Endari – NC Standard

Restricted Product(s)

Restriction applies to brand and generic formulations • Endari® (L-glutamine)

FDA Approved Use

• To reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older

Criteria for Approval of Restricted Product(s)

1. The patient is at least 5 years of age or older; AND 
2. The patient has been diagnosed with sickle cell anemia or sickle β0 –thalassemia; AND 
3. The patient has not received blood products in the last 30 days; AND 
4. The patient has tried (at least a 3 month period) and had an inadequate response, intolerance, or hypersensitivity to hydroxyurea; OR 
   1. The patient has an FDA labeled contraindication to hydroxyurea; AND 
5. The patient has had at least 2 painful sickle cell crises (requiring visits to an emergency room/medical facility for sickle cell disease-related pain which was treated with a parenterally administered narcotic or parenterally administered ketorolac) in the last 12 months; AND 
6. The patient does not have renal insufficiency; AND 
7. The patient does not have uncontrolled liver disease; AND 
8. Treatment dosing details have been provided for review (including patient’s weight and dosing schedule); AND 
9. If the requested medication is brand Endari:
   1. The patient has a known contraindication to an inactive ingredient in generic L-glutamine; AND 
10. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
    
    Duration of Approval: 365 days (1 year)

Quantity Limit Exception Criteria

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND 
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND 
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR 
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed). 

References

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information

August 2024: Criteria change: Added new to market generic L-Glutamine to policy and updated quantity limit chart to remove weight based quantity limit and added QL of 6 packs a day.
August 2023: Criteria update: Criteria reviewed and formatting changes.
August 2021: Criteria update. Annual criteria review. No changes to policy.
Sep 2017: Original utilization management criteria issued