ph-1148
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Verquvo Prior Authorization with Quantity Limit Program Summary

Policy Number: PH-1148

 

This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.

TARGET AGENT(S)

Verquvo (vericiguat)

Brand (generic)

GPI

Multisource Code

Quantity Limit (per day or as listed)

Verquvo (vericiguat)

2.5 mg tablet

40900085000321

M, N, O, or Y

1 tablet

5 mg tablet

40900085000330

M, N, O, or Y

1 tablet

10 mg tablet

40900085000340

M, N, O, or Y

1 tablet

PRIOR AUTHORIZATION CRITERIA FOR APPROVAL

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

    1. 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

    1. 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

      1. 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

      1. ONE of the following:
        1. The requested agent will be used in combination with a beta blocker (e.g., atenolol, bisoprolol, carvedilol, metoprolol)

OR

        1. The patient has an intolerance or hypersensitivity to a beta blocker

OR

        1. The patient has an FDA labeled contraindication to a beta blocker

AND

      1. ONE of the following:
        1. The requested agent will be used in combination with a medication which includes an ACE inhibitor or ARB (e.g., benazepril, lisinopril, losartan)

OR

        1. The patient has an intolerance or hypersensitivity to an ACE inhibitor, ARB, or a combination medication containing an ACE or ARB

OR

        1. The patient has an FDA labeled contraindication to an ACE inhibitor, ARB, or a combination medication containing an ACE or ARB

OR

    1. The patient has another FDA approved indication for the requested agent 

OR

    1. The patient has another indication that is supported in compendia [AHFS, or DrugDex 1 or 2a level of evidence] for the requested agent

AND

  1. ONE of the following:
    1. The patient’s age is within FDA labeling for the requested indication for the requested agent

OR

    1. The prescriber has provided information in support of using the requested agent for the patient’s age

AND

  1. 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

  1. The patient does NOT have any FDA labeled contraindications to the requested agent

AND

  1. ONE of the following:
    1. The requested quantity (dose) does NOT exceed the program quantity limit

OR

    1. ALL of the following:
      1. The requested quantity (dose) is greater than the program quantity limit

AND

      1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication

AND

      1. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit

OR

    1. ALL of the following:
  1. The requested quantity (dose) is greater than the program quantity limit

AND

  1. The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication

AND

  1. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval:  12 months

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

  1. The patient has had clinical benefit with the requested agent

AND

  1. ONE of the following:
    1. The patient’s age is within FDA labeling for the requested indication for the requested agent

OR

    1. The prescriber has provided information in support of using the requested agent for the patient’s age

AND

  1. If the requested agent is being used for heart failure, BOTH of the following:
    1. ONE of the following:
      1. The requested agent will be used in combination with a beta blocker (e.g., atenolol, bisoprolol, carvedilol, metoprolol)

OR

      1. The patient has an intolerance or hypersensitivity to a beta blocker

OR

      1. The patient has an FDA labeled contraindication to a beta blocker

AND

    1. ONE of the following:
      1. The requested agent will be used in combination with a medication which includes an ACE inhibitor or ARB (e.g., benazepril, lisinopril, losartan)

OR

      1. The patient has an intolerance or hypersensitivity to an ACE inhibitor, ARB, or a combination medication containing an ACE or ARB

OR

      1. The patient has an FDA labeled contraindication to an ACE inhibitor, ARB, or a combination medication containing an ACE or ARB

AND

  1. 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

  1. The patient does NOT have any FDA labeled contraindications to the requested agent

AND

  1. ONE of the following:
    1. The requested quantity (dose) does NOT exceed the program quantity limit

OR

    1. ALL of the following:
      1. The requested quantity (dose) is greater than the program quantity limit

AND

      1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication

AND

      1. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit

OR

    1. ALL of the following:
  1. The requested quantity (dose) is greater than the program quantity limit

AND

  1. The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication

AND

  1. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval:  12 months

FDA APPROVED INDICATIONS AND DOSAGE1

Agent(s)

Indication(s)

Dosage

Verquvo®

(vericiguat)

Tablet

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%

Recommended starting dose is 2.5 mg orally once daily with food.  Double the dose approximately every 2 weeks to reach the target maintenance dose of 10 mg once daily, as tolerated by the patient

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 in 20% for Americans ≥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 is 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

ACCF/AHA Stages of HF

ACCF/AHA Stage Description

NYHA Functional Classification

NYHA Functional Classification Description

A

At high risk for HF but without structural heart disease or symptoms of HF

None

None

B

Structural heart disease but without signs or symptoms of HF

I

No limitation of physical activity.  Ordinary physical activity does not cause symptoms of HF

C

Structural heart disease with prior or current symptoms of HF

I

No limitation of physical activity.  Ordinary physical activity does not cause symptoms of HF

II

Slight limitation of physical activity.  Comfortable at rest, but ordinary physical activity results in symptoms of HF

III

Marked limitation of physical activity.  Comfortable at rest, but less than ordinary activity causes symptoms of HF

IV

Unable to carry on any physical activity without symptoms of HF, or symptoms of HF at rest

D

Refractory HF requiring specialized interventions

IV

Unable to carry on any physical activity without symptoms of HF, or symptoms of HF at rest

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

Safety1

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

REFERENCES

  1. Verquvo Prescribing Information. Merck & Co., Inc.  January 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 Accessed 1/27/2021.

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

 

The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.

 

Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

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