CurrentNeighborhood Health Plan of Rhode IslandPolicy PCSK9i 2574-A SGM P2022

PCSK9 inhibitor (evolocumab, alirocumab) coverage criteria

Covers authorization criteria for PCSK9 inhibitor (PCSK9i) use for members with ASCVD, primary hyperlipidemia, or familial hypercholesterolemia when approval criteria are met and no exclusions to therapy exist. Applies to Neighborhood Health Plan of Rhode Island members under this payer policy.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPCSK9 inhibitor (evolocumab, alirocumab) coverage criteria

Policy CodePolicy PCSK9i 2574-A SGM P2022

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documentation of indication-specific LDL-C values and evidence of maximally tolerated statin therapy or statin intolerance.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauth duration

≥70 mg/dLASCVD LDL-C threshold

≥190 mg/dLUntreated LDL-C (adults)

≥100 mg/dLCurrent LDL-C threshold

Coverage Criteria for PCSK9 Inhibitors

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.

A. Clinical atherosclerotic cardiovascular disease (ASCVD)

Authorization of 12 months may be granted for treatment of ASCVD when ALL of the following are met

ASCVD criteria: 1. The member has a history of clinical atherosclerotic cardiovascular disease or has experienced a cardiovascular event; 2. The member has a current LDL-C level greater than, or equal to, 70 mg/dL; 3. The member is receiving maximally tolerated statin therapy or is statin intolerantsee node text

12-month authorization

B. Primary hyperlipidemia

Authorization of 12 months may be granted for treatment of primary hyperlipidemia when ALL of the following are met

Primary hyperlipidemia criteria: 1. The member had an untreated (before any lipid lowering therapy) LDL-C level greater than, or equal to, 190 mg/dL; 2. The member has a current LDL-C level greater than, or equal to, 100 mg/dL; 3. The member is receiving maximally tolerated statin therapy or is statin intolerantsee node text

12-month authorization

C. Familial hypercholesterolemia

Authorization of 12 months may be granted for treatment of familial hypercholesterolemia (HeFH or HoFH) when ALL of the following are met

Familial hypercholesterolemia criteria: 1. The member meets one of the following: (a) The member is 18 years of age or older and had an untreated (before any lipid lowering therapy) LDL-C level greater than, or equal to, 190 mg/dL OR (b) The member is less than 18 years of age and had an untreated (before any lipid lowering therapy) LDL-C level greater than, or equal to, 160 mg/dL; 2. The member has a current LDL-C level greater than, or equal to, 100 mg/dL; 3. The member is receiving maximally tolerated statin therapy or is statin intolerantsee node text

12-month authorization

III. Continuation of therapy

Continuation of therapy

Continuation criteria: Authorization of 12 months may be granted for members who are continuing therapy with a PCSK9iN/A

Continuation requires prior authorization per policy

Indications other than the FDA-approved indications and compendial uses listed in this policy are considered experimental/investigational and not medically necessary. The FDA-approved indications include: members with established atherosclerotic cardiovascular disease (ASCVD), members with an untreated LDL-C ≥ 190 mg/dL, and members with familial hypercholesterolemia.

All indications not specified as FDA-approved indications or recognized compendial uses in this policy are considered not medically necessary (experimental/investigational) and may be denied. The policy’s FDA-approved indications are limited to: established ASCVD; untreated LDL-C ≥ 190 mg/dL; and familial hypercholesterolemia.

Thresholds and Definitions

inv-07: ASCVD LDL-C threshold — LDL-C ≥ 70 mg/dL

ASCVD LDL-C thresholdCurrent LDL-C ≥ 70 mg/dL for members with clinical ASCVD

Authorization durationPrior authorization may be granted for 12 months when criteria are met

Statin requirementMember must be receiving maximally tolerated statin therapy or be statin intolerant

inv-08: Current LDL-C threshold for primary hyperlipidemia and familial hypercholesterolemia — LDL-C ≥ 100 mg/dL

Current LDL-C thresholdCurrent LDL-C ≥ 100 mg/dL for primary hyperlipidemia and familial hypercholesterolemia

Untreated LDL-C requirement (primary hyperlipidemia)Untreated LDL-C ≥ 190 mg/dL (before any lipid‑lowering therapy)

Statin requirementMember must be receiving maximally tolerated statin therapy or be statin intolerant

inv-09: Untreated LDL-C thresholds — Adults ≥190 mg/dL; Children (<18) for FH ≥160 mg/dL

