11 — Prior Authorization

Table of Contents

1.0 Overview

PCSK9 inhibitors (evolocumab, alirocumab) and inclisiran typically require prior authorization (PA) from the patient’s insurance plan before coverage is approved. This document provides templates, documentation checklists, and guidance for navigating the PA process at The Sandusky Dyslipidemia Model clinic.

2.0 General PA Documentation Requirements

Most insurance plans require the following elements regardless of the specific agent:

2.1 Documentation Checklist

# Element Details
1 Diagnosis Primary diagnosis with ICD-10 code(s)
2 Risk category ASCVD, FH, or high-risk primary prevention with documentation
3 Baseline lipid values LDL-C, total cholesterol, HDL-C, triglycerides (untreated or pre-treatment)
4 Current lipid values On maximally tolerated therapy
5 Statin trial documentation Agent, dose, duration, response (% LDL-C reduction), tolerability
6 Ezetimibe trial documentation Dose, duration, response, tolerability
7 Statin intolerance documentation (if applicable) Symptoms, CK levels (if checked), rechallenge attempt and outcome
8 Clinical rationale Why this specific agent is needed per guidelines
9 Prescriber information NPI, DEA (if required), specialty

2.2 Common ICD-10 Codes

Code Description Use When
E78.01 Familial hypercholesterolemia Confirmed or clinically diagnosed FH
E78.00 Pure hypercholesterolemia, unspecified Primary hypercholesterolemia without FH
E78.2 Mixed hyperlipidemia Combined hyperlipidemia
E78.5 Dyslipidemia, unspecified General dyslipidemia
I25.10 Atherosclerotic heart disease of native coronary artery CAD/ASCVD
I25.110 Atherosclerotic heart disease with unstable angina ACS history
I63.9 Cerebral infarction, unspecified History of ischemic stroke
I73.9 Peripheral vascular disease, unspecified PAD
Z87.74 Personal history of transient ischemic attack Prior TIA

3.0 PCSK9 Inhibitor Prior Authorization

3.1 Typical Insurance Criteria for PCSK9i Approval

Most commercial and Medicare plans require:

Criterion Typical Requirement
Diagnosis Established ASCVD or HeFH or primary prevention at very high risk
Statin trial Documented trial of maximally tolerated statin for ≥ 3 months (or documented intolerance)
Ezetimibe trial Documented trial of ezetimibe for ≥ 3 months (or documented contraindication/intolerance)
Current LDL-C Still above goal despite maximally tolerated statin + ezetimibe
Prescriber Cardiologist, endocrinologist, or lipidologist (some plans)

3.2 Letter of Medical Necessity Template — PCSK9 Inhibitor 

LETTER OF MEDICAL NECESSITY — PCSK9 INHIBITOR

Date: [DATE]
Patient: [PATIENT NAME]
DOB: [DOB]
Insurance ID: [INSURANCE ID]
Prescriber: [PROVIDER NAME], [CREDENTIALS]
NPI: [NPI]
Clinic: The Sandusky Dyslipidemia Model

DIAGNOSIS:
☐ Atherosclerotic cardiovascular disease (ASCVD)
  - Specific: [MI / Stroke / PAD / Revascularization / Other]
  - Date of event: [DATE]
  - ICD-10: [CODE]
☐ Heterozygous familial hypercholesterolemia (HeFH)
  - DLCN Score: [SCORE] / Genetic confirmation: [YES/NO]
  - ICD-10: E78.01
☐ High-risk primary prevention
  - 10-year ASCVD risk: [X]% (PREVENT)
  - Risk enhancers: [LIST]

LIPID VALUES:
Baseline (untreated or off therapy):
  LDL-C: [X] mg/dL | Total-C: [X] mg/dL | HDL-C: [X] mg/dL
  TG: [X] mg/dL | ApoB: [X] mg/dL (if available)
  Date: [DATE]

