Praluent (alirocumab) Letter of Medical Necessity
Praluent (alirocumab) PA criteria mirror Repatha requirements but may additionally require step therapy through the formulary-preferred PCSK9 inhibitor. The ODYSSEY OUTCOMES trial supports CV mortality reduction.
FDA-Approved Indications
- ● primary hyperlipidemia (HeFH or clinical ASCVD)
- ● cardiovascular risk reduction in established ASCVD
Why Praluent Prior Authorization Gets Denied
The most common denial reasons across major payers:
- 1. Maximally tolerated statin + ezetimibe not documented
- 2. Step therapy through Repatha (preferred PCSK9)
- 3. Statin intolerance rechallenge not performed
- 4. LDL-C threshold not met
What to Include in a Praluent Letter of Medical Necessity
Document ASCVD or FH diagnosis, maximally tolerated statin plus ezetimibe regimen, serial LDL-C values, statin intolerance documentation if applicable, prior PCSK9 inhibitor trial if step therapy requires it, and ODYSSEY OUTCOMES data supporting use.
Key clinical evidence to cite:
- ✓ ODYSSEY OUTCOMES cardiovascular outcomes trial
- ✓ ODYSSEY LONG TERM
- ✓ ODYSSEY FH I and II
- ✓ ODYSSEY ALTERNATIVE (statin-intolerant)
Relevant guidelines:
- 📖 ACC/AHA 2018 Cholesterol Guidelines
- 📖 NLA PCSK9 Inhibitor Recommendations
Payers Covering Praluent
RxCheckUp tailors each LMN to the specific payer's medical policy and step therapy requirements:
Praluent Prior Authorization FAQ
Why was my Praluent prior authorization denied?
The most common denial reasons for Praluent are: Maximally tolerated statin + ezetimibe not documented; Step therapy through Repatha (preferred PCSK9); Statin intolerance rechallenge not performed; LDL-C threshold not met.
What should a Praluent Letter of Medical Necessity include?
Document ASCVD or FH diagnosis, maximally tolerated statin plus ezetimibe regimen, serial LDL-C values, statin intolerance documentation if applicable, prior PCSK9 inhibitor trial if step therapy requires it, and ODYSSEY OUTCOMES data supporting use.
Which payers cover Praluent?
Praluent is covered by major US payers including UnitedHealthcare, Aetna, Cigna, BCBS, Medicare Part D, though formulary tier and prior authorization criteria vary.