CurrentCentenePolicy CP.PHAR.391

Lanreotide (Somatuline Depot) (PDF)

Defines medical necessity criteria, step therapy/redirection, dosing limits, approval durations, continued therapy requirements, exclusions, coding implications, and state-specific step-therapy exceptions for Somatuline Depot and unbranded lanreotide across Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerCentene

PolicyLanreotide (Somatuline Depot) (PDF)

Policy CodePolicy CP.PHAR.391

Change TypeRevisions; additions; coding updates; state step-therapy changes

Effective Date08.14.18

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) supporting that member has met all approval criteria

SourceLink

POLICY UPDATE CHANGES

Added confirmatory diagnostic requirements for acromegaly (IGF-I or GH) and clarified NET criteria including DIPNECH and SSTR requirements; updated HCPCS codes (removed C9399, added J3490).

Added redirection to octreotide acetate LAR and to Sandostatin LAR Depot if generic unavailable, and requirement to use generic lanreotide for Somatuline Depot requests when available.

Added Appendix E states and step therapy bypass details; added Mississippi and Indiana to Appendix E over time and applied IL HIM bypass per IL HB 5395 effective 1/1/2026.

Revised GH threshold wording from 'µg/mL' to 'µg/L' per PS/ES guidelines and ACG.

Added unbranded lanreotide formulation and newly approved carcinoid syndrome indication to FDA Approved Indication(s).

3Covered Indications (Acromegaly; Carcinoid Syndrome; Neuroendocrine Tumors)

120 mg/4 weeks

Maximum Routine Dose

≥18Minimum Age (years)

J1930, J1932, J3490Referenced HCPCS Codes

Coverage Summary

This policy (CP.PHAR.391, status: CURRENT) covers lanreotide (Somatuline Depot and unbranded lanreotide) with defined medical necessity criteria for acromegaly, carcinoid syndrome, and neuroendocrine tumors (NETs). The policy aligns coverage and dosing expectations with guideline recommendations (including NCCN and specialty society guidance) and requires documentation of diagnosis and specialist involvement as specified in the criteria. For most members the policy enforces step-therapy/redirection to octreotide acetate LAR products (generic Sandostatin LAR Depot and, if unavailable due to shortage, brand Sandostatin LAR Depot) prior to approval of lanreotide except where state-specific exceptions or other policy-specified exceptions apply.

Quick Facts / Thresholds

Serum GH after 2-hour OGTT≥ 1 µg/L

Max dosing frequency≤ 120 mg every 4 weeks

Minimum age≥ 18 years

Referenced HCPCS codesJ1930 (Injection, lanreotide, 1 mg); J1932 (Injection, lanreotide, (cipla), 1 mg); J3490 (Unclassified drugs)

Initial Therapy Criteria

A. Acromegaly - Initial Therapy (must meet all)

Covered when ALL of the following are met:

ALL of the following

ONE of
- Pre-treatment insulin-like growth factor-I (IGF-I) level above the upper limit of normal based on age and gender for the reporting laboratory
- Serum growth hormone (GH) level ≥ 1 µg/L after a 2-hour oral glucose tolerance test≥ 1 µg/L
Prescribed by or in consultation with an endocrinologist

Continuation Therapy Criteria

II. Continued Therapy - Acromegaly (must meet all)

Covered when ALL of the following are met:

ALL of the following

ANY of the following
- Currently receiving medication via Centene benefit or member has previously met initial approval criteria
- Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations
  Refer to state specific addendums
For Somatuline Depot requests, member must use generic lanreotide if available, unless contraindicated or clinically significant adverse effects are experienced

Provider Actions & Billing Requirements

Documentation Required

Submit clinical documentation

Provider must submit office chart notes, laboratory results, or other clinical information supporting that the member has met all approval criteria for lanreotide (Somatuline Depot or unbranded lanreotide). Documentation should demonstrate diagnoses, prior treatments (including step therapy attempts when applicable), relevant labs (e.g., IGF‑I or GH for acromegaly), and any evidence cited to justify dosing above standard limits.

Prior Authorization

Prior authorization required

Prior authorization (PA) is required for requests for lanreotide. PA may require evidence of failure of specified octreotide acetate LAR products (generic Sandostatin LAR Depot) or other supporting evidence for off‑label dosing/regimens. Prior authorization may also be required for octreotide acetate LAR and Sandostatin LAR Depot.