Current (on maximally tolerated therapy):
  LDL-C: [X] mg/dL | Total-C: [X] mg/dL | HDL-C: [X] mg/dL
  TG: [X] mg/dL | ApoB: [X] mg/dL (if available)
  Date: [DATE]

STATIN THERAPY HISTORY:
Statin 1: [AGENT] [DOSE] for [DURATION]
  Response: LDL-C reduced to [X] mg/dL ([X]% reduction)
  Tolerability: [TOLERATED / INTOLERANT — describe symptoms]

Statin 2 (if applicable): [AGENT] [DOSE] for [DURATION]
  Response: [X]
  Tolerability: [X]

☐ Patient is statin-intolerant (see attached documentation)
  - Statin(s) attempted: [LIST]
  - Symptoms: [DESCRIBE]
  - Rechallenge: [ATTEMPTED / NOT TOLERATED]

EZETIMIBE TRIAL:
  Ezetimibe 10 mg daily for [DURATION]
  Response: LDL-C reduced from [X] to [X] mg/dL
  Tolerability: [TOLERATED / INTOLERANT]

CURRENT REGIMEN:
  [LIST ALL CURRENT LIPID-LOWERING MEDICATIONS WITH DOSES]

GUIDELINE-BASED LDL-C TARGET: < [55 / 70 / 100] mg/dL
CURRENT LDL-C: [X] mg/dL (above target by [X] mg/dL)

CLINICAL RATIONALE:
The patient has [DIAGNOSIS] with an LDL-C of [X] mg/dL despite
maximally tolerated statin therapy and ezetimibe. Per the 2026
ACC/AHA/Multisociety Guideline on the Management of Dyslipidemia,
the recommended LDL-C target is < [X] mg/dL. A PCSK9 inhibitor is
medically necessary to achieve guideline-recommended lipid targets
and reduce the patient's risk of cardiovascular events.

[Additional clinical context: risk enhancers, ApoB level, Lp(a)
level, CAC score, prior cardiovascular events, etc.]

REQUESTED MEDICATION:
☐ Evolocumab (Repatha) 140 mg SC every 2 weeks
☐ Evolocumab (Repatha) 420 mg SC monthly
☐ Alirocumab (Praluent) 75 mg SC every 2 weeks
☐ Alirocumab (Praluent) 150 mg SC every 2 weeks

Prescriber Signature: _________________________
Date: [DATE]

4.0 Inclisiran Prior Authorization

4.1 Typical Insurance Criteria for Inclisiran Approval

Criterion Typical Requirement
Diagnosis Established ASCVD or HeFH
Statin trial Documented maximally tolerated statin trial (or intolerance)
Ezetimibe trial Documented trial (some plans require)
Current LDL-C Above goal on maximally tolerated therapy
Administration Must be administered by a healthcare provider (buy-and-bill)

4.2 Letter of Medical Necessity Template — Inclisiran 

LETTER OF MEDICAL NECESSITY — INCLISIRAN (LEQVIO)

Date: [DATE]
Patient: [PATIENT NAME]
DOB: [DOB]
Insurance ID: [INSURANCE ID]
Prescriber: [PROVIDER NAME], [CREDENTIALS]
NPI: [NPI]
Clinic: The Sandusky Dyslipidemia Model

DIAGNOSIS:
☐ Atherosclerotic cardiovascular disease (ASCVD)
  - Specific: [MI / Stroke / PAD / Revascularization / Other]
  - Date of event: [DATE]
  - ICD-10: [CODE]
☐ Heterozygous familial hypercholesterolemia (HeFH)
  - DLCN Score: [SCORE] / Genetic confirmation: [YES/NO]
  - ICD-10: E78.01

LIPID VALUES:
Baseline (untreated or off therapy):
  LDL-C: [X] mg/dL | ApoB: [X] mg/dL
  Date: [DATE]

