CurrentIndependent HealthPolicy M20180626056

Lutetium Lu 177 Dotatate (Lutathera) and Lutetium Lu 177 Vipivotide Tetraxetan (Pluvicto)

Customize your policy alerts

Sign up for Independent Health Policy M20180626056 alerts

Get alerted when Policy M20180626056 changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Medical necessity and coverage criteria for Lutetium Lu 177 Dotatate (Lutathera) for somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and Lutetium Lu 177 Vipivotide Tetraxetan (Pluvicto) for PSMA-positive metastatic castration-resistant prostate cancer (mCRPC); applies to Independent Health lines of business noted in the policy.

Policy Summary

PayerIndependent Health

PolicyLutetium Lu 177 Dotatate (Lutathera) and Lutetium Lu 177 Vipivotide Tetraxetan (Pluvicto)

Policy CodePolicy M20180626056

Change TypeNo material change

Effective DateAug 1, 2018

Last ReviewJan 1, 2025

Next Review Date

Key ActionObtain pre-authorization and submit documentation including age, imaging confirming receptor/PSMA positivity, prior systemic therapies, and pathology with Ki-67 where required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4 dosesmaximum dosing course covered (1 year)

Up to 6

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

CurrentIndependent HealthPolicy M20180626056

Lutetium Lu 177 Dotatate (Lutathera) and Lutetium Lu 177 Vipivotide Tetraxetan (Pluvicto)

Customize your policy alerts

Sign up for Independent Health Policy M20180626056 alerts

Get alerted when Policy M20180626056 changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Policy Summary

PayerIndependent Health

PolicyLutetium Lu 177 Dotatate (Lutathera) and Lutetium Lu 177 Vipivotide Tetraxetan (Pluvicto)

Policy CodePolicy M20180626056

Change TypeNo material change

Effective DateAug 1, 2018

Last ReviewJan 1, 2025

Next Review Date

Key ActionObtain pre-authorization and submit documentation including age, imaging confirming receptor/PSMA positivity, prior systemic therapies, and pathology with Ki-67 where required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4 dosesmaximum dosing course covered (1 year)

Up to 6

maximum doses covered

≥18minimum patient age for therapies

PSMA > liverPluvicto imaging requirement

Coverage Criteria

Initial therapy - Lutathera

Lutathera is considered medically necessary when ALL of the following are met:

Coverage of Lutathera (lutetium Lu 177 dotatate) is limited to adult patients and is subject to specific eligibility and dosing constraints. The policy requires patients to be ≥18 years of age and not pregnant or breastfeeding, have unresectable, locally advanced or metastatic somatostatin receptor–positive GEP‑NET confirmed by NetSpot (68Ga DOTATATE PET/CT) or Octreoscan (111‑In pentetreotide), show disease progression despite somatostatin analog therapy or molecular targeted therapy (e.g., everolimus), and have a well‑differentiated tumor with a documented Ki‑67 index ≤ 20%. Dosing is IV: 7.4 GBq (200 mCi) every 8 weeks (+1 week) for a total of 4 doses, with coverage provided for 1 year (4 doses) and may NOT be renewed.

Requests that do not meet the policy’s specified indication criteria will be considered not medically necessary. Examples include patients younger than 18 years, absence of the required receptor or PSMA imaging confirmation, lack of required prior systemic therapies, tumor grade outside the required threshold (for Lutathera, Ki‑67 > 20%), or exceeding the allowed total number of doses for the indicated agent. Documentation supporting age, imaging results, prior therapies, and pathology (including Ki‑67 for GEP‑NETs) is necessary to establish medical necessity.

Covered Regimens

Regimen	Indication	Dose & Schedule	Maximum covered doses
Lutathera (Lutetium Lu 177 Dotatate)
Well-differentiated, somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs)
IV: 7.4 GBq (200 mCi) every 8 weeks (±1 week)
4 doses (coverage provided for 1 year); may not be renewed

Regimen	Indication	Dose & Schedule	Maximum covered doses / Renewal criteria
Pluvicto (Lutetium Lu 177 Vipivotide Tetraxetan)
PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) after prior AR pathway inhibition and taxane chemotherapy
IV: 7.4 GBq (200 mCi) every 6 weeks until disease progression or unacceptable toxicity
Up to 6 doses total. Renewal permitted if patient continues to meet indication-specific criteria, has acceptable toxicity, and demonstrates disease stabilization or response (patient has not received >6 doses)

Biomarker and Eligibility Requirements

PSMA (imaging uptake) — threshold

PSMA imaging requirementAt least one tumor lesion with gallium Ga-68 gozetotide uptake greater than normal liver

Applies to therapyRequired for Pluvicto (PSMA-targeted radiopharmaceutical) eligibility

DocumentationImaging report (Ga-68 gozetotide PET) must state lesion uptake relative to normal liver

Somatostatin receptor expression — required tests

Accepted assaysNetSpot (68Ga DOTATATE PET/CT) or Octreoscan (111‑In pentetreotide)

PurposeConfirm somatostatin receptor over‑expression for Lutathera eligibility

Line of Therapy

Coding

Ki-67 index — key value

Key thresholdKi‑67 index ≤ 20%

Clinical useRequired to establish well‑differentiated GEP‑NETs for Lutathera coverage

Required documentationPathology report with Ki‑67 percentage must be provided

Provider Actions

Prior Authorization

Prior Authorization Required

Pre-authorization is required for Lutathera and Pluvicto.

