CurrentMass General Brigham Health PlanPolicy N/A

PCSK9 Inhibitors: Praluent (alirocumab) Repatha (evolocumab)

Prior authorization and coverage criteria for Praluent (alirocumab) and Repatha (evolocumab) under the Mass General Brigham Health Plan pharmacy benefit, including initial and continuation criteria for primary hyperlipidemia, HeFH, HoFH, and ASCVD.

Policy Summary

PayerMass General Brigham Health Plan

PolicyPCSK9 Inhibitors: Praluent (alirocumab) Repatha (evolocumab)

Policy CodePolicy N/A

Change TypeRevised coverage criteria and reauthorization requirements

Effective Date09/01/2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis, at least 12 weeks of highest tolerable statin therapy (or statin intolerance/contraindication), and recent LDL-C labs.

SourceLink

POLICY UPDATE CHANGES

Updated initial criteria to require diagnosis and trial/failure of at least 12 weeks on highest tolerable statin dose, intolerance to at least two statins, or contraindication to all statins; specified baseline LDL while on statin therapy or allowance for members already on PCSK9 with LDL within past 12 months within normal limits.

Updated HoFH criteria to require diagnosis confirmed by genetic mutations or untreated LDL >400 mg/dL plus either xanthoma before age 10 or evidence of HeFH in both parents; age requirement of 10 years or older noted; allowed either receiving other lipid-lowering therapy or unable to take such therapy.

Updated continuation (reauthorization) criteria to require demonstrated reduction in LDL-C from baseline and continuation (or inability to take) other lipid-lowering therapy; initial approval length increased to 6 months.

6 monthsInitial approval length

12 monthsReauthorization length

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Coverage Criteria

Praluent - Initial Therapy

Covered when ALL of the following are met

Praluent initial - primary hyperlipidemia/HeFH/ASCVD: a) Member has a diagnosis of primary hyperlipidemia, heterozygous familial hypercholesterolemia (HeFH), or atherosclerotic cardiovascular disease (ASCVD). b) For HeFH pediatric indication, member is 8 years of age or older. c) Member has met ONE of the following statin requirements: i) has been receiving at least 12 consecutive weeks of highest tolerable dose of statin therapy; OR ii) has a contraindication to all statins; OR iii) is statin intolerant as evidenced by inability to tolerate at least two statins, with at least one started at the lowest starting daily dose, due to intolerable symptoms or clinically significant biomarker changes (e.g., liver function or creatine kinase). d) Member requires ≥25% LDL-C reduction to achieve goal AND meets ONE of the following on maximally tolerated lipid‑lowering therapy (e.g., statins) within the past 120 days: i) LDL‑C ≥70 mg/dL with ASCVD; OR ii) LDL‑C ≥100 mg/dL without ASCVD. Alternatively, member may already be receiving PCSK9 therapy as adjunct to maximally tolerated lipid‑lowering therapy with LDL‑C values drawn within the past 12 months while on therapy within normal limits.see LDL thresholds

Prescriber must document statin trial/intolerance and LDL labs.

Repatha - Initial Therapy

Covered when ALL of the following are met

Repatha initial - primary hyperlipidemia/HeFH/ASCVD: a) Member has a diagnosis of primary hyperlipidemia, heterozygous familial hypercholesterolemia (HeFH), or atherosclerotic cardiovascular disease (ASCVD). b) For HeFH pediatric indication, member is 10 years of age or older. c) Member has met ONE of the following statin requirements: i) has been receiving at least 12 consecutive weeks of highest tolerable dose of statin therapy; OR ii) is statin intolerant as evidenced by inability to tolerate at least two statins, with at least one started at the lowest starting daily dose, due to intolerable symptoms or clinically significant biomarker changes; OR iii) has a contraindication to all statins. d) Member requires ≥25% LDL‑C reduction to achieve goal AND meets ONE of the following while on maximally tolerated lipid‑lowering therapy within the last 120 days: i) LDL‑C ≥70 mg/dL with ASCVD; OR ii) LDL‑C ≥100 mg/dL without ASCVD. e) Where specified, trial and failure, intolerance, or contraindication to Praluent is required before Repatha. Alternatively, member may have been receiving PCSK9 therapy as adjunct to maximally tolerated lipid‑lowering therapy with LDL‑C values drawn within the past 12 months while on therapy within normal limits.see LDL thresholds

Praluent trial requirement may apply per criteria.

Homozygous Familial Hypercholesterolemia (HoFH) - Initial Therapy

Covered when ONE of the diagnosis confirmation pathways is met

HoFH diagnosis confirmation: Diagnosis of homozygous familial hypercholesterolemia (HoFH) confirmed by ONE of the following: a) genetic confirmation of two pathogenic mutations in LDLR, ApoB, PCSK9, or LDLRAP1 (ARH); OR b) untreated LDL‑C >400 mg/dL PLUS either i) xanthoma before 10 years of age OR ii) evidence of heterozygous familial hypercholesterolemia (HeFH) in both parents.untreated LDL-C >400 mg/dL

Member should be receiving other lipid‑lowering therapy (e.g., statin, ezetimibe) or be unable to take such therapy; pediatric/age thresholds apply per product labeling.

