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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.

POLICY REVIEW CYCLE                                                                                                                                                                           

Effective Date

Date of Origin 

10/1/2023              

FDA APPROVED INDICATIONS AND DOSAGE

Agent(s)

FDA Indication(s)

Notes

Ref#

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

See package insert for FDA prescribing information:  https://dailymed.nlm.nih.gov/dailymed/index.cfm

CLINICAL RATIONALE

HEART FAILURE

Heart failure (HF) is a complex clinical syndrome with symptoms and signs that result from any structural or functional impairment of ventricular filling or ejection of blood.  The American Heart Association/American College of Cardiology (AHA/ACC) stages of heart failure emphasize the development and progression of disease.  The New York Heart Association (NYHA) classification is used to characterize symptoms and functional capacity of patients with symptomatic or advanced heart failure.  It is a subjective assessment by a clinician and can change over time.  It is widely used in clinical practice to determine the eligibility of patients for treatment strategies. (2) 

ACC/AHA Stages of HF

ACC/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)

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)

REFERENCES                                                                                                                                                                            

Number

Reference

1

Verquvo Prescribing Information. Merck & Co., Inc.  February 2023.

2

2022 ACCF/AHA Guideline for the Management of Heart Failure”.  Circulation.  145, (18) e895-e1032.  May 2022.  Available at: https://www.ahajournals.org/doi/epub/10.1161/CIR.0000000000001063

POLICY AGENT SUMMARY PRIOR AUTHORIZATION

Target Brand Agent(s)

Target Generic Agent(s)

Strength

Targeted MSC

Available MSC

Final Age Limit

Preferred Status

Verquvo

vericiguat tab

10 MG ; 2.5 MG ; 5 MG

M ; N ; O ; Y

N

POLICY AGENT SUMMARY QUANTITY LIMIT

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

QL Amount

Dose Form

Day Supply

Duration

Addtl QL Info

Allowed Exceptions

Targeted NDCs When Exclusions Exist

Verquvo

vericiguat tab

10 MG ; 2.5 MG ; 5 MG

30

Tablets

30

DAYS

CLIENT SUMMARY – PRIOR AUTHORIZATION

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Client Formulary

Verquvo

vericiguat tab

10 MG ; 2.5 MG ; 5 MG

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

CLIENT SUMMARY – QUANTITY LIMITS

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Client Formulary

Verquvo

vericiguat tab

10 MG ; 2.5 MG ; 5 MG

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

PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

Initial Evaluation

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

  1. ONE of the following:
    1. The requested agent is eligible for continuation of therapy AND ONE of the following:

Agent(s) Eligible for Continuation of Therapy

All target agents are eligible for continuation of therapy

      1. Information has been provided that indicates the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR
      2. The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) 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 prior to therapy with the requested agent 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
    2. The patient has another FDA approved indication for the requested agent and route of administration OR
    3. The patient has another indication that is supported in compendia for the requested agent and route of administration AND
  1. If the patient has an FDA approved indication, then 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 for the requested indication AND
  2. 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
  3. The patient does NOT have any FDA labeled contraindications to the requested agent 

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

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

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
  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

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

Length of Approval:  12 months

QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

QL with PA

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

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.

 

 

Commercial _ PS _ Verquvo _PAQL _ProgSum_ 10/1/2023