Pharmacologic Treatment of High Cholesterol
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This policy governs medical necessity and site-of-service review for pharmacologic treatments used to lower cholesterol (including injectable and IV agents) for Premera members, detailing coverage criteria, dosing limits, and prior authorization/administration site requirements for adults and selected pediatric ages.
Added coverage criteria for Tryngolza (olezarsen) for the treatment of familial chylomicronemia syndrome.
Added coverage criteria for Lerochol (lerodalcibep-liga) for treatment of HeFH and hypercholesterolemia.
Added coverage criteria for Redemplo (plozasiran) for the treatment of familial chylomicronemia syndrome.
Updated age and indication criteria for multiple agents (Leqvio, Evkeeza, Praluent, Repatha, Juxtapid) and changed some indications from 'primary hyperlipidemia' to 'hypercholesterolemia'.
Updated criteria for Leqvio (inclisiran) HeFH age requirement from 18 years to 12 years or older and added coverage criteria for treatment of HoFH.
Updated Evkeeza age requirement to 1 year and clarified prior Repatha requirement for individuals aged 10 years and older.
Coverage Criteria and Medical Necessity
Leqvio (inclisiran) — ASCVD
Covered when ALL of the following are met
Site-of-service review applies for administration; document prior therapies and LDL-C values.
Leqvio (inclisiran) — HeFH
Covered when ALL of the following are met
Accepts genetic or clinical scoring (Simon Broome/Dutch) to establish HeFH.
Leqvio (inclisiran) — HoFH
Covered when ALL of the following are met
HoFH requires high LDL thresholds or genetic confirmation; document prior maximal tolerated therapy.
Icosapent ethyl — cardiovascular risk reduction
Covered when ALL of the following are met
Document statin use or intolerance and risk-factor criteria; REDUCE-IT trial population informed criteria.
Icosapent ethyl — severe hypertriglyceridemia (generic)
Covered when ALL of the following are met
Step therapy requires prior fibrate or niacin trial; document prior medications and TG values.
Evkeeza (evinacumab-dgnb) and Juxtapid (lomitapide) — HoFH
Covered when ALL of the following are met
ELIPSE-HoFH trial used 15 mg/kg IV q4w; avoid in pregnancy per prescribing information.
Quantity limits specified; document prior therapies and genetic/LDL thresholds.
Lerochol (lerodalcibep) and other PCSK9/PCSK9-like agents — HeFH and hypercholesterolemia
Covered when ALL of the following are met
Accepts genetic or clinical scoring to establish HeFH; trials enrolled patients on maximally tolerated statins.
Different LDL thresholds (eg, >=100 mg/dL) apply for hypercholesterolemia indications per policy.
Nexletol / Nexlizet (bempedoic acid ) - ASCVD, HeFH, hypercholesterolemia
Covered when ALL of the following are met
Initial approval typically 3 years; reauthorization requires documentation of continued clinical benefit.
Documentation of prior statin trial or intolerance required; initial approval 3 years.
Lovaza / omega-3-acid ethyl esters — severe hypertriglyceridemia
Covered when ALL of the following are met
Step therapy with generic omega-3 required; document prior TG measurements and prior product trials.
Nexletol / Nexlizet (bempedoic acid ) - hypercholesterolemia
May be considered medically necessary when ALL of the following are met
Dose limited to 180 mg bempedoic acid daily
Praluent (alirocumab) — ASCVD, HeFH, HoFH, hypercholesterolemia
May be considered medically necessary when ALL of the following are met (drug-specific for each indication)
See indication-specific nodes for exact age cutoffs.
For HeFH: untreated LDL-C >=190 mg/dL or genetic/clinical criteria; for HoFH: untreated LDL-C >400 mg/dL or treated >=300 mg/dL or genetic confirmation of two mutant alleles.
Document prior PCSK9 (Repatha) trial and response.
Dose limits and formulations per agent (eg, Praluent 150 mg Q2W or 300 mg Q4W).
