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Therapeutic Radiopharmaceuticals in Oncology

Section: Prescription Drugs
Effective Date: January 15, 2020
Revised Date: January 15, 2020
Last Reviewed: January 22, 2020

Description

Neuroendocrine tumors

Neuroendocrine tumors are a heterogeneous group of tumors that originate from the neuroendocrine cells in the diffuse neuroendocrine system anywhere in the body but more commonly in the gastrointestinal tract and the respiratory system.

Pheochromocytoma and Paraganglioma

Pheochromocytoma and paraganglioma are rare neuroendocrine tumors that originate from the chromaffin cells of the adrenal glands.Chromaffin cells produce catecholamine neurotransmitters, such as epinephrine, norepinephrine, and dopamine. Compared to the normal chromaffin cells, pheochromocytomas and paraganglioma express high levels of the norepinephrine transporter on their cell surfaces. The excess amount of norepinephrine causes the clinical signs and symptoms like hypertension, headache, sweating, tremor, and palpitation. While most pheochromocytoma and paraganglioma are non-malignant (non-metastatic), about 10% of pheochromocytoma are malignant and about 25% of paraganglioma are malignant (metastatic) which can spread to other parts of the body, such as the liver, lungs, bone, or distant lymph nodes.

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Lutetium 177

Initial Treatment

Lutetium 177 (Lu 177) dotatate treatment is considered medically necessary when conditions 1 through 8 are met:

  • Individual is an adult (≥18 years of age)
  • Individual has documented low or intermediate grade (Ki-67 index ≤20%), locally advanced or metastatic, gastroenteropancreatic (including foregut, midgut, and hindgut) or bronchopulmonary or thymus neuroendocrine tumor
  • Individual has documented somatostatin receptor expression of a neuroendocrine tumor as detected by somatostatin receptor-based imaging (68Ga-dotate positron emission tomography or computed tomography, which is preferred) or somatostatin receptor scintigraphy
  • Individual has documented disease progression while on octreotide long-acting release therapy
  • Individual is not receiving long-acting somatostatin analogues for at least 4 weeks prior to initiating Lu 177 dotatate
  • Individual does not have severe renal impairment (creatinine clearance, <30 mL/min)
  • Individual has adequate bone marrow and hepatic function as determined by the treating physician
  • Individual has documented Karnofsky Performance Status score of 60 or greater

Procedure Codes

A9513

Continuation of Treatment

Continuation of Lu 177 dotatate is considered medically necessary when conditions 1 through 5 are met:

  • No recurrent grade 2, 3, or 4 thrombocytopenia
  • No recurrent grade 3 or 4 anemia and neutropenia
  • No recurrent hepatotoxicity
  • No recurrent grade 3 or 4 nonhematologic toxicity
  • Renal toxicity requiring a treatment delay of 16 weeks or longer

Procedure Codes

A9513

Lu 177 dotatate treatment is considered investigational in all other situations in which the above criteria are not met

Lu 177 dotatate treatment greater than a total of 4 doses as per the Food and Drug Administration-approved regimen is considered investigational

A9513

Iobenguane I 131

Iobenguane I 131 is considered medically necessary when conditions 1 through 5 are met:

  • Individual has documented iobenguane scan positive, locally advanced or metastatic pheochromocytoma and paraganglioma
  • Individual is 12 years or older
  • Individual has progressed on prior therapy for pheochromocytoma or paraganglioma OR is not a candidate for chemotherapy
  • Individual does not have severe renal impairment (creatinine clearance <30 mL/min)
  • Individual has platelet count greater than 80,000/mcL OR absolute neutrophil count greater than 1,200/mcL

Procedure Codes

A9590

Iobenguane I 131 treatment is considered investigational for all other indications including neuroblastoma and gastroenteropancreatic neuroendocrine tumors

Procedure Codes

A9590

Use of iobenguane I 131 not in accordance with FDA approved dosing (first dosimetric dose followed by two therapeutic doses administered 90 days apart) is considered investigational

Procedure Codes

A9590

Diagnosis Codes

C7A.010 C7A.011 C7A.012 C7A.019 C7A.020 C7A.021 C7A.022
C7A.023 C7A.024 C7A.025 C7A.026 C7A.029 C7A.090 C7A.091
C7A.092 C7A.093 C7A.094 C7A.095 C7A.096 C7A.098 C7A.1
C7A.8 C7B.00 C7B.01 C7B.02 C7B.03 C7B.04 C7B.09
C7B.8

Professional Statements and Societal Positions Guidelines

Practice Guidelines and Position Statements

The National Comprehensive Cancer Network guidelines (v.1.2019) for neuroendocrine and adrenal tumors added key eligibility criteria for individuals treated with lutetium 177 dotatate for neuroendocrine tumors. Eligibility criteria include low or intermediate grade neuroendocrine tumor (proliferation index Ki-67 < 20%), detection of somatostatin receptor expression using somatostatin-based receptor imaging, and adequate bone marrow, renal and hepatic function. Table 13 summarizes the National Comprehensive Cancer Network guidelines for neuroendocrine and adrenal tumors.

Table 13. Recommendations for Use of Lutetium 177 Dotatate for Neuroendocrine Tumors

Treatment Category

Recommendation Category

Mid-gut locoregional advanced or distant metastases gastrointestinal neuroendocrine tumors after disease progression on somatostatin analogues 1
Bronchopulmonary/thymic locoregional advanced or distant metastases neuroendocrine tumors if there is clinically significant tumor burden and low grade (typical) or evidence of progression or intermediate grade (atypical) 2A
Locoregional advanced or distant metastases gastrointestinal neuroendocrine tumors after disease progression on somatostatin analogues 2A
Locoregional advanced or distant metastases pancreatic neuroendocrine tumors after disease progression on somatostatin analogues 2A

The National Comprehensive Cancer Network guidelines (v.1.2019) for neuroendocrine and adrenal tumors gives iobenguane I 131 category 2A recommendation for treatment of individuals with locally unresectable or distant metastatic tumors with positive MIBG (iobenguane) scan.

ND Committee Review

Internal Medical Policy Committee 3-16-2020

Links

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving and the Company reserves the right to review and update medical policy periodically.