CurrentEmblemHealthPolicy MG.MM.PH.127

Azedra (iobenguane I-131) — coverage criteria

Policy governs medical necessity, coverage criteria, dosing, and authorization requirements for Azedra (iobenguane I-131) for members with unresectable, locally advanced, or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy.

Policy Summary

PayerEmblemHealth

PolicyAzedra (iobenguane I-131) — coverage criteria

Policy CodePolicy MG.MM.PH.127

Change TypeMaterial revisions — eligibility and renewal

Effective Date

Next Review Date

Key ActionObtain prior authorization and submit clinical documentation that the member meets criteria, including mIBG positivity and that disease requires systemic chemotherapy.

SourceLink

POLICY UPDATE CHANGES

Renewal language changed to state coverage cannot be renewed.

Initial criteria updated to require that the patient's disease requires systemic chemotherapy (replacing prior language allowing primary treatment after positive MIBG scan if not a candidate for chemo/surgery).

Length of authorization clarified to 6 months for 3 doses (one dosimetric imaging dose and two therapeutic doses at least 90 days apart) and may NOT be renewed.

3 dosesauthorized course

6 monthslength of authorization

weight‑baseddosing

PLT ≥80k; ANC ≥1,200

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Azedra (iobenguane I-131)

Initial Therapy

Covered when ALL of the following are met:

Primary criteria: Member has unresectable, locally advanced, or metastatic pheochromocytoma or paraganglioma; AND disease is iobenguane (mIBG) scan positive per FDA‑labeled indication; AND patient's disease requires systemic chemotherapy.

Applies to patients >= 12 years per FDA label

Dosage and Authorization Limits

Treatment regimen requirements (ALL):

Dosing and schedule: One dosimetric imaging dose followed by two therapeutic doses given at least 90 days apart; total course limited to 3 doses and authorization for up to 6 months; coverage may not be renewed.

Dosimetric and therapeutic weight‑based dosing specified below (see thresholds).

Dose component	Dose / schedule
Dosimetric (imaging) dose	Weight > 50 kg: 185–222 MBq (5–6 mCi); Weight < 50 kg: 3.7 MBq/kg (0.1 mCi/kg)
Therapeutic dose (each)	Weight > 62.5 kg: 18,500 MBq (500 mCi); Weight ≤ 62.5 kg: 296 MBq/kg (8 mCi/kg)
Schedule	One dosimetric imaging dose followed by two therapeutic doses given at least 90 days apart (total course = 3 doses)

Azedra is not considered medically necessary for use after documented disease progression on the same iobenguane (mIBG)–based regimen or in patients who have previously received systemic radiotherapy. The policy also excludes use for indications that are not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature. These exclusions apply in addition to the standard coverage criteria and dosing limits specified elsewhere in the policy.

Treatment with Azedra is contraindicated if the member has hematologic values below the policy minimums: specifically, a platelet count < 80,000/mcL or an absolute neutrophil count (ANC) < 1,200/mcL. Patients must meet these hematologic thresholds prior to administration.

Azedra is considered not medically necessary when administered after disease progression on the same regimen or following prior systemic radiotherapy. Additionally, requests for indications lacking support from CMS‑recognized compendia or acceptable peer‑reviewed literature will be deemed not approvable and not reimbursable.

Authorized Regimens and Dosing

Regimen	Details	Coverage status
Indication	Unresectable, locally advanced, or metastatic pheochromocytoma or paraganglioma requiring systemic chemotherapy (mIBG scan positive per FDA label)
Course length and limits	One course consisting of 3 doses (1 dosimetric imaging dose + 2 therapeutic doses); authorization up to 6 months; course may not be renewed
Dose schedule	Therapy consists of a dosimetric dose followed by 2 therapeutic doses given at least 90 days apart
Dosimetric dosing	Weight > 50 kg: 185–222 MBq (5–6 mCi); Weight < 50 kg: 3.7 MBq/kg (0.1 mCi/kg)
Therapeutic dosing	Weight > 62.5 kg: 18,500 MBq (500 mCi); Weight ≤ 62.5 kg: 296 MBq/kg (8 mCi/kg)
Dose interval	Therapeutic doses separated by at least 90 days

Therapeutic dosing thresholds — weight-based and dosimetric ranges

Therapeutic dosing — weight > 62.5 kg18,500 MBq (500 mCi)

