CurrentColorado Rocky Mountain Health PlansPolicy 2026 P 2062-22

Praluent (alirocumab) prior authorization / medical necessity

Prior authorization and medical necessity criteria for coverage of Praluent (alirocumab) for primary hyperlipidemia (including HeFH), ASCVD, and HoFH; includes required trials/intolerances, LDL-C thresholds, combination exclusions, documentation and authorization duration. Effective for UnitedHealthcare Pharmacy Clinical Pharmacy Programs.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyPraluent (alirocumab) prior authorization / medical necessity

Policy CodePolicy 2026 P 2062-22

Change TypeCriteria revisions and clarifications (material)

Effective DateMay 1, 2026

Next Review Date

Key ActionObtain prior authorization and document statin trials, Repatha failure/contraindication/intolerance, and LDL-C values per criteria; approvals issued for 12 months.

POLICY UPDATE CHANGES

Removed ezetimibe trial requirement for primary hyperlipidemia and ASCVD.

Lowered LDL-C initiation threshold from 100 to 55 mg/dL (previous change in 2/2025).

Added criterion for patients less than 10 years of age to align with pediatric label (5/2024).

Added exclusion that Praluent is not to be used in combination with Leqvio (inclisiran).

Simplified diagnosis requirements for HeFH, ASCVD, and primary hyperlipidemia and removed diet requirement.

Praluent is typically excluded from coverage; plan-specific exclusion/try/fail criteria may apply.

12 monthsAuthorization duration

>=55 mg/dLLDL-C initiation threshold

Required statin trial duration

2015-2026P&T review history

Coverage Summary

Coverage is for Praluent (alirocumab) as prior authorization/medical necessity for primary hyperlipidemia (including HeFH), atherosclerotic cardiovascular disease (ASCVD), and homozygous familial hypercholesterolemia (HoFH). Authorization is issued for 12 months. Note that plan-specific exclusions or step/try-fail requirements may apply and Praluent is typically excluded for some plans; check member-specific benefits.

Key thresholds and durations

LDL-C initiation threshold>= 55 mg/dL

Statin trial duration>= 12 consecutive weeks

Statin intolerance symptom duration>> 2 weeks

Authorization duration12 months

Initial Therapy Criteria — Primary Hyperlipidemia (including HeFH) and ASCVD

Primary Hyperlipidemia (including HeFH) and ASCVD - Initial Approval

Praluent will be approved based on ALL of the following criteria:

Statin therapy requirement (ONE of)

Patient has been receiving at least 12 consecutive weeks of high-intensity statin therapy (i.e., atorvastatin 40-80 mg, rosuvastatin 20-40 mg) and will continue to receive a high-intensity statin at maximally tolerated dose
Must document continuation at maximally tolerated dose
If not on high-intensity statin
- ALL of the following
  - Myalgia (muscle symptoms without creatine kinase [CK] elevations)
  - Myositis (muscle symptoms with CK elevations < 10 times upper limit of normal [ULN])

Initial Therapy Criteria — Homozygous Familial Hypercholesterolemia (HoFH)

Continuation Therapy Criteria

Authorizations are issued for 12 months. Continuation/renewal requires documentation of ongoing treatment at the maximally tolerated statin dose (or documented statin intolerance per defined criteria) and recent LDL-C monitoring meeting threshold requirements; approval may be granted based on prior claim/medication history, diagnosis codes, and/or LDL-C values per automated processes.

Combination / Exclusion Rules

Payer-level exclusions may apply: Praluent is typically excluded from coverage for some plans and plan-specific exclusions or step/try-fail criteria may be in place. Always check member-specific benefits for coverage status.

Provider Actions / Prior Authorization

Prior Authorization

Prior authorization required

Authorization required and will be issued for 12 months when criteria met; approval may be based on prior claim/medication history, diagnosis codes and/or claim logic per automated UnitedHealthcare processes.

Documentation Required

Document trials, intolerance and LDL-C

Document diagnosis and dates and reasons for Repatha (evolocumab) failure, contraindication, or intolerance when claimed; document statin trial durations and maximally tolerated doses and include LDL-C values (thresholds specified).

Applicable Codes

No specific billing codes listed in documentmixed

No codes listed

Clinical Evidence & References

Key references include the Praluent package insert (October 2025) and major guideline and society publications (ACC/AHA and specialty society guidelines from 2013–2023 with selected updates through 2025), as cited in the policy. The policy aligns coverage criteria with these guideline and label updates.

