ModifiedmhnPolicy CP.PHAR.384

Lutetium Lu 177 dotatate (Lutathera) coverage

Defines medical necessity, prior authorization, dosing, and coverage criteria for Lutetium Lu 177 dotatate (Lutathera) for commercial, HIM, and Medicaid lines of business; applies to providers requesting authorization for members meeting the listed neuroendocrine tumor and select off-label indications.

Policy Summary

Payermhn

PolicyLutetium Lu 177 dotatate (Lutathera) coverage

Policy CodePolicy CP.PHAR.384

Change TypeCriteria and dosing updatespediatric expansionIL step therapy bypass

Effective DateMay 22, 2018

Next Review Date

Key ActionPrior authorization is required; provider must document tumor type, grade (including Ki-67 when applicable), disease extent, and a dosing plan consistent with the updated prescribing information.

SourceLink

POLICY UPDATE CHANGES

Added coverage for well-differentiated, grade 3 NET and carcinoid syndrome per NCCN; revised qualifiers for NETs to include recurrent or unresectable disease.

Revised dosing interval language to allow every 8 week dosing ± 1 week and extended approval duration from 32 to 36 weeks.

Updated NET criteria to reflect pediatric age expansion (patients ≥ 12 years) per 3Q2024 review.

Added option for first-line use in gastrointestinal or pancreatic NET with Ki-67 ≥ 10% and clinically significant tumor burden per NCCN.

Added step therapy bypass for Illinois HIM requests per IL HB 5395.

≥12minimum age for coverage

7.4 GBqmax per-dose activity

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36 wksapproval duration

Coverage Criteria

Initial Therapy - Neuroendocrine Tumors

Covered when ALL of the following are met for Neuroendocrine Tumors:

NET Initial Criteria: 1. Diagnosis of a somatostatin receptor–positive neuroendocrine tumor (one of): (a) gastrointestinal tract or pancreas; (b) lung or thymus (off-label); (c) well-differentiated, grade 3 NET (off-label). 2. Prescribed by or in consultation with an oncologist. 3. Age ≥ 12 years. 4. Disease status: one of (a) recurrent, metastatic, locally advanced, or unresectable; (b) for well-differentiated, grade 3 NETs only: disease is metastatic or locally advanced AND unresectable AND demonstrates favorable biology (e.g., relatively low Ki-67, < 55%); (c) poorly controlled carcinoid syndrome associated with lung or thymus NET. 5. Prior therapy: one of (a) disease progression while on a somatostatin analog (e.g., octreotide, lanreotide) [step therapy]; (b) member has a well-differentiated, grade 3 NET; (c) member has a gastrointestinal or pancreas NET with Ki-67 ≥ 10% and clinically significant tumor burden (allows first-line use per NCCN). 6. Dosing limits: per-dose activity does not exceed 7.4 GBq (200 mCi) every 8 weeks (± 1 week), for up to a total of 4 doses.

Approval duration: 36 weeks (no more than 4 total doses).

Initial Therapy - Pheochromocytoma/Paraganglioma (off-label)

Covered when ALL of the following are met for somatostatin receptor–positive pheochromocytoma/paraganglioma:

Pheo/PGL Initial Criteria: 1. Diagnosis of a somatostatin receptor–positive pheochromocytoma or paraganglioma. 2. Prescribed by or in consultation with an oncologist. 3. Disease is metastatic or locally unresectable. 4. Dosing limits: per-dose activity does not exceed 7.4 GBq (200 mCi) every 8 weeks (± 1 week), for up to a total of 4 doses.

Approval duration: 36 weeks (no more than 4 total doses).

Continuation Therapy

Covered when ALL of the following are met for continuation:

Continuation Criteria: 1. Member is currently receiving Lutathera via the Centene benefit, or documentation supports current receipt for a covered indication. 2. Member is responding positively to therapy. 3. Member has received fewer than 4 doses of Lutathera. 4. If request is for a dose increase, the new per-dose activity does not exceed 7.4 GBq (200 mCi) every 8 weeks (± 1 week), and total doses remain ≤ 4.

Approval duration: 36 weeks (no more than 4 total doses).

Covered indications (updated)

Covered when criteria updated per NCCN and PI are met

NET - general: Well-differentiated NETs (including newly added grade 3) and carcinoid syndrome are covered when disease qualifiers are met (for NETs beyond the specifically named subtypes this includes recurrent or unresectable disease), with dosing and approval duration consistent with the updated prescribing information.

See documentation and prior authorization requirements for specifics

Pheochromocytoma/paraganglioma: Covered when disease is metastatic or locally unresectable (language revised from prior 'metastatic or locally advanced, and unresectable').

First-line option - GI/pancreas NET: First-line use is allowed for gastrointestinal or pancreas NET with Ki-67 ≥ 10% and clinically significant tumor burden per NCCN (added 3Q2025).Ki-67 >= 10%

Added 3Q2025

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation of efficacy and safety consistent with the applicable off‑label use policies: CP.CPA.09 (commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid).

