/day; Sandostatin LAR Depot up to 30 mg every 4 weeks), OR (b) dose is supported by practice guidelines or peer‑reviewed literature with prescriber evidence submission. Prescribed regimen must be FDA‑approved or recommended by NCCN.

Continued Therapy — Selected Off‑Label Oncology Indications

Covered when ALL of the following are met:

Meningioma/Thymoma/Thymic carcinoma/Merkel cell carcinoma continued therapy: 1) Currently receiving medication via Centene benefit, or documentation supports current receipt of Sandostatin Injection or Sandostatin LAR Depot for a covered indication 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 unavailable due to shortage; 5) Member is responding positively to therapy; 6) If request is for a dose increase, new dose is within the FDA maximum limit for any FDA‑approved indication OR is supported by practice guidelines or peer‑reviewed literature for the off‑label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA‑approved or recommended by NCCN.

Other Diagnoses/Indications

Covered when ONE of the following is met:

Other uses: 1) If the drug has undergone a label change within the last 6 months that is not yet reflected in this policy, follow the referenced formulary/no‑coverage or non‑formulary policies for the relevant line of business (see policy cross‑references), OR 2) If the requested use is not listed under section III and criterion 1 does not apply, refer to the off‑label use policy for the relevant line of business (policy references provided).

See policy cross‑references CP.CPA.190, HIM.PA.103, CP.PMN.255, CP.CPA.09, HIM.PA.154, CP.PMN.53.

Coverage criteria summary

Coverage and medical necessity include indication‑specific diagnostic confirmation, prior response/tolerability for certain formulations, and adherence to generic‑first/product redirection rules.

Generic‑first and product redirection: Member must use generic octreotide acetate LAR for brand Sandostatin LAR requests; member must use generic octreotide acetate for Sandostatin Injection for continued therapy; Mycapssa requests are redirected to lanreotide or generic octreotide acetate LAR, with brand Sandostatin LAR Depot allowed if generic is unavailable due to shortage.

Applies across indications per policy revisions

Diagnostic confirmation for acromegaly: For acromegaly, confirmatory diagnostic testing with IGF‑I or GH per professional society/Endocrine Society practice guidelines is required.

Added in prior reviews per practice guideline alignment

Sandostatin LAR depot sequencing/response: For Sandostatin LAR Depot requests when used for symptom management and for Mycapssa, member must have responded to and tolerated treatment with octreotide or lanreotide, or member will receive Sandostatin Injection per revised language.

If the requested use is not specifically listed under Section III (Diagnoses/Indications for which coverage is NOT authorized) and none of the other coverage criteria apply, providers should follow the policy routing described in the policy text. If the drug has had a recent label change within the last 6 months that is not yet reflected in this policy, refer to the formulary or non‑formulary policies for the member's line of business as directed in Section G(1). If the requested use is not a recent label change and is not listed, refer to the applicable off‑label use policy for the relevant line of business as directed in Section G(2) (CP.CPA.09 for commercial, HIM.PA.154 for marketplace, CP.PMN.53 for Medicaid).

Non‑FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policy for the member’s line of business (see CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid). Requests for such indications should include clinical evidence per those off‑label policies to support medical necessity.

References to Bynfezia were removed from this policy due to product discontinuation; Bynfezia is no longer included in the policy language, criteria, or referenced formulary lists.

HCPCS and other codes listed in this clinical policy are provided for informational purposes only and their presence does not guarantee coverage. Inclusion or exclusion of codes does not change medical necessity determinations; providers must submit supporting clinical documentation and should verify current coding guidance prior to claim submission. The policy also describes specific conditions under which therapy may be considered not medically necessary elsewhere in the payer's program documentation.

Codes, Dosing Limits, and Approval Durations

Prior auth / affected productsmixed

N/A	Document references that prior authorization may be required for Somatuline Depot, generic octreotide acetate LAR, and Sandostatin LAR Depot but does not list specific billing codes in this section.

HCPCS codes referencedHCPCS

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

Dose maximums — octreotide formulations

Sandostatin Injection maximumUp to 1,500 mcg per day in divided doses (note: some indications such as VIPoma list 750 mcg/day maximum)

Sandostatin LAR Depot maximumUp to 40 mg every 4 weeks (typical range 20–40 mg q4wk depending on indication; carcinoid/VIPoma maximum 30 mg q4wk)

Mycapssa (oral) maximumUp to 80 mg per day (4 capsules) — titrate from 20 mg PO BID to a maximum of 40 mg PO QD per prescribing guidance

Maximum doses — per formulation

Sandostatin Injection (specific maximum)1,500 mcg per day in divided doses

Sandostatin LAR Depot (acromegaly)

Prior Authorization, Documentation, and Step-Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required for requests for Sandostatin Injection, Sandostatin LAR Depot, Mycapssa, Somatuline (lanreotide) Depot, and generic octreotide acetate LAR/Injection when applicable. Approval is contingent on meeting the indication‑specific criteria in this policy (initial and continued therapy) and any step‑therapy or redirection rules described below.

Prior authorization may be required for Somatuline Depot, generic octreotide acetate LAR, and Sandostatin LAR Depot.
Inclusion on the formulary or therapeutic alternative list does not remove PA requirement; agents listed in Appendix B may still require prior authorization.

Step Therapy

Prior Authorization and Product‑Use / Step Requirements

Some product‑use and sequencing rules apply before approval will be granted. For Sandostatin Injection and Sandostatin LAR Depot, members must use generic octreotide formulations when available unless contraindicated or they have clinically significant adverse effects. For Mycapssa, redirection/step requirements apply: failure of lanreotide (Somatuline Depot) or generic octreotide acetate LAR is required prior to approval unless intolerance or contraindication is documented. If generic octreotide acetate LAR is unavailable due to shortage, redirection to brand Sandostatin LAR Depot is allowed.

Clinical Background

Octreotide acetate is a somatostatin analog available in immediate‑release injection, long‑acting depot (LAR) formulations, and oral maintenance forms. It is used to reduce growth hormone and insulin‑like growth factor‑1 concentrations in acromegaly and to control symptoms such as diarrhea and flushing associated with carcinoid tumors and VIPomas. The policy outlines indication‑specific diagnostic confirmation, response requirements, and formulation‑specific sequencing and dose limits.

Definitions and Formulations

Octreotide acetate formulations

Sandostatin InjectionSandostatin Injection (octreotide acetate) — short‑acting formulation for SC or IV use

Sandostatin LAR DepotSandostatin LAR Depot (octreotide acetate) — long‑acting intramuscular depot formulation (IM q4wk)

MycapssaMycapssa (octreotide capsules) — oral maintenance formulation for long‑term treatment of acromegaly after response/tolerability to octreotide or lanreotide

IGF-I definition

IGF-I (definition)Insulin‑like growth factor I (IGF‑I), also known as somatomedin C

Clinical roleIGF‑I is used with GH measurements to confirm and monitor acromegaly

OpenPayer

Clinical Policy: Octreotide Acetate (Sandostatin, Sandostatin LAR Depot, Mycapssa)

Coverage and Medical Necessity Criteria

Codes, Dosing Limits, and Approval Durations

Prior Authorization, Documentation, and Step-Therapy

Clinical Background

Definitions and Formulations