WHA
 

Tryngolza (olezarsen sodium)

Indications for Prior Authorization

Tryngolza (olezarsen sodium)
  • For diagnosis of Familial chylomicronemia syndrome (FCS)
    Indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS)

Criteria

Tryngolza

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

  • Diagnosis of familial chylomicronemia syndrome (FCS) (type 1 hyperlipoproteinemia)
    • AND
  • One of the following:
    • Disease is confirmed by the presence genetic confirmation of biallelic pathogenic variants in FCS-causing genes (i.e., LPL, GPIHBP1, APOA5, APOC2, or LMF1) as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
      • OR
    • A North American FCS (NAFCS) Score of greater than or equal to 45 [4]
      • OR
    • A Moulin score greater than 10
    AND
  • Both of the following:
    • One of the following:
      • Patient has tried or will receive treatment with standard of care triglyceride lowering therapy (i.e., prescription omega-3 fatty acid [e.g. Lovaza, Vascepa] and a fibrate [e.g., fenofibrate, gemfibrozil])
        • OR
      • Patient has an intolerance to standard of care triglyceride lowering therapy (i.e., prescription omega-3 fatty acid [e.g. Lovaza, Vascepa] and a fibrate [e.g., fenofibrate, gemfibrozil])
      AND
    • Baseline fasting triglyceride levels are greater than or equal to 880 mg/dL prior to treatment with requested drug
    AND
  • Requested drug will be used as adjunct to a low-fat diet
    • AND
  • Requested drug will not be used in combination with Redemplo (plozasiran)
    • AND
  • Prescribed by or in consultation with one of the following:
    • Cardiologist
    • Endocrinologist
    • Gastroenterologist
    • Lipid specialist (lipidologist)
Tryngolza

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

  • Patient demonstrates positive clinical response to therapy (e.g., reduction in triglyceride levels from baseline)
    • AND
  • Requested drug will not be used in combination with Redemplo (plozasiran)

  • Guideline ID
    GL-506279

  • Formulary
    Premium

  • Effective date
    Apr 1, 2026

  • P&T approval date
    Feb 20, 2025

P & T Revisions

2026-01-30, 2025-03-20, 2025-02-10

  1. Tryngolza Prescribing Information. Ionis Pharmaceuticals, Inc. Carlsbad, CA 92010. January 2025.
  2. Stroes ESG, Alexander VJ, Karwatowska-Prokopczuk E, et al. Olezarsen, Acute Pancreatitis, and Familial Chylomicronemia Syndrome. N Engl J Med. 2024;390(19):1781-1792. doi:10.1056/NEJMoa2400201
  3. Study Details | A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) Administered to Patients With Familial Chylomicronemia Syndrome (FCS) | ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT04568434. Accessed January 10, 2024.
  4. Hegele RA, Ahmad Z, Ashraf A, et al. Development and validation of clinical criteria to identify familial chylomicronemia syndrome (FCS) in North America. J Clin Lipidol. Published online November 12, 2024. doi:10.1016/j.jacl.2024.09.008
  5. Clinical consult with cardiologist. January 15, 2026.
  6. Clinical consult with cardiologist. January 23, 2026.
  1. Per clinical consult with a cardiologist from January 2026, Tryngolza demonstrated a consistent lowering effect on triglycerides during a 12-month treatment period [5].
  • 2026-01-30: 2026 Annual Review. (1) Extend initial approval duration to 12 months. (2) Update to standard genetic testing language. (3) Addition of another diagnosis confirmation option. (4) Addition of examples of omega-3-fatty acids and fibrates. (5) Add criteria to ensure no combination use with Redemplo (plozasiran). (6) Updated references.
  • 2025-03-20: EHB formulary added to guideline.
  • 2025-02-10: New program