How to Fight Insurance Denials for Cardiology Drugs: PCSK9 Inhibitors, Entresto, Tafamidis, Camzyos & More

Modern cardiology has delivered breakthrough medications that dramatically reduce heart attacks, prevent heart failure hospitalizations, and extend lives in conditions once considered untreatable. But these drugs—PCSK9 inhibitors like Repatha and Praluent, the heart failure drug Entresto, tafamidis (Vyndamax) for a rare form of heart failure called ATTR cardiomyopathy, Camzyos for hypertrophic cardiomyopathy, SGLT2 inhibitors, and others—often cost $5,000 to $20,000 per month. Insurers deny them routinely, citing "step therapy not met," "experimental," or "not medically necessary," even when major medical societies have published explicit recommendations and large trials have proven benefit. This guide explains the common denial templates, the specific guidelines and trials that carry weight in appeals, and how to structure a rebuttal that forces reconsideration.

Why Insurers Deny Cardiology Drugs

Insurers use a handful of standardized denial templates for expensive cardiovascular medications. Understanding the pattern helps you recognize what you're up against and tailor your response.

1. "Step therapy not completed."

The most common reason for PCSK9 inhibitor denials. The insurer claims you haven't tried and failed—or haven't tried long enough—a high-intensity statin plus ezetimibe (Zetia). Many policies demand 6–12 weeks on maximum-tolerated statin plus ezetimibe with documented LDL levels still above threshold before they'll consider a PCSK9 inhibitor. If your doctor added ezetimibe only four weeks ago, or if the medical record doesn't explicitly state the statin dose and duration, the algorithm denies.

2. "Not FDA-approved for this indication" or "Experimental."

Used frequently for tafamidis (Vyndamax/Vyndaqel) when the diagnostic workup for ATTR cardiomyopathy is incomplete in the insurer's eyes—especially if they suspect you might have AL amyloidosis instead, which tafamidis doesn't treat. Also applied to Camzyos (mavacamten) for hypertrophic cardiomyopathy (HCM) by insurers who haven't updated policies since the 2024 AHA/ACC HCM Guideline, or to GLP-1 receptor agonists (Wegovy, Zepbound) prescribed for cardiovascular risk reduction rather than diabetes, despite the March 2024 FDA approval based on the SELECT trial.

3. "Try a cheaper alternative first."

Common for Entresto. The denial letter says "try a generic ARB [like losartan or valsartan] or ACE inhibitor first." This ignores the 2022 AHA/ACC/HFSA Heart Failure Guideline, which elevated ARNIs (angiotensin receptor-neprilysin inhibitors, i.e., Entresto) to Class I recommendation—meaning it should be offered simultaneously with beta-blockers, mineralocorticoid receptor antagonists, and SGLT2 inhibitors as part of quadruple therapy for heart failure with reduced ejection fraction (HFrEF), not reserved as a last resort.

4. "LDL not high enough" or "Risk category not met."

For PCSK9 inhibitors, insurers often cite an outdated LDL threshold (e.g., requiring LDL ≥100 mg/dL on therapy) when current expert consensus, specifically the 2022 ACC Expert Consensus Decision Pathway on Non-Statin Therapies, sets the bar at LDL ≥70 mg/dL for very-high-risk ASCVD (atherosclerotic cardiovascular disease) and a goal of <55 mg/dL. If your cardiologist documented "very high risk" but the insurer's policy pre-dates 2022, they may apply obsolete criteria.

5. "Requested service does not meet coverage criteria" for rare-disease drugs.

Tafamidis for ATTR cardiomyopathy (transthyretin amyloid cardiomyopathy) and Camzyos for obstructive HCM fall into this bucket. Tafamidis denials often hinge on missing or ambiguous confirmatory testing: the insurer wants proof of cardiac uptake on PYP (pyrophosphate) or DPD nuclear imaging (often expressed as a heart-to-contralateral-lung ratio ≥1.5 or visual grade 2–3), explicit exclusion of AL (light-chain) amyloidosis via serum and urine immunofixation plus free light chains, and TTR genotyping to distinguish hereditary from wild-type ATTR-CM. Camzyos denials may cite lack of demonstrated "obstructive physiology" (a pressure gradient ≥50 mmHg at rest or with provocation) or NYHA functional class documentation.

