Tryngolza – NC Standard

Restricted Products 

• Tryngolza™ (olezarsen)

FDA Approved Use

• Indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS).
  

Criteria for Approval of Restricted Product(s)

1. The patient is 18 years of age or greater; AND
2. The patient has genetically confirmed familial chylomicronemia syndrome (FCS)(medical record documentation required); AND
3. The patient has fasting triglyceride (TG) levels ≥880 mg/dL while on maximally tolerated statins, omega-3 fatty acids, fibrates, or other lipid-lowering medications (medical record documentation required); AND
4. The patient is following a very-low-fat diet (i.e., no more than 20 to 30 gm fat per day, healthcare provided nutrition support) (medical record documentation required); AND
5. The prescribed dose and quantity are appropriate based on intended use and FDA labeling; AND
6. The patient is being managed by or in consultation with a specialist in the area of the patient’s diagnosis (e.g., cardiologist, endocrinologist); AND
7. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval:  365 days (1 year)

Continuation Criteria

1. The patient has been previously approved for Tryngolza with Blue Cross and Blue Shield of North Carolina (Blue Cross NC) or would have met initial criteria for approval upon the start of therapy; AND
2. The patient has shown clinical benefit with improvement in fasting triglyceride (TG) levels (medical record documentation required); AND
3. The patient will continue to follow very-low-fat diet (i.e., no more than 20 to 30 gm fat per day, healthcare provided nutrition support) (medical record documentation required); AND
4. The prescribed dose and quantity are appropriate based on intended use and FDA labeling; AND
5. The patient continues to be managed by or in consultation with a specialist in the area of the patient’s diagnosis (e.g cardiologist, endocrinologist).

Duration of Approval:  365 days (1 year)

Quantity Limitations

Quantity limitations apply to brand and associated generic products.

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).

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.

January 2025: Original utilization management criteria issued.