Repatha (evolocumab) — ASCVD, HeFH, HoFH, hypercholesterolemia
May be considered medically necessary when ALL of the following are met (drug-specific per indication)
Dose limits: evolocumab formulations 140 mg Q2W or 420 mg Q4W; HeFH/HoFH age cutoffs: HeFH >=10 yrs; HoFH >=10 yrs.
Evolocumab dosing and administration per label; for HoFH dosing may be 420 mg monthly.
Redemplo (plozasiran) and Tryngolza (olezarsen) — Familial chylomicronemia syndrome (FCS)
May be considered medically necessary when ALL of the following are met
Document genetic or clinical confirmation to support FCS diagnosis.
Document dietary management and specialist involvement; do not co-prescribe Redemplo and Tryngolza.
Vascepa (icosapent ethyl) — cardiovascular risk reduction and severe hypertriglyceridemia
May be considered medically necessary when the following criteria are met
Document statin therapy or intolerance, prior generic icosapent ethyl trial, and risk-factor criteria.
Step therapy with generic icosapent ethyl required before brand Vascepa for severe HTG.
Zetia (ezetimibe), niacin, fibrates, brand statins — trials and prior use
May be considered medically necessary when trials of generic alternatives have been attempted and failed or were not tolerated
Initial approval 3 years; reauthorization based on continued clinical benefit.
Initial approval typically 3 years; reauthorization requires documentation of clinical benefit.
Statin intolerance due to myopathy or transaminitis
Medically necessary substitutions for statin intolerance when ALL criteria are met
Document evaluation and symptom resolution after statin discontinuation when applicable.
Document LFT trends and therapeutic attempts to reduce statin dose.
Advanced lipid-lowering therapy (e.g., PCSK9 inhibitors) — initiation criteria
Coverage and medical necessity for PCSK9 inhibitors and other advanced lipid-lowering therapies are tied to documented inadequate LDL-C response on maximally tolerated statin therapy and dosing/titration guidance:
Dosing and titration guidance (eg, alirocumab 75 mg Q2W with up-titration to 150 mg Q2W if inadequate) and response assessment timing described.
Use diagnostic scoring or genetic confirmation to support coverage eligibility.
Initial therapy coverage criteria
Covered when ALL of the following are consistent with trial populations and drug labeling
Trials for alirocumab, evolocumab, and inclisiran required maximally tolerated statin; inclisiran trials excluded individuals on PCSK9 inhibitors.
Use agent-specific numeric thresholds documented in policy sections.
Measure LDL-C 4-8 weeks after initiation/titration to assess response; document background therapy.
Trial-supported candidate criteria (informational)
Therapies supported by pivotal trials in specified populations:
ELIPSE-HoFH: 65 participants; consistent LDL reduction across background therapies.
Two 52-week randomized trials (N=1,844 combined) reported ~50–55% LDL-C reductions versus placebo.
Efficacy greatest at week 12; trials included high CV risk, HeFH, and statin-intolerant cohorts.
BALANCE: randomized 50 mg, 80 mg, or placebo SC q4w for 49 weeks; safety profile acceptable.
Tryngolza (olezarsen) - Initial coverage criteria (excerpt)
Selected coverage updates and criteria clarifications (excerpted):
See full Tryngolza/Redemplo sections for detailed numeric and stepwise criteria.
Age and indication updates (excerpt)
Revisions to age and indication criteria for multiple agents:
See Leqvio-specific section for LDL thresholds and prior therapy requirements.
General coverage stance and agent-specific criteria
Covered when criteria specific to each agent are met as detailed in the policy
This policy does not apply to Medicare Advantage members; document required clinical elements for prior authorization.
Newly added agent criteria (summary)
Recent additions and updates effective 2026-08-01:
Dosing and LDL thresholds specified in Lerochol section.
Policy clarifies Tryngolza/Redemplo cannot be used together.
