Currentblue cross blue shield - south dakotaPolicy 06.01.38

06.01.38 Lutathera (Lutetium Lu 177 Dotatate)

Defines medical necessity, prior approval, patient eligibility, dosing regimen, investigational exclusions, and clinical/diagnostic requirements for Lutathera (Lutetium Lu 177 Dotatate) in adults and pediatric patients 12 years and older for specified neuroendocrine tumor indications.

Policy Summary

Payerblue cross blue shield - south dakota

Policy06.01.38 Lutathera (Lutetium Lu 177 Dotatate)

Policy CodePolicy 06.01.38

Change TypeRevised (annual review; Nov 2024; reviewed Nov 2025)

Effective DateMay 2018

Next Review Date

Key ActionPrior approval is required before Lutathera administration.

POLICY UPDATE CHANGES

Policy updated with review date November 2025 and revision noted November 2024; pediatric FDA approval in April 2024 noted.

Policy Revised during annual reviews (most recently November 2025).

4Maximum FDA-approved doses

12Min pediatric age (years)

<=20%Ki-67 eligibility threshold

SSTR-PET > liverImaging requirement

RCTs cited for GEP-NETs

922Patients in pooled safety analysis

Coverage Summary

Scope: This policy (Policy #: 06.01.38) defines medical necessity, prior approval, patient eligibility, dosing regimen, investigational exclusions, and clinical/diagnostic requirements for Lutathera (Lutetium Lu 177 Dotatate) in adults and pediatric patients 12 years and older for specified neuroendocrine tumor indications. Status and dates: policy is CURRENT; original effective date May 2018; most recent review November 2025 with revision noted November 2024. Payer actions: Prior approval is required before Lutathera administration. Headline eligibility: covered for adults and pediatric patients aged ≥ 12 years with specified somatostatin receptor–positive neuroendocrine tumor indications (see criteria), with dosing limited to the FDA‑approved regimen of 7.4 GBq (200 mCi) every ~8 weeks for up to 4 doses and organ‑function and imaging requirements documented prior to treatment.

Key thresholds and quick facts

Maximum FDA-approved doses4

Minimum pediatric age (FDA)12 years

Ki-67 eligibility cutoff for GEP-NET<= 20%

SSTR imaging requirementSSTR-PET lesion uptake greater than liver

Typical dosing (recommended)7.4 GBq (200 mCi) every ~8 weeks for up to 4 doses

Specified HCPCS codeA9513 (Lutetium Lu 177, Dotatate, 1 mCi)

Creatinine clearance threshold (NETTER-1 inclusion)>= 50 mL/min (protocol); exclude <40 mL/min in some trials

Medically Necessary and Exclusion Criteria

Medically Necessary Criteria

Lutetium 177 (Lu 177) dotatate treatment is considered medically necessary in adult and pediatric patients 12 years and older in one of the following (Choose one, 1-5):

ANY of the following

1
- 1.a: Low grade (typical) < 2 mitoses/10 HPF and no necrosis; OR evidence of progression; OR Intermediate grade (atypical) 2-10 mitoses/10 HPF and/or foci of necrosis
  See histologic grading criteria
- 1.c: Lutathera will be given as primary therapy
2

Evidence Summaries and Indication Sections

Background: Lutetium Lu 177 dotatate is a peptide receptor radionuclide therapy — a radiolabeled somatostatin analogue that binds somatostatin receptors on neuroendocrine tumors, is internalized, and delivers beta radiation to tumor and neighboring cells. The agent was FDA‑approved for somatostatin receptor‑positive GEP‑NETs in adults in January 2018 and for pediatric patients aged 12 years and older on 04/23/2024. Evidence supporting use includes randomized controlled trials (e.g., NETTER‑1 and NETTER‑2), multicenter registry (SEPTRALU), and the ERASMUS retrospective cohort, which demonstrated improvements in overall response rate, progression‑free survival, and overall survival in selected populations.

Evidence Summaries and Indication Sections

Evidence and conclusions for specific tumor types summarized; not a formal coverage criteria listing in this part:

ALL of the following

GEP-NETs: Gastroenteropancreatic neuroendocrine tumors (GEP‑NETs): Evidence includes 2 open‑label RCTs, a multicenter registry (SEPTRALU), and a retrospective cohort (ERASMUS); RCTs showed statistically significant and clinically meaningful effects on ORR, PFS, and OS versus long‑acting octreotide; retrospective studies consistent with benefit.
See NETTER-1, NETTER-2, ERASMUS, SEPTRALU

Definitions & Clinical Thresholds

Clinical definitions: the policy uses standard clinical definitions including somatostatin receptor–positive (SSTR‑positive) status defined as uptake in measurable lesions greater than the liver on SSTR‑based imaging (SSTR‑PET preferred), Ki‑67‑based grading for well‑differentiated NETs (G1 <3%; G2 3–20%) with an eligibility Ki‑67 threshold of ≤ 20% for many GEP‑NET indications, and histologic mitotic counts for lung/thymus typical (<2 mitoses/10 HPF) versus atypical (2–10 mitoses/10 HPF).