The Citations Insurers Respect

Appeals succeed when you anchor your argument in named guidelines and landmark trials. Payers have medical directors who recognize these references; citing them signals that the request isn't off-label experimentation but standard-of-care medicine.

For PCSK9 Inhibitors (Repatha, Praluent, Leqvio):

• 2018 ACC/AHA Guideline on the Management of Blood Cholesterol (Grundy et al., Circulation 2019). Defines "very high risk" ASCVD as a history of multiple major ASCVD events (e.g., recent acute coronary syndrome, MI, ischemic stroke, or symptomatic peripheral artery disease) or one major event plus multiple high-risk conditions. Recommends LDL goal <70 mg/dL, and if not achieved on maximally tolerated statin plus ezetimibe, consider adding a PCSK9 inhibitor (Class IIa).
• 2022 ACC Expert Consensus Decision Pathway on the Role of Non-Statin Therapies for LDL-Cholesterol Lowering (Lloyd-Jones et al., JACC 2022). Updated thresholds: for very-high-risk ASCVD, LDL goal <55 mg/dL; add PCSK9 inhibitor (or inclisiran) if LDL ≥70 mg/dL on maximal statin ± ezetimibe. For heterozygous familial hypercholesterolemia (HeFH) in primary prevention, LDL goal <100 mg/dL; add PCSK9 inhibitor if LDL ≥100 mg/dL on statin + ezetimibe.
• FOURIER trial (NEJM 2017, Sabatine). Evolocumab (Repatha) reduced major cardiovascular events by 15% in stable ASCVD patients on statin therapy.
• ODYSSEY OUTCOMES (NEJM 2018, Schwartz). Alirocumab (Praluent) reduced major adverse cardiovascular events by 15% post-acute coronary syndrome.
• ORION-10 and ORION-11 (NEJM 2020, Ray). Inclisiran (Leqvio) demonstrated sustained LDL reduction with dosing every six months.

For Heart Failure Drugs (Entresto, SGLT2 Inhibitors, Verquvo, Corlanor):

• 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure (Heidenreich et al., Circulation 2022). Quadruple therapy for HFrEF (LVEF ≤40%): ARNI (e.g., Entresto), beta-blocker, mineralocorticoid receptor antagonist (MRA), and SGLT2 inhibitor—all Class I, meaning benefit far outweighs risk and should be offered to all eligible patients. SGLT2 inhibitors also Class IIa for HFpEF (LVEF ≥50%) and HFmrEF (LVEF 41–49%).
• PARADIGM-HF trial (NEJM 2014, McMurray). Sacubitril/valsartan (Entresto) reduced cardiovascular death and heart failure hospitalization by 20% versus enalapril in HFrEF.
• DAPA-HF (NEJM 2019, McMurray) and EMPEROR-Reduced (NEJM 2020, Packer). Dapagliflozin (Farxiga) and empagliflozin (Jardiance) each reduced the composite of cardiovascular death or worsening heart failure in HFrEF, regardless of diabetes status.
• EMPEROR-Preserved (NEJM 2021, Anker) and DELIVER (NEJM 2022, Solomon). Empagliflozin and dapagliflozin reduced heart failure hospitalization in HFpEF.
• VICTORIA trial (NEJM 2020, Armstrong). Vericiguat (Verquvo) reduced cardiovascular death or heart failure hospitalization in high-risk HFrEF patients recently hospitalized for heart failure or requiring IV diuretics (Class IIb recommendation).

For Tafamidis (Vyndaqel/Vyndamax) in ATTR Cardiomyopathy:

• ATTR-ACT trial (NEJM 2018, Maurer). Tafamidis reduced all-cause mortality by 30% and cardiovascular-related hospitalizations by 32% in patients with transthyretin amyloid cardiomyopathy compared to placebo.
• 2023 ACC Expert Consensus Decision Pathway on Comprehensive Multidisciplinary Care for the Patient With Cardiac Amyloidosis (Kittleson et al., JACC 2023). Describes diagnostic algorithm: noninvasive confirmation by cardiac PYP or DPD scintigraphy (heart-to-contralateral-lung ratio ≥1.5 or visual grade 2–3) plus exclusion of monoclonal protein by serum/urine immunofixation and serum free light chains, followed by TTR genotyping.