Current (on maximally tolerated therapy):
  LDL-C: [X] mg/dL | ApoB: [X] mg/dL
  Date: [DATE]

STATIN THERAPY HISTORY:
  [Same format as PCSK9i template above]

EZETIMIBE TRIAL:
  [Same format as PCSK9i template above]

CURRENT REGIMEN:
  [LIST ALL CURRENT LIPID-LOWERING MEDICATIONS WITH DOSES]

RATIONALE FOR INCLISIRAN OVER PCSK9 MONOCLONAL ANTIBODY:
☐ Patient adherence concerns with biweekly/monthly self-injection
☐ Patient preference for in-office administration
☐ Prior PCSK9 mAb trial with adherence issues
☐ Clinical judgment: twice-yearly dosing is optimal for this patient
☐ Other: [EXPLAIN]

CLINICAL RATIONALE:
[Same as PCSK9i template — include guideline reference, target,
current gap, and supporting clinical data]

REQUESTED MEDICATION:
Inclisiran (Leqvio) 284 mg SC
  Schedule: Day 0, Day 90, then every 6 months
  Administered in-office by healthcare provider

Prescriber Signature: _________________________
Date: [DATE]

5.0 Appeals Process

5.1 When to Appeal

Scenario Action
Initial PA denied for administrative reasons Correct documentation and resubmit
Initial PA denied despite meeting criteria File Level 1 appeal with additional clinical justification
Level 1 appeal denied File Level 2 (external) appeal; consider peer-to-peer review
All appeals denied Explore manufacturer patient assistance programs; consider alternative agents

5.2 Peer-to-Peer Review Tips

  1. Have the patient’s chart, lipid values, and statin trial documentation ready
  2. Cite the 2026 ACC/AHA/Multisociety Guidelines specifically
  3. Emphasize ASCVD event risk and the cardiovascular outcomes trial data (FOURIER, ODYSSEY Outcomes, CLEAR Outcomes)
  4. If the patient has FH, emphasize lifelong LDL-C exposure and premature ASCVD risk
  5. For statin-intolerant patients, document the rechallenge attempt
  6. Request the denial in writing with the specific clinical criteria that were not met

5.3 Manufacturer Patient Assistance Programs

Agent Program Notes
Evolocumab (Repatha) Amgen Assist 360 Income-based eligibility; copay cards for commercially insured
Alirocumab (Praluent) Praluent Copay Card / MyPraluent Copay assistance; patient assistance for uninsured
Inclisiran (Leqvio) Novartis Patient Assistance Income-based; buy-and-bill assistance for providers

6.0 CPT and HCPCS Codes

Code Description Use
96372 Therapeutic SC injection Inclisiran administration
J3490 Unclassified drug (or specific J-code if assigned) Inclisiran drug
J3590 Unclassified biologic PCSK9i if no specific code
99213/99214 Office visit E/M Concurrent office visit

HCPCS codes may change. Verify current codes with your billing department before submission.

7.0 Version History

Version Date Description
1.0.0 2026-03-30 Initial release

References

  1. 2026 ACC/AHA/Multisociety Guideline on the Management of Dyslipidemia. J Am Coll Cardiol. 2026.
  2. Sabatine MS, Giugliano RP, Keech AC, et al. Evolocumab and clinical outcomes in patients with cardiovascular disease (FOURIER). N Engl J Med. 2017;376(18):1713–1722.
  3. Schwartz GG, Steg PG, Szarek M, et al. Alirocumab and cardiovascular outcomes after acute coronary syndrome (ODYSSEY Outcomes). N Engl J Med. 2018;379(22):2097–2107.
  4. Ray KK, Wright RS, Kallend D, et al. Two phase 3 trials of inclisiran in patients with elevated LDL cholesterol (ORION-10 and ORION-11). N Engl J Med. 2020;382(16):1507–1519.

© 2026 The Sandusky Dyslipidemia Model. For clinical decision support only. Not a substitute for clinical judgment.