Definitions and thresholds

SSTR-positiveUptake in measurable lesions greater than liver on SSTR-based imaging (SSTR-PET preferred)

Well-differentiated NET grades (Ki-67)G1 (low): Ki-67 <3%; G2 (intermediate): Ki-67 3–20%

Ki-67 eligibility threshold for Lu-177 in GEP-NET criteria<= 20%

Mitotic count (lung/thymus) definitionsTypical (low grade): <2 mitoses/10 HPF and no necrosis; Atypical (intermediate): 2–10 mitoses/10 HPF and/or foci of necrosis

Coding

HCPCS - LutatheraHCPCSCovered

A9513

Lutetium Lu 177, Dotatate, therapeutic 1 millicurie (Lutathera)

CPT - Provider Services (no specific CPT codes provided)CPT

CPT codes not specified in this document part

Place of Servicemixed

Outpatient

Place of Service indicated as Outpatient

Type of Servicemixed

Radiopharmaceuticals Oncology

Type of service classification

Coding (referenced; details in Codes table)mixed

See referenced Codes table for CPT, HCPCS, Revenue, and ICD diagnosis codes; HCPCS A9513 specified for Lutathera

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required before administration of Lutathera (Lutetium Lu 177 Dotatate). Submit the request with supporting documentation (pathology, imaging, and baseline labs) and await approval prior to scheduling treatment. For members already receiving therapy, contact the payer for guidance on continuation requests and required interval documentation.

Prior approval required before first dose and for any requests to exceed FDA‑approved regimen (more than 4 doses).
Include proposed treatment dates and treating facility information in the request.

Documentation Required

Pathology and Imaging Documentation

Provide pathology and imaging documentation with the prior authorization request. Ensure reports clearly document tumor differentiation, Ki‑67, histologic grade, and somatostatin receptor imaging results.

Revision History

2018-01-26FDA approval (adult)

FDA approved Lutathera (lutetium Lu 177 dotatate) for treatment of somatostatin receptor‑positive gastroenteropancreatic neuroendocrine tumors in adults.

2022-05-05Production suspension announced

Novartis announced temporary suspension of Lutathera production at Ivrea, Italy and Millburn, New Jersey due to potential quality issues; supply impact expected and treatment sites were advised to monitor patients closely.

2022-06-30Production resumed

Novartis resumed production and delivery of Lutathera ahead of schedule in early June 2022.

Policy Summary

Payerblue cross blue shield - south dakota

Policy06.01.38 Lutathera (Lutetium Lu 177 Dotatate)

Policy CodePolicy 06.01.38

Change TypeRevised (annual review; Nov 2024; reviewed Nov 2025)

Effective DateMay 2018

Next Review Date

Key ActionPrior approval is required before Lutathera administration.

On This Page

2.a: Disease progression despite somatostatin analog therapy (e.g., octreotide or lanreotide) or molecularly targeted therapy (e.g., everolimus)

2.b: Pathology report documents tumor is well differentiated with a Ki-67 index ≤ 20%<= 20%

See Ki-67 definitions

3.a: Low grade (typical) < 2 mitoses/10 HPF
3.b: No necrosis
3.c: Lutathera will be used as subsequent therapy with progression on first-line therapy (i.e., octreotide or lanreotide)

4.a: No prior treatment with radiolabeled somatostatin analog (i.e., octreotide or lanreotide)

5.a: Symptom progression on octreotide LAR OR lanreotide, OR telotristat

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Investigational / Not Medically Necessary

Lutathera is considered investigational when any of the following apply:

ANY of the following

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B: Pediatric individuals 17 years or less<= 17 years
FDA pediatric approval applies to patients 12 years and older; policy lists pediatric ≤17 as investigational in exclusions
C: When the above medical necessity criteria have not been met
D: For all other indications not listed above

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Regimen and Treatment Duration Constraints

Treatment must follow FDA-approved dosing and limits:

ALL of the following

Dose: Recommended dose: 7.4 GBq (200 mCi) every 8 weeks for a total of 4 doses7.4 GBq every 8 weeks x4
Schedule flexibility: Every 8-week schedule may be changed/delayed for adverse reactions (eg, thrombocytopenia, anemia, renal toxicity, hepatotoxicity)
Total dose limit: Total doses should not exceed 4 doses<= 4 doses

