CurrentNeighborhood Health Plan of Rhode IslandPolicy UM ONC_1498

Um Onc_1498 Hicon Sodium Iodide I 131_05312024

Policy governing clinical indications, inclusion and exclusion criteria, and authorization/approval authority for use of Hicon (sodium iodide I 131) for treatment of cancer (notably differentiated thyroid carcinoma) for Neighborhood Health Plan of Rhode Island; defines acceptable evidence sources and limits on continuation requests.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyUm Onc_1498 Hicon Sodium Iodide I 131_05312024

Policy CodePolicy UM ONC_1498

Change TypeNo material change

Effective DateMay 31, 2024

Next Review Date

Key ActionMedication requests must be supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements and processed by Evolent for authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes were identified in this update.

1Primary Covered Indication (thyroid carcinoma)

2Single-dose safety thresholds

1Continuation exemption rule set

Coverage Summary

Coverage stance: covered_with_criteria for Hicon (sodium iodide I 131). Scope: policy governs clinical indications, inclusion and exclusion criteria, and authorization/approval authority for use of Hicon for treatment of cancer (notably differentiated thyroid carcinoma) for Neighborhood Health Plan of Rhode Island. Effective date: 2024-05-31. Last review/committee approval: 2024-05-08.

Initial Therapy Criteria

Thyroid Carcinoma - Adult Members

Hicon may be used in adult members with thyroid carcinoma when ALL of the following apply:

ALL of the following

Histology
- Member has a diagnosis of follicular carcinoma
- Member has a diagnosis of papillary carcinoma
- Member has a diagnosis of oncocytic carcinoma
Surgical or disease status
- Member had a thyroidectomy
- Member has locoregional, metastatic, or recurrent disease

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Continuation Therapy Criteria

Continuation Requests Exemption from Policy

Continuation requests for a not-approvable medication shall be exempt provided ALL of the following are met:

ALL of the following

The member has not experienced disease progression on the requested medication
The requested medication was used within the last year without a lapse of more than 30 days of having an active authorization
Additional medication(s) are not being added to the continuation request

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Documentation Required

Continuation authorization documentation

For continuation (renewal) requests, document all of the following: 1) the member has not experienced disease progression while on the requested medication; 2) the requested medication was used within the last year without a lapse of more than 30 days of having an active authorization; and 3) no additional medication(s) are being added to the continuation request.

No disease progression on the requested medication
Used within the last year with no >30-day lapse of active authorization
No additional medications added to the request

Exclusion Criteria / Not Allowed Uses

Exclusion Criteria (Not Allowed)

Use is NOT acceptable when ANY of the following are present:

ANY of the following

Disease progression while taking Hicon (sodium iodide I 131)
Concurrent use with other anti-thyroid therapies
Dosing exceeds single dose limit of 100 millicuries (3,700 megabecquerels) for ablation of normal thyroid tissue
Dosing exceeds single dose limit of 200 millicuries (7,400 megabecquerels) for subsequent ablation of metastases
ALL of the following
- Criteria for insufficient evidence (any one may support exclusion)
  - Clinical characteristics of the patient and the cancer are not adequately represented in published evidence
  - The administered oncologic therapy regimen is not adequately represented in published evidence
  - Reported study outcomes do not represent clinically meaningful outcomes (ASCO guidance e.g., HR < 0.80 and survival benefit for OS/PFS at least 3 months preferred)
  - Experimental design is inappropriate to address the investigative question
  - Non-randomized trials without a significant number of subjects may be supportive but case reports are generally inadequate
  - Abstracts without full peer-reviewed articles lack sufficient evidence

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Denial Risk

Dose limit denial risk

Single-dose limits: 100 millicuries (3,700 megabecquerels) for ablation of normal thyroid tissue, and 200 millicuries (7,400 megabecquerels) for subsequent ablation of metastases. Claims that exceed these single-dose thresholds may be denied.

100 mCi (3,700 MBq) — ablation of normal thyroid tissue
200 mCi (7,400 MBq) — subsequent ablation of metastases
Claims may be excluded/denied if these limits are exceeded

OpenPayer

Um Onc_1498 Hicon Sodium Iodide I 131_05312024

Coverage Summary

Initial Therapy Criteria

Continuation Therapy Criteria

Exclusion Criteria / Not Allowed Uses

Provider Actions

Applicable Codes

Clinical Evidence

Background

Revision History