Other quantitative policy metrics

P&T review history (selected approvals)Multiple P&T approvals listed 5/2015–2/2026

Authorization duration (supporting)12 months (authorization will be issued for 12 months)

LDL-C threshold (supporting)>=55 mg/dL

Background

Praluent (alirocumab) is a PCSK9 inhibitor indicated to reduce major adverse cardiovascular events and lower LDL-C in adults with hypercholesterolemia, adults and pediatric patients aged 8 years and older with HeFH, and adults with HoFH. The policy includes a pediatric initiation pathway (including allowances for patients under 10 years to align with the pediatric label), aligns criteria with guideline and label updates (including statin trial/intolerance pathways), and requires genetic confirmation documentation for HoFH per the HoFH criteria.

Glossary:

- High-intensity statin: atorvastatin 40–80 mg or rosuvastatin 20–40 mg.

- Low/moderate-intensity statin examples: atorvastatin 10–20 mg, rosuvastatin 5–10 mg, simvastatin ≥10 mg, pravastatin ≥10 mg, lovastatin 20–40 mg, fluvastatin formulations, pitavastatin ≥1 mg.

- Statin intolerance (persistent): intolerable and persistent symptoms lasting > 2 weeks (e.g., myalgia or myositis as defined).

Revision History

2/2026revisedLatest

Removed ezetimibe trial requirement for primary hyperlipidemia and ASCVD.

2/2026revisedLatest

LDL-C initiation threshold lowered from 100 to 55 mg/dL per ACC guidance (change noted previously 2/2025).

2/2025revised

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyPraluent (alirocumab) prior authorization / medical necessity

Policy CodePolicy 2026 P 2062-22

Change TypeCriteria revisions and clarifications (material)

Effective DateMay 1, 2026

Next Review Date

Key ActionObtain prior authorization and document statin trials, Repatha failure/contraindication/intolerance, and LDL-C values per criteria; approvals issued for 12 months.

On This Page

Patient has been receiving at least 12 consecutive weeks of low-intensity or moderate-intensity statin therapy (i.e., atorvastatin 10-20 mg, rosuvastatin 5-10 mg, simvastatin ≥ 10 mg, pravastatin ≥ 10 mg, lovastatin 20-40 mg, fluvastatin XL 80 mg, fluvastatin 20-40 mg up to 40 mg twice daily or pitavastatin ≥ 1 mg) and will continue to receive a low- or moderate-intensity statin at maximally tolerated dose

Must document continuation at maximally tolerated dose

If unable to tolerate low/moderate and high-intensity statins

One of the following intolerable and persistent (> 2 weeks) symptoms for low/moderate- and high-intensity statins: Myalgia (muscle symptoms without CK elevations) OR Myositis (muscle symptoms with CK elevations < 10 times ULN)
Patient has a contraindication to all statins
Patient has experienced rhabdomyolysis or muscle symptoms with statin treatment with CK elevations > 10 times ULN

Patient has LDL-C greater than or equal to 55 mg/dL>= 55 mg/dL

Special pediatric / Repatha trial exceptions (ONE of)

Patient is less than 10 years of age
History of failure, contraindication, or intolerance to Repatha (evolocumab); document date of trial and reason for therapeutic failure, contraindication, or intolerance

Billing Rule

Combination exclusions (billing risk)

Do not use Praluent in combination with other PCSK9 inhibitors (e.g., Repatha, Lerochol) or with Leqvio (inclisiran); for HoFH do not combine with Repatha or Juxtapid (lomitapide). Claims for prohibited combinations risk denial.

Step Therapy

Step therapy / supply limits may apply

Supply limits and step therapy may be in place; plan-specific exclusions may apply and Praluent is typically excluded from coverage for some plans—check member-specific benefits.

Lowered LDL-C threshold from 100 to 55 mg/dL (administrative/clinical clarification).

5/2024added

Added pediatric initiation pathway: criterion for patients less than 10 years of age to align with pediatric label (patients aged 8 years and older with HeFH).

6/2023added

Added exclusion: Praluent is not to be used in combination with Leqvio (inclisiran).

6/2021added

Noted that Praluent is typically excluded from coverage; plan-specific exclusions/try/fail criteria may apply and coverage may require checking member-specific benefits.