Azedra (iobenguane I-131) (Intravenous) coverage criteria
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Defines Moda Health coverage, billing limits, and medical necessity criteria for Azedra (iobenguane I-131) for patients with pheochromocytoma/paraganglioma and related neuroendocrine adrenal tumors; affects providers submitting claims and seeking prior authorization for doses. Pre-payment claim edits apply; prior authorization criteria noted but PA does not apply for this policy for payment edits.
No material clinical or coverage changes in this revision.
Coverage Criteria for Azedra (iobenguane I-131)
Initial Approval Criteria
Covered when ALL of the following are met:
supports safe use due to radiation
required to demonstrate target uptake
aligns with FDA/compendia indication
required to protect thyroid from radioiodine
bone marrow exposure limit to reduce hematologic toxicity
therapeutic doses are calculated from dosimetric imaging
Patients are NOT eligible if their disease is not iobenguane scan–positive, or if the disease is resectable and does not meet the policy’s requirement for locally advanced, unresectable, or metastatic disease requiring systemic chemotherapy. Coverage also requires that the patient be at least 12 years of age, females of reproductive potential have a negative pregnancy test prior to initiating treatment, and that appropriate thyroid blockade be given starting at least 24 hours before and continued for 10 days after each Azedra dose. Patients who have received systemic radiotherapy, whole-body radiation, or external beam radiotherapy to more than 25% of bone marrow are excluded from initial approval.
Authorization is granted for the initial dosing sequence and will not be renewed beyond the initial authorized period. Continuation of therapy beyond the specified dosing schedule/duration described in the policy is not supported.
| Regimen | Dosing schedule & sequencing | Billing limits (HCPCS A9590 units) |
|---|---|---|
| Azedra (iobenguane I-131): one imaging dosimetric dose followed by two therapeutic doses | Initial imaging dosimetric dose administered first to acquire whole-body gamma camera images; followed by two therapeutic doses administered at least 90 days apart. Therapeutic dosing is calculated from post-dosimetric imaging and patient weight; therapeutic dose reductions may be required for critical organ absorption limits. | Imaging dosimetric dose: up to 30 billable units; Therapeutic doses: up to 675 billable units per dose (two doses), administered ≥90 days apart. |
Dosing Regimens and Administration
| Dose component | Dose details (weight-based where specified) | Timing / sequencing | Coverage label |
|---|---|---|---|
| Imaging dosimetric dose | Patients >50 kg: 185–222 MBq (5–6 mCi) IV; Patients ≤50 kg: 3.7 MBq/kg (0.1 mCi/kg) IV | Given first to acquire Day 0 (within 1 hour pre-void), Day 1–2, and Day 2–5 scans to calculate therapeutic activity | Covered |
| Therapeutic dose (patients >62.5 kg) | Calculated target: 18,500 MBq (500 mCi) IV per therapeutic administration; may be reduced based on calculated organ absorption limits | Two administrations, each at least 90 days apart; dose determined from dosimetric imaging and patient weight | Covered |
| Therapeutic dose (patients ≤62.5 kg) | Calculated target: 296 MBq/kg (8 mCi/kg) IV per therapeutic administration; may be reduced based on calculated organ absorption limits | Two administrations, each at least 90 days apart; dose determined from dosimetric imaging and patient weight | Covered |
| Billing conversion note | HCPCS A9590 billed as 1 billable unit = 1 millicurie; therapeutic calculations converted to billable units per dosing event | Maximum billed per imaging dosimetric dose: 30 units; maximum billed per therapeutic dose: 675 units; up to 2 therapeutic doses (each billed separately) | Covered |
Billing Codes, Units, and Diagnosis Codes
| A9590 | Iodine i-131 iobenguane, 1 millicurie; 1 billable unit = 1 millicurie |
| 71258-0015-xx | Azedra dosimetric vial NDC (1,110 MBq / 30 mCi) and therapeutic vial (12,488 MBq / 337.5 mCi) at calibration time |
| 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 |
| 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 |
| C75.5 | Malignant neoplasm of aortic body and other paraganglia |
| C7B.8 | Other secondary neuroendocrine tumors |
| Z85.858 | Personal history of malignant neoplasm of other endocrine glands |
Prior Authorization, Documentation, and Billing Notices
Initial prior authorization window: 6 months for 1 dosimetric + 2 therapeutic doses
Prior authorization validity will be provided initially for 6 months to cover up to 3 doses: one imaging dosimetric dose followed by two therapeutic doses. The initial authorization explicitly covers the imaging dosimetric dose plus two therapeutic doses administered at least 90 days apart; prior authorization may NOT be renewed.
