Plozasiran (Redemplo) — coverage criteria for familial chylomicronemia syndrome
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This policy governs medical necessity criteria, prior authorization, and coverage for plozasiran (Redemplo) as adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS) for QualChoice lines of business.
Added option for prescription by gastroenterologist or pancreatologist.
In continued therapy, specified that Redemplo is not prescribed concurrently with Tryngolza.
Consolidated FCS diagnostic criteria and added requirement for history of triglycerides >1,000 mg/dL at least three times for clinically suggestive FCS.
Added ICHRA line of business.
Coverage Criteria
inv-01: Initial Therapy
Covered when ALL of the following are met for Initial Approval (FCS):
inv-02: Continuation Therapy
Covered when ALL of the following are met for Continued Therapy (FCS):
Non-FDA approved indications that are not specifically addressed in this policy are not authorized unless the request is supported by sufficient documentation of efficacy and safety per the applicable off-label use policy for the member's line of business (see: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace/ICHRA, and CP.PMN.53 for Medicaid).
Coverage determinations under this clinical policy are intended as medical necessity guidance only and are subject to all terms, conditions, exclusions, and limitations of the member's coverage documents (for example, evidence of coverage, certificate of coverage, policy, or contract of insurance) as well as applicable state and federal requirements and Health Plan administrative policies and procedures.
Uses or requests that are not listed under the authorized diagnoses/indications in section III, and where a recent label change does not apply, should be routed to the off‑label use policies for the appropriate line of business (see CP.CPA.09, HIM.PA.154, CP.PMN.53). Such requests may be considered not medically necessary if they do not meet the applicable off‑label policy criteria.
Initial Therapy — FCS
Continuation Therapy — FCS
inv-21: Continuation Therapy - FCS
Criteria for continued therapy in FCS
Coding and Lab Thresholds
Provider Actions and Prior Authorization
Prior authorization required; use HCPCS C9399 or J3490 for unclassified drug billing
Prior authorization is required for Redemplo; submit clinical documentation with the authorization request. For billing of unclassified drug products, use HCPCS codes C9399 (Unclassified drugs or biologicals) or J3490 (Unclassified drugs) as referenced in the policy.
Prior authorization governed by plan-level procedures and member coverage
This clinical policy is a medical-necessity guide used to support coverage decisions; actual prior authorization requirements and execution follow Health Plan-level administrative policies and the member's coverage documents.
- Follow plan-specific prior authorization procedures and member coverage documents for submission and adjudication.
Route requests for uses not listed to off‑label use policies per line of business
If the requested use is not listed under section III of this policy and any recent FDA label change does not apply, route the request to the applicable off‑label use policy for the member's line of business (e.g., CP.CPA.09, HIM.PA.154, CP.PMN.53).
- Refer to off‑label use policy per line of business when use is not covered by this policy.
- Use referenced off‑label policies: CP.CPA.09 (Commercial), HIM.PA.154 (ICHRA), CP.PMN.53 (Medicaid).
Unlabeled provider action
(Placeholder) No additional unlabeled provider action text provided in the source policy.
Submit office notes and labs showing FCS diagnosis and criteria
Providers must submit supporting documentation such as office chart notes and laboratory results demonstrating diagnosis of familial chylomicronemia syndrome (FCS) and that the member meets the listed approval criteria (e.g., fasting triglycerides ≥ 880 mg/dL within 90 days, genetic testing or documented triglyceride history).
- Include fasting triglyceride lab dated within 90 days showing ≥ 880 mg/dL (or ≥ 10 mmol/L) when available.
- Include genetic testing confirming loss‑of‑function mutation OR documentation of triglycerides >1,000 mg/dL on at least three occasions plus associated clinical features.
Providers must follow policy terms and applicable Health Plan procedures when submitting claims
Providers and those submitting claims are bound by the terms and conditions of this clinical policy and must follow applicable Health Plan administrative policies and member coverage documents when providing services or requesting authorization.
- Providers are independent contractors and agree to be bound by the policy terms when providing services or submitting claims.
- Follow applicable Health Plan administrative policies and procedures in addition to this clinical policy.
Missing documentation may lead to denial
Failure to provide required documentation (office notes, lab results, or other clinical information) demonstrating that the member meets all approval criteria may result in denial of the authorization request.
- Ensure submission of all requested clinical records to avoid adverse coverage determinations.
Coverage decisions subject to member coverage documents and Health Plan rules (denial risk)
Coverage and authorization decisions are subject to all terms, conditions, exclusions, and limitations of the member's coverage documents and applicable Health Plan policies and procedures; this policy does not guarantee payment.
- Verify member benefits, exclusions, and plan‑level rules; state and federal requirements may also apply.
Step Therapy
| Step | Requirement / Routing |
|---|---|
| 1 | If the requested use is not listed in section III of this policy and a recent label change (within the last 6 months) does not apply, route the request to the applicable off‑label use policy for the member's line of business: CP.CPA.09 (Commercial), HIM.PA.154 (ICHRA/health insurance marketplace), or CP.PMN.53 (Medicaid). |
Quantity Limits
Site of Care
Pre-filled syringe available; no home site restriction specified
Product is supplied as a pre‑filled syringe (25 mg/0.5 mL); the policy does not impose a specific site‑of‑care restriction for home use in this section.
Office providers must follow Health Plan terms; no additional site‑of‑care rules specified
Providers are independent contractors and must comply with Health Plan terms when providing services; the policy does not specify additional office site‑of‑care restrictions in this section.
Background
Plozasiran (Redemplo) is an siRNA therapeutic that targets apolipoprotein C‑III (apoC‑III) and is indicated, as an adjunct to diet, to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS).
Definitions and Policy Scope
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