Continuation of Therapy

Reauthorization approved when ALL of the following are met

Continuation of therapy - primary hyperlipidemia/HeFH/ASCVD: 1) Member demonstrates positive clinical response to therapy as evidenced by reduction in LDL‑C levels from baseline. 2) Member continues to receive other lipid‑lowering therapy (e.g., statins, ezetimibe) at the maximally tolerated dose OR is unable to take other lipid‑lowering therapy (e.g., statins, ezetimibe).

Reauthorization periods are 12 months (initial approval length noted elsewhere as 6 months).

Authorization may be granted for members who are new to the plan within the past 90 days and who are currently receiving the requested medication. This exception does not apply when the product was obtained as samples or through a manufacturer's patient assistance program.

Requests that do not meet the specific diagnosis and treatment requirements are not supported. Specifically, use of Praluent or Repatha outside the specified diagnoses (primary hyperlipidemia, HeFH, HoFH, or ASCVD) is not covered. Prior authorization will be denied when the provider fails to document the required statin trial, statin intolerance/contraindication, or when required LDL-C laboratory values within the specified timeframe are not provided.

For Repatha, an additional prerequisite in some situations is documentation of trial and failure, intolerance, or contraindication to Praluent before Repatha will be approved. Manufacturer samples or medications obtained via patient assistance programs do not qualify for the "currently receiving" exception described for members new to the plan.

Laboratory Thresholds and Key Clinical Parameters

LDL-C thresholds and timing

LDL-C threshold with ASCVDLDL-C ≥70 mg/dL while on maximally tolerated lipid‑lowering therapy (lab drawn within past 120 days)

LDL-C threshold without ASCVDLDL-C ≥100 mg/dL while on maximally tolerated lipid‑lowering therapy (lab drawn within past 120 days)

HoFH untreated thresholdUntreated LDL-C >400 mg/dL supports HoFH diagnosis

Timing window for LDL labsLDL-C values must be drawn within the past 120 days; alternatively, for members already receiving PCSK9 adjunct therapy, LDL values within the past 12 months while on therapy may be acceptable

Statin trial requirements

Required statin trial durationAt least 12 consecutive weeks on the highest tolerable dose of statin therapy

Provider Actions and Documentation Requirements

Prior Authorization

Prior authorization required for Praluent and Repatha

Prior authorization is required for Praluent (alirocumab) and Repatha (evolocumab) under the pharmacy benefit. Authorization may be granted for members new to the plan within the past 90 days who are currently receiving the requested medication (excluding samples or manufacturer patient assistance program supplies).

Step Therapy

Step therapy — statin trial required; Praluent trial may be required for Repatha

Members must have trial and failure, intolerance, or contraindication to statins (at least 12 consecutive weeks on the highest tolerable dose, or inability to tolerate ≥2 statins with one started at the lowest dose, or contraindication to all statins). For Repatha, the criteria additionally specify trial and failure, intolerance, or contraindication to Praluent in some situations.

Statin requirement: ≥12 consecutive weeks on highest tolerable statin dose OR statin intolerance (unable to tolerate ≥2 statins, one started at lowest dose) OR contraindication to all statins (chunks 7, 9).
Repatha-specific: trial and failure, intolerance, or contraindication to Praluent may be required per Repatha criteria (chunk 9).

Definitions

PCSK9 inhibitors

DefinitionPCSK9 inhibitors are monoclonal antibodies (eg, alirocumab, evolocumab) that lower LDL‑C as adjunctive therapy to diet and other LDL‑lowering agents

Mechanism/roleThey inhibit proprotein convertase subtilisin/kexin type 9 (PCSK9), increasing LDL receptor availability and lowering circulating LDL‑C

Clinical useUsed to reduce LDL‑C and reduce risk of cardiovascular events in adults with established CVD and for primary hyperlipidemia including familial forms; some agents have pediatric indications

Clinical diagnosis definitions

HeFHHeterozygous familial hypercholesterolemia — primary hyperlipidemia due to one mutated allele; an indicated diagnosis for PCSK9 therapy (pediatric age thresholds vary by product)

HoFH

Background

Praluent (alirocumab) and Repatha (evolocumab) are PCSK9 inhibitors indicated as adjunctive lipid-lowering therapies for primary hyperlipidemia, heterozygous familial hypercholesterolemia (HeFH), and for secondary prevention in atherosclerotic cardiovascular disease (ASCVD). These monoclonal antibodies lower low-density lipoprotein cholesterol (LDL-C) and are used when patients require additional LDL-C reduction despite maximally tolerated statin therapy, or when statins are contraindicated or not tolerated.

Clinical use under this policy requires documentation of diagnosis, adequate trial of maximally tolerated statin therapy (or documented statin intolerance/contraindication), and recent LDL-C values to confirm the need for additional LDL-C lowering as specified in the criteria.

Revision History

2025-09-01policy_effective_dateLatest

Material revisions effective 09/01/2025: operationalized prior statin trial requirements (>=12 weeks on highest tolerable dose or intolerance/contraindication), specified baseline LDL documentation rules including allowance for members already on PCSK9 adjunct therapy with LDL within past 12 months, clarified HoFH diagnostic criteria and pediatric age threshold, and extended initial approval length to 6 months.

2025-05-14policy_review_update

05/14/2025 P&T review updated initial criteria to require diagnosis and a prior statin trial/intolerance/contraindication, clarified HoFH confirmation pathways and age criteria, changed reauthorization evidence and increased initial approval length; these updates take effect 09/01/2025.