Therapeutic dosing — weight <= 62.5 kg296 MBq/kg (8 mCi/kg)

Dosimetric imaging dose — weight > 50 kg185–222 MBq (5–6 mCi)

Dosimetric imaging dose — weight < 50 kg3.7 MBq/kg (0.1 mCi/kg)

Hematologic minimums required for treatment

Platelet count minimumPlatelets >= 80,000/mcL

Absolute neutrophil count minimum

Relevant Procedure, Drug, and Diagnosis Codes

Applicable Procedure CodesHCPCSCovered

A9590

Iodine I-131 iobenguane, diagnostic, 1 millicurie

Applicable NDCsNDCCovered

71258-0015-02	Azedra (iobenguane I-131) 15 mCi/mL injection solution, 2 mL vial
71258-0015-22	Azedra (iobenguane I-131) 15 mCi/mL injection solution, 22.5 mL vial

Applicable ICD-10 DiagnosesICD-10Covered

C74.10	Malignant neoplasm of medulla of unspecified adrenal gland
C74.11	Malignant neoplasm of medulla of right adrenal gland
C74.12	Malignant neoplasm of medulla of left adrenal gland
C75.5	Malignant neoplasm of aortic body and other paraganglia
C74.90	Malignant neoplasm of unspecified part of unspecified adrenal gland
C74.91	Malignant neoplasm of unspecified part of right adrenal gland
C74.92	Malignant neoplasm of unspecified part of left adrenal gland
C7B.8	Other secondary neuroendocrine tumors
Z85.858	Personal history of malignant neoplasm of other endocrine glands

Therapeutic dosing thresholds (coding cross-reference)

Cross-reference — therapeutic dosing (>62.5 kg)A therapeutic dose of 18,500 MBq (500 mCi) applies for patients > 62.5 kg.

Cross-reference — therapeutic dosing (<=62.5 kg)A therapeutic dose of 296 MBq/kg (8 mCi/kg) applies for patients <= 62.5 kg.

Cross-reference — dosimetric imaging dosesDosimetric imaging dose: >50 kg = 185–222 MBq (5–6 mCi); <50 kg = 3.7 MBq/kg (0.1 mCi/kg).

Provider Requirements and Authorization

Prior Authorization

Prior Authorization Required and Course Limit

Prior authorization is required for Azedra (iobenguane I-131). Coverage is limited to a single course of therapy consisting of one imaging/dosimetric dose followed by two therapeutic doses (total of 3 doses) given over up to 6 months. This single course may NOT be renewed.

Single course: 1 dosimetric dose + 2 therapeutic doses (total 3 doses)
Doses spaced at least 90 days apart
Authorization duration: coverage provided for up to 6 months
Course is non‑renewable

Step Therapy

Step Therapy / Clinical Indication Requirement

Policy requires the treated disease to be unresectable, locally advanced, or metastatic pheochromocytoma or paraganglioma and the patient's disease must require systemic chemotherapy. Requests that do not document that systemic anticancer therapy is required may not meet step therapy requirements.

Line of Therapy Considerations

not_specified

Line-of-therapy: Indicated for patients whose disease requires systemic chemotherapy; policy does not specify prior lines or mandate prior systemic therapies beyond the chemotherapy requirement.

Diagnostic and Biomarker Requirements

iobenguane (mIBG) scan positivity — requirement per FDA label

Required biomarker for eligibilitymIBG (iobenguane) scan positive per FDA‑labeled indication

FDA age indicationFDA approval for patients 12 years and older

Indication scopeUnresectable, locally advanced, or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy.

Definitions

Radioactive therapeutic agent description — Azedra (iobenguane I-131)

Agent nameAzedra (iobenguane I-131)

Mechanism of uptakeTaken up via the norepinephrine transporter into adrenergically innervated tissues and neural crest tumors (e.g., pheochromocytoma, paraganglioma)

FDA‑approved populationAdults and pediatric patients 12 years and older with iobenguane‑positive, unresectable, locally advanced or metastatic disease who require systemic anticancer therapy

Background

Iobenguane labeled with I‑131 (Azedra) is a targeted radiotherapeutic taken up by tumors expressing the norepinephrine transporter, such as pheochromocytomas and paragangliomas. The agent delivers radiation selectively to these neuroendocrine tumor cells; dosing and administration are subject to weight‑based single‑dose limits and hematologic minimums described in this policy.