CurrentHealth-New-EnglandPolicy UM700POL

Lutetium Therapeutic Radiopharmaceuticals - Medical Policy

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This policy governs medical necessity and prior authorization for Lutetium-177 dotatate (Lutathera) and Lutetium-177 vipivotide tetraxetan (Pluvicto) for specified neuroendocrine tumors and metastatic castration-resistant prostate cancer. It applies to Health New England commercial, Medicare, and Medicaid lines of business.

Policy Summary

PayerHealth-New-England

PolicyLutetium Therapeutic Radiopharmaceuticals - Medical Policy

Policy CodePolicy UM700POL

Change TypeRevised

Effective DateFebruary 1, 2027

Last ReviewSep 1, 2026

Next Review DateNot specified

Key ActionSubmit clinical evidence showing that the patient meets the applicable medical necessity criteria when requesting prior authorization.

SourceLink

POLICY UPDATE CHANGES

The Lutathera criterion for tumor differentiation and Ki-67 index was revised to cover well-differentiated G1 or G2 neuroendocrine tumors with Ki-67 less than 20% or well-differentiated G3 tumors with Ki-67 less than 55%.

Definitions, including well-differentiated neuroendocrine tumors and Ki-67 index, were updated.

Medicare coverage is directed to LCD L37205 for Lutetium-177 dotatate and Lutetium-177 vipivotide tetraxetan.

2Lutetium radiopharmaceuticals addressed

4Required Lutathera clinical criteria

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CurrentHealth-New-EnglandPolicy UM700POL

Lutetium Therapeutic Radiopharmaceuticals - Medical Policy

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Policy Summary

PayerHealth-New-England

PolicyLutetium Therapeutic Radiopharmaceuticals - Medical Policy

Policy CodePolicy UM700POL

Change TypeRevised

Effective DateFebruary 1, 2027

Last ReviewSep 1, 2026

Next Review DateNot specified

Key ActionSubmit clinical evidence showing that the patient meets the applicable medical necessity criteria when requesting prior authorization.

SourceLink

POLICY UPDATE CHANGES

Definitions, including well-differentiated neuroendocrine tumors and Ki-67 index, were updated.

Medicare coverage is directed to LCD L37205 for Lutetium-177 dotatate and Lutetium-177 vipivotide tetraxetan.

2Lutetium radiopharmaceuticals addressed

4Required Lutathera clinical criteria

Required Pluvicto clinical criteria

2HCPCS codes requiring prior authorization

3Applicable lines of business

Medical Necessity Criteria

Lutathera initial therapy

Covered as medically necessary when ALL of the following are met.

Lutathera medical necessity

Disease extent: Member has unresectable, locally advanced, or metastatic disease
Prior therapy and progression: Member has had disease progression despite somatostatin analog therapy or molecularly targeted therapy such as everolimus
Receptor imaging: An appropriate imaging study documents over-expression of somatostatin receptors by the target lesions
Tumor differentiation and Ki-67
- G1 or G2 pathway: Well-differentiated G1 or G2 neuroendocrine tumorKi-67 less than 20%
- G3 pathway: Well-differentiated G3 neuroendocrine tumorKi-67 less than 55%

Pluvicto initial therapy

Covered as medically necessary when ALL of the following are met.

Pluvicto medical necessity

Disease extent: Member has unresectable metastatic disease
PSMA imaging: Patient has a PSMA-positive gallium-68-labeled PSMA-11 positron-emission tomographic-computed tomographic scan
Androgen therapy progression: Patient has disease progression despite advanced androgen therapy, such as at least one androgen-receptor-pathway inhibitor, demonstrated by PSA progressionPSA progression after at least four weeks
Taxane progression:

Lutathera experimental and investigational use

Not covered under the stated medical necessity criteria.

Lutathera experimental or investigational use: Treatment is experimental and investigational when the Lutathera criteria are not met or treatment exceeds the FDA-approved regimen

Pluvicto experimental and investigational use

Not covered under the stated medical necessity criteria.