Site-of-service rules require that infusion or injection administration occur in medically appropriate locations. Preferred medically necessary sites include a physician's office, infusion center, or home infusion when available; hospital-based outpatient settings and outpatient hospital IV infusion departments are considered medically necessary only when the policy's site-of-service criteria are met (for example, no infusion center within 50 miles or no contracted home infusion agency, or when the member has a clinical condition that increases the risk of complications). If the site-of-service criteria in this policy are not satisfied, the hospital outpatient IV infusion department and hospital-based outpatient settings are considered not medically necessary for infusion or injectable therapy services.
Uses of the listed medications that are not specifically enumerated in the Medical Necessity sections are classified as investigational or not medically necessary and may be denied. The policy explicitly lists multiple agents whose indications outside the medical necessity sections are considered investigational; similarly, specified branded and discontinued products and other uses not included in the medical necessity criteria are considered not medically necessary.
Benefit assignment varies by agent: most drugs in this policy are managed through the pharmacy benefit. Exceptions managed through the medical benefit include Evkeeza (evinacumab-dgnb) and Leqvio (inclisiran). Redemplo (plozasiran) and Tryngolza (olezarsen) may be managed through both pharmacy and medical benefits. Applicable HCPCS/administration coding (for example J1305, J1306, J3490) and prior authorization requirements should be followed based on benefit assignment.
Pivotal trials for some agents excluded individuals already receiving PCSK9 inhibitors; for example, inclisiran (LEQVIO) trials excluded participants on PCSK9 inhibitors. This trial-design detail informs step/eligibility logic: documentation should show appropriate prior therapy or rationale (e.g., maximally tolerated statin with or without other lipid-modifying therapy) consistent with trial populations when requesting coverage.
Evinacumab (Evkeeza) has a pregnancy/embryo-fetal toxicity caution in its safety information. The prescribing information notes the potential for fetal harm based on animal studies, and recommends obtaining a pregnancy test prior to initiating treatment and use of contraception during treatment and for at least 5 months after the last dose.
Coverage criteria and references for several discontinued products were removed in recent updates. The policy updates note removal of coverage language for multiple discontinued agents (for example, certain discontinued statins and fibrates), reflecting that criteria for those products are no longer included in the policy.
This medical policy does not apply to Medicare Advantage members. Coverage determinations under this policy are subject to the limits and conditions of the member's benefit plan, and providers should consult the member benefit booklet or customer service to confirm applicability and benefit limitations.
If site-of-service criteria are not met for outpatient infusion or injection services, the request may be denied as not medically necessary. Examples of site-of-service criteria include distance to a local infusion center, availability of a contracted home infusion agency, or the presence of a clinical condition that increases infusion risk (e.g., unstable cardiac or pulmonary disease, unstable vascular access, or history of severe hypersensitivity).
The policy includes a specific investigational/not medically necessary list: all uses of agents that are not included in the Medical Necessity sections are considered investigational or not medically necessary and may be denied. Additionally, certain branded products and specified agents are listed as not medically necessary when used for indications outside the policy's covered criteria.
Requests that do not include required medical record documentation may be considered not medically necessary. The record must include office visit notes documenting the diagnosis, relevant history, physical examination, lipid panels, and a medication history to demonstrate that the coverage criteria are met.
For some agents the intended use is to achieve long-term clinical outcomes, but the policy highlights where long-term outcome evidence is limited. For example, labels and trial summaries note limited evidence for long-term clinical outcome effects for PCSK9 inhibitors; coverage decisions focus on achieving specified lipid thresholds and documented LDL-C or triglyceride responses rather than assumed long-term outcome benefits.
Some sections of the policy excerpts do not contain explicit 'not medically necessary' declarations. Historical updates (for example the 2018 and 2020 reviews) noted that added trial evidence did not change the medical necessity criteria, and several chunks in the record do not include new not-medically-necessary language.
