CurrentIndependent HealthPolicy M20180626056

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

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Medical necessity criteria, dosing, and pre-authorization requirements for Lutathera for somatostatin receptor-positive GEP-NETs and Pluvicto for PSMA-positive metastatic castration-resistant prostate cancer; applies to Independent Health commercial, Medicare Advantage, MediSource and related lines of business.

Policy Summary

PayerIndependent Health

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

Policy CodePolicy M20180626056

Change TypeNo material changes

Effective DateAug 1, 2018

Last ReviewJan 1, 2026

Next Review Date

Key ActionSubmit pre-authorization with documentation of age, pregnancy status (for Lutathera), pathology including Ki-67, receptor-positive imaging, prior therapies, and toxicity/response assessments.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4approved dosing course for GEP-NETs

6maximum approved doses for mCRPC

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CurrentIndependent HealthPolicy M20180626056

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

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Policy Summary

PayerIndependent Health

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

Policy CodePolicy M20180626056

Change TypeNo material changes

Effective DateAug 1, 2018

Last ReviewJan 1, 2026

Next Review Date

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4approved dosing course for GEP-NETs

6maximum approved doses for mCRPC

>=18minimum patient age

Pre-authauthorization requirement

<=20%Ki-67 requirement

Coverage Criteria

inv-01: Lutathera - Initial Therapy

Covered when ALL of the following are met

Lutathera eligibility: Patient is at least 18 years of age and not pregnant or breastfeeding; AND the patient has unresectable, locally advanced or metastatic somatostatin receptor-positive GEP-NET confirmed by NetSpot (68Ga DOTATATE PET/CT) or Octreoscan (111-In pentetreotide); AND disease progression despite somatostatin analog therapy or molecular targeted therapy (e.g., everolimus); AND appropriate imaging documents somatostatin receptor over-expression in target lesions; AND tumor is well-differentiated with Ki-67 index ≤ 20% as documented in pathology reportIV 7.4 GBq (200 mCi) every 8 weeks ±1 week for a total of 4 doses

Coverage provided for 1 year (4 doses) and may NOT be renewed.

inv-02: Pluvicto - Initial and Renewal Therapy

Covered when ALL of the following are met

Pluvicto eligibility: Patient is at least 18 years of age; AND has metastatic castration-resistant prostate cancer (mCRPC); AND has PSMA-positive disease defined as at least one tumor lesion with Ga-68 gozetotide uptake greater than normal liver; AND has been treated with androgen receptor (AR) pathway inhibition (e.g., abiraterone) and taxane-based chemotherapy (e.g., docetaxel)IV 7.4 GBq (200 mCi) every 6 weeks until progression or unacceptable toxicity, up to 6 doses total

Renewal requires continued meeting of criteria, absence of unacceptable toxicity, demonstration of disease response (stabilization or partial response), and total doses not exceeding 6.

Lutathera is contraindicated in patients who are pregnant or breastfeeding. The policy requires that the patient be at least 18 years of age and explicitly states the patient must be “not pregnant or breastfeeding” as a condition of coverage for Lutathera for somatostatin receptor–positive GEP‑NETs.

Use of these Lu‑177 radiopharmaceuticals beyond the policy-specified maximum total doses or without the required receptor‑positive diagnostic imaging is considered not medically necessary. Specifically, Lutathera coverage is limited to a total of 4 doses (IV 7.4 GBq/200 mCi every 8 weeks ±1 week) and may not be renewed beyond that year-long course, and Pluvicto is limited to a total of up to 6 doses (IV 7.4 GBq/200 mCi every 6 weeks) or until progression/unacceptable toxicity. Additionally, coverage requires documented receptor‑positive imaging: somatostatin receptor confirmation (NetSpot 68Ga DOTATATE PET/CT or Octreoscan) for Lutathera and Ga‑68 PSMA PET demonstrating at least one lesion with uptake greater than normal liver for Pluvicto.

Provider Actions and Requirements

Prior Authorization

Pre-authorization required

Pre-authorization is required for these radiopharmaceutical therapies.

Step Therapy

Verify required prior therapies

Confirm prior systemic therapies before authorization: Lutathera requires disease progression despite somatostatin analog therapy or molecular targeted therapy (e.g., everolimus); Pluvicto requires prior treatment with an androgen receptor (AR) pathway inhibitor (e.g., abiraterone) and taxane-based chemotherapy (e.g., docetaxel).

Lutathera: documentation that disease progressed on somatostatin analog therapy or molecular targeted therapy.
Pluvicto: documentation of prior AR pathway inhibition and taxane chemotherapy.

Covered Regimens and Dosing

Regimen	Indication	Dosing / Schedule	Coverage status
IV Lutathera 7.4 GBq (200 mCi)	Well-differentiated somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs)	Every 8 weeks (±1 week) for a total of 4 doses; coverage provided for 1 year (4 doses) and may NOT be renewed.	Covered with criteria

Regimen	Indication	Dosing / Schedule	Coverage status
IV Pluvicto 7.4 GBq (200 mCi)	PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) after prior AR pathway inhibition and taxane-based chemotherapy	Every 6 weeks until disease progression or unacceptable toxicity, for up to 6 doses total.	Covered with criteria

Biomarker and Imaging Requirements

Somatostatin receptor expression (imaging)

Required imaging modalitiesSomatostatin receptor expression must be confirmed by NetSpot (68Ga DOTATATE PET/CT) or Octreoscan (111-In pentetreotide).

Indication tied to imagingImaging confirmation is required to document over-expression of somatostatin receptors in target lesions for Lutathera eligibility.

Age/pregnancy notePatient must be at least 18 years of age and not pregnant or breastfeeding when imaging-confirmed disease is used for treatment decision-making.