For Camzyos (Mavacamten) in Obstructive Hypertrophic Cardiomyopathy:

• 2024 AHA/ACC/AMSA Guideline for the Management of Hypertrophic Cardiomyopathy (Ommen et al., Circulation 2024). Cardiac myosin inhibitors (mavacamten) Class I for symptomatic obstructive HCM (left ventricular outflow tract gradient ≥50 mmHg, NYHA class II–III) when maximally tolerated medical therapy has not controlled symptoms.
• EXPLORER-HCM trial (Lancet 2020, Olivotto). Mavacamten improved exercise capacity (peak VO₂) and reduced left ventricular outflow tract gradient and NYHA class.
• VALOR-HCM trial (NEJM 2023, Desai). Mavacamten enabled 64% of patients with obstructive HCM to achieve guideline-recommended goals and avoid septal reduction therapy.

For Kerendia (Finerenone) in Chronic Kidney Disease + Type 2 Diabetes:

• FIDELIO-DKD (NEJM 2020, Bakris) and FIGARO-DKD (NEJM 2021, Pitt). Finerenone, a non-steroidal MRA, reduced kidney disease progression and cardiovascular events in patients with CKD and type 2 diabetes with albuminuria.
• 2022 KDIGO Clinical Practice Guideline for Diabetes Management in CKD. Recommends finerenone in patients with CKD, type 2 diabetes, and urine albumin-to-creatinine ratio (UACR) ≥30 mg/g despite RAAS inhibition.

For Vascepa (Icosapent Ethyl):

• REDUCE-IT trial (NEJM 2019, Bhatt). Icosapent ethyl 4 g/day reduced major adverse cardiovascular events by 25% in statin-treated patients with elevated triglycerides and established cardiovascular disease or diabetes plus risk factors.

For GLP-1 Receptor Agonists (Wegovy/Semaglutide, Zepbound/Tirzepatide) for Cardiovascular Risk Reduction:

• SELECT trial (NEJM 2023, Lincoff). Semaglutide 2.4 mg weekly reduced major adverse cardiovascular events by 20% in patients with established cardiovascular disease and overweight or obesity without diabetes, leading to FDA approval for cardiovascular risk reduction in March 2024.

How to Argue Against "Step Therapy Not Met" (PCSK9 Inhibitors)

What the denial says: "Patient has not completed required trial of high-intensity statin plus ezetimibe for the specified duration."

Why it's often wrong: Your cardiologist likely did prescribe both, but the denial hinges on documentation gaps or arbitrary timelines. The 2022 ACC Expert Consensus uses clinical judgment and LDL response, not a rigid 12-week countdown.

Concrete steps to rebut:

1. Reconstruct the medication timeline with dates and labs. State baseline LDL before statin, LDL after statin monotherapy (with date and duration), then LDL after adding ezetimibe (with date and duration). Example: "Baseline LDL 195 mg/dL (1/10/2026). Started atorvastatin 80 mg daily. LDL 6 months later 112 mg/dL (7/15/2026). Added ezetimibe 10 mg. LDL 14 weeks later 98 mg/dL (10/28/2026). Goal per 2022 ACC Consensus for very-high-risk ASCVD: <55 mg/dL. Despite maximally tolerated statin plus ezetimibe, LDL remains 43 mg/dL above goal."

2. Cite the 2022 ACC Expert Consensus Decision Pathway threshold: LDL ≥70 mg/dL on maximal therapy warrants PCSK9 inhibitor. Spell it out: "Per Lloyd-Jones et al., JACC 2022, in very-high-risk ASCVD, if LDL ≥70 mg/dL on maximally tolerated statin ± ezetimibe, adding a PCSK9 inhibitor or inclisiran is recommended."

3. Define "very high risk" explicitly. The 2018 ACC/AHA Cholesterol Guideline lists: history of multiple major ASCVD events, or one major event plus multiple high-risk conditions (prior MI <12 months, diabetes, hypertension, CKD stage 3–4, current smoking, LDL ≥100 mg/dL on maximally tolerated therapy, history of heart failure). List your patient's criteria verbatim: "Patient has very-high-risk ASCVD: prior STEMI 2/2024, ischemic stroke 9/2025, and peripheral artery disease (ABI 0.68). This meets the multi-event criterion."

4. Document statin intolerance if relevant. If the patient couldn't tolerate high-intensity statins due to muscle pain or elevated liver enzymes, state which statins were tried, the adverse effects, and the dates. "Patient trialed atorvastatin 80 mg 3/2025—discontinued after 4 weeks due to CK elevation to 1,200 U/L and myalgias. Switched to rosuvastatin 20 mg 5/2025—discontinued after 6 weeks due to recurrent myalgias. Maximally tolerated statin: pravastatin 40 mg."