Applicable Codes

HCPCS / Billing Codes referencedHCPCS

J1930	Injection, lanreotide, 1 mg
J1932	Injection, lanreotide, (cipla), 1 mg
J3490	Unclassified drugs

Clinical Evidence & Guidance

Key references include the Somatuline Depot and Lanreotide Prescribing Information (2024), the NCCN Neuroendocrine and Adrenal Tumors guideline and NCCN Drugs & Biologics Compendium, and specialty guidance such as Endocrine Society and Pituitary Society updates/consensus statements. The policy explicitly references Somatuline Depot and lanreotide labeling and cites NCCN/practice guidelines for allowable off-label dosing or regimens when applicable. Policy updates and redirection/step-therapy changes were made per SDC and review cycles documented in the policy history.

Background

Background: Lanreotide (Somatuline Depot and unbranded lanreotide) is a somatostatin analog indicated for long-term treatment of acromegaly after inadequate response to or inability to undergo surgery/radiotherapy, for adults with unresectable or metastatic well- or moderately-differentiated GEP-NETs to improve progression-free survival, and for treatment of adults with carcinoid syndrome. The policy covers both brand Somatuline Depot and unbranded lanreotide formulations and incorporates a step-therapy/redirection requirement directing use of generic octreotide acetate LAR (generic Sandostatin LAR Depot) and, if unavailable due to shortage, brand Sandostatin LAR Depot before approving lanreotide in most situations; additional requirements (e.g., specialist prescriber, diagnostic confirmation, and dosing limits) are specified in the coverage criteria.

Definitions

GEP-NETGastroenteropancreatic neuroendocrine tumor

SSTRSomatostatin receptor

DIPNECHDiffuse idiopathic pulmonary neuroendocrine cell hyperplasia

Revision History

4Q 2022annual_review

4Q 2022 annual review: Added confirmatory diagnostic requirements for acromegaly (IGF‑I or GH) per Pituitary Society/Endocrine Society guidance; clarified NET criteria including SSTR requirements (thymic/bronchopulmonary → lung NET, insulinomas require SSTR positivity or hormonal symptoms) and added coverable Grade 3 NETs with favorable biology; template and continued therapy updates applied.

02.21.23policy_update

Per February SDC and prior clinical guidance added redirection to Sandostatin LAR Depot (octreotide acetate LAR) for step therapy.

08.17.23policy_update

Per SDC, added unbranded lanreotide formulation to the policy and product listings.

Policy Summary

PayerCentene

PolicyLanreotide (Somatuline Depot) (PDF)

Policy CodePolicy CP.PHAR.391

Change TypeRevisions; additions; coding updates; state step-therapy changes

Effective Date08.14.18

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) supporting that member has met all approval criteria

SourceLink

On This Page

Inadequate response to surgical resection or pituitary irradiation, or member is not a candidate for such treatment

See Appendix D

Request is for either Somatuline Depot or unbranded lanreotide

For Somatuline Depot requests, member must use generic lanreotide if available, unless contraindicated or clinically significant adverse effects are experienced

ALL of the following

Generic octreotide acetate LAR (generic Sandostatin LAR Depot), unless octreotide acetate LAR is unavailable due to shortage
Prior authorization may be required
If member is unable to use generic octreotide acetate LAR due to shortage: Sandostatin LAR Depot

Dose does not exceed 120 mg every 4 weeks≤ 120 mg per 4 weeks

B. Carcinoid Syndrome - Initial Therapy (must meet all)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of carcinoid syndrome (associated with NETs of the gastrointestinal tract, lung, and thymus)
Prescribed by or in consultation with an oncologist
Age ≥ 18 years≥ 18 years
Request is for either Somatuline Depot or unbranded lanreotide
For Somatuline Depot requests, member must use generic lanreotide if available, unless contraindicated or clinically significant adverse effects are experienced
Member meets one of the following
- Failure of both of the following, unless clinically adverse effects are experienced or both are contraindicated: (i) Generic octreotide acetate LAR (generic Sandostatin LAR Depot), unless octreotide acetate LAR is unavailable due to shortage; (ii) If unable to use generic octreotide acetate LAR due to shortage: Sandostatin LAR Depot
  Prior authorization may be required
- Request is for treatment-associated cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E)
  See Appendix E for listed states
ANY of the following
- Dose does not exceed 120 mg every 4 weeks≤ 120 mg per 4 weeks
- Dose 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