In the portions of the document reviewed, no new not-medically-necessary conditions were added; prior literature and update summaries indicate that trial outcomes reinforced existing criteria and did not create additional not-medically-necessary rules in these excerpts.
Coverage under this policy is subject to member benefit limitations. Even when medical necessity criteria are met, services may be denied if they exceed the member's contract limits or are not a covered benefit. Providers should verify benefits and document necessity fully to minimize benefit-related denials.
Prior Authorization, Documentation, and Billing Requirements
Prior authorization and site‑of‑service review
Prior authorization and site-of-service review are required for listed injectable/IV agents (e.g., Leqvio/inclisiran); Leqvio is subject to site-of-service review and administration is limited to the medically appropriate site as described in policy (initial course/site-specific coverage for first 90 days or re-initiation after ≥6 months).
- Leqvio (inclisiran) is subject to site-of-service review and may be covered in the most appropriate, safe, and cost‑effective site; initial course or re‑initiation after ≥6 months is covered for the first 90 days.
- Prior authorization must demonstrate the drug‑specific medical necessity criteria are met (e.g., ASCVD/HeFH/HoFH criteria for inclisiran).
Prior authorization and applicable HCPCS
Prior authorization is required per the drug‑specific medical necessity criteria; applicable HCPCS codes called out in the policy include J1305 (evinacumab), J1306 (inclisiran/Leqvio) and J3490 for unclassified drugs (used to report agents such as Redemplo or Tryngolza).
Benefit and code management (medical vs pharmacy benefit)
Certain injectable agents are managed through the medical benefit while most drugs are managed through the pharmacy benefit; Evkeeza and Leqvio are managed via the medical benefit and Redemplo/Tryngolza may be reported/managed using unclassified drug codes. Prior authorization follows the applicable medical or pharmacy benefit rules.
- Evkeeza (evinacumab) and Leqvio (inclisiran) are managed through the medical benefit.
- Redemplo (plozasiran) and Tryngolza (olezarsen) are managed through pharmacy and medical benefit and may be reported with J3490.
- Prior authorization must be submitted per the benefit assignment (medical vs pharmacy).
Prior authorization for PCSK9‑targeted therapies and inclisiran
For PCSK9‑targeted therapies and inclisiran, prior authorization must confirm the diagnosis (HeFH or clinical ASCVD), baseline LDL‑C indicating need for further reduction, and that the member is on maximally tolerated statin therapy (or statin intolerant), consistent with trial entry criteria.
- Document baseline LDL‑C and that one high‑intensity statin trial (≥8 weeks) was attempted with LDL‑C remaining above policy thresholds OR document statin intolerance.
- Trials for inclisiran and PCSK9 agents excluded individuals already taking PCSK9 inhibitors, so PA should reflect applicable prior biologic use restrictions.
Prior authorization: candidate selection (trial‑based)
Candidate selection for specialty agents should align with pivotal trial inclusion criteria—e.g., Tryngolza candidates had confirmed FCS with fasting triglycerides ≥880 mg/dL and genetic confirmation in trials; use trial criteria to inform who should be considered for PA.
- Tryngolza (olezarsen) trial enrollment required fasting TG ≥880 mg/dL and genetic confirmation of FCS.
- Use trial‑derived thresholds and background therapy requirements to identify appropriate candidates for prior authorization.
Authorization rule changes and non‑formulary exception duration
Authorization rules were updated: initial authorization requirements to use certain agents with a high‑intensity statin were removed for some specialty agents, and non‑formulary exception authorizations may be approved up to 12 months.
- Removed initial authorization requirement to use in combination with a high‑intensity statin for Evkeeza, Juxtapid, Nexletol, and Nexlizet.
- Non‑formulary exception authorizations for listed drugs may be approved up to 12 months.
Prior authorization required for listed lipid‑lowering agents
Prior authorization is required for many listed lipid‑lowering agents; policy history documents additions/removals of HCPCS codes and PA requirements for agents including Leqvio, Repatha, Praluent, Evkeeza, Juxtapid, Nexletol, Nexlizet, and Tryngolza.
