CurrentEmblemHealthPolicy MG.MM.PH.45

Lutathera (lutetium Lu 177 dotatate) Intravenous

Clinical coverage criteria and utilization controls for Lutathera (lutetium Lu 177 dotatate) for treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in members of EmblemHealth/ConnectiCare plans.

Policy Summary

PayerEmblemHealth

PolicyLutathera (lutetium Lu 177 dotatate) Intravenous

Policy CodePolicy MG.MM.PH.45

Change TypeMaterial updates to age eligibility and dosing limits

Effective Date

Next Review Date

Key ActionObtain prior authorization and submit clinical evidence showing member meets all criteria; coverage is limited to four doses (200 billable units per dose).

SourceLink

POLICY UPDATE CHANGES

Updated age limitations from 18 years to 12 years of age.

Updated ICD-10 Codes.

Added dosing limits and updated formatting.

4maximum doses approved

200per dose units

12 yrsminimum age

1 yrauthorization length

Coverage Criteria for Lutathera

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Initial therapy

Covered when ALL of the following are met:

GEP-NET diagnosis: Patient has a diagnosis of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs)

Disease status: Disease is unresectable, locally advanced, or metastatic

Receptor confirmation: Somatostatin receptor positivity on all target lesions confirmed via Octreoscan

Prior therapy: Disease progression despite somatostatin analog therapy or molecularly targeted therapy (e.g., everolimus)

Tumor grade: Tumor is well differentiated with Ki-67 index < 20%Ki-67 < 20%

Age: Patient is at least 12 years of age>= 12 years

Performance status: Karnofsky performance-status score of >= 60KPS >= 60

Pregnancy/breastfeeding: Not currently pregnant or breastfeeding; pregnancy status verified if sexually-active female of reproductive potential

Renal function: Creatinine clearance >= 30 mL/min by Cockcroft-Gault>= 30 mL/min

Hepatic function: Total bilirubin < 3 times upper limit of normal< 3x ULN

Provider qualifications: Administered by physicians qualified by specific training and approved by the appropriate governmental agency; prescribed by or in consultation with an oncologist or specialist in GEP-NETs

Somatostatin analog timing: Long-acting somatostatin analogs discontinued at least 4 weeks prior and short-acting octreotide discontinued at least 24 hours prior to initiating Lutathera; long-acting octreotide 30 mg IM given 4–24 hours after each Lutathera dose and every 4 weeks after completion until progression or up to 18 months

Dosing regimen: Lutathera administered at 7.4 GBq IV every 8 weeks for a total of 4 doses7.4 GBq every 8 weeks x4

Regimen	Dose / Frequency	Somatostatin analog scheduling	Coverage status
Lutathera (lutetium Lu 177 dotatate)
7.4 GBq (200 mCi) IV every 8 weeks for a total of 4 doses
Long-acting octreotide 30 mg IM administered 4–24 hours after each Lutathera dose; discontinue long-acting somatostatin analogs at least 4 weeks prior and short-acting octreotide at least 24 hours prior to initiating Lutathera
Covered with criteria

Coverage for Lutathera is limited to a single course of therapy and may not be renewed. Approval will be granted for a maximum of 4 doses only.

Use of Lutathera outside the policy-defined criteria is not supported. This includes requests for more than 4 doses or use without the required confirmations, laboratory results, and documentation specified in the coverage criteria; such requests will not be authorized under this policy.

Applicable Codes and Diagnostic Criteria

Applicable Procedure CodesHCPCSCovered

A9513

Lutetium lu 177, dotatate, therapeutic, 1 millicurie, 1 billable unit

Applicable NDCsNDC

69488-0003-01

Lutathera, 370 MBq/ml, sterile preservative-free and clear, colorless to slightly yellow solution for intravenous use

Applicable ICD-10 Diagnoses (examples)ICD-10Covered

C7A.0	Malignant neuroendocrine tumor / malignant carcinoid tumors (multiple subcodes listed in policy)
C25.0 - C25.9	Malignant neoplasm of pancreas (including endocrine pancreas and other specific pancreatic sites)

inv-07: Ki-67 index — < 20%

Ki-67 indexTumor must be well differentiated with Ki-67 index < 20%

PurposeRequired to confirm tumor proliferation rate for eligibility

Source assessmentKi-67 threshold applied to classify low‑grade/eligible GEP‑NETs

inv-08: Creatinine clearance (Cockcroft-Gault) — >= 30 mL/min

Creatinine clearance (Cockcroft‑Gault)Creatinine clearance >= 30 mL/min by Cockcroft‑Gault required for eligibility

Assessment methodCalculate using Cockcroft‑Gault formula as specified in clinical record

RationaleEnsures sufficient renal function for Lutathera administration

inv-09: Total bilirubin — < 3 times upper limit of normal

Total bilirubinTotal bilirubin must be < 3 times the upper limit of normal (ULN)

Assessment timingLatest laboratory value should be submitted with prior authorization request

RationaleEnsures adequate hepatic function for treatment safety

Provider Actions, Prior Authorization, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Requests for Lutathera (lutetium Lu 177 dotatate) require prior authorization. Coverage is limited to a single course of therapy consisting of a maximum of 4 doses (7.4 GBq; HCPCS A9513 billed as 200 billable units per dose).