Pre-authorization required prior to initiation of therapy.

Step Therapy

Prior Therapy Requirements

Lutathera: Patient must have had disease progression despite somatostatin analog therapy or molecular targeted therapy (e.g., everolimus). Pluvicto: Patient must have been treated with androgen receptor (AR) pathway inhibition (e.g., abiraterone) and taxane-based chemotherapy (e.g., docetaxel) prior to Pluvicto.

Documentation Required

Required Documentation

Definitions

Castration resistant prostate cancer (CRPC) — definition

DefinitionProstate cancer that progresses despite therapy‑induced castrate levels of testosterone (serum testosterone <50 ng/dL), evidenced by rising PSA, new metastases, or progression of existing metastases

Related termAlso referred to as castration‑resistant prostate cancer (CRPC) or mCRPC when metastatic

RelevanceRequired diagnosis for Pluvicto eligibility

GEP‑NETs — definition

DefinitionGastroenteropancreatic neuroendocrine tumors (GEP‑NETs) are tumors derived from neuroendocrine cells anywhere along the gastrointestinal tract, including foregut, midgut, and hindgut sites

Alternate namesAlso known as carcinoids and islet cell tumors

Background

Lutathera is an FDA‑approved radiolabeled somatostatin analogue used to treat somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors (GEP‑NETs). It binds somatostatin receptors on target lesions and delivers targeted beta radiation; because it is a radiopharmaceutical, appropriate patient selection and handling by qualified providers are required.

Policy Metrics and Limits

4Lutathera maximum doses (1 year)

6Pluvicto maximum doses

18Minimum patient age (years)

PSMA>liverPSMA imaging requirement

Revision History

2018-08-01policy_effective

Policy became effective for Lutathera and Pluvicto (Policy M20180626056).

2019-01-01revision

Policy revised (owner: Medical Management).

2020-01-01revision

Policy revised (owner: Medical Management).

Policy Summary

PayerIndependent Health

PolicyLutetium Lu 177 Dotatate (Lutathera) and Lutetium Lu 177 Vipivotide Tetraxetan (Pluvicto)

Policy CodePolicy M20180626056

Change TypeNo material change

Effective DateAug 1, 2018

Last ReviewJan 1, 2025

Next Review Date

Key ActionObtain pre-authorization and submit documentation including age, imaging confirming receptor/PSMA positivity, prior systemic therapies, and pathology with Ki-67 where required.

SourceLink

On This Page

Imaging report confirming somatostatin receptor–positive disease

Ki-67 index — threshold

Policy thresholdKi‑67 index ≤ 20%

RoleUsed to document well‑differentiated tumor grade for Lutathera eligibility

Source of resultPathology report must document Ki‑67 percentage

Requests must include documentation of the following: patient age; for Lutathera, documentation that the patient is not pregnant or breastfeeding; receptor/PSMA imaging results confirming eligibility (NetSpot 68Ga DOTATATE PET/CT or Octreoscan for Lutathera; Ga-68 PSMA imaging with uptake > normal liver for Pluvicto); pathology report with Ki-67 index for Lutathera when applicable; and records of prior therapies (somatostatin analog or molecular targeted therapy for Lutathera; AR-pathway inhibitor and taxane chemotherapy for Pluvicto).

Age and pregnancy/breastfeeding status (Lutathera).
Imaging confirming receptor or PSMA positivity (NetSpot or Octreoscan for Lutathera; Ga-68 PSMA with liver-comparison for Pluvicto).
Pathology report with Ki-67 index for Lutathera.
Documentation of prior relevant therapies.

Denial Risk

Denial Triggers

Requests that do not meet the medical necessity criteria should be denied. Common denial triggers include: patient under 18 years of age; pregnancy or breastfeeding for Lutathera; lack of documented receptor/PSMA-positive imaging; absence of required prior therapies; tumor not well-differentiated or Ki-67 index >20% for Lutathera; or failure to provide supporting pathology or treatment records.

Age < 18 years.
Pregnant or breastfeeding (Lutathera).
No confirmatory NetSpot/Octreoscan or PSMA imaging showing required uptake.
No documentation of prior somatostatin analog or molecular targeted therapy (Lutathera).
No documentation of prior AR pathway inhibition and taxane chemotherapy (Pluvicto).
Tumor not well-differentiated or Ki-67 > 20% (Lutathera).
Missing pathology or treatment records.

RelevanceSomatostatin receptor–positive GEP‑NETs are the indication for Lutathera

Ki‑67 — definition and policy threshold

Marker descriptionKi‑67 (pKi‑67) is a nuclear protein and established prognostic/predictive indicator reflecting cellular proliferation

Policy thresholdPolicy requires Ki‑67 ≤ 20% to qualify as well‑differentiated for Lutathera

Documentation requiredKi‑67 percentage must be documented in the pathology report

2020-12-01review

Policy reviewed (owner: Health Care Services).

2021-11-01review

Policy reviewed (owner: Health Care Services).

2022-11-01revision

Policy revised (owner: Health Care Services).

2023-11-01revision

Policy revised (owner: Health Care Services).

2024-01-01revision

Policy revised (owner: Health Care Services).

2025-01-01reviewLatest

Policy reviewed (owner: Health Care Services).