ModifiedmhnPolicy CP.PHAR.459

Clinical Policy: Iobenguane I-131 (Azedra)

Defines medical necessity criteria, dosing, and coverage stance for Azedra (iobenguane I-131) for treatment of pheochromocytoma and paraganglioma and related authorization rules for Centene-affiliated health plans.

Policy Summary

Payermhn

PolicyIobenguane I-131 (Azedra)

Policy CodePolicy CP.PHAR.459

Change TypeManufacturer discontinuation — initial approvals removed

Effective DateMar 1, 2020

Next Review DateFeb 25, 2025

Key ActionSubmit prior authorization showing member is currently receiving Azedra with ≥30 days of therapy and documentation of clinical response.

SourceLink

POLICY UPDATE CHANGES

Initial approval criteria were removed due to manufacturer discontinuation.

Added information regarding manufacturer discontinuation and limited ongoing manufacturing into first quarter of 2024 to allow current patients to complete therapy.

removed initial approval criteria due to manufacturer discontinuation

updated Appendix D and HCPCS code references during 1Q 2022 annual review

12+minimum age for FDA indication

up to 2therapeutic doses authorized

A9590HCPCS code

<80kdo not administer if platelets

Policy Summary

Payermhn

PolicyIobenguane I-131 (Azedra)

Policy CodePolicy CP.PHAR.459

Change TypeManufacturer discontinuation — initial approvals removed

Effective DateMar 1, 2020

Next Review DateFeb 25, 2025

Key ActionSubmit prior authorization showing member is currently receiving Azedra with ≥30 days of therapy and documentation of clinical response.

SourceLink

On This Page

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Coverage Criteria

Continued Therapy (Pheochromocytoma and Paraganglioma)

Covered when ALL of the following are met

Continued therapy for pheochromocytoma/paraganglioma: 1) Member is currently receiving Azedra via the Centene benefit, or documentation supports current receipt of Azedra for a covered indication and the member has received the medication for at least 30 days; 2) Member is responding positively to therapy, e.g., reduction or discontinuation of medications needed to control catecholamine-related symptoms such as antihypertensives; 3) If the request is for a dose increase, the new dose meets one of the following: (a) does not exceed dosimetric dose or therapeutic dose limits (dosimetric dose: for weight >50 kg: 185–222 MBq [5–6 mCi]; for weight ≤50 kg: 3.7 MBq/kg [0.1 mCi/kg]; therapeutic dose up to two doses ≥90 days apart: for weight >62.5 kg: 18,500 MBq [500 mCi]; for weight ≤62.5 kg: 296 MBq/kg [8 mCi/kg]); OR (b) new dose is supported by practice guidelines or peer-reviewed literature with prescriber-submitted supporting evidence. Prescribed regimen must be FDA-approved or recommended by NCCN.see dosing thresholds

Approval duration: Medicaid/HIM — 6 months (one dosimetric dose and up to two therapeutic doses); Commercial — 6 months or to member renewal date (one dosimetric dose and up to two therapeutic doses).

Non‑FDA approved indications not specifically addressed in this clinical policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety per the applicable off‑label use policies (for commercial: CP.CPA.09; health insurance marketplace: HIM.PA.154; Medicaid: CP.PMN.53) or the member’s evidence of coverage. Providers should reference these policies when requesting coverage for off‑label uses.

Initial approval criteria that previously allowed initiation of Azedra have been removed due to manufacturer discontinuation. See Appendix E for details regarding the discontinuation and transitional guidance for members who were already receiving therapy at the time of supply limitations.

Initiation of Azedra for members who are not currently receiving the drug is not permitted. Requests for new starts will be denied; only continued therapy for current users is considered under the continuation criteria (see Section II and Appendix E).

