Azedra (iobenguane I-131) IV — Prior Authorization and Medical Necessity Criteria
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Prior authorization form and medical necessity criteria for AvMed coverage of Azedra (iobenguane I-131) IV for treatment of pheochromocytoma and paraganglioma, affecting providers prescribing or administering the drug for AvMed members in North Carolina.
No material clinical or coverage changes in this revision.
Coverage Criteria for Azedra (iobenguane I-131)
Initial Therapy
Covered when ALL of the following are met
Administrative and baseline clinical requirements
Indication-specific requirements
Safety exclusions related to prior radiation exposure and blood pressure
See dosing table for exact MBq/mCi per weight and imaging schedule
Coverage for Azedra (iobenguane I-131) is limited to a single authorization period of 6 months, which covers a total of 3 doses — one imaging dosimetric dose followed by two therapeutic doses administered at least 90 days apart. Authorizations may NOT be renewed beyond this 6-month period.
Requests that do not meet all listed approval criteria are not eligible for coverage. Key required criteria include documented iobenguane scan positivity in at least one tumor site and absence of uncontrolled/unstable hypertension, as well as other administrative and clinical requirements (age ≥ 12 years, oncologist requester, negative pregnancy test for females of reproductive potential, life expectancy ≥ 6 months, Karnofsky ≥ 60, appropriate thyroid blockade, etc.).
Coding and Dosing Details
| A9590 | Iodine I-131 iobenguane (Azedra) IV |
Provider Actions, Documentation, and Authorization
Prior Authorization Required
Prior authorization is required for Azedra (iobenguane I-131) IV (HCPCS A9590). The prescribing physician must sign and clearly print their name on the prior authorization request (preprinted stamps are not valid). Fax the completed form to 1-877-535-1391. Incomplete, incorrect, or illegible information (including missing phone/fax numbers) may delay processing or lead to denial.
- Prior authorization required for HCPCS A9590 (Azedra).
- Prescribing physician signature mandatory; preprinted stamps not acceptable.
- Fax completed request to 1-877-535-1391.
Authorization Duration
Coverage will be provided for a single authorization period of 6 months to allow for up to 3 doses (one imaging/dosimetric dose followed by two therapeutic doses given at least 90 days apart). Authorization may not be renewed.
- Authorization duration: 6 months.
- Maximum doses covered: 3 (1 dosimetric + 2 therapeutic, therapeutic doses ≥90 days apart).
- Authorization is non-renewable.
Required Supporting Documentation
Provide complete supporting documentation to substantiate each approval criterion. This includes relevant lab results, diagnostic imaging reports (including evidence of iobenguane scan-positivity), chart notes, weight and date weight obtained, dosing schedule, diagnosis and ICD code, and documentation of prior therapies. Missing or insufficient documentation may delay or result in denial.
- Include weight and date weight obtained, dosing schedule, diagnosis, and ICD code.
- Attach lab results, diagnostic imaging (e.g., scans showing iobenguane positivity), and chart notes.
- Document prior therapies; prior therapy verification may be performed via pharmacy claims or chart review.
Sample and Prior Therapy Verification / Incomplete Documentation Risk
Use of samples to initiate therapy does not meet preauthorization criteria. Previous therapies will be verified via pharmacy paid claims or submitted chart notes. If information provided is not complete, correct, or legible, authorization can be delayed or denied.
- Samples may not be used to meet preauthorization requirements.
- Plan may verify prior therapies through pharmacy claims or chart documentation.
- Incomplete/illegible requests may be delayed or denied.
Covered Dosimetric and Therapeutic Regimens
| Dose component | Weight threshold | MBq | Notes |
|---|---|---|---|
| Initial imaging (dosimetric) dose | |||
| Patients > 50 kg | |||
| 185–222 MBq | |||
| Administer intravenously; used to perform scans to calculate therapeutic dosing (acquire whole body images Day 0, Day 1–2, and Days 2–5 as described). | |||
| Initial imaging (dosimetric) dose | |||
| Patients ≤ 50 kg | |||
| 3.7 MBq/kg | |||
| Administer intravenously; weight-based per kg dosing for patients 50 kg or less; used to perform scans to calculate therapeutic dosing. | |||
| Therapeutic dose (per dose) | |||
| Patients > 62.5 kg | |||
| 18,500 MBq | |||
| Administer as two intravenous doses at least 90 days apart; may require reduction based on estimated critical organ absorption limits. | |||
| Therapeutic dose (per dose) | |||
| Patients ≤ 62.5 kg | |||
| 296 MBq/kg | |||
| Administer as two intravenous doses at least 90 days apart; weight-based (per kg) dosing for patients 62.5 kg or less; may require reduction based on organ absorption limits. |
Line of Therapy
second-line
Indicates use after progression or when chemotherapy/curative options are not appropriate
Definitions and Dose Terms
Background
Azedra (iobenguane I-131) is a radiotherapeutic agent used for both an initial imaging dosimetric scan and for targeted systemic radiotherapy in patients with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma that are iobenguane scan-positive. Treatment consists of a single dosimetric imaging dose to calculate therapeutic dosing followed by two therapeutic doses given at least 90 days apart; dosing and dose reductions are determined by patient weight and estimated critical organ absorption limits.
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