- Submit PA per each agent’s medical necessity criteria; initial approvals generally up to 12 months unless agent‑specific longer periods noted.
- Refer to policy HCPCS coding history for code changes affecting PA submissions.
Step therapy requirements
Most therapies require stepwise trials: document a trial of a high‑intensity statin (e.g., atorvastatin 40 mg+ or rosuvastatin 20 mg+) for ≥8 continuous weeks unless statin intolerance is documented; many specialty agents also require prior trial and inadequate response or intolerance to an alternative biologic (e.g., Repatha) where specified.
- High‑intensity statin trial: atorvastatin ≥40 mg daily or rosuvastatin ≥20 mg daily for at least 8 continuous weeks.
- Where specified (e.g., Praluent, some Evkeeza/Juxtapid age groups), must document prior inadequate response or intolerance to Repatha (evolocumab).
Required trials and step therapy (PCSK9 biologics)
For PCSK9 inhibitors and similar biologics, prior to approval the record must show a high‑intensity statin trial (≥8 weeks) with persistent elevated LDL‑C or documented statin intolerance, and where indicated, prior inadequate response or intolerance to the alternative PCSK9 agent (e.g., Repatha vs Praluent).
- Document LDL‑C remained ≥70 mg/dL (ASCVD/HeFH/HoFH) after high‑intensity statin trial or document statin intolerance per policy definitions.
- If policy specifies, document trial and inadequate response/intolerance to Repatha before approving Praluent (or vice versa as updated).
Dosing and response assessment
Dosing guidance: for PCSK9 inhibitors start alirocumab 75 mg SQ every 2 weeks and up‑titrate to 150 mg Q2W if LDL‑C response inadequate; measure LDL‑C 4–8 weeks after initiation or titration to assess response.
- Measure LDL‑C within 4–8 weeks after initiation/titration to determine need for dose change.
- Evolocumab dosing examples: 140 mg Q2W or 420 mg monthly depending on indication; provide injections per label.
Step: maximally tolerated statin therapy prior to PCSK9 or inclisiran
Policy requires patients to be on maximally tolerated statin therapy (with or without other lipid‑modifying therapy) before initiating PCSK9 agents or inclisiran, consistent with trial populations and coverage criteria.
- Document maximally tolerated statin dose in the medical record.
- Trials and coverage criteria excluded individuals already taking PCSK9 inhibitors for inclisiran trials—ensure prior biologic status is clear.
Step therapy implication for PCSK9/anti‑PCSK9 biologic
Step therapy implication: Lerochol and other PCSK9‑like agents were studied in patients already on maximally tolerated statin therapy, implying these agents are for patients needing additional LDL‑C lowering after statin optimization.
- Ensure documentation shows ongoing maximally tolerated statin therapy when requesting Lerochol or similar PCSK9 agents.
- Cite trial enrollment details showing requirement for background statin therapy.
Step therapy modifications
Step therapy requirements have been modified historically for certain agents—e.g., Evkeeza and Juxtapid previously required PCSK9 inhibitor trials; updates clarify Repatha is the required prior biologic in specific age groups.
- Check the updated policy history for agent‑specific step changes (Evkeeza/Juxtapid: Repatha requirement clarified for ages ≥10).
- Document prior biologic trials per current policy version when submitting PA.
Step therapy and required prior medication trials
Step therapy and required prior medication trials vary by agent; historically Evkeeza and Juxtapid required trials of PCSK9 inhibitors (updated to Repatha only), and some brand agents require trials of generic alternatives before brand coverage.
- Document trials of generic alternatives (e.g., generic icosapent ethyl) prior to brand Vascepa when specified.
- Follow agent‑specific prior therapy sequences in the policy when requesting authorization.