5. If the denial cites a waiting period (e.g., "must try ezetimibe for 12 weeks"), counter that clinical guidelines prioritize LDL response, not calendar time. If LDL remains ≥70 mg/dL after an adequate trial (typically 6–12 weeks), further delay increases cardiovascular risk. Cite FOURIER: every year of delay in achieving LDL goal increases cumulative event risk.

How to Argue Against "Try a Cheaper Alternative First" (Entresto for Heart Failure)

What the denial says: "Patient should trial a generic ARB or ACE inhibitor before Entresto (sacubitril/valsartan)."

Why it's outdated: The 2022 AHA/ACC/HFSA Heart Failure Guideline made ARNIs a Class I recommendation for HFrEF, on par with beta-blockers, MRAs, and SGLT2 inhibitors. The guideline explicitly states these four pillars should be initiated simultaneously, not sequentially.

Concrete steps to rebut:

1. Quote the 2022 HF Guideline: "In patients with chronic HFrEF, an ARNI (sacubitril/valsartan) is recommended to reduce morbidity and mortality (Class I, Level of Evidence B-R). The guideline recommends quadruple therapy—ARNI + beta-blocker + MRA + SGLT2 inhibitor—initiated rapidly and titrated to target doses." (Heidenreich et al., Circulation 2022.)

2. Cite PARADIGM-HF outcomes: "The PARADIGM-HF trial (NEJM 2014) demonstrated that sacubitril/valsartan reduced the risk of cardiovascular death or heart failure hospitalization by 20% compared to enalapril. Absolute risk reduction translates to 1 fewer death or hospitalization for every 21 patients treated over 27 months."

3. Document current heart failure severity: LVEF (ejection fraction), NYHA functional class, NT-proBNP level, and recent hospitalizations or emergency visits for heart failure. Example: "LVEF 28% on echocardiogram 2/15/2026. NYHA class III symptoms despite optimal beta-blocker (metoprolol succinate 200 mg) and MRA (spironolactone 25 mg). NT-proBNP 2,840 pg/mL. Hospitalized 1/20/2026 for acute decompensated heart failure requiring IV diuresis."

4. Explain that delaying ARNI initiation increases morbidity and mortality. "Current guidelines emphasize early, simultaneous initiation of all four drug classes. Requiring sequential 'failure' of generic ARB contradicts the evidence base and delays life-saving therapy."

5. If the patient is already on an ACE inhibitor or ARB, state that switching to Entresto is the recommended next step, not adding another drug from the same class. "Patient currently on lisinopril 40 mg. Per guideline, the appropriate escalation is to replace the ACE inhibitor with sacubitril/valsartan, not to continue lisinopril."

How to Argue Against "Not FDA-Approved" or "Experimental" (Tafamidis for ATTR-CM)

What the denial says: "Requested drug is experimental or not approved for this indication."

Why it's wrong for tafamidis: Tafamidis received FDA approval in 2019 for the treatment of cardiomyopathy caused by transthyretin-mediated amyloidosis (ATTR-CM) based on the ATTR-ACT trial, which showed a 30% reduction in all-cause mortality. However, insurers often deny when the diagnostic confirmation is incomplete or ambiguous.

Concrete steps to rebut:

1. Confirm the diagnosis with imaging and lab data. State the results of PYP or DPD scintigraphy: "Tc-99m PYP cardiac scintigraphy 12/5/2025 demonstrated diffuse myocardial uptake with heart-to-contralateral-lung ratio 1.7 (visual grade 3), consistent with transthyretin cardiac amyloidosis."

2. Explicitly rule out AL amyloidosis. "Serum and urine immunofixation: negative for monoclonal protein. Serum free light chains: kappa 18 mg/L, lambda 15 mg/L, ratio 1.2 (normal). These results exclude AL (light-chain) amyloidosis per 2023 ACC Expert Consensus (Kittleson et al., JACC 2023)."

3. Provide TTR genotyping results. "TTR gene sequencing: wild-type (no pathogenic variant identified)." Or if hereditary: "TTR gene V122I variant (p.Val142Ile), consistent with hereditary ATTR-CM prevalent in individuals of African descent."