Discontinuation Criteria

Permanently discontinue Lu 177 dotatate if any of the following toxicity thresholds are met:

ANY of the following

Hepatotoxicity: Bilirubinemia > 3 times upper limit of normal (Grade 3 or 4)> 3 x ULN
Hypoalbuminemia < 30 g/L with decreased prothrombin ratio < 70%Albumin < 30 g/L; PT ratio < 70%
Renal toxicity: creatinine clearance < 40 mL/min (Cockcroft-Gault, actual body weight), OR 40% increase in baseline serum creatinine, OR 40% decrease in baseline creatinine clearance (Cockcroft-Gault, actual body weight)CrCl < 40 mL/min OR 40% change

Somatostatin Analogue Timing Considerations

To minimize receptor competition:

ALL of the following

Long-acting stop: Do not administer long-acting somatostatin analogues for 4 to 6 weeks prior to each Lu 177 dotatate treatment4-6 weeks
Short-acting stop: Stop short-acting somatostatin analogues 24 hours before each Lu 177 dotatate treatment24 hours
Resume: Both long-acting and short-acting somatostatin analogues can be resumed 4 to 24 hours after each Lu 177 dotatate treatment4-24 hours post-treatment

Bronchopulmonary or thymus neuroendocrine tumors: Evidence consists of retrospective ERASMUS cohort, bicenter retrospective case series, and registry data; small sample sizes and no RCTs; outcomes variable and FDA judged some ERASMUS data not interpretable for time‑to‑event analyses.

Pheo-Paraganglioma: Pheochromocytoma and paraganglioma: Evidence includes systematic reviews/meta‑analyses of single‑arm studies, multicenter registry (SEPTRALU), and case series; pooled objective response rate for Lu‑177 dotatate ~26% (95% CI 18–35%); disease control rates ~82–85% across studies; comparative evidence vs iobenguane I‑131 limited but some meta‑analysis suggests longer PFS with Lu‑177 dotatate in certain samples.

Safety profile: Analysis of 922 patients (NETTER‑1 + ERASMUS) shows common AEs nausea (65%), vomiting (53%), fatigue (38%); common grade 3–4 events include lymphopenia (44%), elevated gamma‑GT (20%); chronic toxicities in ERASMUS: myelodysplastic syndrome (2%), renal failure (2%), cardiac failure (2%), acute leukemia (1%).

Compact evidence metrics

NETTER-1 median PFS (Lu-177)22.8 months

NETTER-1 ORR (Lu-177)43%

Control (octreotide) median PFS (NETTER-1)8.5 months

SEPTRALU registry (N=522) median PFS (pancreatic/midgut/other)19.8 / 31.3 / 24.3 months; DCR 84.8%, 93.5%, 85.4%

ERASMUS investigator-assessed ORR16% (N=360 GEP‑NET subset), median DOR 35 months

Pooled safety population (NETTER-1 + ERASMUS)N=922; common AEs: nausea 65%, vomiting 53%, fatigue 38%; grade 3–4 lymphopenia 44%; chronic MDS ~2%

Pheochromocytoma/paraganglioma pooled ORR~26% (95% CI 18–35%); pooled DCR ~82–85%

SSTR-PET uptake criterion (trial/policy)

Lesion uptake greater than liver (octreoscan uptake >= liver in NETTER-1)

Creatinine clearance thresholds>=50 mL/min required in NETTER-1; protocol exclusions included <40 mL/min in some trials

Dosing schedules referenced in studiesNETTER-1/NETTER-2: 7.4 GBq (200 mCi) every ~8 weeks x4; ERASMUS: 7.4 GBq every 6–13 weeks up to 4 doses; SEPTRALU: every 8–10 weeks up to 4 doses

Pathology: histologic grade and Ki‑67 proliferation index (must be ≤ 20% for GEP‑NET indication per policy criteria).
Imaging: somatostatin receptor (SSTR) imaging report (SSTR‑PET preferred) demonstrating tumor uptake greater than normal liver.
Include prior and recent cross‑sectional imaging (CT/MRI) showing extent of disease and measurable target lesions.

Documentation Required

Organ Function Documentation

Document baseline organ function prior to each dose and provide monitoring data. Include required laboratory values and note discontinuation thresholds that would delay or hold therapy.

Baseline labs within an appropriate timeframe prior to each dose: CBC with differential, serum creatinine (or eGFR), hepatic panel (AST, ALT, bilirubin), and pregnancy test if applicable.
Documentation that bone marrow, renal and hepatic function meet treating physician criteria for administration; record any prior cytopenias or renal impairment.
Record monitoring plan and any dose delays due to toxicity per regimen guidance (see dosing schedule and discontinuation thresholds).