C. Neuroendocrine Tumors (NETs) - Initial Therapy (must meet all)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of one of the following
- GEP-NET (see Appendix D for tumor types); if insulinoma, disease is somatostatin receptor (SSTR)-positive
- Pheochromocytoma or paraganglioma (adrenal NETs)
- Diffuse idiopathic pulmonary neuroendocrine cell hyperplasia (DIPNECH)
- ANY of the following
  - Thymic NET
  - Lung NET
  - Grade 3 NET with favorable biology (i.e., relatively low Ki-67 [< 55%], slow growing, or SSTR-positive based PET imaging)
Prescribed by or in consultation with an oncologist
Age ≥ 18 years≥ 18 years
Request is for either Somatuline Depot or unbranded lanreotide
For Somatuline Depot requests, member must use generic lanreotide if available, unless contraindicated or clinically significant adverse effects are experienced
Member meets one of the following
- Failure of both of the following, unless clinically adverse effects are experienced or both are contraindicated: (i) Generic octreotide acetate LAR (generic Sandostatin LAR Depot), unless octreotide acetate LAR is unavailable due to shortage; (ii) If unable to use generic octreotide acetate LAR due to shortage: Sandostatin LAR Depot
  Prior authorization may be required
- Request is for treatment-associated cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E)
  See Appendix E for listed states
ANY of the following
- Dose does not exceed 120 mg every 4 weeks≤ 120 mg per 4 weeks
- Dose 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

D. Other diagnoses/indications

If not covered above, follow steps:

ANY of the following

If drug had a recent label change within 6 months not reflected in this policy, refer to formulary/no-coverage or non-formulary policies (CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16)
If requested use not specifically listed and above does not apply, refer to off-label use policy for relevant line of business: CP.CPA.09, HIM.PA.154, CP.PMN.53

Member is responding positively to therapy (see Appendix D)

If request is for a dose increase, new dose does not exceed 120 mg every 4 weeks≤ 120 mg per 4 weeks

Step Therapy

Step therapy / redirection requirement

Step therapy/redirection applies for most states: members must fail generic octreotide acetate LAR (generic Sandostatin LAR Depot), and if octreotide acetate LAR is unavailable due to shortage, the member must try brand Sandostatin LAR Depot, before coverage of lanreotide. For Somatuline Depot requests, the member must use generic lanreotide if available unless contraindicated or clinically significant adverse effects occur.

Step Therapy

State-specific step therapy bypass

Some states have statutory or regulatory exceptions to step therapy/redirection for cancer treatment (see Appendix E). Appendix E lists states with prohibitions against redirections in cancer and has been updated to add Mississippi and Indiana. Illinois HIM step therapy bypass applies per IL HB 5395 effective 1/1/2026.

Billing Rule

Dose limit enforcement

Dose limits are enforced: claims should not exceed 120 mg every 4 weeks unless the higher dose is supported by practice guidelines or peer‑reviewed literature and prior authorization has been obtained. Requests for dose increases above this threshold require supporting evidence and PA.

Threshold: ≤ 120 mg every 4 weeks

11.16.23policy_update

For carcinoid syndrome and NETs added redirection bypass when request is for treatment-associated cancer in states with regulations against step therapy; added Appendix E to list those states.

06.05.24appendix_update

Updated Appendix E to include Mississippi among states with regulations against redirections in cancer.

4Q 2024annual_review

4Q 2024 annual review: Revised GH threshold wording from 'µg/mL' to 'µg/L' per Pituitary Society/Endocrine Society and Acromegaly Consensus Group; added diagnosis of DIPNECH to NET criteria and changed 'bronchopulmonary NET' to 'lung NET'; removed inactive HCPCS code C9399 and added J3490; references updated.

RT4 2024 (per source)label_update

RT4: For unbranded lanreotide, added newly approved carcinoid syndrome indication to FDA Approved Indication(s).

02.26.25policy_update

Per December SDC and reflected Feb 26, 2025 P&T: Added redirection to octreotide acetate LAR (generic Sandostatin LAR Depot), redirection to brand Sandostatin LAR Depot if generic unavailable due to shortage, and requirement that members use generic lanreotide for Somatuline Depot requests when generic is available.

07.10.25annual_review

4Q 2025 annual review: no significant clinical changes; added step therapy bypass for Illinois HIM per IL HB 5395 (effective 1/1/2026) and extended initial therapy language.

03.31.26appendix_updateLatest

Per March 31, 2026 update: Appendix E updated to add Indiana (IN); IL HIM bypass applied per IL HB 5395 effective 1/1/2026 (state-specific step therapy bypass additions).