ALIROCUMAB INJ,SOLN
Clinical Criteria Summary
Criteria for ALIROCUMAB INJ,SOLN and EVOLOCUMAB INJ,SOLN (Alirocumab-preferred, Evolocumab-non-preferred)
- Exclusion Criteria (Patient should NOT receive either drug if any apply)
- End-stage renal disease on dialysis
- Advanced heart failure with limited prognosis
- Severe comorbid non-cardiovascular condition that is expected to limit life expectancy
- Pregnant or lactating
- Primary Inclusion Criteria (One of the following must be met)
- History of ASCVD
- Severe primary hypercholesterolemia (e.g., HeFH, LDL-C > 190 mg/dL) without ASCVD
- Statin Intolerance & Therapeutic Trial Requirements (All additional criteria below must be met)
- Contraindication, intolerance to, or insufficient LDL-C reduction requiring further LDL-C lowering to reduce ASCVD risk consistent with established guidelines after a trial of:
- Maximally tolerated dose of statin
- Ezetimibe
- Confirmed statin intolerance is defined as intolerance to at least 2 statins, one at the lowest approved daily dose.
- For patients completely intolerant of statin therapy where ezetimibe has not or is not expected to provide clinically desired LDL-C reduction or achieve LDL-C goal consistent with established guidelines, use may be considered.
- For patients on lower than optimal statin doses (including alternate day dosing) taking ezetimibe, if LDL reduction from untreated baseline is less than clinically desired and/or LDL-C goal is not achieved despite confirmed adherence, consideration can be given to using monoclonal antibody inhibitors of PCSK9.
- High-Risk Patients Without Established ASCVD and LDL-C <190 mg/dL
- Ezetimibe, bile acid sequestrant (BAS), or the combination should be utilized first.
- For patients at high-risk for an event (e.g., diabetes mellitus, 10-year risk score > 20%, presence of subclinical atherosclerosis by imaging including coronary artery calcium assessment and coronary CT), if LDL-C is not reduced by a clinically meaningful percentage from baseline (>30% or >50% based on risk assessment and clinical need) and/or LDL-C goals are not reached despite confirmed adherence, use of monoclonal antibody inhibitors of PCSK9 may be considered.
- Reproductive Safety & Counseling (Select if applicable)
- For patients who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy.
- If a patient becomes pregnant during treatment and a decision is made to continue therapy, providers are encouraged to report exposure.
- Lipoprotein A Exception
- Use of alirocumab or evolocumab can be used in patients with elevated lipoprotein a (Lip[a]) who have not met their LDL-C goals with a maximally tolerated dose of statin, without requiring use of ezetimibe.