Indications
Repatha® is indicated:
  • In adults with established cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization
  • As an adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (LDL-C)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH) to reduce LDL-C

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THE 2022 ACC CONSENSUS PATHWAY* ELEVATES THE ROLE OF PCSK9i mAbs IN ASCVD

This Consensus Pathway is endorsed by the National Lipid Association

REPATHA® CAN HELP YOUR PATIENTS WITH ASCVD LOWER THEIR LDL-C TO REDUCE THEIR RISK OF MI, STROKE, AND CORONARY REVASCULARIZATION1

2022 ACC CONSENSUS PATHWAY NON-STATIN RECOMMENDATIONS

The ACC developed the 2022 Consensus Pathway to address gaps in care for LDL-C lowering to reduce ASCVD risk. It relies on evidence established by the 2013 ACC/AHA and 2018 AHA/ACC/Multi-Society cholesterol guidelines and provides further recommendations regarding the use of non-statin therapies.*

The 2022 ACC Consensus Pathway elevated the role of PCSK9i mAbs from the current guideline recommendations, based on:2

The demonstrated safety profile, efficacy, and cardiovascular outcomes data from outcomes trials

Improved cost-effectiveness due to updated 2018 pricing of PCSK9i mAbs

KEY UPDATES

The ACC Consensus Pathway recommends ≥50% LDL-C reduction and a lower threshold LDL-C of:2

  • 55 mg/dL for adult patients with ASCVD at very high-risk†
  • 70 mg/dL for adult patients with ASCVD not at very high-risk

PCSK9i mAbs are preferred by the 2022 ACC Consensus Pathway as the agent of choice targeting PCSK9 for ASCVD patients due to the demonstrated safety profile, efficacy, and cardiovascular outcomes data from outcomes trials2

PCSK9i mAbs may be preferred by the 2022 ACC Consensus Pathway as the initial non-statin agent in adult patients with ASCVD at very high risk when more than 25% of additional LDL-C lowering is required2

AHA = American Heart Association; PCSK9 = proprotein convertase subtilisin/kexin type 9.

*Note that this process did not involve formal systematic reviews, grading of evidence, or synthesis of evidence. The goal was to provide practical guidance in situations not covered by the 2018 AHA/ACC/Multi-Society cholesterol guideline until the next round of guidelines has the opportunity to formally review recent scientific evidence.

†Defined as having a history of major ASCVD events or having 1 major ASCVD event and multiple high-risk conditions (eg, aged ≥65 years, heterozygous familial hypercholesterolemia, history of prior coronary artery bypass surgery or percutaneous coronary intervention outside of the major ASCVD event[s]).

WHEN TO CONSIDER ADDING A PCSK9i mAb TO YOUR PATIENTS’ LIPID-LOWERING TREATMENT

For both not very high-risk and very high-risk ASCVD patients, a PCSK9i mAb, like Repatha®, may be considered.2

Use the chart below as a guide for suggested treatment options for your patients with high LDL-C and when a ≥50% reduction in LDL-C is needed.

What if optimal reduction isn’t achieved with statins?2,*

Is your patient considered very high-risk and has an LDL-C ≥55 mg/dL or <50% LDL-C reduction?

Consider PCSK9i mAbs, like evolocumab and/or ezetimibe.†,‡ If still not achieved...

May consider bempedoic acid or inclisiran

Is your patient considered not very high-risk and has an LDL-C ≥70 mg/dL or <50% LDL-C reduction?

Consider ezetimibe. If still not achieved...

May consider adding or replacing with PCSK9i mAbs, like evolocumab.† If still not achieved...

May consider bempedoic acid or inclisiran

Adults in Above Categories With Possible Statin-Associated Side Effects2

Consider the below drug therapy options or referral to lipid specialist:

  • 1st PCSK9i mAbs and/or ezetimibe. If still not achieved...
  • 2nd Bempedoic acid or inclisiran. If still not achieved in adults with an LDL-C of ≥190 mg/dL...
  • 3rd Evinacumab for HoFH

Very high-risk ASCVD patients include those with:2

  • One major ASCVD event and multiple high-risk conditions§OR
    • OR
  • Multiple major ASCVD events**

HoFH = homozygous familial hypercholesterolemia.

*Non-statin pharmacologic options are considered after optimizing lifestyle, controlling ASCVD risk factors, adhering to guideline-recommended statin therapy (and increasing to high-intensity statin if not already taking), and evaluating for statin intolerance.

†Strongly consider PCSK9i mAbs if fully statin intolerant and attempts to lower LDL-C with ezetimibe or bile acid sequestrants result in persistent <50% LDL-C reduction (or may consider if LDL-C ≥70 mg/dL or non-HDL-C ≥100 mg/dL). Consider PCSK9i mAbs if on maximally tolerated statin therapy (and either ezetimibe or bile acid sequestrants if not very high-risk ASCVD), with persistent <50% if LDL-C reduction (or may consider if LDL-C ≥70 mg/dL or non-HDL-C ≥100 mg/dL). No cardiovascular outcome studies exist for bempedoic acid or inclisiran.

