CurrentMass General Brigham Health PlanPolicy 033

Lutathera (177Lu dotatate) — coverage criteria

This policy governs authorization requirements and medical necessity criteria for Lutathera (177Lu dotatate) for Mass General Brigham Health Plan members (Commercial, Qualified Health Plans, MassHealth ACO, and Medicare Advantage) aged 12 years and older with SSTR-positive gastroenteropancreatic neuroendocrine tumors.

Policy Summary

PayerMass General Brigham Health Plan

PolicyLutathera (177Lu dotatate) — coverage criteria

Policy CodePolicy 033

Key ActionObtain prior authorization and document SSTR-positive GEP‑NET diagnosis; plan for 4 doses given at 8‑week intervals.

Change TypeMaterial coverage addition (Medicare Advantage added)editorial updates

Effective DateAugust 2018 (original); updates through Feb 2025

Next Review Date

SourceLink

POLICY UPDATE CHANGES

Medicare Advantage added to table and statement regarding indications supported by NCCN Compendia added (March 2023).

Reorganized policy sections and added MassHealth variation language in February 2025.

Summary of evidence was added in March 2025 and references updated.

>=12 yearsminimum patient age for coverage per FDA indication

4 dosesstandard approval duration (given at 8-week intervals)

A9513HCPCS code listed for Lutetium Lu 177 dotatate (1 mCi)

~2.6%risk of therapy-related myeloid neoplasm reported in evidence summary

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Coverage and Medical Necessity Criteria

Initial therapy

Covered when ALL of the following are met

Patient population: Member is age >= 12 years and has a documented diagnosis of a gastroenteropancreatic neuroendocrine tumor (GEP-NET)age >= 12

Mass General Brigham Health Plan may authorize coverage for adult or pediatric members aged 12 years and older

Tumor biomarker: Tumor has been shown to be somatostatin receptor (SSTR)-positiveSSTR-positive

Required for coverage; requests for other SSTR-positive indications (eg, lung or thymus) will be reviewed individually

Prescribing provider: Prescribed by an oncologist

Policy specifies oncologist prescriber

Treatment regimen/duration: Plan for 4 doses administered at 8-week intervals4 doses, 8-week intervals

Approval duration specified in policy

Coverage for Lutathera (177Lu dotatate) requires that indications supported by the National Comprehensive Cancer Network (NCCN) meet at least category 2A recommendations. Requests for indications that are not supported by NCCN category 2A or higher may be considered not medically necessary and are subject to denial. Additionally, prior progression on or following Lutathera is an exclusion that will preclude coverage.

Use of Lutathera for tumors other than gastroenteropancreatic neuroendocrine tumors (GEP-NETs) lacks sufficient evidence to be considered medically necessary. Such requests will be reviewed on an individual basis, but indications not supported by NCCN category 2A or higher recommendations may be denied.

Regimen	Indication	Coverage status
Lutathera administered as four doses given at 8‑week intervals	SSTR‑positive gastroenteropancreatic neuroendocrine tumors (GEP‑NETs) in patients age ≥12 years	Covered when all criteria are met (see Coverage Criteria)

Regimen / Use	Indication	Coverage status
Use of Lutathera for NETs of the lung, thymus, or other non‑GEP sites — reviewed on an individual basis	Somatostatin receptor–positive NETs arising outside the gastroenteropancreatic system (e.g., lung or thymus)	Evidence insufficient for routine medical necessity; considered on an individual basis

Biomarker Requirements and Definitions

SSTR (somatostatin receptor) — demonstrated SSTR-positivity required

Required biomarker statusDemonstrated somatostatin receptor (SSTR)–positivity on the tumor is required for coverage of Lutathera.

Patient ageMember is age >= 12 years (FDA indication includes adults and pediatric patients 12 years and older).

Indication scopeCoverage applies to documented gastroenteropancreatic neuroendocrine tumors (GEP-NETs); other SSTR-positive NET sites (e.g., lung or thymus) are reviewed individually.

Prescribing requirementTreatment must be prescribed by an oncologist as specified in the policy.

