CurrentAvMedPolicy N/A

Tryngolza (olezarsen) — Pharmacy prior authorization and step-edit coverage criteria

Form and clinical criteria governing prior authorization and step therapy for Tryngolza (olezarsen) for AvMed members; applies to prescribers requesting coverage through the pharmacy prior authorization process.

Policy Summary

PayerAvMed

PolicyTryngolza (olezarsen) — Pharmacy prior authorization and step-edit coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must complete and sign the pharmacy prior authorization/step-edit request form and provide required clinical documentation including genetic test results and fasting triglyceride labs.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12initial auth (months)

12reauthorization (months)

1qty limit /30 days

≥880triglyceride threshold

≥18min age

Coverage Criteria for Tryngolza (olezarsen)

Initial Therapy

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

Initial Authorization - core requirements: Member is 18 years of age or older; prescribed by or in consultation with a cardiologist, endocrinologist, or specialist experienced in treating severe hypertriglyceridemia; diagnosis of Familial Chylomicronemia Syndrome (FCS) supported by genetic testing showing biallelic pathogenic variants in FCS-causing genes (LPL, LMF1, GPIHBP1, APOC2, APOA5) (submit genetic test results); fasting triglyceride level >= 880 mg/dL (submit lab results from the past 30 days); requested medication will be used as an adjunct to a low-fat diet (<= 20 g of fat per day).

All documentation must be provided or request may be denied.

Initial Authorization - step therapy alternatives: Member meets ONE of the following: inadequate response after an adherent 6-month trial of Redemplo (plozasiran) with prescriber's medical reasoning and verification (pharmacy paid claims and chart notes); OR adverse reaction to Redemplo documented with clinical chart notes and a completed MedWatch form (verified by chart notes and pharmacy paid claims); OR documentation that Tryngolza will NOT be used in combination with Redemplo (verified by chart notes and pharmacy paid claims).

Policy Summary

PayerAvMed

PolicyTryngolza (olezarsen) — Pharmacy prior authorization and step-edit coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Continuation Therapy / Reauthorization

Reauthorization criteria — all must be met:

Reauthorization: Member has experienced positive clinical response demonstrated by improvement in fasting triglyceride levels (submit lab results from the past 90 days); requested medication will continue to be used as an adjunct to a low-fat diet (<= 20 g of fat per day); member has not experienced serious adverse events related to the medication (e.g., thrombocytopenia, hypersensitivity to olezarsen).

Reauthorization period: 12 months. All supporting documentation (labs, chart notes) must be provided or request may be denied.

Tryngolza (olezarsen) must not be administered concurrently with Redemplo (plozasiran). Requests for Tryngolza that indicate combination therapy with Redemplo will not meet coverage criteria and must be verified by chart notes and pharmacy paid claims; documentation showing the medications will not be used together is required for approval when relevant to step-therapy exceptions (e.g., documentation that Tryngolza will not be used in combination with Redemplo).

Initial Authorization Requirements

Initial Therapy

Initial authorization criteria

Initial therapy nodes: All baseline criteria: member is >= 18 years old; prescribed by or in consultation with an appropriate specialist (cardiologist, endocrinologist, or specialist experienced in severe hypertriglyceridemia); genetic confirmation of FCS with biallelic pathogenic variants in LPL, LMF1, GPIHBP1, APOC2, or APOA5 (submit genetic test results); fasting triglycerides >= 880 mg/dL (submit lab results from the past 30 days); medication to be used as adjunct to a low-fat diet (<= 20 g fat/day).

Initial authorization: 12 months. Provide all documentation or request may be denied.

Prior therapy requirement: Either: inadequate response after an adherent 6-month trial of Redemplo (plozasiran) with prescriber's medical justification and verification by pharmacy paid claims and chart notes; OR adverse reaction to Redemplo with clinical chart notes AND a completed MedWatch form (verified by chart notes and pharmacy paid claims); OR documentation that Tryngolza will NOT be used in combination with Redemplo (verified by chart notes and pharmacy paid claims).

Reauthorization / Continuation Requirements

Reauthorization

Reauthorization requirements for continued coverage

Reauthorization nodes: Improvement in fasting triglyceride levels (submit lab results from the past 90 days); continued use as adjunct to a low-fat diet (<= 20 g fat/day); no serious adverse events related to olezarsen (e.g., thrombocytopenia, hypersensitivity).

Reauthorization duration: 12 months. All documentation must be provided to support each item.