Pluvicto experimental or investigational use: Treatment is experimental and investigational when the Pluvicto criteria are not met or treatment exceeds the FDA-approved regimen

Lutathera is not medically necessary for non-FDA-approved indications, including pheochromocytomas and paragangliomas.

Pluvicto is not medically necessary for non-FDA-approved indications. Coverage is limited to the policy’s criteria for adult patients with PSMA-positive metastatic castration-resistant prostate cancer.

Lutathera is not medically necessary when the applicable medical necessity criteria are not met, when treatment exceeds the FDA-approved regimen, or when it is used for a non-FDA-approved indication.

Pluvicto is not medically necessary when the applicable medical necessity criteria are not met, when treatment exceeds the FDA-approved regimen, or when it is used for a non-FDA-approved indication.

Coding and Clinical Thresholds

HCPCS codes requiring prior authorizationHCPCS

A9513

Lutetium Lu 177, dotatate, therapeutic, 1 mCi

HCPCS codes requiring prior authorizationHCPCS

A9607

Lutetium LU 177 Vipivotide Tetraxetan, therapeutic, 1 Millicurie

Lutathera Ki-67 Threshold — G1/G2

ThresholdLess than 20% Ki-67

Applies toWell-differentiated Grade 1 or Grade 2 neuroendocrine tumors

CriterionTumor must meet the well-differentiated G1 or G2 pathway for Lutathera coverage

Lutathera Ki-67 Threshold — G3

ThresholdLess than 55% Ki-67

Applies toWell-differentiated Grade 3 neuroendocrine tumors

Criterion

Authorization and Submission Requirements

Prior Authorization

Prior Authorization Required: Lutathera

Obtain prior authorization before billing Lutathera (lutetium Lu 177 dotatate).

HCPCS A9513 — Lutetium Lu 177 dotatate, therapeutic, 1 mCi.

Prior Authorization

Prior Authorization Required: Pluvicto

Obtain prior authorization before billing Pluvicto (lutetium Lu 177 vipivotide tetraxetan).

HCPCS A9607 — Lutetium Lu 177 vipivotide tetraxetan, therapeutic, 1 millicurie.

Step Therapy

Prior Therapy Required Before Lutathera

Before requesting Lutathera, document disease progression despite prior somatostatin analog therapy or molecularly targeted therapy, such as everolimus.

Therapeutic Context

Lutetium therapeutic radiopharmaceuticals are targeted systemic radiotherapies in which a radioactive isotope is linked to a molecule that targets specific receptors on tumor cells. Lutetium-177 dotatate (Lutathera) targets somatostatin receptors in selected neuroendocrine tumors, while lutetium-177 vipivotide tetraxetan (Pluvicto) targets PSMA-positive metastatic castration-resistant prostate cancer. The policy focuses on receptor-positive disease, progression after specified systemic therapies, and appropriate disease extent.

Clinical Definitions

PSMA

Full termProstate-specific membrane antigen

DescriptionA protein found mainly on prostate cancer cells

Also known asFolate hydrolase I and glutamate carboxypeptidase II

MCRPC

AbbreviationMCRPC

Full termMetastatic castration-resistant prostate cancer

Policy relevanceThe cancer type addressed by Pluvicto coverage criteria

Policy Summary

PayerHealth-New-England

PolicyLutetium Therapeutic Radiopharmaceuticals - Medical Policy

Policy CodePolicy UM700POL

Change TypeRevised

Effective DateFebruary 1, 2027

Last ReviewSep 1, 2026

Next Review DateNot specified

Key ActionSubmit clinical evidence showing that the patient meets the applicable medical necessity criteria when requesting prior authorization.

