CurrentViva HealthPolicy N/A

Somatostatin Analogs - Lutathera Utilization Management Medical Policy

Defines prior authorization criteria, dosing limits, authorized prescribers, covered indications (FDA-approved NETs and supported use for pheochromocytoma/paraganglioma), exclusions, and approval durations for Lutathera medical benefit coverage.

Policy Summary

PayerViva Health

PolicySomatostatin Analogs - Lutathera Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeAge clarif.; added first-line option (Ki‑67 ≥10% + tumor burden)

Effective Date

Next Review Date

Key ActionPrior Authorization is recommended; approve for 1 year when criteria and dosing are met and ensure Lutathera is prescribed by or in consultation with an appropriate specialist.

POLICY UPDATE CHANGES

Age requirement for NETs was changed from ≥ 18 to ≥ 12 years of age (noted in history).

Option added to approve as first-line therapy if Ki-67 index ≥ 10% and clinically significant tumor burden.

Annual revision noted with 'No criteria changes.' for 04/23/2025 review.

2Covered Indication Groups (FDA-approved NETs; Pheochromocytoma/Paraganglioma supported)

4Maximum Doses

7.4 GBqPer-dose Amount

8 weeksMinimum Dosing Interval

Coverage Summary

Coverage stance: covered with criteria for Lutathera (lutetium Lu 177 dotatate) medical benefit use. Scope includes FDA‑approved neuroendocrine tumors (NETs) of the gastroenteropancreatic tract, lung, thymus, and pancreas and supported use for pheochromocytoma/paraganglioma. Effective/status: policy review date 04/23/2025; status CURRENT.

Dosage & Limits

Dose per administration7.4 GBq [200 mCi]

Dosing intervalNo more frequently than once every 8 weeks

Maximum number of dosesMaximum of 4 doses

Ki67 index>= 10%

Initial Therapy Criteria — FDA-Approved NETs

Somatostatin receptor-positive imaging: Imaging demonstrating somatostatin receptor expression such as Gallium-68 dotatate PET/CT or PET/MRI or somatostatin receptor scintigraphy.

Clinically significant tumor burden: Examples include inoperable tumor, large tumor size, location of tumor, or presence of symptoms.

Initial Therapy Criteria — Other Uses with Supportive Evidence

Other Uses with Supportive Evidence — Pheochromocytoma and Paraganglioma

Approve for 1 year if the patient meets ALL of the following (A, B, C, and D):

ALL of the following

A: Patient is ≥ 18 years of age
B: Patient has locally unresectable disease or distant metastases
C: Patient has somatostatin receptor-positive tumor as detected by somatostatin receptor-based imaging
Examples include Gallium-68 dotatate PET/CT or PET/MRI or somatostatin receptor scintigraphy

Provider Actions

Prior Authorization

Prior authorization required

Prior Authorization is recommended for medical benefit coverage of Lutathera. Approval is recommended for those who meet the Criteria and Dosing. All approvals are provided for the durations specified. Approvals are for 1 year when the criteria are met.

Documentation Required

Imaging documentation required

Document somatostatin receptor-positive status by somatostatin receptor-based imaging. Examples of acceptable imaging include Gallium-68 dotatate PET/CT, Gallium-68 dotatate PET/MRI, or somatostatin receptor scintigraphy.

Applicable Codes

Drug productNDC

No codes listed

Clinical Evidence & Guidelines

Key clinical evidence sources: Prescribing information: Lutathera intravenous infusion, Advanced Accelerator Applications USA; November 2024 (prescribing information).

Guideline: NCCN Neuroendocrine and Adrenal Tumors Clinical Practice Guidelines v1.2025 (March 27, 2025), which supports use in additional NET sites including bronchopulmonary and thymus NETs when somatostatin receptor‑positive and criteria are met.

Background

Indication summary: Lutathera is a radiolabeled somatostatin analog indicated for somatostatin receptor‑positive gastroenteropancreatic NETs in patients ≥ 12 years and may be considered for bronchopulmonary and thymus NETs per NCCN.

Standard regimen: 7.4 GBq [200 mCi] administered intravenously once every 8 weeks for a total of 4 doses (no more frequently than every 8 weeks; maximum of 4 doses).

Use requires specialized monitoring and should be prescribed by or in consultation with a specialist (oncologist, radiologist, or endocrinologist) because of the specialized skills required for evaluation, diagnosis, and monitoring.

Revision History

05/15/2024material_change

Age requirement for NETs changed from ≥ 18 to ≥ 12 years of age. (History notes early annual revision reflecting this change.)

Annual revision (added per guideline) 2024 - noted in history; reflected in policy as of 04/23/2025material_change

Added option to approve Lutathera as first-line therapy when the patient has Ki-67 index ≥ 10% and a clinically significant tumor burden. This option was added based on the NCCN guideline update and is reflected in the criteria that allow first-line use when Ki67 ≥ 10% and clinically significant tumor burden.

04/23/2025revisionLatest

Policy Summary

PayerViva Health

PolicySomatostatin Analogs - Lutathera Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeAge clarif.; added first-line option (Ki‑67 ≥10% + tumor burden)

Effective Date

Next Review Date

Key ActionPrior Authorization is recommended; approve for 1 year when criteria and dosing are met and ensure Lutathera is prescribed by or in consultation with an appropriate specialist.

On This Page

D: Lutathera is prescribed by or in consultation with an oncologist or radiologist

Evidence supporting non‑FDA uses includes the Lutathera prescribing information (Advanced Accelerator Applications USA; November 2024) and the NCCN Neuroendocrine and Adrenal Tumors Clinical Practice Guidelines v1.2025 (March 27, 2025).

The NCCN guideline notes consideration of Lutathera for bronchopulmonary and thymus NETs when somatostatin receptor‑positive and with disease progression on octreotide or lanreotide.

Documentation Required

Prescriber specialty requirement

Lutathera must be prescribed by or in consultation with a physician who specializes in the condition being treated. For NETs this includes an oncologist, radiologist, or endocrinologist. For pheochromocytoma and paraganglioma this includes an oncologist or radiologist.

Billing Rule

Dose exceptions handled case-by-case

Requests for doses outside the established dosing documented in this policy will be considered on a case-by-case basis by a clinician (e.g., Medical Director or Pharmacist).

Annual revision noted: 'No criteria changes.' (policy review date 04/23/2025).