CurrentNeighborhood Health Plan of Rhode IslandPolicy UM ONC_1498

Hicon (sodium iodide I-131) Drug Policy / Coverage Criteria

Defines accepted indications, inclusion and exclusion criteria, and authorization/approval processes for use of Hicon (sodium iodide I‑131) for cancer treatment; applies to network ordering providers whose members obtain coverage through Neighborhood Health Plan of Rhode Island (managed/processed by Evolent).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyHicon (sodium iodide I-131) Drug Policy

Policy CodePolicy UM ONC_1498

Change TypeNo material changes

Effective DateMay 31, 2024

Next Review Date

Key ActionSubmit prior authorization requests to Evolent with supporting FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

100 / 200 mCisingle dose limits

Thyroid carcinomaprimary covered diagnosis

FDA + compendia + NCCN/ASCOevidence sources

Utilization Mgmt Committeefinal approval

Coverage Criteria

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Inclusion criteria

Covered when ALL of the following are met for continuation or when diagnosis criteria are met for thyroid carcinoma:

Continuation exemption: Member has not experienced disease progression on the requested medication AND the requested medication was used within the last year without a lapse of more than 30 days of having an active authorization AND additional medication(s) are not being added to the continuation request.

From continuation requests section

Thyroid carcinoma indication: Member is an adult with a diagnosis of follicular, papillary, or oncocytic carcinoma AND member had a thyroidectomy OR member has locoregional, metastatic, or recurrent disease.

From thyroid carcinoma inclusion criteria

Requests for Hicon (sodium iodide I‑131) will be excluded when there is disease progression while taking Hicon, or when the medication is prescribed for concurrent use with other anti‑thyroid therapies. Additionally, requests exceed coverage when dosing would be greater than the single‑dose limits: 100 millicuries (3,700 MBq) for ablation of normal thyroid tissue or 200 millicuries (7,400 MBq) for ablation of metastatic disease. Investigational or off‑label indications lacking sufficient evidence as defined by CMS‑recognized compendia or acceptable peer‑reviewed literature are also exclusions.

Provider Actions and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for all requests for Hicon (sodium iodide I 131). Evolent is responsible for processing medication requests from network ordering providers; final approval authority rests with the Utilization Management Committee. Medications not authorized by Evolent may be deemed not approvable and not reimbursable.

All requests must be submitted to Evolent for prior authorization
Final approval is by the Utilization Management Committee
Medications not authorized by Evolent may be denied reimbursement

Documentation Required

Evidence / Documentation Required

Requests must be supported by appropriate evidence/documentation. Acceptable sources include FDA-approved product labeling, CMS-recognized compendia, National Comprehensive Cancer Network (NCCN) or American Society of Clinical Oncology (ASCO) clinical guidelines, or peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements. Documentation should demonstrate the clinical indication, prior treatment history, dosing (including single-dose limits), and data supporting the requested use (especially for off-label indications).

Acceptable evidence: FDA labeling, CMS-recognized compendia, NCCN or ASCO guidelines, or supportive peer-reviewed literature meeting CMS standards
Provide clinical rationale and history (diagnosis, prior therapies, response/progression)
Include planned dosing; note single-dose limits: ≤100 millicuries (3,700 MBq) for ablation of normal thyroid tissue and ≤200 millicuries (7,400 MBq) for ablation of metastases
For off-label requests, include literature demonstrating patient/cancer representation, regimen relevance, clinically meaningful outcomes, and study design adequacy per policy criteria

Initial Therapy Criteria

Initial therapy

Initial use is acceptable when consistent with FDA labeling or recognized oncology compendia/guidelines.

Evidence basis: Use supported by FDA approved product labeling, CMS‑approved compendia, NCCN or ASCO guidelines, or peer‑reviewed literature that meets CMS requirements.

Evidence requirement for initial therapy

Continuation Therapy Criteria

Continuation therapy

Continuation requests may be granted without full re‑review when all conditions below are met.

Continuation criteria: No disease progression on Hicon; Hicon used within the last year without a >30‑day authorization lapse; no additional medications being added to the continuation request.

Continuation requests exemption

Background

Sodium iodide I‑131 (Hicon) is a radiotherapeutic agent used primarily for ablation and treatment of differentiated thyroid carcinoma, including use after thyroidectomy and for locoregional, recurrent, or metastatic disease. Appropriate use should follow FDA labeling and accepted oncology compendia or guidelines; administration setting and medication management details are provided in the FDA label/package insert.