Medical Policy
Effective Date:03/01/2019 Title:Lutathera (lutetium Lu 177 dotatate)
Revision Date:10/01/2023 Document:BI602:00
CPT Code(s):A9513
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Lutathera (lutetium Lu 177 dotatate) requires prior authorization.

2)    Lutathera is used in the treatment of specific gastroenteropancreatic neuroendocrine tumors (NETs).
Medical Statement

Lutathera (lutetium Lu 177 dotatate) is considered medically necessary for members meeting the following criteria:

 

1)    Neuroendocrine Tumors (must meet all):

a.    Diagnosis of a somatostatin receptor-positive NET of one of the following origins (i or ii):

                                          i.    Gastrointestinal tract or pancreas;

                                        ii.    Lung or thymus (off-label)

b.    Prescribed by or in consultation with an oncologist;

c.    Age > 18 years of age;

d.    Disease is metastatic or locally advanced, and unresectable;

e.    Member experienced disease progression while on a long-acting somatostatin analog (e.g. octreotide, lanreotide);

 

f.     Dose does not exceed 7.4GBq (200mCi) every 8 weeks, up to a total of 4 doses.

Approval duration: 32 weeks (no more than 4 total doses)

 

2)    Pheochromocytoma/Paraganglioma (off-label) (must meet all):

a.    Diagnosis of somatostatin receptor-positive pheochromocytoma/paraganglioma;

b.    Prescribed by or in consultation with an oncologist;

c.    Disease is metastatic or locally advanced, and unresectable;

d.    Dose does not exceed 7.4GBq (200 mCi) every 8 weeks, up to a total of 4 doses.

Approval duration: 32 weeks (no more than 4 total doses).

 

Codes Used In This BI:

 

A9513 – Lutetium Lu 177, dotatate, therapeutic, 1 millicurie
Limits

Lutathera is limited to no more than 4 total doses.
Reference

1. Lutathera Prescribing Information. Millburn, NJ: Advanced Accelerator Applications USA, Inc.; June 2021. Available at: https://www.lutathera.com. Accessed May 3, 2022.

 

2. National Comprehensive Cancer Network. Neuroendocrine and Adrenal Tumors. Version 4.2021. Available at: https://www.nccn.org/professionals/physician_gls/pdf/neuroendocrine.pdf. Accessed May 3, 2022.

 

3. National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at: http://www.nccn.org/professionals/drug_compendium. Accessed May 3, 2022.

 

4. Strosberg J, El-Haddad G, Wolin E, et al. Phase 3 trial of 177Lu-dotatate for midgut neuroendocrine tumors. N Engl J Med. 2017; 376(2): 125-135.

 

5. Brabander T, van der Zwan WA, Teunissen JJM, et al. Long-term efficacy, survival, and safety of [177Lu-DOTA0,Tyr3]octreotate in patients with gastroenteropancreatic and bronchial neuroendocrine tumors. Clin Cancer Res. 2017; 1-8.

 

6. Clinical Pharmacology [database online]. Elsevier, Inc.; 2022. Available at: https://www.clinicalkey.com/pharmacology/.

 

Addendum:

1)    Effective 10/01/2023: Updated criteria for initial approval by removing max 4 dose received item.
Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.