Treatment plan linked to biomarkerPlan consistent with Lutathera regimen — 4 doses given at 8‑week intervals for eligible SSTR-positive GEP-NET patients.

Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Lutathera for Commercial, Qualified Health Plans, MassHealth, and Medicare Advantage members. Typical authorization is for four doses administered at 8-week intervals.

Affected plans: Commercial, Qualified Health Plans, MassHealth, Medicare Advantage
Typical authorization: 4 doses, given every 8 weeks

Documentation Required

Prescribing and Documentation Requirements

Prescribing requirements: Lutathera must be prescribed by an oncologist. Authorization will only be considered when the member has a documented diagnosis of a gastroenteropancreatic neuroendocrine tumor (GEP-NET) and the tumor has been shown to be somatostatin receptor (SSTR)–positive. Requests for other SSTR-positive indications supported by NCCN Compendia (for example, carcinoid tumors of lung or thymus) will be reviewed individually.

Informational Codes

Informational HCPCS codeHCPCS

A9513

Lutetium Lu 177, dotatate, therapeutic, 1 mCi

Line of Therapy Considerations

Line of therapy

Line of therapy: Policy does not specify a required line of therapy; evidence (NETTER-1 and guideline guidance) supports use for progressive SSTR-positive NETs, including patients enrolled after progression on somatostatin analog therapy

Background and Clinical Context

Peptide receptor radionuclide therapy with 177Lu dotatate (Lutathera) is indicated for patients with somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors and is consistent with FDA labeling and NCCN guidance. The pivotal evidence (for example, NETTER-1) demonstrated improved outcomes for progressive midgut NETs compared with somatostatin analog therapy alone. Use in pediatric patients aged >=12 years is considered reasonable by extrapolation from adult data given limited treatment options and low pediatric incidence. Clinicians and reviewers should also be aware of reported safety signals in the evidence base, including a small but measurable risk of therapy-related myeloid neoplasms.

Policy Revision History

2025-03ad_hoc_reviewLatest

Summary of evidence added and references updated.

2025-02annual_review

Reorganized policy sections and MassHealth variation language added.

2024-02annual_review

Annual review recorded.

Policy Summary

PayerMass General Brigham Health Plan

PolicyLutathera (177Lu dotatate) — coverage criteria

Policy CodePolicy 033

Key ActionObtain prior authorization and document SSTR-positive GEP‑NET diagnosis; plan for 4 doses given at 8‑week intervals.

Change TypeMaterial coverage addition (Medicare Advantage added)editorial updates

Effective DateAugust 2018 (original); updates through Feb 2025

Next Review Date

SourceLink

On This Page

SSTR-positive — definition for tumors demonstrating somatostatin receptor expression

DefinitionTumors demonstrating expression of somatostatin receptors (SSTR-positive).

Clinical relevanceSSTR-positivity is required for Lutathera eligibility and underlies patient selection in pivotal trials (e.g., NETTER-1).

Diagnostic implicationSSTR expression should be documented (typically via functional imaging) to support authorization requests.

Required documentation: diagnosis of GEP-NET and evidence of SSTR-positivity

Prescriber requirement: oncologist

Step Therapy

Step Therapy and Denial Triggers

Step therapy / prior treatment requirements: there is no specified multi-step therapeutic trial sequence in this policy. However, indications not supported by NCCN category 2A or higher, or prior disease progression on or after Lutathera, are exclusionary and may lead to denial. Authorization requests for indications outside GEP-NET (even if SSTR-positive) will be reviewed individually and may require supporting NCCN compendium evidence.

No explicit step-therapy sequence required by policy
Denial triggers: indications lacking NCCN 2A+ support or prior progression on Lutathera

2023-03annual_review

Medicare Advantage added to table and statement regarding indications supported by NCCN Compendia added; Medicare variation language and references updated.

2022-03annual_review

Annual review with exclusions added and references updated.

2021-02annual_review

Annual review; references updated.

2020-02annual_review

Annual review; references updated.

2019-02annual_review

Added requirement that tumor be somatostatin receptor–positive; approval duration revised and reauthorization criteria removed.

2018-08effective_date

Policy originally effective.