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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 |
10-01-2024 |
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FDA LABELED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Verquvo® |
Reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for HF or need for outpatient IV diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45% |
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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, and advanced stages and progression are associated with reduced survival. The New York Heart Association (NYHA) classification is used to characterize symptoms and functional capacity of patients with symptomatic (NYHA Class II-IV) HF or advanced HF. In HF, NYHA functional class I includes patients with no limitations in physical activity resulting from their HF. NYHA class II includes patients who are comfortable at rest but have slight symptoms resulting from HF (dyspnea, fatigue, lightheadedness) with ordinary activity. NYHA class III includes patients who are comfortable at rest but have symptoms of HF with less than ordinary activity. NYHA class IV includes patients who are unable to carry out any physical activity without symptoms and have symptoms at rest. It is a subjective assessment by a clinician and can change over time. Although reproducibility and validity can be limited, the NYHA functional classification is an independent predictor of mortality, and it is widely used in clinical practice to determine the eligibility of patients for treatment strategies. Because of the complexity of HF management and coordination of other health and social services required, HF care is ideally provided by multidisciplinary teams that include cardiologists, nurses, and pharmacists who specialize in HF as well as dieticians, mental health clinicians, social workers, primary care clinicians, and additional specialists.(2)
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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) a second 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. By directly stimulating 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) |
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Safety |
Verquvo is contraindicated in patients with concomitant use of other soluble guanylate cyclase (sGC) stimulators and in patients that are pregnant.(1)
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REFERENCES
Number |
Reference |
1 |
Verquvo prescribing information. Merck Sharp & Dohme LLC. July 2023. |
2 |
Heidenreich PA, Bozkurt B, Aguilar D, 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. Circulation. 2022;145(18). doi: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 |
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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 |
|
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Verquvo |
vericiguat tab |
10 MG ; 2.5 MG ; 5 MG |
30 |
Tablets |
30 |
DAYS |
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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 |
||
PA |
Initial Evaluation Target Agent(s) will be approved when ALL of the following are met:
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 Target Agent(s) will be approved when ALL of the following are met:
NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. |
QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
QL |
Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:
Length of Approval: up to 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_ 10-01-2024
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