ModifiedCentenePolicy CP PHAR.459

Iobenguane I-131 (Azedra)

Defines medical necessity, authorization, dosing, and coverage rules for iobenguane I-131 (Azedra) for commercial, HIM, and Medicaid lines of business; affects providers requesting initiation or continuation of Azedra therapy for eligible members.

Policy Summary

PayerCentene

PolicyIobenguane I-131 (Azedra)

Policy CodePolicy CP PHAR.459

Change TypeRemoved initial approvalcontinued therapy retained for current patients

Effective DateMar 1, 2020

Next Review DateFeb 25, 2025

Key ActionDo not request initial authorization; submit prior authorization only for continuation with supporting clinical documentation.

SourceLink

POLICY UPDATE CHANGES

Initial approval criteria were removed due to manufacturer discontinuation.

Information about manufacturer discontinuation and limited ongoing manufacturing through Q1 2024 was added.

1Q 2025 annual review: removed initial approval criteria due to manufacturer discontinuation; added information regarding manufacturer discontinuation to Appendix E; references reviewed and updated.

12+min age (years)

Up to 2therapeutic doses

6 monthsapproval duration

A9590

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Coverage Criteria

Continued Therapy — Covered when ALL of the following are met for members currently receiving Azedra

Covered when ALL of the following are met for members currently receiving Azedra:

Continued Therapy Preconditions: Member is currently receiving Azedra via the Centene benefit or documentation confirms the member has received Azedra for at least 30 daysat least 30 days

Supports continuation only; initial initiation is not permitted

Clinical Response: Member is responding positively to therapy as evidenced by reduction or discontinuation of medications needed to control catecholamine-related symptoms (for example, reduction in antihypertensive medication)clinical improvement

Prescriber must provide documentation of clinical response (e.g., office notes, labs)

Dosing Limits and Sequencing: Dosimetric dose must be administered first; therapeutic dosing limited to up to two doses administered at least 90 days apart; new dose does not exceed weight-based dosimetric or therapeutic dosing limitssee dosing thresholds (Appendix D)

Dose increases require dosimetric justification or supporting practice guideline/peer-reviewed literature

Non‑FDA approved indications not addressed in this policy are not authorized unless the provider submits sufficient documentation of efficacy and safety consistent with the applicable off‑label use policies (e.g., CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, CPPMN.53 for Medicaid) or other evidence of coverage.

Inclusion or exclusion of procedure or billing codes in this policy does not guarantee coverage. Codes referenced here (for example, HCPCS code A9590) are provided for informational purposes only; providers must follow their plan's prior authorization processes and current professional coding guidance when submitting claims.

Initial authorization to start Azedra is not permitted under this policy due to manufacturer discontinuation; requests to initiate therapy will be considered not authorized. Continuation requests for members already receiving Azedra should follow the policy’s continuation criteria and prior authorization processes. Providers should reference the informational HCPCS coding note (e.g., A9590) and submit required clinical documentation to support continuation requests.

Coding

Referenced HCPCSHCPCS

A9590

Referenced HCPCS CodesHCPCS

A9590

Weight-based dosing thresholds — dosimetric dose and therapeutic dose weight thresholds

Dosimetric dose thresholdPatients >50 kg: 185–222 MBq (5–6 mCi); Patients ≤50 kg: 3.7 MBq/kg (0.1 mCi/kg)

Therapeutic dose thresholdPatients >62.5 kg: 18,500 MBq (500 mCi); Patients ≤62.5 kg: 296 MBq/kg

Therapeutic dosing intervalTherapeutic doses may be administered up to two times, at least 90 days apart, following dosimetry determination

Provider Actions / Prior Authorization

Prior Authorization

Prior Authorization/Continuation Only

Prior authorization required for continuation only. Initial authorizations are not permitted because the manufacturer has discontinued Azedra; members may not initiate therapy with Azedra. Continuation/renewal requests require prior authorization and must document the member is currently receiving Azedra via the Centene benefit or has received it for at least 30 days.

Authorization for new starts is not permitted due to manufacturer discontinuation — only continuation/renewal requests will be considered.
Continuation requests must demonstrate active treatment through benefit or clinical documentation (see Supportive Documentation).

