CurrentColorado Rocky Mountain Health PlansPolicy 2026 P 1512-1

Redemplo (plozasiran) prior authorization

Defines prior authorization and reauthorization criteria for Redemplo (plozasiran) for treatment of familial chylomicronemia syndrome (FCS) under Colorado Rocky Mountain Health Plans' clinical pharmacy programs.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyRedemplo (plozasiran) prior authorization

Policy CodePolicy 2026 P 1512-1

Change TypeNew policy

Effective DateMay 1, 2026

Next Review Date

Key ActionSubmit prior authorization showing diagnosis of familial chylomicronemia syndrome (FCS) and that Redemplo will not be used with Tryngolza; authorization issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

New prior authorization program for Redemplo (plozasiran) created.

12 monthsauthorization duration (initial)

12 monthsauthorization duration (reauth)

02/2026P&T approval

05/01/2026effective

Coverage Criteria for Redemplo (plozasiran)

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inv-01: Initial Therapy

Covered when ALL of the following are met for initial authorization:

Initial Authorization

Criterion A: Diagnosis: familial chylomicronemia syndrome (FCS) (monogenic chylomicronemia, type 1 hyperlipoproteinemia)
Criterion B: Therapy not used in combination with Tryngolza (olezarsen)

Operational note: Prior authorization required; initial approval issued for 12 months.

inv-02: Reauthorization / Continuation Therapy

Covered when ALL of the following are met for reauthorization:

Reauthorization

Criterion A: Documentation of positive clinical response to Redemplo therapy (examples: reduction in triglycerides, reduction in episodes of acute pancreatitis)
Criterion B: Therapy not used in combination with Tryngolza (olezarsen)

Operational note: Reauthorization documentation must demonstrate clinical benefit; reauthorization issued for 12 months.

Use of Redemplo in combination with Tryngolza (olezarsen) is excluded from coverage/authorization.

Use of Redemplo for diagnoses other than familial chylomicronemia syndrome (FCS) is not supported by the specified coverage criteria; initial authorization requires a documented diagnosis of FCS (monogenic chylomicronemia, type 1 hyperlipoproteinemia).

Reauthorization / Continuation Criteria

inv-14: Reauthorization requirements

Reauthorization requires evidence of clinical benefit.

Reauthorization: Documentation of positive clinical response to Redemplo therapy (e.g., reduction in triglycerides, reduction in episodes of acute pancreatitis)

12-month reauthorization

Not in combination: Redemplo is not used in combination with Tryngolza (olezarsen)

Coding and Clinical Response

Referenced coding/claimsmixed

No codes listed

Clinical response examples

Example clinical response — laboratoryReduction in triglycerides (documented decrease from baseline)

Example clinical response — clinical event frequencyReduction in episodes of acute pancreatitis (fewer pancreatitis events compared with pre-treatment period)

Documentation requirementReauthorization requires documentation of positive clinical response (examples above)

Provider Actions and Authorization Rules

Prior Authorization

Prior Authorization Required

Prior authorization required. Initial requests must meet specific diagnostic and usage criteria; authorization (initial) will be issued for 12 months.

Initial approval requires a diagnosis of familial chylomicronemia syndrome (FCS) (monogenic chylomicronemia, type 1 hyperlipoproteinemia).
Redemplo must not be used in combination with Tryngolza (olezarsen).
Initial authorization duration: 12 months.

Denial Risk

Denial Triggers

Requests may be denied if required diagnosis or usage conditions are not met. Specifically, lack of an FCS diagnosis or concurrent use with Tryngolza (olezarsen) are denial triggers.

Denial triggers: No documented diagnosis of familial chylomicronemia syndrome (FCS).
Denial triggers: Request indicates Redemplo used concurrently with Tryngolza (olezarsen).

Billing Rule

Additional Utilization Rules

Automated approval processes and utilization limits may apply. UnitedHealthcare (the plan administrator) may approve initial or reauthorization requests based on prior claim/medication history, diagnosis codes, and claim logic. Supply limits and medical necessity review may be enforced.

Automated approval or re-approval may occur based on prior claims, medication history, ICD-10 diagnosis codes, and internal claim logic.
Supply limits and medical necessity criteria may be applied to initial and continued therapy.

Documentation Required

Reauthorization Documentation

For continuation (reauthorization), documentation of a positive clinical response to Redemplo is required.

Reauthorization requires documentation of positive clinical response (e.g., reduction in triglycerides, reduction in episodes of acute pancreatitis).
Redemplo must not be used in combination with Tryngolza (olezarsen) for reauthorization.

Background

Redemplo (plozasiran) is an ApoC‑III–directed siRNA indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). Initial prior authorization requires a documented diagnosis of FCS and that Redemplo is not used in combination with Tryngolza (olezarsen). When these criteria are met, authorization is issued for 12 months.

Definitions

Familial chylomicronemia syndrome (FCS)

DefinitionFamilial chylomicronemia syndrome (FCS) — monogenic chylomicronemia, also referred to as type 1 hyperlipoproteinemia

Clinical characterization — lipid abnormalityMarkedly elevated triglycerides; indication for Redemplo as adjunct to diet to reduce triglycerides in adults with FCS

Clinical characterization — complication riskIncreased risk of acute pancreatitis associated with severely elevated triglycerides