4. Cite ATTR-ACT and the 2023 ACC Consensus. "Tafamidis is FDA-approved and guideline-recommended (2023 ACC Expert Consensus) for ATTR-CM. The ATTR-ACT trial (NEJM 2018, Maurer) showed 30% reduction in all-cause mortality and 32% reduction in cardiovascular hospitalizations. Patient meets all diagnostic criteria: positive PYP imaging, exclusion of AL, and confirmed TTR amyloidosis."

5. Emphasize the narrow therapeutic window. "ATTR-CM is a progressive, fatal disease. Tafamidis is the only disease-modifying therapy shown to reduce mortality. Delay or denial accelerates irreversible cardiac damage."

How to Argue Against "Experimental" or Coverage Exclusion (Camzyos for Obstructive HCM)

What the denial says: "Mavacamten is investigational" or "does not meet plan criteria for hypertrophic cardiomyopathy."

Why it's outdated: The 2024 AHA/ACC/AMSA Guideline for the Management of Hypertrophic Cardiomyopathy gave cardiac myosin inhibitors (mavacamten, Camzyos) a Class I recommendation for symptomatic obstructive HCM inadequately controlled by maximally tolerated medical therapy.

Concrete steps to rebut:

1. Document obstructive physiology. State peak left ventricular outflow tract (LVOT) gradient at rest or with provocation: "Resting LVOT gradient 68 mmHg on echocardiogram 1/22/2026. Peak provocation gradient 95 mmHg. Obstructive HCM confirmed."

2. Document functional limitation. "Patient is NYHA class III, with dyspnea on exertion and fatigue limiting activities of daily living. Cardiopulmonary exercise test 2/1/2026: peak VO₂ 14 mL/kg/min (45% predicted)."

3. List prior medical therapy and response. "Maximally tolerated beta-blocker: metoprolol succinate 200 mg daily for 6 months. Symptoms persist. Disopyramide not tolerated due to urinary retention. Verapamil trialed: inadequate gradient reduction, discontinued due to peripheral edema."

4. Cite the 2024 HCM Guideline and EXPLORER-HCM. "Per 2024 AHA/ACC HCM Guideline (Ommen et al., Circulation 2024), cardiac myosin inhibitors are Class I for symptomatic obstructive HCM (LVOT gradient ≥50 mmHg, NYHA II–III) when medical therapy has not controlled symptoms. EXPLORER-HCM (Lancet 2020) demonstrated mavacamten improved peak VO₂, reduced LVOT gradient by 36 mmHg, and improved NYHA class in 65% of patients."

5. Confirm REMS enrollment. Camzyos has a Risk Evaluation and Mitigation Strategy (REMS) program due to risk of systolic dysfunction; prescribers and patients must enroll. State: "Prescribing cardiologist Dr. [Name] is REMS-certified. Patient enrolled in Camzyos REMS program, with echocardiographic monitoring per protocol."

How to Argue Against "LDL Not High Enough" (PCSK9 Inhibitors)

What the denial says: "LDL-C level does not meet threshold for PCSK9 inhibitor coverage" (e.g., policy requires LDL ≥100 mg/dL or ≥130 mg/dL).

Why it's outdated: The 2022 ACC Expert Consensus lowered the intervention threshold to LDL ≥70 mg/dL (from prior ≥100 mg/dL) for very-high-risk ASCVD, based on data showing incremental benefit at lower LDL levels.

Concrete steps to rebut:

1. State the patient's current LDL and the guideline-recommended goal. "Patient's LDL 89 mg/dL on rosuvastatin 40 mg + ezetimibe 10 mg for 12 weeks. Goal per 2022 ACC Expert Consensus for very-high-risk ASCVD: <55 mg/dL. Patient is 34 mg/dL above goal."

2. Quote the 2022 ACC threshold: "Lloyd-Jones et al., JACC 2022: In very-high-risk ASCVD, if LDL ≥70 mg/dL on maximally tolerated statin ± ezetimibe, adding a PCSK9 inhibitor or inclisiran is recommended."

3. Cite evidence that lower is better. "FOURIER trial post hoc analysis (Circulation 2018) showed that patients achieving LDL <20 mg/dL had the lowest event rates, with continued linear benefit and no safety signal. Every 40 mg/dL reduction in LDL reduces major cardiovascular events by approximately 20%."