Coding and Lab Thresholds

Quantity Limit - Tryngolza (olezarsen) autoinjectorNDCCovered

80 mg/0.8 mL

autoinjector strength and presentation - one autoinjector per 30 days

Fasting triglyceride level — clinical threshold

Threshold valueFasting triglyceride level >= 880 mg/dL

Supporting documentation timeframe (initial)Submit fasting triglyceride lab results from the past 30 days

Use contextMedication to be used as adjunct to a low-fat diet (<= 20 g of fat per day)

Minimum ageMember is 18 years of age or older

Quantity Limits and Product Details

Tryngolza (olezarsen) autoinjector 80 mg/0.8 mL — one autoinjector

Product and strengthTryngolza (olezarsen) autoinjector 80 mg/0.8 mL

Quantity limitOne autoinjector per 30 days

Quantity context in formQuantity Limit listed on drug information form as 80 mg/0.8 mL autoinjector - one autoinjector per 30 days

Provider Actions, Documentation, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization required — prescriber must complete and sign the pharmacy prior authorization/step-edit request form. The prescribing physician must sign and clearly print name (preprinted stamps not valid). Fax completed form to 1-305-671-0200. Incomplete, incorrect, or illegible information (including missing phone/fax) can delay authorization.

Fax: 1-305-671-0200
Prescriber signature required (stamps not valid)
Form must include correct phone and fax numbers

Step Therapy

Step Therapy Requirement

Step therapy requirement — member must meet step criteria before approval. For initial approval, member must have an inadequate response to an adherent 6-month trial of Redemplo (plozasiran) with supporting medical reasoning, or documented adverse reaction to Redemplo (with MedWatch and chart notes), or documentation that Tryngolza will not be used in combination with Redemplo. Pharmacy paid claims and chart notes will be verified.

Inadequate response after adherent 6-month trial of Redemplo (plozasiran) — submit medical reasoning and supporting documentation
Adverse reaction to Redemplo — submit clinical chart notes AND completed MedWatch form
Documentation that Tryngolza will not be used concurrently with Redemplo (verify via chart notes and pharmacy paid claims)

Documentation Required

Required Documentation

Required documentation — all checklist items and supporting documentation must be provided. Submit prescriber signature, genetic testing results confirming biallelic pathogenic variants for FCS-causing genes, fasting triglyceride lab results (initial: within past 30 days; reauthorization: within past 90 days), chart notes, and any MedWatch forms when applicable.

Prescriber signature and printed name on request form
Genetic testing results showing biallelic pathogenic variants in LPL, LMF1, GPIHBP1, APOC2, or APOA5
Fasting triglyceride lab results: ≥ 880 mg/dL (submit labs from past 30 days for initial)
Reauthorization labs: submit fasting triglyceride labs from past 90 days showing improvement
Chart notes supporting trials, adverse events, dietary counseling, and treatment rationale
Completed MedWatch form if adverse reaction to Redemplo is claimed

Denial Risk

Denial Risks

Denial risks — requests may be denied if required information or documentation is missing, incomplete, incorrect, or illegible. Common reasons include absent prescriber signature, missing genetic testing, missing fasting triglyceride labs, lack of chart notes supporting step-therapy or adverse-event claims, or use of sample medication to initiate therapy.

Incomplete/incorrect/illegible request form or missing prescriber signature
Missing genetic testing results for FCS diagnosis
Missing fasting triglyceride lab results or labs outside required timeframe
Insufficient chart notes to support inadequate response, intolerance, or treatment rationale
Use of samples to initiate therapy (does not meet step edit/preauthorization criteria)

Step Therapy Documentation Requirements

Step	Requirement
1
Documentation of an adherent 6-month trial of Redemplo (plozasiran) with prescriber-submitted medical reasoning why Tryngolza (olezarsen) is expected to have superior clinical effect (verification required via pharmacy paid claims and chart notes; examples include number of new hospitalizations for acute pancreatitis, dietary fat intake records, pre- and post-treatment triglyceride labs)

Site of Care / Dispensing

Note

Specialty pharmacy — Proprium Rx

Medication is provided through the specialty pharmacy Proprium Rx and must be obtained via that channel.

Medication being provided by Specialty Pharmacy - Proprium Rx

Key Definitions

FCS (Familial Chylomicronemia Syndrome) — genetic confirmation

DefinitionFamilial Chylomicronemia Syndrome (FCS) supported by genetic testing showing biallelic pathogenic variants in FCS-causing genes (LPL, LMF1, GPIHBP1, APOC2, APOA5)

Documentation requiredSubmit results of genetic testing to support biallelic pathogenic variants

Associated requirementDiagnosis used as a coverage requirement for Tryngolza (olezarsen)

Background

Familial Chylomicronemia Syndrome (FCS) is a genetic disorder characterized by very high fasting triglyceride levels and an increased risk of pancreatitis. Coverage of Tryngolza (olezarsen) for FCS is limited to adults (age ≥ 18 years) with genetic confirmation of FCS (biallelic pathogenic variants in LPL, LMF1, GPIHBP1, APOC2, or APOA5) and fasting triglycerides of ≥ 880 mg/dL. Tryngolza is intended as an adjunct to a very low‑fat diet (≤ 20 g of fat per day). Prior authorization is required; initial approvals are for 12 months and reauthorizations require evidence of clinical benefit (improved fasting triglyceride levels) and absence of serious drug‑related adverse events. Step‑therapy rules apply: members must demonstrate inadequate response to an adherent 6‑month trial of Redemplo (plozasiran) with supporting documentation, or documented intolerance to Redemplo, unless the prescriber documents that Tryngolza will not be used in combination with Redemplo.