CurrentColorado Rocky Mountain Health PlansPolicy Program Number, 1 = 2025 P 3146-6

Step therapy for Nexletol and Nexlizet

Defines step therapy requirements for coverage of Nexletol (bempedoic acid) and Nexlizet (bempedoic acid/ezetimibe) for Colorado Rocky Mountain Health Plans members; applies to providers requesting prior authorization for these medications.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyStep therapy for Nexletol and Nexlizet

Policy CodePolicy Program Number, 1 = 2025 P 3146-6

Change TypeRemoved ezetimibe requirementclarified statin sections

Effective DateJan 17, 2026

Next Review Date

Key ActionObtain prior authorization and document a >=12-week trial of maximally tolerated statin therapy or evidence of statin intolerance/contraindication.

SourceLink

POLICY UPDATE CHANGES

Removed ezetimibe requirement.

Condensed low-intensity and moderate-intensity statin therapy sections and added footnote that statin requirement is supported by FDA labeling.

>=12 wksrequired trial duration of statin therapy prior to approval

12 moauthorization duration

2medications covered by program

2020-2025P&T approvals

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Coverage Criteria

Initial therapy — Nexletol or Nexlizet will be approved when ANY one of the following alternative pathways is met:

Nexletol or Nexlizet will be approved when ANY one of the following alternative pathways is met:

Main approval logic

Pathway 1: High-intensity statin: Patient has been receiving at least 12 consecutive weeks of high-intensity statin therapy and will continue high-intensity statin at maximally tolerated dose>= 12 weeks; high-intensity statin defined as atorvastatin 40-80 mg or rosuvastatin 20-40 mg
Pathway 2: Intolerant to high-intensity statin: Patient is unable to tolerate high-intensity statin (persistent intolerable symptoms >2 weeks: myalgia or myositis with CK <10x ULN) AND has been receiving at least 12 consecutive weeks of low- or moderate-intensity statin therapy and will continue at maximally tolerated dose>= 12 weeks; myositis CK <10x ULN
Low/moderate statin examples listed in policy (e.g., atorvastatin 10-20 mg, rosuvastatin 5-10 mg, simvastatin ≥10 mg, pravastatin ≥10 mg, lovastatin 20-40 mg, fluvastatin regimens, pitavastatin ≥1 mg)
Pathway 3: Intolerant to all statins or contraindication: Patient is unable to tolerate low-, moderate-, or high-intensity statins as evidenced by persistent intolerable symptoms (>2 weeks) OR has a labeled contraindication to all statins OR has experienced rhabdomyolysis or muscle symptoms with CK >10x ULNrhabdomyolysis CK >10x ULN
Any one of the subconditions (intolerance, contraindication, or rhabdomyolysis) satisfies this pathway

Supporting requirement (applies when pathway 1 or 2 used): When pathway 1 or 2 is selected, statin therapy must be continued at the maximally tolerated dose as specified in the pathway

High-intensity and low/moderate-intensity definitions are provided in policy

Coverage of Nexletol and Nexlizet may be affected by state mandates, federal regulatory requirements, and the individual member’s benefit plan. Other organizational policies and utilization management programs (for example, prior authorization rules) may also apply and could modify coverage determinations.

Use of Nexletol or Nexlizet without meeting the policy’s required step-therapy criteria is not recommended and is not eligible for approval. Specifically, members must meet one of the statin trial or documented statin intolerance/contraindication pathways (see policy). Failure to document the required duration and intensity of prior statin therapy or acceptable evidence of intolerance/contraindication may result in denial of the request.

Coding and Clinical Thresholds

Statin trial duration

Required durationAt least 12 consecutive weeks of statin therapy

Applies toHigh-intensity statin when following Pathway 1; low-/moderate-intensity when following Pathway 2 (also 12 weeks)

DocumentationProvider must document duration (>=12 consecutive weeks) and continuation at maximally tolerated dose

Myositis CK threshold

Myositis CK thresholdCK elevations < 10 times the upper limit of normal (ULN)

Clinical contextMyositis defined as muscle symptoms with CK elevations meeting the threshold above and persistent >2 weeks

Use in criteriaSupports Pathway 2 and Pathway 3 intolerance assessments

Rhabdomyolysis CK threshold

Rhabdomyolysis CK thresholdCK elevations > 10 times the upper limit of normal (ULN)

Clinical implicationHistory of rhabdomyolysis with CK >10x ULN qualifies for Pathway 3 (intolerance/contraindication)

DocumentationProvider should document prior rhabdomyolysis or CK >10x ULN with statin use

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Nexletol and Nexlizet. Approval is granted only when the member meets the documented statin trial or intolerance/contraindication criteria described below. Authorization will be issued for up to 12 months; state mandates, federal requirements, and member-specific benefit plans may affect coverage.

