CurrentCignaPolicy IP0125

Verquvo (vericiguat) for heart failure

Defines medical necessity, initial and reauthorization criteria, authorization duration, and coverage exclusions for vericiguat (Verquvo) for adults with symptomatic chronic heart failure and reduced ejection fraction under Cigna coverage policy IP0125.

Policy Summary

PayerCigna

PolicyVerquvo (vericiguat) for heart failure

Policy CodePolicy IP0125

Change TypeNo material change

Effective DateJan 1, 2024

Next Review DateJan 1, 2025

Key ActionDocument medical necessity criteria (age ≥18, LVEF <45%, recent HF hospitalization within 6 months or outpatient IV diuretics within 3 months, and cardiologist prescribing/consultation) for coverage and provide documentation of benefit for reauthorization.

POLICY UPDATE CHANGES

No material changes

1Covered Indication (HF with LVEF <45% post-hospitalization or IV diuretics)

12mAuthorization Duration

18+Minimum Age

Coverage Summary

Coverage Policy IP0125: Vericiguat (Verquvo) is covered with criteria for adults with symptomatic chronic heart failure when medical necessity criteria are met. Key initial criteria include: age >= 18 years; left ventricular ejection fraction <45% prior to initiation; and either a hospitalization for heart failure within the last 6 months or outpatient intravenous diuretics within the last 3 months. Medication must be prescribed by or in consultation with a cardiologist. Continuation requires documentation of beneficial response. Receipt of sample product does not satisfy coverage criteria.

Initial Therapy Criteria

Medical Necessity Criteria - Initial Therapy

Vericiguat (Verquvo) is considered medically necessary when the following are met:

Heart failure. Individual meets ALL of the following criteria

Individual is 18 years of age or older>= 18 years
EITHER of the following
- Hospitalization for heart failure was required within the last 6 monthswithin the last 6 months
- Outpatient intravenous diuretics were given within the last 3 monthswithin the last 3 months
Left ventricular ejection fraction less than 45% prior to the initiation of Verquvo< 45%
Medication is prescribed by, or in consultation with, a cardiologist

Continuation / Reauthorization Criteria

Reauthorization Criteria / Continuation Therapy

Continuation is considered medically necessary when initial criteria are met AND there is demonstrated benefit:

ALL of the following

Initial medical necessity criteria are still met
Documentation of beneficial response to vericiguat

Documentation Required

Documentation of beneficial response for reauthorization

For continuation/reauthorization, providers must supply documentation of beneficial response and that initial criteria remain met. Approval duration for initial and reauthorization requests is up to 12 months.

Provider Actions & Authorization

Prior Authorization

Prior authorization required

Coverage is subject to medical necessity review; prescriber must document criteria (age, LVEF <45%, recent HF hospitalization within 6 months or outpatient IV diuretics within 3 months, and cardiologist prescribing or consultation).

Age ≥ 18 years
Left ventricular ejection fraction < 45%
Hospitalization for heart failure within the last 6 months OR outpatient intravenous diuretics within the last 3 months
Medication prescribed by, or in consultation with, a cardiologist

Billing Rule

Authorization duration

Initial and reauthorization approval duration: up to 12 months.

Clinical Evidence & References

Evidence includes the VICTORIA Study: Armstrong et al., Verquvo in patients with heart failure and reduced ejection fraction (N Engl J Med. 2020;382(20):1883-1893), and the Verquvo prescribing information (Verquvo tablets [prescribing information]. Merck; January 2021). The clinical indication supported by these sources is reduction in risk of cardiovascular death and heart failure hospitalization in adults with symptomatic chronic heart failure and ejection fraction <45% following a hospitalization for heart failure or need for outpatient intravenous diuretics.

Background

Verquvo (vericiguat) is a soluble guanylate cyclase stimulator indicated to reduce the risk of cardiovascular death and heart failure hospitalization in adults with symptomatic chronic heart failure and an ejection fraction <45% following a hospitalization for heart failure or need for outpatient intravenous diuretics. Coverage under this policy requires meeting the specified medical necessity criteria; receipt of sample product does not satisfy coverage requirements.