Reltone – Essential & Net Results

Restricted Product(s)

• Reltone® (ursodiol) 
• Ursodiol (authorized generic Reltone®)

FDA Approved Use

• For the prevention of gallstone formation in obese patients experiencing rapid weight loss 
• For patients with radiolucent, noncalcified gallbladder stones with a diameter of less than 20 mm in patients who cannot undergo elective cholecystectomy because of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for patients who refuse surgery

Criteria for Approval of Restricted Product(s)

1. ONE of the following:
   1. The patient is utilizing the requested medication for the prevention of gallstones in patients who are obese and experiencing rapid weight loss; OR 
   2. The patient is utilizing the requested medication for the treatment of radiolucent, noncalcified gallbladder stones with a diameter of less than 20 mm in patients who cannot undergo elective cholecystectomy due to:
      1. Increased surgical risk due to systemic disease; OR 
      2. Advanced age; OR
      3. Idiosyncratic reaction to general anesthesia; AND 
2. The request is for brand Reltone; AND
   1. The provider has given a written statement as to why the patient is unable to utilize generic ursodiol 300 mg, including a valid explanation of the undue risk this would result in for the patient’s health (medical record documentation required); OR 
3. The request is for Ursodiol (authorized generic Reltone); AND
   1. The provider has given a written statement as to why the patient is unable to utilize generic ursodiol 300 mg, including a valid explanation of the undue risk this would result in for the patient’s health (medical record documentation required); AND 
   2. The provider has given a written statement as to why the patient is unable to utilize brand Reltone, including a valid explanation of the undue risk this would result in for the patient’s health (medical record documentation required); AND 
4. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
   
   Duration of Approval: 365 days (1 year)

References

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

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q2 annually.

April 2024: Original utilization management policy issued.