HCPCS: A9513 — lutetium Lu 177 dotatate (1 millicurie = 1 billable unit)
Dose limit: 200 billable units (7.4 GBq) every 8 weeks, up to 4 doses
Length of authorization: Coverage provided for 1 year (4 doses only) and may not be renewed

Prior Authorization

Prior Therapy Required

Prior therapy requirement: Clinical documentation must show disease progression despite prior somatostatin analog therapy or molecularly targeted therapy (e.g., everolimus) before Lutathera will be considered.

Documentation Required

Required Clinical Documentation

Required clinical documentation: The treating physician must submit clinical evidence that the patient meets all coverage criteria, including diagnosis of somatostatin receptor–positive GEP‑NET, confirmation of somatostatin receptor positivity on all target lesions (e.g., Octreoscan), prior therapy history, performance status, relevant laboratory results (creatinine clearance, total bilirubin), pregnancy status when applicable, and documentation that administration will occur by appropriately qualified physicians. Requests missing required documentation may not be properly reviewed and may be denied.

Confirmatory imaging: Octreoscan or equivalent demonstrating somatostatin receptor positivity on all target lesions
Prior therapies: evidence of progression despite somatostatin analogs or targeted therapy
Labs: creatinine clearance ≥ 30 mL/min (Cockcroft‑Gault); total bilirubin < 3x ULN
Reproductive status: pregnancy test for females of reproductive potential; not pregnant or breastfeeding
Provider qualification: administration by physicians with appropriate radiopharmaceutical training and authorization

Denial Risk

Insufficient Documentation May Lead to Denial

Insufficient documentation: Requests that lack the necessary clinical information (diagnosis confirmation, receptor positivity, prior therapy documentation, labs, provider qualifications) may be denied due to incomplete documentation and inability to complete medical necessity review.

Denial Risk

Exceeds Dose Limits

Exceeds dose limits: Coverage is limited to a single authorized course of Lutathera of up to 4 doses. Requests that exceed the maximum of 4 doses or seek renewal beyond the single authorized 4‑dose course will be denied.

Maximum: 4 doses total (200 billable units / 7.4 GBq per dose)
Coverage may not be renewed beyond the 4‑dose course

Biomarker and Imaging Requirements

inv-18: Somatostatin receptor status (Octreoscan) — requirement for receptor positivity confirmation

RequirementSomatostatin receptor positivity must be confirmed on all target lesions by Octreoscan

DocumentationImaging report demonstrating receptor‑positive uptake on all target lesions must be submitted

Role in eligibilityConfirmation of receptor status is a core criterion for Lutathera coverage

inv-19: Ki-67 — < 20%

Ki-67 thresholdKi-67 index < 20% required (well‑differentiated tumors)

Clinical useUsed to confirm tumor grade consistent with policy eligibility

Documentation tipInclude pathologic report with Ki‑67 percentage in prior authorization submission

Definitions

inv-16: Lutathera (lutetium Lu 177 dotatate) — definition and recommended dosing summary

DefinitionLutathera (lutetium Lu 177 dotatate) is a radiolabeled somatostatin analog radiopharmaceutical indicated for somatostatin receptor‑positive GEP‑NETs

Recommended dose7.4 GBq (200 mCi) administered IV every 8 weeks for a total of 4 doses

Concomitant somatostatin analogLong‑acting octreotide 30 mg IM administered 4–24 hours after each Lutathera dose and then every 4 weeks after completion until progression or up to 18 months

Administration precautionsMust be administered under control of physicians qualified by training and governmental approval for radiopharmaceuticals

Regimen name	Administration schedule	Post-treatment octreotide plan	Duration / authorization limits
Lutetium Lu 177 dotatate regimen for somatostatin receptor–positive GEP‑NETs
7.4 GBq (200 mCi) IV every 8 weeks for 4 doses
Long-acting octreotide 30 mg IM 4–24 hours after each Lutathera dose; then long-acting octreotide 30 mg IM every 4 weeks thereafter until progression or for up to 18 months
Coverage limited to a single course of 4 doses (prior authorization required); maximum 200 billable HCPCS units per dose