Coding and Dosing Intervals

Referenced HCPCSHCPCS

A9590

Iodine I-131, iobenguane 1 millicurie

Referenced HCPCS CodesHCPCS

A9590

Iodine I-131, iobenguane 1 millicurie

inv-07: Therapeutic dosing interval — therapeutic doses must be administered at least 90 days apart

Therapeutic dosing intervalTherapeutic doses must be administered at least 90 days apart

Dosimetric dose must be given firstDosimetry (single dosimetric dose) is used to calculate therapeutic dosing before therapeutic doses are administered

Quantity limits per courseOne dosimetric dose and up to two therapeutic doses per course

Provider Actions and Prior Authorization

Prior Authorization

Authorization limited to current users

Prior authorization is required. Azedra (iobenguane I-131) is authorized only for members who are already receiving the medication — initial authorizations for new starts are not permitted. Requests for continued therapy must document that the member has been receiving Azedra for at least 30 days or otherwise currently receiving it via the plan benefit. Requests to initiate therapy will be denied.

Authorization limited to current users: member must be currently receiving Azedra and have received it for ≥ 30 days (or be receiving it under the Centene benefit)
No new starts: initial authorization for members not already on Azedra will be denied

Prior Authorization

Prior authorization and coding

Providers must obtain prior authorization and follow this clinical policy along with applicable benefit terms when requesting coverage for Azedra. Prior authorization/medical necessity determinations will be made consistent with the criteria in this policy.

Prior authorization required and decisions follow this clinical policy and member benefit terms

Definitions and Dose Terminology

inv-17: Dosimetric dose — initial single dose used to calculate therapeutic dosing and weight-based dosing ranges

DefinitionInitial single dosimetric dose used to calculate therapeutic dosing

Recommended dose — >50 kg185 to 222 MBq (5 to 6 mCi)

Recommended dose — ≤50 kg3.7 MBq/kg (0.1 mCi/kg)

inv-18: Therapeutic dose — up to two therapeutic doses administered at least 90 days apart with weight-based dosing

DefinitionTherapeutic dose: up to two therapeutic doses administered at least 90 days apart

Recommended dose — >62.5 kg18,500 MBq (500 mCi)

Initial Therapy Criteria

Initial Therapy

Initial therapy rules

Initial therapy: Authorization for initiation is not permitted; members may not start Azedra. If member is currently using Azedra, see continuation criteria for continued therapy.

Initial Therapy

Initial approval criteria previously existed but were removed due to manufacturer discontinuation.

Initial approval status: Initial approval criteria removed because the manufacturer discontinued the product; see Appendix E for manufacturer discontinuation information.

Continuation Criteria

Continuation

Continued therapy allowed only for current users meeting all criteria

Continuation: Member is currently receiving Azedra for a covered indication with at least 30 days of therapy; clinical response is demonstrated (for example, reduction/discontinuation of medications for catecholamine-related symptoms); dosing is within the dosimetric/therapeutic limits specified or any dose escalation is supported by practice guidelines or peer-reviewed literature and the prescribed regimen is FDA-approved or recommended by NCCN.

Quantity Limits

inv-23: Azedra (iobenguane I-131) — One dosimetric dose and up to two therapeutic doses

Authorized doses per courseOne dosimetric dose and up to two therapeutic doses

Administration sequenceAdminister dosimetric dose first, then therapeutic doses based on dosimetry

Therapeutic intervalTherapeutic doses must be administered at least 90 days apart

Site of Care and Administration

Documentation Required

Use and handling under qualified physician control (hospital outpatient)

Radiopharmaceuticals such as Azedra must be used by or under the control of physicians qualified by training and experience and licensed by appropriate governmental agencies, and handled with appropriate radiation safety measures and shielding.

Verify pregnancy status in females of reproductive potential prior to administering Azedra.
Ensure radiation safety practices (waterproof gloves, shielding) and appropriate licensure (e.g., NRC or state health department).

Background

Azedra (iobenguane I‑131) is a radiopharmaceutical indicated for iobenguane scan–positive, unresectable, locally advanced, or metastatic pheochromocytoma or paraganglioma in patients aged 12 years and older. Administration uses an initial dosimetric dose followed by up to two therapeutic doses given with radiation safety precautions and thyroid blockade; therapeutic doses must be administered at least 90 days apart. Azedra handling and administration should occur under appropriate radiation safety controls by qualified personnel in authorized settings.