- Initial authorization period: 6 months
- Covered doses under initial PA: 1 imaging dosimetric dose + 2 therapeutic doses
Dosimetric-to-therapeutic sequencing required (imaging dosimetric → two therapeutic doses ≥90 days apart)
Treatment must start with an initial imaging dosimetric dose, followed by two therapeutic doses calculated from post‑dosimetric imaging and administered at least 90 days apart; therapeutic dose reductions may be required based on calculated critical organ absorption limits.
- Sequence: imaging dosimetric dose → post‑dosimetric imaging scans → two therapeutic doses
- Therapeutic dosing: administered as two doses ≥90 days apart and based on dosimetric imaging; may be reduced for organ absorption limits
- Dosimetric imaging protocol: series of 3 scans (Day 0 within 1 hour, Day 1–2 after voiding, Day 2–5 after voiding) to calculate therapeutic dose
Required clinical documentation to support eligibility and safety
Clinical documentation submitted must demonstrate patient age ≥12, a negative pregnancy test for females of reproductive potential prior to initiating treatment, iobenguane scan–positive disease at ≥1 tumor site, use of appropriate thyroid blockade starting ≥24 hours before and continuing 10 days after each dose, and that the patient has not received radiation to >25% of bone marrow.
- Age: documentation showing patient is at least 12 years old
- Pregnancy test: negative result for females of reproductive potential before treatment
- Disease confirmation: imaging/report showing iobenguane scan–positive disease in at least one tumor site
- Thyroid protection: record of inorganic iodine blockade starting ≥24 hours before and continued for 10 days after each Azedra dose
- Radiation history: documentation that prior radiation did not expose >25% of bone marrow
- Diagnosis coding: claim diagnosis consistent with covered ICD‑10 codes (see Appendix 1)
Pre-payment edits may trigger denials for diagnosis or unit limits
Moda applies pre‑payment claims edits that may deny claims if submitted diagnosis criteria or maximum unit criteria are not met; PA criteria do not exempt claims from these pre‑payment edits.
- Pre‑payment edits check diagnosis criteria against covered ICD‑10 codes (Appendix 1) and maximum HCPCS unit limits
- Maximum billed units allowed: up to 30 units for the imaging dosimetric dose and up to 675 units per therapeutic dose
Indicated Line(s) of Therapy
salvage
Definitions and Dose Types
Background
Azedra (iobenguane I-131) is a radiopharmaceutical for patients with malignant, recurrent, and/or unresectable pheochromocytoma or paraganglioma that are iobenguane scan–positive. Administration requires an initial low-activity imaging dosimetric dose to document target uptake and plan therapy, followed by definitive therapeutic doses determined from the dosimetric imaging. Use is limited to patients with locally advanced, unresectable, or metastatic disease that requires systemic chemotherapy, and standard radiation-safety precautions and thyroid protection are required. Patients must be at least 12 years old and females of reproductive potential must have a negative pregnancy test prior to treatment; prior radiation exposure to > 25% of bone marrow disqualifies patients from receiving Azedra under these criteria.
Revision History
Policy originated (Date of Origin: 09/05/2018).
Policy reviewed (07/2019).
Policy reviewed (07/2020).
Policy reviewed (07/2021).
Policy reviewed (07/2022).
Policy reviewed (07/2023).
Policy reviewed (10/2024).
Last review date and current effective/last review date recorded as 10/02/2025; document lists policy number IC-0376 and notes MODA applies pre-payment claims edits to diagnosis criteria and maximum units.
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