Required documentation for prior authorization (statin trials specifics)
Required documentation for PA must include evidence of trials of specified high‑intensity statin therapy (e.g., atorvastatin ≥40 mg or rosuvastatin ≥20 mg daily for ≥8 weeks) with LDL‑C values remaining above policy thresholds, or documentation meeting the policy’s statin intolerance definitions.
- Provide lipid panel results showing LDL‑C before and after statin trial.
- If claiming statin intolerance, document rhabdomyolysis or muscle symptoms that resolved on discontinuation per policy definitions.
Required documentation — office notes and supporting records
Submit office visit notes documenting the diagnosis, relevant history, physical exam, lipid panels, and complete medication history to demonstrate medical necessity for the requested agent.
- Include office notes with diagnosis and rationale linking the patient’s lipid values to the requested therapy.
- Attach recent lipid panel and medication trial history to the PA submission.
Required medical record elements
Medical records must show the diagnosis, relevant history/physical exam findings, lipid panel results, and medication history to support that medical necessity criteria are met.
- Records should include dates and results of statin trials, prior biologic use, and LDL‑C values used to justify therapy.
- Include specialist consultation notes where required by the policy.
Required clinical documentation (baseline LDL‑C and therapy history)
Clinical documentation must include baseline LDL‑C and evidence of maximally tolerated statin therapy (or documented statin intolerance) as required for PCSK9‑targeting agents and inclisiran, consistent with trial populations.
- Baseline LDL‑C value and date.
- Evidence of statin regimen and duration (e.g., atorvastatin 40 mg daily × ≥8 weeks) or documentation of intolerance.
Clinical trial population details (inform operational selection)
Clinical trial population details (HoFH for Evkeeza; maximally tolerated statin requirement for Lerochol; FCS criteria for Tryngolza) should be used to operationally select candidates and document PA rationale.
- Evkeeza trial ELIPSE‑HoFH: IV evinacumab 15 mg/kg every 4 weeks in HoFH with LDL‑C reductions ~47%–49%.
- Lerochol trials required maximally tolerated statin background therapy.
- Tryngolza trials required fasting TG ≥880 mg/dL and genetic confirmation of FCS.
Tryngolza documentation requirements (genetic testing or qualifying clinical criteria)
Tryngolza (olezarsen) documentation must include genetic testing or a qualifying clinical diagnosis to confirm familial chylomicronemia syndrome; the policy specifies the drug must be prescribed by or in consultation with an endocrinologist and cannot be used in combination with Redemplo (plozasiran).
- Confirm FCS with genetic testing or qualifying clinical criteria and fasting TG ≥880 mg/dL per trial evidence.
- Include endocrinology prescription or consultation documentation and affirm no concurrent Redemplo use.
Specialist prescribing/consultation requirements
Certain agents require prescribing by or consultation with specific specialists; Tryngolza must be prescribed by or in consultation with an endocrinologist, and other agents (Evkeeza, Juxtapid) require cardiology/endocrinology or lipid specialist involvement per policy. Include specialty consult notes when applicable.
- Tryngolza: prescribed by or in consultation with an endocrinologist.
- Evkeeza and Juxtapid: prescribed by or in consultation with a cardiologist, endocrinologist, or physician focused on lipid disorders.
Site‑of‑service denial risk
If site‑of‑service criteria are not met for outpatient infusion or injection services, the request may be considered not medically necessary and denied; Leqvio is explicitly subject to site‑of‑service review.
- Outpatient hospital IV infusion department and hospital‑based outpatient settings may be considered not medically necessary if policy SOS criteria are unmet.
- Leqvio administration location is subject to site‑of‑service review per the policy history and site‑of‑service section.
Investigational / Not Medically Necessary uses
Use of listed medications for indications not enumerated in the Medical Necessity sections is considered investigational or not medically necessary and may be denied.
- All uses of agents for non‑listed indications are investigational per the policy.
- Check the Medical Necessity sections for the allowed indications before submitting PA.