Documentation Required

Providers must submit documentation (such as office chart notes, laboratory results, imaging, dosimetry reports, and other clinical information) that supports the member meets all approval criteria. Failure to provide required documentation may result in denial or delay of the request.

Background

Azedra (iobenguane I‑131) is a radiopharmaceutical indicated for adults and pediatric patients aged 12 years and older with iobenguane scan–positive, unresectable, locally advanced, or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy. It is administered as a single dosimetric dose first to calculate therapeutic dosing, followed—when appropriate—by up to two therapeutic doses given at least 90 days apart. Use requires specialized radiopharmaceutical handling and pre‑administration safety checks (for example, pregnancy status verification, complete blood counts, thyroid blockade, and withholding interacting medications) and should be performed by or under the control of qualified physicians licensed by applicable governmental authorities.

Definitions and Handling

Dosimetric dose definition — initial single low activity dose used to calculate therapeutic dosing (must be first)

Dosimetric dose (definition)An initial single low-activity intravenous dose administered first to calculate radiation dose estimates used to determine subsequent therapeutic dosing

PurposeUsed to generate dosimetry (radiation dose estimates) that guide adjustment of therapeutic Azedra doses

Administration orderMust be administered before any therapeutic dose

Radiopharmaceutical handling requirements — PPE, shielding, and qualified physician administration/license notes

Personal protective equipment (PPE)Use waterproof gloves when handling Azedra to minimize radiation exposure

Radiation shieldingUse effective radiation shielding when handling Azedra to minimize exposure

Initial Therapy Criteria

Initial Therapy — initiation of Azedra therapy

Initiation of Azedra therapy

Initial therapy prohibition: Initiation of Azedra is not permitted due to manufacturer discontinuationN/A

If member is currently using Azedra, consider continuation criteria instead; initial approval criteria were removed

Initial therapy criteria — policy note

Policy note regarding initial therapy

Operational note: Initial approval criteria removed due to manufacturer discontinuation

See Appendix E for manufacturer discontinuation information; inclusion of codes does not guarantee coverage

Continuation Therapy Criteria

Continuation Therapy — continuation permissible for members already receiving Azedra who meet response and dosing criteria

Continuation therapy is permissible for members already receiving Azedra and who meet response and dosing criteria.

Current therapy: Member currently receives Azedra via Centene benefit or documentation supports current therapy for at least 30 days>=30 days

Continuation only

Clinical benefit: Member is demonstrating clinical response (for example, reduction in catecholamine-related symptoms or reduced antihypertensive medication)clinical improvement

Provider must submit supporting clinical documentation

Dosing and sequencing:

Step Therapy

Dose type	Weight threshold / description	Dose
Dosimetric dose (must be administered first)	Patients > 50 kg	185 to 222 MBq (5 to 6 mCi)
Dosimetric dose (must be administered first)	Patients ≤ 50 kg	3.7 MBq/kg (0.1 mCi/kg)
Therapeutic dose (based on dosimetry; up to two doses)	Patients > 62.5 kg	18,500 MBq (500 mCi) — dose adjusted per dosimetry
Therapeutic dose (based on dosimetry; up to two doses)	Patients ≤ 62.5 kg	296 MBq/kg (8 mCi/kg) — dose adjusted per dosimetry

Quantity Limits

Azedra quantity limits — one dosimetric dose and up to two therapeutic doses

Dosimetric dose quantity limitOne dosimetric dose per course

Therapeutic dose quantity limitUp to two therapeutic doses per course (therapeutic doses administered at least 90 days apart)

Approval duration contextApproval durations reference one dosimetric dose and up to two therapeutic doses (e.g., Medicaid/HIM and Commercial: 6 months or to member renewal date)

Site of Care

Note

Hospital outpatient — qualified physician control and safety

Radiopharmaceuticals, including Azedra, should be used by or under the control of physicians who are qualified by training and experience and approved by the appropriate governmental agency (e.g., Nuclear Regulatory Commission or state health departments).

Use appropriate radiation safety measures (waterproof gloves, shielding) and verify contraindications (e.g., platelet <80,000/mcL or ANC <1,200/mcL)

Note

Site of care — additional specifics not specified

Site-of-care specifics beyond hospital outpatient are not detailed in this policy; follow local plan/site requirements and the policy's site-of-care notes.

Policy does not specify additional site‑of‑care restrictions in this section