Verquvo (vericiguat)

Verquvo (vericiguat) is FDA-approved to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45%. The requirement of hospitalization for heart failure indicates progression of the disease and is associated with substantially worsened prognosis compared with outpatients who were not hospitalized for heart failure. Likewise, heart failure decompensation requiring IV diuretics to treat congestion predicts unfavorable outcomes.

Verquvo (vericiguat) may lower the chance of dying from heart disease, or the need to be treated in the hospital for heart failure. Depending on the cause of heart failure, the type of heart failure, and associated symptoms - one or more of the following drugs may be needed to:

• Help to dilate arteries and veins - such as Angiotensin-converting enzyme (ACE) inhibitors (e.g., lisinopril, ramipril), angiotensin receptor blockers (ARBs) (e.g., losartan, valsartan), and angiotensin receptor neprilysin inhibitor (ARNIs) (e.g., sacubitril with valsartan)
• Slow the heart rate - such as Beta-blockers (e.g., bisoprolol, carvedilol, long-acting metoprolol (extended-release))
• Help the body get rid of excess sodium and water by increasing the need to urinate more often - such as diuretics (e.g., furosemide, bumetanide, hydrochlorothiazide), or Aldosterone antagonists (e.g., spironolactone, eplerenone)
• Help the heart pump blood better - such as digoxin
• Relax the blood vessels and lower blood pressure - such as vasodilators (e.g., hydralazine, nitrates)
• Lower the heart rate and decrease the heart's workload - such as If channel blocker (e.g., ivabradine)
• That has been shown to improve symptoms and quality of life in people with heart failure - such as Sodium-glucose cotransporter-2 inhibitors (SGLT-2 inhibitors) (e.g., canagliflozin, dapagliflozin)

Definitions

Decompensation refers to the inability to maintain adequate functionality or the loss of physiological balance.

Diuretic refers to a drug or chemical that increases the elimination of waste through the urine.

Heart failure refers to the condition when a person’s heart muscle does not pump blood as well as it should. Contributing factors of heart failure include damage, weakening, stiffness, or insufficient filling of the ventricles.

Left ventricular ejection fraction or LVEF refers to the measurement of how well the heart is pumping and is used to help classify heart failure and guide treatment. In a normal healthy heart, the ejection fraction is above 50%, meaning that more than half of the blood that fills the ventricle is pumped out with each beat. Generally, heart failure begins with the left ventricle, the heart's main pumping chamber.

Medical Necessity Criteria for Initial Authorization

The Plan considers Verquvo (vericiguat) medically necessary when ALL of the following criteria are met:

1. Prescribed by or in consultation with cardiologist; AND
2. The member is at least 18 years of age or older; AND
3. The member has diagnosis of symptomatic chronic heart failure (New York Heart Association [NYHA] class II-IV); AND
4. The member has documentation (e.g., echocardiogram, multigated radionuclide angiography (MUGA), or magnetic resonance imagery (MRI)) of left ventricular ejection fraction (LVEF) less than 45% following a worsening heart failure event, defined as:
   • heart failure hospitalization within 6 months; or
   • use of outpatient IV diuretics for heart failure within 3 months; AND
5. The member has documented evidence of concomitant or prior treatment with BOTH of the following (unless contraindicated or there is a clinical reason why the member cannot take these medications):

• An ACE inhibitor (e.g., captopril, enalapril, lisinopril), angiotensin receptor blocker (e.g., candesartan, losartan, valsartan), or angiotensin receptor–neprilysin inhibitor (e.g.,sacubitril-valsartan); and
• An evidence-based β-blockers (e.g., bisoprolol, carvedilol, or metoprolol succinate extended-release); AND

6. The member does NOT meet any of the following:
   • Has concurrent or anticipated use of ANY of the following:
   1. a sGC stimulator such as Adempas (riociguat); or
   2. phosphodiesterase type 5 (PDE5) inhibitors such as vardenafil, tadalafil, or sildenafil; or
   • Has an estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m2 or chronic dialysis; or
   • Has severe hepatic impairment (e.g., Child-Pugh C); or
   • Is a female and meets ONE of the following:
   1. is not of reproductive potential, defined as ONE of the following:
   1. is postmenopausal (defined as at least 12 months with no menses in women ≥45 years of age); or
   2. has had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion; or
   3. has a congenital or acquired condition that prevents childbearing; or
   2. is of reproductive potential and has documentation of a recent negative pregnancy test result (within 30 days); AND
7. Is being prescribed within the manufacturer’s published dosing guidelines or falls within dosingguidelines found in a compendia of current literature; AND
8. Chart documentation and supporting laboratory test results are provided for review to substantiate the above listed requirements.

