Pharmacy Prior Authorization Criteria

Redemplo (plozasiran)

Indications for Prior Authorization

Redemplo (plozasiran)

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

Criteria

Redemplo

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 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 Tryngolza (olezarsen)
AND
• Prescribed by or in consultation with one of the following:
• Cardiologist
• Endocrinologist
• Gastroenterologist
• Lipid specialist (lipidologist)

Redemplo

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 Tryngolza (olezarsen)

P & T Revisions

2026-01-22

References

1. Redemplo Prescribing Information. Arrowhead Pharmaceuticals, Inc. Pasadena, CA 91105. November 2025.
2. Watts GF, Rosenson RS, Hegele RA, et al. Plozasiran for Managing Persistent Chylomicronemia and Pancreatitis Risk. N Engl J Med. 2025;392(2):127-137. doi:10.1056/NEJMoa2409368
3. Study Details | NCT05089084 | Study of ARO-APOC3 (Plozasiran) in Adults With Familial Chylomicronemia Syndrome (FCS) | ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT0508908. Accessed January 5 2026.
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. Javed F, Hegele RA, Garg A, et al. Familial chylomicronemia syndrome: An expert clinical review from the National Lipid Association. J Clin Lipidol. 2025;19(3):382-403. doi:10.1016/j.jacl.2025.03.013

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End Notes

1. The primary endpoint in PALISADE (NCT05089084) was percent change from baseline in fasting triglycerides (TG) at month 10. An initial authorization period of 12 months allows sufficient time to assess this.

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Revision History

• 2026-01-22: New program.

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