Documentation‑related denial risk
Insufficient documentation—missing office visit notes, diagnosis, history, lipid panels, or medication history—can trigger denial; ensure the PA includes complete medical records demonstrating criteria are met.
- Submit office visit notes with diagnosis, relevant history, physical exam, lipid panels, and full medication history.
- Incomplete records may lead to requests being considered not medically necessary.
Potential denial risk for missing prior therapy documentation
Failure to document required prior therapy (e.g., lack of evidence of maximally tolerated statin trial or prior biologic trial where required) may result in denial; inclisiran and PCSK9 trials required patients to be on maximally tolerated statin and excluded current PCSK9 users.
- Document duration and dosing of statin trials (≥8 weeks high‑intensity statin) and LDL‑C values post‑trial.
- If policy requires prior Repatha use for certain ages/agents, document inadequate response or intolerance to Repatha.
No explicit prior auth triggers described here
No explicit prior authorization triggers or denial conditions are described in the cited chunk for this topic area.
Tryngolza prescriber and combination restrictions
Tryngolza requests not prescribed by or in consultation with an endocrinologist, or requests proposing concurrent use with Redemplo (plozasiran), may conflict with policy updates and risk denial.
- Policy states Tryngolza must be prescribed by or in consultation with an endocrinologist and must not be used together with Redemplo.
- Include endocrinologist consultation documentation and a statement that Redemplo is not being used concurrently.
Benefit limitations may trigger denial
Coverage is subject to member benefit limitations; services outside member benefit limits or not covered under the member’s contract may be denied—confirm benefit coverage prior to PA submission.
- Member contracts differ; consult the member benefit booklet or customer service to verify coverage.
- Policy does not apply to Medicare Advantage members—check plan applicability.
Billing Codes, Thresholds, and Key Numeric Criteria
| No codes listed |
Background, Definitions and Mechanisms
Familial hypercholesterolemia (FH) is an inherited disorder characterized by defective clearance of LDL cholesterol, leading to markedly elevated LDL-C levels and accelerated atherosclerosis. First-line management includes lifestyle modification and statin therapy; when LDL-C remains elevated despite maximally tolerated statin therapy, or when statin intolerance is documented, non-statin pharmacologic agents (including PCSK9-targeted therapies, inclisiran, ANGPTL3 inhibitors, bempedoic acid, and agents targeting triglycerides) are considered according to the agent-specific criteria in this policy.
Policy Revision History and Material Changes
Added coverage criteria for Lerochol (lerodalcibep-liga), Redemplo (plozasiran), and clarified Tryngolza (olezarsen) requirements including prescriber specialty and combination restrictions; Leqvio age/HoFH indications updated; Evkeeza age and prior-Repatha clarification updated.
Updated multiple agents' age and indication criteria: Leqvio HeFH age lowered to 12 years (later finalized in 2026), Evkeeza age reduced in prior updates, Praluent HeFH age lowered to 8 years, Repatha HeFH/HoFH age requirement clarified to 10 years.
Finalized updates to Leqvio (inclisiran) changing HeFH age requirement to 12 years and added HoFH coverage; clarified Evkeeza pediatric age and Repatha trial sequencing for older children.
Updated step therapy for Evkeeza and Juxtapid to require Repatha (evolocumab) rather than both Praluent and Repatha in prior rules.
Clarified prior biologic/step requirements across agents including explicit Repatha-first sequencing for certain pediatric age groups and historic removal of some initial authorization requirements.
Removed Lescol (fluvastatin) from the policy as discontinued (2025 update).
Removed coverage criteria for multiple discontinued products (Altoprev, Antara, Fenoglide, Niaspan, Pravachol, Triglide, Trilipix) and removed references to non-formulary exception reviews.
Policy restated general coverage-with-criteria stance and added agent-specific criteria effective 2026-08-01, including Lerochol and Redemplo additions and specific prescriber and diagnostic requirements for Tryngolza.
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