Effective Date

Date of Origin 

10/1/2022              

Verquvo^®

(vericiguat)

Tablets

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%

1

CLINICAL RATIONALE

Heart failure (HF) is a clinical syndrome that results from any structural or functional impairment of ventricular filling or ejection of blood.  The cardinal manifestations of HF are dyspnea and fatigue, which may limit exercise tolerance, and fluid retention, which may lead to pulmonary and/or splanchnic congestion, and/or peripheral edema.  There is no single diagnostic test for HF because it is largely a clinical diagnosis based on a careful history and physical examination.  The lifetime risk of developing HF is 20% for Americans greater than or equal to 40 years of age.  Approximately 5.1 million persons in the United States have clinically manifested HF.  The absolute mortality rates of HF are approximately 50% within 5 years of diagnosis.  The 5-year case fatality rates after hospitalization of HF are 42.3%.  The total cost of HF care in the United States exceeds $30 billion annually, with over half of those costs due to hospitalizations.(2)

The ACCF/AHA guideline classifies heart failure by the following in relation to New York Heart Association (NYHA) Functional Classification:(2)

Efficacy

Vericiguat is a stimulator of soluble guanylate cyclase (sGC), an enzyme in the nitric oxide (NO) signaling pathway.  When NO binds to sGC, the enzyme catalyzes the synthesis of intracellular cyclic guanosine monophosphate (cGMP).  cGMP is a messenger that plays a role in the regulation of vascular tone, cardiac contractility, and cardiac remodeling.  Heart failure is associated with impaired synthesis of NO and decreased activity of sGC, which may contribute to myocardial and vascular dysfunction.  Since vericiguat directly stimulates sGC, both independently and synergistically with NO, vericiguat increases levels of intracellular cGMP, leading to smooth muscle relaxation and vasodilation.  Vericiguat also demonstrated a dose-dependent reduction in N-terminal-prohormone B natriuretic peptide (NT-proBNP), a biomarker in heart failure.(1)

Verquvo gained FDA approval through the VICTORIA trial.  This was a randomized, parallel-group, placebo-controlled, double-blind, multicenter trial that enrolled 5,050 adult patients with symptomatic chronic heart failure (New York Heart Association class II-IV) that also had a left ventricular ejection fraction of less than 45%.  Patients also had a worsening heart failure event, defined as a heart failure hospitalization within 6 months before randomization, or use of outpatient intravenous diuretics for heart failure within 3 months before randomization.  At baseline, 93% of patients were on a beta blocker, 73% of patients were on an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB), 70% of patients were on a mineralocorticoid receptor antagonist (MRA), 15% of patients were on a combination of an angiotensin receptor and neprilysin inhibitor (ARNI), 28% of patients had an implantable cardiac defibrillator, and 15% had a biventricular pacemaker. Ninety-one percent of patients were treated with 2 or more heart failure medications (beta blocker, any renin-angiotensin system [RAS] inhibitor or MRA) and 60% of patients were treated with all 3. At baseline, 6% of patients were on ivabradine and 3% of patients were on a sodium glucose co-transporter 2 (SGLT2) inhibitor.  Patients in both the study drug and the placebo group had their doses titrated up as tolerated.  The primary endpoint was a composite of time to first event of cardiovascular (CV) death or hospitalization for heart failure.  The median follow-up for the primary endpoint was 11 months.  Verquvo was found to be superior to placebo in reducing the risk of CV death or heart failure hospitalization.  Over the course of the study, there was a 4.2% annualized absolute risk reduction in CV death or heart failure hospitalization compared with placebo.(1)

Safety

Verquvo is contraindicated in patients with concomitant use of other soluble guanylate cyclase (sGC) stimulators and in patients that are pregnant.(1)

Verquvo carries a black box warning for embryo-fetal toxicity.

• Do not administer VERQUVO to a pregnant female because it may cause fetal harm.
• Females of reproductive potential: Exclude pregnancy before the start of treatment. To prevent pregnancy, females of reproductive potential must use effective forms of contraception during treatment and for one month after stopping treatment.(1)

1

Verquvo Prescribing Information. Merck & Co., Inc.  June 2021.

2

Yancy CW, Jessup M, Bozkurt B, et. al.  “2013 ACCF/AHA Guideline for the Management of Heart Failure”.  JACC.  62, (16) e147-239.  October 15, 2013.  Available at: https://www.jacc.org/doi/pdf/10.1016/j.jacc.2013.05.019 

VERQUVO*vericiguat tab

10 MG ; 2.5 MG ; 5 MG

M ; N ; O ; Y

N

409000850003

VERQUVO*vericiguat tab

10 MG ; 2.5 MG ; 5 MG

30.0

TABS

30

Days

VERQUVO*vericiguat tab

10 MG ; 2.5 MG ; 5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

VERQUVO*vericiguat tab

10 MG ; 2.5 MG ; 5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Initial Evaluation

Target Agent(s) will be approved when ALL of the following are met:

1. ONE of the following:
   1. Information has been provided that indicates the patient has been treated with the requested agent within the past 90 days OR
   2. The prescriber states the patient has been treated with the requested agent within the past 90 days AND is at risk if therapy is changed OR
   3. The patient has a diagnosis of symptomatic chronic heart failure (NYHA class II-IV) and ALL of the following:
      1. The patient has a baseline OR current left ventricular ejection fraction of 45% or less AND
      2. The patient has had a worsening heart failure event, defined as a heart failure hospitalization within 6 months of agent request, or use of outpatient intravenous diuretics for heart failure within 3 months of agent request AND
      3. ONE of the following:
         1. The patient will be using standard CHF therapy (e.g., beta blockers, ACE inhibitors) in combination with the requested agent OR
         2. The patient has an intolerance, hypersensitivity, or FDA labeled contraindication to ALL standard CHF therapy (e.g., beta blockers, ACE inhibitors) that is not expected to occur with the requested agent OR
   4. The patient has another FDA approved indication for the requested agent and route of administration OR
   5. The patient has another indication that is supported in compendia for the requested agent and route of administration AND
2. ONE of the following:
   1. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
   2. The prescriber has provided information in support of using the requested agent for the patient’s age AND
3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., cardiologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
4. The patient does NOT have any FDA labeled contraindications to the requested agent 

Compendia Allowed: AHFS, or DrugDex 1 or 2a level of evidence

Length of Approval:  12 months

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

Renewal Evaluation

Target Agent(s) will be approved when ALL of the following are met:

1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND
2. The patient has had clinical benefit with the requested agent AND
3. If the requested agent is being used for heart failure, ONE of the following:
   1. The patient will be using standard CHF therapy (e.g., beta blockers, ACE inhibitors) in combination with the requested agent OR
   2. The patient has an intolerance, hypersensitivity, or FDA labeled contraindication to ALL standard CHF therapy (e.g., beta blockers, ACE inhibitors) that is not expected to occur with the requested agent AND
4. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., cardiologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
5. The patient does NOT have any FDA labeled contraindications to the requested agent

Length of Approval:  12 months

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:

1. The requested quantity (dose) does NOT exceed the program quantity limit OR
2. ALL of the following:
   1. The requested quantity (dose) is greater than the program quantity limit AND
   2. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
   3. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit OR
3. ALL of the following:
   1. The requested quantity (dose) is greater than the program quantity limit AND
   2. The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication AND
   3. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval: 12 months