If the above prior authorization criteria are met, Verquvo (vericiguat) will be approved for 6 months.

Medical Necessity Criteria for Reauthorization:

Reauthorization for 12 months will be granted if BOTH of the following are met:

1. The member still meets all applicable initial criteria; AND
2. Recent chart documentation (within the last 6 months) shows the member has experienced a positive clinical response to therapy as evidenced by ANY of the following:
• an improvement in ejection fraction and/or heart failure symptoms (exercise tolerance etc); or
• fewer hospitalizations and/or decreased need for IV diuretics; or
• low disease activity and/or improvements in the condition’s signs and symptoms.

Experimental or Investigational / Not Medically Necessary:

Verquvo (vericiguat) for any other indication is considered not medically necessary by the Plan, as it is deemed to be experimental, investigational, or unproven.

References

1. Armstrong PW, Pieske B, Anstrom KJ, et al; VICTORIA Study Group. Vericiguat in patients with heart failure and reduced ejection fraction. N Engl J Med. 2020;382(20):1883-1893. doi:10.1056/NEJMoa1915928
2. Armstrong PW, Roessig L, Patel MJ, et al. A multicenter, randomized, double-blind, placebo- controlled trial of the efficacy and safety of the oral soluble guanylate cyclase stimulator: the VICTORIA Trial. JACC Heart Fail 2018;6:96-104.
3. Arnett DK et al: 2019 ACC/AHA guideline on the primary prevention of cardiovascular disease:executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 74(10):1376-414, 2019
4. Burnett JC. Vericiguat — Another Victory for Targeting Cyclic GMP in Heart Failure. New England Journal of Medicine. 2020; 382:1952-1953 DOI: 10.1056/NEJMe2006855
5. Chang LL, Xu H, DeVore AD, et al. Timing of postdischarge follow-up and medication adherence among patients with heart failure. J Am Heart Assoc 2018;7:e007998.
6. Felker, GM. Building the Foundation for a New Era of Quadruple Therapy in Heart Failure. Circulation Issue: Volume 141(2), 14 January 2020, p 112-114.
7. Heidenreich PA et al. 2022 AHA/ACC/HFSA Guideline for the management of heart failure: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2022;79(17):e263-421
1. Hollenberg SM et al: 2019 ACC expert consensus decision pathway on risk assessment, management, and clinical trajectory of patients hospitalized with heart failure: a report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 74(15):1966-2011, 2019
2. Maddox, TN, Januzzi, JL, et al. 2021 Update to the 2017 ACC Expert Consensus Decision Pathway for Optimization of Heart Failure Treatment: Answers to 10 Pivotal Issues About Heart Failure With Reduced Ejection Fraction. Journal of the American College of Cardiology. 2021. 77(6): 772-810. https://doi.org/10.1016/j.jacc.2020.11.022.
3. Mayoclinic.org. Heart Failure. 2021. Available at: https://www.mayoclinic.org/diseases-conditions/heart-failure/symptoms-causes/syc-20373142. Accessed 25 Feb 2021.
4. McDonagh TA et al: 2021 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 42(36):3599-726, 2021
5. Merriam-Webster.com Dictionary. Merriam-Webster. Available at: https://www.merriam-webster.com/dictionary. Accessed 25 Feb 2021.
6. Pieske B, Patel MJ, Westerhout CM, Anstrom KJ, Butler J, Ezekowitz J, Hernandez AF, Koglin J, Lam CSP, Ponikowski P, Roessig L, Voors AA, O'Connor CM, Armstrong PW; VICTORIA Study Group. Baseline features of the VICTORIA (Vericiguat Global Study in Subjects with Heart Failure with Reduced Ejection Fraction) trial. Eur J Heart Fail. 2019 Dec;21(12):1596-1604. doi: 10.1002/ejhf.1664.
7. Shore, S. 2021 Expert Decision Pathway for HFrEF Treatment Optimization. Journal of the American College of Cardiology. Published 11 Jan 2021. Available at: https://www.acc.org/Latest-in-Cardiology/ten-points-to-remember/2021/01/2021/21/56/2021-Update-Expert-Consensus-for-HFrEF. Accessed 25 Feb 2021.
8. Verquvo (vericiguat) [prescribing information]. Rahway, NJ: Merck Sharp & Dohme LLC; May 2023.
9. Yancy, CW, Jessup, M, et al. 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure. Journal of the American College of Cardiology. 2017. 70(6): 776–803. https://doi.org/10.1016/j.jacc.2017.04.025.

Clinical Guideline Revision / History Information

• Original Date: 03/11/2021
• Reviewed/Revised: 12/01/2021, 03/17/2022, 12/08/2022, 12/14/2023