4. Attach or reference the insurer's own medical policy and highlight the conflict with current guidelines. "Plan policy [cite number] requires LDL ≥100 mg/dL. This criterion is inconsistent with the 2022 ACC Expert Consensus, published after your policy was written, which reflects updated evidence."

5. Appeal to patient safety and cost of future events. "Patient has already suffered two major cardiovascular events. Failing to reduce LDL below 70 mg/dL increases risk of recurrent MI or stroke. The cost of one MI hospitalization (~$50,000–$100,000) or stroke (~$75,000–$150,000 acute care, plus long-term disability) far exceeds the cost of PCSK9 inhibitor therapy."

How to Argue Against Weight-Loss Exclusions (GLP-1 for Cardiovascular Risk Reduction)

What the denial says: "Weight-loss drugs are excluded from coverage."

Why it's wrong: In March 2024, the FDA approved semaglutide 2.4 mg (Wegovy) to reduce the risk of cardiovascular death, nonfatal MI, and nonfatal stroke in adults with established cardiovascular disease and either obesity or overweight, based on the SELECT trial. This is a cardiovascular indication, not a weight-loss indication.

Concrete steps to rebut:

1. Frame the prescription as cardiovascular risk reduction, not weight loss. "Semaglutide 2.4 mg is FDA-approved for reduction of major adverse cardiovascular events in patients with established CVD and overweight or obesity (FDA approval March 2024). This is a cardiovascular indication."

2. Cite SELECT. "The SELECT trial (NEJM 2023, Lincoff) enrolled 17,604 patients with CVD (prior MI, stroke, or peripheral artery disease) and BMI ≥27 kg/m² without diabetes. Semaglutide reduced major adverse cardiovascular events by 20% (hazard ratio 0.80, 95% CI 0.72–0.90, p<0.001)."

3. Document the patient's cardiovascular disease and BMI. "Patient has history of STEMI 6/2023 with stent placement, plus NSTEMI 11/2024. BMI 32 kg/m². This meets SELECT inclusion criteria and FDA-approved indication."

4. Point out that the prescription is for cardiovascular event reduction, not weight management. "The primary therapeutic goal is to reduce recurrent MI and stroke risk, consistent with the SELECT trial endpoint. Any weight loss is a secondary metabolic benefit."

5. If the plan has a blanket exclusion, argue that it conflicts with FDA labeling and standard of care. "Exclusions for 'weight loss drugs' do not apply to FDA-approved cardiovascular indications. Denying coverage for an FDA-approved cardiovascular therapy based on a drug's prior indication is inconsistent with evidence-based medicine."

What We Do

We draft detailed, physician-ready appeal letters that cite the specific guidelines, thresholds, and trial data insurance medical directors recognize. You provide your denial letter, diagnosis, lab results, and medication history; we generate a structured rebuttal that your cardiologist can review, sign, and submit. Most appeals require peer-to-peer review or external review if the internal appeal fails—we help you prepare the documentation to win at each stage. The process typically takes 30–90 days depending on the insurer and the complexity of your case. Persistence and precision matter: appeals that cite the 2022 ACC Expert Consensus, PARADIGM-HF, ATTR-ACT, and the 2024 HCM Guideline by name and year have measurably higher success rates than generic "medical necessity" letters.

Sources

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2. Lloyd-Jones DM, 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. J Am Coll Cardiol. 2022;80(14):1366-1418.

3. Sabatine MS, et al. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease (FOURIER). N Engl J Med. 2017;376(18):1713-1722.

4. Schwartz GG, et al. Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome (ODYSSEY OUTCOMES). N Engl J Med. 2018;379(22):2097-2107.

5. Ray KK, et al. Two Phase 3 Trials of Inclisiran in Patients with Elevated LDL Cholesterol (ORION-10, ORION-11). N Engl J Med. 2020;382(16):1507-1519.

6. Heidenreich PA, et al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure. Circulation. 2022;145(18):e895-e1032.

7. McMurray JJV, et al. Angiotensin-Neprilysin Inhibition versus Enalapril in Heart Failure (PARADIGM-HF). N Engl J Med. 2014;371(11):993-1004.

8. McMurray JJV, et al. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction (DAPA-HF). N Engl J Med. 2019;381(21):1995-2008.

9. Packer M, et al. Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure (EMPEROR-Reduced). N Engl J Med. 2020;383(15):1413-1424.

10. Anker SD, et al. Empagliflozin in Heart Failure with a Preserved Ej