‡PCSK9i mAbs may be preferred by the 2022 ACC Consensus Pathway as the initial non-statin agent in patients who require >25% additional lowering of LDL-C or based on clinician-patient decision-making. Potential considerations in use of PCSK9i mAbs, compared to ezetimibe, include net risk reduction benefits of a PCSK9i mAb, administration through subcutaneous injection, every 2 weeks or once monthly dosing schedule, storage requirements, and cost.

§Includes age ≥65 years, hypertension, diabetes, heterozygous familial hypercholesterolemia, history of prior coronary artery bypass surgery, or percutaneous coronary intervention.

**Includes myocardial infarction, acute coronary syndrome, ischemic stroke, and symptomatic peripheral artery disease.

REPATHA® CAN HELP REDUCE LDL-C FOR MORE OF YOUR ASCVD PATIENTS, EVEN THOSE WHO REMAIN AT RISK DESPITE HIGH- OR MODERATE-INTENSITY STATIN THERAPY1,3

Repatha® added to a statin was studied in 27,564 patients with established CVD and LDL-C ≥70 mg/dL and/or non-HDL-C ≥100 mg/dL despite high- or moderate-intensity statin therapy.1

The FOURIER trial was a double-blind, randomized, placebo-controlled, event-driven trial over a median of 2.2 years. Patients either received subcutaneous injections of Repatha® (140 mg every 2 weeks or 420 mg once monthly) or placebo.1 Patients on stable background lipid-lowering therapy had a median baseline LDL-C of 92 mg/dL.4

    Patient population characteristics:

  • Patients were ≥40 to ≤85 years old4
  • Patients were treated with other CV medications1

63%

mean reduction in LDL-C from baseline at week 12 in the Repatha® + statin group1

84%

of patients on Repatha® + statin achieved LDL-C <55 mg/dL at 4 weeks5

91%

of patients taking Repatha® + statin achieved LDL-C <70 mg/dL at 4 weeks6

  • Primary composite endpoint of time to first occurrence of CV death, MI, hospitalization for unstable angina, stroke, or coronary revascularization: HR 0.85 (95% CI, 0.79-0.92; P<0.0001)1
  • Key secondary composite endpoint of time to first occurence of CV death, MI, or stroke: HR 0.80 (95% CI, 0.73-0.88; P<0.0001). ARR=2.0%
  • Observed HR for CV death: 1.05 (95% Cl, 0.88-1.25) and hospitalizations due to unstable angina: 0.99 (95% Cl, 0.82-1.18)

PATIENTS WITH ASCVD MAY NEED MORE THAN A STATIN AND/OR EZETIMIBE TO REACH LDL-C GOALS7

In a descriptive, retrospective analysis of 186,670 ASCVD patients with index LDL-C >70 mg/dL (mean index LDL-C 108 mg/dL):

  • 21% of ASCVD patients who intensified statins achieved LDL-C values ≤70 mg/dL7,*
  • 23% of ASCVD patients who added ezetimibe to statin therapy achieved LDL-C values ≤70 mg/dL7,*

Patients were identified between January 1, 2012, and August 31, 2014, using the IQVIA US ambulatory electronic medical record database. Treatment exposure to statin and/or ezetimibe was based on observation of a valid prescription recorded in the EMR database, which does not guarantee that the patient filled the prescription or used the medication. This was a descriptive, retrospective analysis that evaluates the associations between exposures and outcomes, but no causal relationships can be established from this observational study.

ARR = absolute risk reduction; CI = confidence interval; CV = cardiovascular; CVD = cardiovascular disease; EMR = electronic medical record; HDL-C = high-density lipoprotein cholesterol; HR = hazard ratio.

* Baseline statin intensity: Among the 75,523 ASCVD patients treated at baseline, 12.18% were on low statin intensity, 58.4% were on moderate statin intensity, 20.6% were on high statin intensity, and 8.8% were treated with other lipid-lowering agents.

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CVD = cardiovascular disease; LDL-C = low-density lipoprotein cholesterol; MI = myocardial infarction.

LDL-C = low-density lipoprotein cholesterol; MI = myocardial infarction.

ACS = acute coronary syndrome; LDL-C = low-density lipoprotein cholesterol; MI = myocardial infarction; PCSK9 = proprotein convertase subtilisin/kexin type 9.

Reference: 1. Repatha® (evolocumab) prescribing information, Amgen.


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INDICATIONSRepatha® is indicated:
  • In adults with established cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization
  • As an adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (LDL-C)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH) to reduce LDL-C
IMPORTANT SAFETY INFORMATION

Contraindication: Repatha® is contraindicated in patients with a history of a serious hypersensitivity reaction to evolocumab or any of the excipients in Repatha®. Serious hypersensitivity reactions including angioedema have occurred in patients treated with Repatha®.

Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema, have been reported in patients treated with Repatha®. If signs or symptoms of serious hypersensitivity reactions occur, discontinue treatment with Repatha®, treat according to the standard of care, and monitor until signs and symptoms resolve.

Adverse Reactions in Primary Hyperlipidemia: The most common adverse reactions (>5% of patients treated with Repatha® and more frequently than placebo) were: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions.

From a pool of the 52-week trial and seven 12-week trials: Local injection site reactions occurred in 3.2% and 3.0% of Repatha®-treated and placebo-treated patients, respectively. The most common injection site reactions were erythema, pain, and bruising. Hypersensitivity reactions occurred in 5.1% and 4.7% of Repatha®-treated and placebo-treated patients, respectively. The most common hypersensitivity reactions were rash (1.0% versus 0.5% for Repatha® and placebo, respectively), eczema (0.4% versus 0.2%), erythema (0.4% versus 0.2%), and urticaria (0.4% versus 0.1%).

Adverse Reactions in the Cardiovascular Outcomes Trial: The most common adverse reactions (>5% of patients treated with Repatha® and more frequently than placebo) were: diabetes mellitus (8.8% Repatha®, 8.2% placebo), nasopharyngitis (7.8% Repatha®, 7.4% placebo), and upper respiratory tract infection (5.1% Repatha®, 4.8% placebo).

Among the 16,676 patients without diabetes mellitus at baseline, the incidence of new-onset diabetes mellitus during the trial was 8.1% in patients treated with Repatha® compared with 7.7% in patients that received placebo.

Immunogenicity: Repatha® is a human monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity with Repatha®.

Please see full Prescribing Information.

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IMPORTANT SAFETY INFORMATION

Contraindication: Repatha® is contraindicated in patients with a history of a serious hypersensitivity reaction to evolocumab or any of the excipients in Repatha®. Serious hypersensitivity reactions including angioedema have occurred in patients treated with Repatha®.

Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema, have been reported in patients treated with Repatha®. If signs or symptoms of serious hypersensitivity reactions occur, discontinue treatment with Repatha®, treat according to the standard of care, and monitor until signs and symptoms resolve.

Adverse Reactions in Primary Hyperlipidemia: The most common adverse reactions (>5% of patients treated with Repatha® and more frequently than placebo) were: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions.

From a pool of the 52-week trial and seven 12-week trials: Local injection site reactions occurred in 3.2% and 3.0% of Repatha®-treated and placebo-treated patients, respectively. The most common injection site reactions were erythema, pain, and bruising. Hypersensitivity reactions occurred in 5.1% and 4.7% of Repatha®-treated and placebo-treated patients, respectively. The most common hypersensitivity reactions were rash (1.0% versus 0.5% for Repatha® and placebo, respectively), eczema (0.4% versus 0.2%), erythema (0.4% versus 0.2%), and urticaria (0.4% versus 0.1%).

Adverse Reactions in the Cardiovascular Outcomes Trial: The most common adverse reactions (>5% of patients treated with Repatha® and more frequently than placebo) were: diabetes mellitus (8.8% Repatha®, 8.2% placebo), nasopharyngitis (7.8% Repatha®, 7.4% placebo), and upper respiratory tract infection (5.1% Repatha®, 4.8% placebo).

Among the 16,676 patients without diabetes mellitus at baseline, the incidence of new-onset diabetes mellitus during the trial was 8.1% in patients treated with Repatha® compared with 7.7% in patients that received placebo.

Immunogenicity: Repatha® is a human monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity with Repatha®.

Please see full Prescribing Information.

References: 1. Repatha® (evolocumab) prescribing information, Amgen. 2. Lloyd-Jones DM, Morris PB, Ballantyne CM, et al. 2022 ACC expert consensus decision pathway on the role of nonstatin therapies for LDL-cholesterol lowering in the management of atherosclerotic cardiovascular disease risk. JACC. 2022. 3. Grundy SM, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the management of blood cholesterol: a report of the American College of Cardiology/American Heart Association task force on clinical practice guidelines. Circulation. 2019;139:el082-e1143. 4. Sabatine MS, Giugliano RP, Keech AC, et al. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med. 2017;376:1713-1722. 5. Data on file, Amgen; [1]; 2021. 6. Data on file, Amgen; [2]; 2021. 7. Chen C-C, Rane PB, Hines DM, Patel J, Harrison DJ, Wade RL. Low-density lipoprotein cholesterol outcomes post-non-PCSK9i lipid-lowering therapies in atherosclerotic cardiovascular disease and probable heterozygous familial hypercholesterolemia patients. Ther Clin Risk Manag. 2018;14:2425-2435.