Billing Rule

Dosing Schedule Adherence

Follow the FDA‑approved dosing schedule for billing and administration. Allowable delays for toxicity should be documented and justified in the medical record.

Dose: 7.4 GBq (200 mCi) per administration.
Schedule: administered approximately every 8 weeks for a total of 4 doses (maximum 4 doses).
Document any treatment delay or omission due to hematologic, renal, or hepatic toxicity and the clinical criteria used to resume therapy.

Documentation Required

Somatostatin Analogue Timing

Document timing of somatostatin analogue (SSA) therapy relative to Lutathera administration. Hold or schedule SSAs per product recommendations to avoid interference with receptor targeting.

Long‑acting SSAs (e.g., octreotide LAR, lanreotide): schedule Lutathera near the end of the long‑acting SSA dosing interval; document dates of last long‑acting SSA injection.
Short‑acting SSAs: hold short‑acting octreotide for at least 24 hours prior to SSTR imaging when needed and per treating physician around Lutathera dosing as clinically indicated.
Record plan for resuming SSAs after Lutathera per clinical protocol.

Documentation Required

Confirm Somatostatin Receptor Expression

Confirm somatostatin receptor expression with appropriate imaging before approval. SSTR‑PET is preferred when available; uptake should exceed liver to support treatment.

Acceptable studies: SSTR‑PET (e.g., Ga‑68 DOTATATE PET) preferred; octreotide SPECT may be acceptable if PET unavailable.
Imaging criterion: tumor uptake greater than normal liver uptake (lesions with uptake > liver required by policy).
Attach the imaging report and representative images if available.

Documentation Required

Baseline Organ Function and Lab Evaluation

Ensure baseline organ function and laboratory evaluation meet criteria before initiating Lutathera and before each subsequent dose. Document results in the medical record and include with any prior authorization or continuation request.

Baseline/pretreatment labs: CBC with differential (platelets, hemoglobin, absolute neutrophil count), serum creatinine/eGFR, liver function tests (AST, ALT, bilirubin), and pregnancy test for women of childbearing potential.
Repeat labs prior to each dose to confirm adequacy for administration; document any abnormalities and management decisions.
Provide documentation of transfusions, growth factor support, or other interventions if used to meet eligibility for subsequent doses.

Documentation Required

Informed Consent and Radiation Precautions

Obtain informed consent that includes radiation precautions and expected post‑treatment safety measures. Document patient education and criteria for release following radioactive treatment.

Informed consent must address benefits, risks including potential acute and long‑term toxicities, and radiation safety precautions for the patient and household contacts.
Document radiation safety instructions provided and criteria for patient release (per institutional and regulatory guidelines).
Record contact information provided for post‑treatment concerns and follow‑up appointment scheduling.

Documentation Required

Monitor for Acute and Long‑Term Toxicities

Monitor patients for acute and long‑term toxicities associated with Lutathera. Provide documentation of surveillance, management of adverse events, and counseling regarding potential late effects.

Common acute/early adverse events to monitor: nausea, vomiting, infusion reactions, transient hematologic toxicities (lymphopenia, thrombocytopenia, anemia), and renal function changes.
Long‑term risks to monitor and document: persistent or delayed cytopenias, myelodysplastic syndrome (MDS) or acute leukemia, progressive renal impairment or renal failure, hepatotoxicity, and radiation‑related effects.
Surveillance schedule: periodic CBC and renal/hepatic panels per treating physician and institutional protocol; document any grade ≥3 toxicities and actions taken (treatment delay, supportive care, referral to hematology/oncology).
Report serious adverse events and long‑term sequelae in the medical record and include relevant information in continuation authorization requests.

Documentation Required

Use Appropriate Codes for Reporting

Use specified reporting codes and appropriate diagnosis/CPT codes when billing for Lutathera. Include the correct HCPCS unit and other applicable procedure codes.

HCPCS: A9513 is specified for Lutathera (report per mCi; A9513 = Lutetium Lu 177 Dotatate, 1 mCi).
Use appropriate CPT, Revenue, and ICD‑10 diagnosis codes for the service and indication as applicable; ensure units billed reflect administered dose (convert GBq to mCi as needed).
Document administration details (dose, date/time, lot number) in the medical record to support billing.

2024-04-23FDA approval (pediatric)

FDA approved lutetium Lu 177 dotatate for pediatric patients 12 years and older with somatostatin receptor‑positive gastroenteropancreatic neuroendocrine tumors.

2024-11-01Policy revision

Policy revised (annual review) in November 2024.

2025-11-01Policy renewalLatest

Policy most recently reviewed November 2025 and action recorded as Policy Renewed.