Documentation requirementPathology and imaging reports demonstrating somatostatin receptor positivity must be submitted with authorization requests.

PSMA (Ga-68 gozetotide PET)

Positivity definition

Line of Therapy / Indication Context

inv-14: salvage — 1 top-level node (line-of-therapy detail for Pluvicto)

Pluvicto line requirement: Prior treatment with an androgen receptor (AR) pathway inhibitor and taxane-based chemotherapy is required

Policy aligns with use after AR-directed therapy and chemotherapy (salvage line).

inv-15: salvage — 1 top-level node (line-of-therapy detail for Lutathera)

Lutathera prior therapy context: Patient has had disease progression despite somatostatin analog therapy or molecular targeted therapy (e.g., everolimus)

Used after progression on these therapies (salvage line).

Definitions

Castration resistant prostate cancer (CRPC) — definition and diagnostic criteria

Core definitionCastration resistant prostate cancer (CRPC) occurs when prostate cancer progresses despite castrate levels of serum testosterone (<50 ng/dL).

Clinical evidence of progressionProgression may be demonstrated by rising PSA, new metastases, or progression of existing metastases while on androgen deprivation therapy (ADT).

Therapy context for PluvictoPluvicto is indicated for mCRPC patients who have received prior AR pathway inhibition and taxane-based chemotherapy; CRPC status is required for eligibility.

Gastroenteropancreatic neuroendocrine tumors (GEP-NETs)

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

Typical characteristics

Background

Lutathera is a radiolabeled somatostatin analog (Lutetium‑177) approved for adult patients with unresectable, locally advanced, or metastatic somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors (GEP‑NETs). The agent delivers beta‑emitting Lu‑177 to tumor cells expressing somatostatin receptors and is administered intravenously at 7.4 GBq (200 mCi) every 8 weeks ±1 week for a total of 4 doses. Treatment is intended for well‑differentiated tumors with a documented Ki‑67 index ≤ 20% and after progression on somatostatin analog therapy or molecular targeted therapy.

Policy Summary

PayerIndependent Health

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

Policy CodePolicy M20180626056

Change TypeNo material changes

Effective DateAug 1, 2018

Last ReviewJan 1, 2026

Next Review Date

SourceLink

On This Page

Documentation Required

Required clinical documentation to support authorization

Submit clinical documentation with the initial authorization request and for renewals as specified: include patient age (≥18), pregnancy/breastfeeding status for Lutathera, pathology report with Ki-67 for GEP‑NETs, imaging confirming receptor positivity (NetSpot/68Ga DOTATATE PET or Octreoscan for Lutathera; Ga‑68 PSMA PET showing lesion uptake > normal liver for Pluvicto), prior therapies received, and toxicity/response assessments for renewals.

Age ≥ 18 documented.
For Lutathera: documentation that patient is not pregnant or breastfeeding and pathology showing Ki-67 ≤ 20%.
Imaging: NetSpot (68Ga DOTATATE PET/CT) or Octreoscan (111-In pentetreotide) for somatostatin receptor positivity; Ga‑68 gozetotide PSMA PET with at least one lesion uptake greater than normal liver for Pluvicto.
For Pluvicto renewals: absence of unacceptable toxicity and evidence of disease response (stabilization or partial response).

Billing Rule

Adhere to dose limits and monitor toxicity

Do not exceed the policy-specified maximum doses and document toxicity; exceeding dose limits or evidence of unacceptable toxicity may result in non-coverage or denial.

Lutathera dosing limit: IV 7.4 GBq (200 mCi) every 8 weeks (±1 week) for a total of 4 doses; coverage is provided for 1 year (4 doses) and may NOT be renewed.
Pluvicto dosing limit: IV 7.4 GBq (200 mCi) every 6 weeks until progression or unacceptable toxicity for up to 6 doses total.
Unacceptable toxicities (examples for Pluvicto): myelosuppression (anemia, thrombocytopenia, leukopenia, neutropenia), severe renal toxicity—document and exclude if present for renewal.

Denial Risk

Denial risk if biomarker or imaging confirmation is missing

If required receptor-positive imaging or pathology is missing, the request may be denied; obtain and submit definitive diagnostic confirmation before authorization.

Lutathera: must document somatostatin receptor-positive disease by NetSpot (68Ga DOTATATE PET/CT) or Octreoscan (111-In pentetreotide) and pathology with Ki-67 ≤ 20%.
Pluvicto: must document PSMA-positive disease with Ga‑68 gozetotide PET showing at least one lesion with uptake greater than normal liver.

PSMA-positive disease is defined as at least one tumor lesion with gallium Ga-68 gozetotide uptake greater than normal liver.

Indication linkThis imaging criterion is required for Pluvicto eligibility in metastatic castration-resistant prostate cancer (mCRPC).

Documentation requirementSubmit Ga-68 PSMA PET/CT report showing lesion uptake relative to liver for prior authorization and renewal reviews.

Renewal considerationContinued imaging or clinical evidence of response and absence of unacceptable toxicity are required for renewal; imaging supports disease response assessment.

GEP-NETs may be well-differentiated and are assessed for somatostatin receptor expression and proliferation index (Ki-67) to guide Lutathera eligibility.

Indication for LutatheraLutathera is FDA-approved for somatostatin receptor-positive, unresectable, locally advanced or metastatic GEP-NETs in adults.

Ki-67 (proliferation marker)

Marker descriptionKi-67 (pKi67) is a nuclear proliferation marker used as a prognostic and predictive indicator on pathology specimens.

Policy threshold for LutatheraEligibility for Lutathera requires a documented Ki-67 index of 20% or less (≤ 20%).

Documentation requirementKi-67 index must be documented in the pathology report submitted with the authorization request.