This policy does not list other explicit exclusions in the sections cited; prior references to off‑label guidance have been consolidated and updated to the internal off‑label use reference HIM.PA.154 as noted in the document history and coding implications.

Uses that are non‑FDA approved and that lack sufficient supporting documentation per the applicable off‑label use policies are considered not authorized (not medically necessary) under this policy.

No specific not‑medically‑necessary conditions are listed in the cited portions of the document.

Coding

HCPCS CodesHCPCSCovered

A9513

Lutetium Lu 177, dotatate, therapeutic, 1 millicurie (mCi)

Referenced internal policy codesmixed

HIM.PA.154

Reference for off-label use (replaces HIM.PHAR.21)

State legislative referencesmixed

IL HB 5395

Illinois legislation adding step therapy bypass

Per-dose activity — inv-12: Per-dose activity

Per-dose activity≤ 7.4 GBq (200 mCi) per dose, administered every 8 weeks (± 1 week)

Dosing interval allowanceEach dose may be given within a ±1 week window around the 8‑week schedule

Approval duration contextUp to 4 doses total (approval duration: 36 weeks)

Total doses allowed — inv-13: Total doses allowed

Total doses allowedUp to 4 doses total

Relation to approval durationApproval duration: 36 weeks (no more than 4 total doses)

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required — Prior authorization is required. Provider must demonstrate the member meets the listed medical necessity criteria (diagnosis, prescriber, age, disease status, prior therapy or exception, and dosing limits).

Prior authorization is required for Lutathera for NET indications per policy CP.PHAR.384.
Requests must document diagnosis, prescriber specialty, patient age, tumor grade/differentiation, and disease extent (recurrent, metastatic, locally advanced, or unresectable as specified).

Step Therapy

Step Therapy Requirements

Step therapy applies for most NET indications — generally requires prior progression on a somatostatin analog (e.g., octreotide, lanreotide) before approval of Lutathera, except where policy lists specific exceptions.

Standard requirement: documentation of disease progression while on a somatostatin analog prior to Lutathera.
Exception: well-differentiated, grade 3 NETs (may qualify without prior somatostatin analog progression).

Covered Regimens and Dosing

Regimen	Indication / Notes	Coverage Status
7.4 GBq (200 mCi) IV every 8 weeks (± 1 week) for a total of 4 doses
GEP-NET (and select off-label NETs / pheochromocytoma / paraganglioma) per policy criteria; approval duration: 36 weeks (no more than 4 total doses)
Covered

Regimen	Indication / Notes	Coverage Status
Lutetium Lu 177 dotatate administered every 8 weeks ± 1 week for up to 36 weeks
Dosing interval and duration aligned with updated product label and policy; approval duration up to 36 weeks per revised PI
Covered

Line of Therapy

first-line | second-line

Line of therapy for GI/pancreas NET: Allows as second-line after progression on a somatostatin analog OR as first-line for gastrointestinal or pancreas NET with Ki-67 ≥ 10% and clinically significant tumor burden per NCCN.

Step therapy bypass for Illinois HIM per IL HB 5395.

first-line

First-line - GI/pancreas NET: First-line use allowed when Ki-67 ≥ 10% and clinically significant tumor burden per NCCN.Ki-67 >= 10%

Added 3Q2025

Biomarker and Imaging Requirements

somatostatin receptor expression (imaging) — inv-29

Required imagingSomatostatin receptor expression must be demonstrated by receptor-based imaging

Preferred modality68Ga-dotatate PET/CT (preferred per NCCN)

Alternative modalitySomatostatin receptor scintigraphy

Ki-67 — inv-30

Ki-67 threshold for first-line GI/pancreas NET>= 10% (required for the newly added first-line option)

Grade 3 NET 'favorable biology' noteWell-differentiated, grade 3 NETs may be considered to have favorable biology when Ki-67 < 55%

Policy origin

Background

Lutetium Lu 177 dotatate (Lutathera) is a radiolabeled somatostatin analog indicated for somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors (GEP‑NETs) in patients aged ≥ 12 years. The policy and associated updates reflect NCCN‑aligned coverage for well‑differentiated NETs (including grade 3 NET and carcinoid syndrome where qualifiers are met) and include revised dosing and approval duration consistent with updated prescribing information (dosing every 8 weeks ± 1 week; approval course up to 36 weeks).

Definitions

gastroenteropancreatic neuroendocrine tumor — inv-24

DefinitionGEP-NET = gastroenteropancreatic neuroendocrine tumor

Anatomic scopeIncludes NETs of the gastrointestinal tract and pancreas

Context in policyGEP-NETs are the primary indicated tumor type for Lutathera coverage

somatostatin receptor-based imaging — inv-25

Imaging modalities includedSomatostatin receptor-based imaging includes 68Ga-dotatate PET/CT and somatostatin receptor scintigraphy

Preferred test68Ga-dotatate PET/CT is preferred per NCCN

Purpose

Revision History

2025-3Q (implemented 3Q2025)addedLatest

Added first-line option for gastrointestinal or pancreatic NET with Ki-67 ≥ 10% and clinically significant tumor burden per NCCN; added Illinois step therapy bypass (IL HB 5395).