Untreated LDL-C — adultsUntreated LDL-C ≥ 190 mg/dL (before any lipid‑lowering therapy)

Untreated LDL-C — children (<18) for FHUntreated LDL-C ≥ 160 mg/dL (before any lipid‑lowering therapy)

ContextUntreated LDL-C is used as an eligibility threshold for primary hyperlipidemia and familial hypercholesterolemia

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required for covered indications — Prior authorization for PCSK9 inhibitors may be granted for up to 12 months when the member meets the specified clinical criteria for one of the FDA‑approved indications: clinical atherosclerotic cardiovascular disease (ASCVD) with current LDL‑C ≥70 mg/dL; primary hyperlipidemia with untreated LDL‑C ≥190 mg/dL and current LDL‑C ≥100 mg/dL; or familial hypercholesterolemia (HeFH or HoFH) meeting age-specific untreated LDL‑C thresholds and current LDL‑C ≥100 mg/dL. Continuation of therapy may also be authorized for 12 months when the member is already receiving a PCSK9 inhibitor.

Authorization duration: 12 months for initial and continuation therapy
Covered indications: ASCVD; primary hyperlipidemia; familial hypercholesterolemia

Documentation Required

Statin Therapy Requirement

Statin therapy requirement — Members must be receiving maximally tolerated statin therapy or have documented statin intolerance as part of the criteria for authorization for all covered indications.

Maximally tolerated statin therapy or documented intolerance required for ASCVD, primary hyperlipidemia, and familial hypercholesterolemia

Documentation Required

Required Clinical Documentation

Required clinical documentation — Documentation must demonstrate the member meets the specific indication criteria: for ASCVD, a history of clinical ASCVD or cardiovascular event and current LDL‑C ≥70 mg/dL; for primary hyperlipidemia, an untreated LDL‑C ≥190 mg/dL and current LDL‑C ≥100 mg/dL; for familial hypercholesterolemia, age‑specific untreated LDL‑C thresholds (≥190 mg/dL if ≥18 years; ≥160 mg/dL if <18 years) and current LDL‑C ≥100 mg/dL. Include lab results and evidence of prior statin use or intolerance.

ASCVD: history of clinical ASCVD or cardiovascular event; current LDL‑C ≥70 mg/dL
Primary hyperlipidemia: untreated LDL‑C ≥190 mg/dL; current LDL‑C ≥100 mg/dL
Familial hypercholesterolemia: untreated LDL‑C thresholds by age; current LDL‑C ≥100 mg/dL
Labs and documentation of statin therapy or documented intolerance

Denial Risk

Non‑covered Indications

Non‑covered indications — Requests for uses that are not FDA‑approved (or supported by compendia) for PCSK9 inhibitors are considered experimental/investigational and are not medically necessary. Examples include indications outside ASCVD, primary hyperlipidemia, or familial hypercholesterolemia, and any other off‑label uses.

All indications not listed as FDA‑approved are not covered
Examples: any off‑label use outside ASCVD, primary hyperlipidemia, or familial hypercholesterolemia

Definitions

inv-15: Untreated LDL-C — LDL-C level measured before any lipid-lowering therapy, used as an eligibility threshold (e.g., ≥190 mg/dL for adults; ≥160 mg/dL for chi...)

DefinitionUntreated LDL-C = LDL-C level measured before any lipid‑lowering therapy

Adult eligibility exampleUsed as an eligibility threshold (e.g., ≥190 mg/dL for adults)

Pediatric FH exampleUsed as an eligibility threshold (e.g., ≥160 mg/dL for children <18 in familial hypercholesterolemia)

inv-16: HeFH / HoFH — Heterozygous familial hypercholesterolemia (HeFH) and homozygous familial hypercholesterolemia (HoFH) as familial forms of high LDL-C con...

HeFH / HoFHHeterozygous familial hypercholesterolemia (HeFH) and homozygous familial hypercholesterolemia (HoFH) are familial forms of high LDL‑C considered under the familial hypercholesterolemia indication

Age-specific untreated LDL-C thresholdsAdults (≥18) require untreated LDL‑C ≥190 mg/dL; children (<18) require untreated LDL‑C ≥160 mg/dL

Current LDL-C requirementCurrent LDL‑C ≥100 mg/dL in addition to untreated LDL‑C threshold for FH approvals

OpenPayer

PCSK9 inhibitor (evolocumab, alirocumab) coverage criteria

Coverage Criteria for PCSK9 Inhibitors

Thresholds and Definitions

Provider Requirements and Prior Authorization

Background

Definitions