SourceLink

On This Page

Patient has disease progression after at least one taxane regimen

At least one taxane regimen

Tumor must meet the well-differentiated G3 pathway for Lutathera coverage

PSA Progression Requirement

Progression measureProstate-specific antigen (PSA) progression

Therapy contextAdvanced androgen therapy, including at least one androgen-receptor-pathway inhibitor

TimingAfter at least four weeks

Applicable to adult patients with somatostatin receptor-positive gastroenteropancreatic, bronchopulmonary, or thymus neuroendocrine tumors.
Include the prior therapy and evidence demonstrating progression.

Step Therapy

Prior Therapy Required Before Pluvicto

Before requesting Pluvicto, document disease progression despite advanced androgen therapy, such as at least one androgen-receptor-pathway inhibitor, and after at least one taxane regimen.

PSA progression after advanced androgen therapy must be demonstrated after at least four weeks.
Document the prior taxane regimen and evidence of progression.

Documentation Required

Submit Clinical Evidence for Prior Authorization

Submit clinical evidence with every prior authorization request so Health New England can verify that the applicable medical-necessity criteria are met. Without supporting documentation and information, the request cannot be properly reviewed.

For Lutathera, submit evidence of unresectable, locally advanced or metastatic disease; progression despite somatostatin analog or molecularly targeted therapy; appropriate imaging documenting somatostatin-receptor overexpression; and eligible tumor differentiation and Ki-67 findings.
For Pluvicto, submit evidence of unresectable metastatic disease; a PSMA-positive gallium-68-labeled PSMA-11 PET/CT scan; progression despite advanced androgen therapy; and progression after at least one taxane regimen.
Include relevant clinical records, imaging reports, pathology or Ki-67 results, treatment history, and documentation of progression.

Denial Risk

Lutathera Denial Risk

Lutathera may be denied as experimental and investigational or not medically necessary when the required criteria are not met, when treatment exceeds the FDA-approved regimen, or when used for a non-FDA-approved indication.

Examples of non-FDA-approved indications include pheochromocytomas and paragangliomas.
Confirm all coverage criteria and regimen limits before submitting the request.

Denial Risk

Pluvicto Denial Risk

Pluvicto may be denied as experimental and investigational or not medically necessary when the required criteria are not met, when treatment exceeds the FDA-approved regimen, or when used for a non-FDA-approved indication.

Confirm PSMA-positive metastatic castration-resistant prostate cancer and all required prior therapies before submitting the request.
Confirm that the requested treatment is within the FDA-approved regimen.

Somatostatin Receptor Positive

DescriptionA protein on the surface of cells that binds to the hormone somatostatin

Cancer associationMay be present in higher-than-normal amounts on some types of cancer cells

Clinical useReceptor amount in tumor tissue may help diagnose cancer and plan treatment

Neuroendocrine Tumors

OriginTumors that form from cells that release hormones into the blood in response to a signal from the nervous system

BehaviorMay be benign or malignant

Hormone productionMay release higher-than-normal amounts of hormones and cause symptoms

Gastroenteropancreatic Neuroendocrine Tumors

DescriptionRare tumors that can form in the pancreas or gastrointestinal tract

SitesStomach, appendix, small intestine, rectum, or colon

BehaviorMay be malignant or benign and may secrete extra hormones or other substances

Peptide Receptor Radionuclide Therapy

Therapy typeA type of targeted radiation therapy used to treat certain types of neuroendocrine tumors

MechanismA radioactive chemical is linked to a peptide that targets cancer cells

Cell targetingThe radioactive peptide binds to a specific receptor found on some cancer cells

Well-Differentiated Neuroendocrine Tumors

DescriptionA neuroendocrine neoplasm with well-differentiated histology

Grade 1Ki-67 less than 3%

Grade 2Ki-67 from 3% to 20%

Grade 3Ki-67 greater than 20%

Ki-67 Index

DefinitionThe percentage of tumor cells that stain positive for the Ki-67 protein on immunohistochemistry

InterpretationA higher Ki-67 index indicates a faster-growing tumor

Clinical implicationA higher index typically indicates a more aggressive tumor