FDA LABELED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Zycubo® (copper histidinate) Subcutaneous injection |
Treatment of Menkes disease in pediatric patients Limitation of Use: Not indicated for the treatment of occipital horn syndrome |
|
1 |
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL
|
Module |
Clinical Criteria for Approval |
|
QL Standalone |
Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met: 1. The requested quantity (dose) does NOT exceed the program quantity limit OR 2. The requested quantity (dose) exceeds the program quantity limit AND ONE of the following: A. BOTH of the following: 1. The requested agent does NOT have a maximum FDA labeled dose for the requested age and indication AND 2. There is support for therapy with a higher dose for the requested age and indication OR B. BOTH of the following: 1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested age and indication AND 2. There is support for why the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does NOT exceed the program quantity limit Length of Approval: up to 12 months |
QUANTITY LIMIT CLINICAL CRITERIA OPERATIONAL LEVEL OF EVIDENCE REQUIREMENTS
|
Module |
Ops Set Up |
Validation Options |
Other Explanation |
|
QL Standalone |
Validation: Apply Baseline and go to Validation Options |
|
|
CLINICAL RATIONALE
Utilization Management |
Utilization management (UM) is not applied to patients less than 1 year of age to prevent delays in initiating therapy for a time-sensitive, life-threatening condition where early treatment is critical to clinical outcomes. For patients 1 year of age and older, quantity limits are applied to ensure alignment with FDA-labeled dosing and to prevent inappropriate continuation of higher infant dosing or excess utilization. |
Number |
Reference |
1 |
Zycubo prescribing information. Sentynl Therapeutics, Inc. January 2026. |
POLICY AGENT SUMMARY QUANTITY LIMIT
Target Agent GPI |
Target Brand Name(s) |
Target Generic Name(s) |
Strength |
QL Amount |
Dose Form |
Days Supply |
Duration |
Targeted NDCs When Exclusions Exist |
Age Limit |
Effective Date |
Term Date |
|
|||||||||||
79900010162110 |
Zycubo |
copper histidinate for subcutaneous soln |
2.9 MG |
30 |
Vials |
30 |
Days |
|
Applies to ages 1 and older |
|
|
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
|
|||
Zycubo |
copper histidinate for subcutaneous soln |
2.9 MG |
Commercial ; HIM ; WY NetR-Commercial Custom |