Program requires prior authorization before coverage for Nexletol (bempedoic acid) or Nexlizet (bempedoic acid/ezetimibe).
Approval duration: up to 12 months.

Step Therapy

Step Therapy Requirement

Step therapy is required: members must have a trial of maximally tolerated statin therapy before Nexletol or Nexlizet will be approved, unless there is documented statin intolerance or a contraindication to statins.

Required trial: at least 12 consecutive weeks of high-intensity statin therapy at maximally tolerated dose (e.g., atorvastatin 40-80 mg or rosuvastatin 20-40 mg) OR documented intolerance to high-intensity statin plus at least 12 consecutive weeks of a lower-intensity statin at maximally tolerated dose.
If patient cannot tolerate any statin (low-, moderate-, or high-intensity), provide documentation of intolerance, contraindication, rhabdomyolysis, or CK elevations > 10× ULN.

Documentation Required

Required Supporting Clinical Documentation / Denial Risk

Document the duration and intensity of prior statin therapy, or provide clear evidence of statin intolerance or contraindication. Missing documentation of the required 12-week statin trial or intolerance evidence may result in denial of the request.

Documentation must show at least 12 consecutive weeks of the specified statin intensity and that the statin will be continued at the maximally tolerated dose.
Acceptable evidence of intolerance includes persistent (more than 2 weeks) muscle symptoms (myalgia or myositis), CK elevations consistent with myositis (< 10× ULN) or rhabdomyolysis (CK > 10× ULN), or a labeled contraindication to all statins.
If the required statin trial is not documented, the authorization request is at risk of denial.

Initial Authorization Criteria

Initial authorization — Initial approval requires meeting one of the step therapy pathways below.

Initial approval requires meeting one of the step therapy pathways below.

Initial approval pathways: See coverage criteria for the three alternative pathways: (1) ≥12 weeks high-intensity statin and continuing; (2) intolerance to high-intensity plus ≥12 weeks low/moderate statin and continuing; (3) intolerance to all statins or labeled contraindication or prior rhabdomyolysis

Refer to policy for definitions of intolerance, CK thresholds, and examples of statin intensities

Reauthorization / Continuation Criteria

Reauthorization — Reauthorization conditions and duration (authorization duration 12 months).

Reauthorization conditions and duration.

Reauthorization: Authorization will be issued for 12 months; reauthorization may be approved based on previous claim/medication history, diagnosis codes, and/or claim logic per program automated processes.12 months

Medical necessity and/or supply limits may apply; state mandates and member-specific benefit plan coverage may affect approval

Step Therapy Table

Coverage requirement	Details / required documentation
Trial of maximally tolerated statin therapy (high-intensity preferred)
Patient has been receiving at least 12 consecutive weeks of high‑intensity statin therapy (e.g., atorvastatin 40–80 mg or rosuvastatin 20–40 mg) and will continue high‑intensity statin at maximally tolerated dose. Documentation: record of medication, dose, and dates showing ≥12 consecutive weeks.
Intolerance to high‑intensity statin with trial of low/moderate statin
Patient unable to tolerate high‑intensity statin (persistent intolerable symptoms >2 weeks) AND has been receiving at least 12 consecutive weeks of low‑ or moderate‑intensity statin therapy (examples: atorvastatin 10–20 mg, rosuvastatin 5–10 mg, simvastatin ≥10 mg, pravastatin ≥10 mg, lovastatin 20–40 mg, fluvastatin regimens, pitavastatin ≥1 mg) and will continue at maximally tolerated dose. Documentation: symptom description, CK if applicable, and medication history showing ≥12 consecutive weeks.
Intolerance/contraindication to all statins or prior rhabdomyolysis
Patient unable to tolerate low, moderate, or high‑intensity statins OR has a labeled contraindication to all statins OR has experienced rhabdomyolysis (CK >10× ULN). Documentation: clinical notes documenting intolerance/contraindication or CK results showing >10× ULN.

Definitions

High-intensity statin

DefinitionHigh-intensity statin = atorvastatin 40–80 mg or rosuvastatin 20–40 mg

Role in policyPreferred intensity for initial 12-week trial (Pathway 1) and must be continued at maximally tolerated dose

DocumentationProvider must document use of a high-intensity statin and duration when applying Pathway 1

Low-/Moderate-intensity statin

ExamplesAtorvastatin 10–20 mg; rosuvastatin 5–10 mg; simvastatin ≥ 10 mg; pravastatin ≥ 10 mg

Policy useUsed for the required 12-week low-/moderate-intensity trial when patient cannot tolerate high-intensity statin (Pathway 2)

ContinuationMust be continued at maximally tolerated dose if relying on this pathway