2024-3Q (implemented 3Q2024)added

Updated NET criteria to reflect pediatric expansion allowing coverage for patients age ≥ 12 years.

2023-04-20revised

Policy Summary

Payermhn

PolicyLutetium Lu 177 dotatate (Lutathera) coverage

Policy CodePolicy CP.PHAR.384

Change TypeCriteria and dosing updatespediatric expansionIL step therapy bypass

Effective DateMay 22, 2018

Next Review Date

SourceLink

On This Page

Continuation constraintContinuation requests permitted only if member has received fewer than 4 doses

Ki-67 index — inv-14: Ki-67 index

Ki-67 index threshold>= 10%

Use caseRequired for first-line option in gastrointestinal or pancreatic NET with clinically significant tumor burden

Reference contextKi-67 ≥ 10% added as a first-line qualifier per 3Q2025 update

First-line use allowed for GI or pancreas NET with Ki-67 ≥ 10% and clinically significant tumor burden per NCCN (added 3Q2025).

Step Therapy

State-specific Step Therapy Modification (Illinois)

Illinois HIM step therapy bypass — Per IL HB 5395, a step therapy bypass was added for Illinois Health Insurance Marketplace (HIM) requests effective 1/1/2026; therefore the somatostatin-analog progression requirement does not apply for IL HIM requests.

IL HIM requests (effective 1/1/2026) are exempt from the somatostatin-analog step therapy requirement.
All other plan lines remain subject to standard step therapy unless another exception in policy applies.

Documentation Required

Required Clinical Documentation

Required clinical documentation — Provider must submit documentation (office chart notes, pathology reports, radiology reports, laboratory results, and prior treatment records) supporting tumor type, differentiation and grade (including Ki-67 where applicable), disease status (recurrent, unresectable, metastatic, or locally advanced), prior therapies and response, and rationale for any exceptions to step therapy.

Document tumor grade and differentiation; for well-differentiated, grade 3 NETs include Ki-67 and evidence of favorable biology when required (e.g., Ki-67 < 55% where noted).
Document disease extent: recurrent, metastatic, locally advanced, or unresectable as applicable.
For continuation requests, document current response to therapy and number of prior Lutathera doses (approval limited to ≤ 4 total doses and dosing not to exceed 7.4 GBq every 8 weeks ±1 week).
If request is for an off‑label indication, include sufficient documentation of efficacy and safety per applicable off‑label use policies (HIM.PA.154, CP.CPA.09, CP.PMN.53).

Denial Risk

Denial Triggers from Criteria Noncompliance

Denial triggers from criteria noncompliance — Requests lacking required documentation or failing to meet policy qualifiers will be denied. Common denial triggers include absent or insufficient documentation of tumor grade/Ki-67, disease status not meeting 'recurrent' or 'unresectable' qualifiers where required, lack of documentation of prior somatostatin-analog progression when step therapy applies, or dosing/approval duration requests that exceed policy limits.

Insufficient supporting documentation (chart notes, imaging, pathology) to confirm criteria.
Tumor does not meet covered NET definitions (e.g., somatostatin receptor–positive NET not documented).
Failure to document prior somatostatin-analog progression when required (unless IL HIM bypass or other exception applies).
Request for > 4 total doses or dosing that exceeds 7.4 GBq every 8 weeks (±1 week).
Off‑label indications without sufficient efficacy/safety documentation per off‑label policies will be denied.

First-line Ki-67 criterion added in 3Q2025 per NCCN guidance

Ki-67 — inv-31

Ki-67 threshold (explicit)>= 10%

ApplicationUsed to determine eligibility for first-line use in gastrointestinal or pancreatic NETs per updated criteria

Documentation requirementClinical documentation should support tumor grade and Ki-67 index when applicable

Demonstrates somatostatin receptor expression required for eligibility

clinically significant tumor burden — inv-26

Clinically significant tumor burden (usage)Required qualifier for allowing first-line Lutathera in gastrointestinal or pancreatic NETs with Ki-67 ≥ 10% per NCCN

Policy incorporationAdded as part of the 3Q2025 update permitting first-line use when both Ki-67 ≥ 10% and clinically significant tumor burden are present

DocumentationClinical documentation should support presence of clinically significant tumor burden when invoking the first-line option

Per 3Q2023 review and P&T approval, added coverage for well-differentiated, grade 3 NET and carcinoid syndrome; revised NET qualifiers to include recurrent or unresectable disease; changed pheochromocytoma/paraganglioma wording to 'metastatic or locally unresectable'; revised dosing language and extended approval duration from 32 to 36 weeks to align with updated prescribing information allowing dosing every 8 weeks ±1 week.