CurrentCignaPolicy N/A

Cardamyst (etripamil) Prior Authorization Policy

This policy governs prior authorization requirements for Cardamyst (etripamil nasal spray) for treatment of paroxysmal supraventricular tachycardia (PSVT) for Cigna-administered health benefit plans and specifies clinical criteria, prescribing restrictions, and coverage duration.

Policy Summary

PayerCigna

PolicyCardamyst (etripamil) Prior Authorization Policy

Policy CodePolicy N/A

Change TypeClarified clinical criterion

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document patient is ≥18, has history of sustained (≥20 minutes) PSVT, and prescription is by or in consultation with a cardiologist or electrophysiologist.

SourceLink

POLICY UPDATE CHANGES

The requirement for history of paroxysmal supraventricular tachycardia was clarified to include that this is sustained (≥ 20 minutes).

≥18minimum age for approval

≥20 minrequired PSVT duration

1 yearapproval duration

Not coveredoff‑label stance

RAPIDkey evidence

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Coverage Criteria for Cardamyst (etripamil)

Initial (FDA‑approved) Therapy

Approve for 1 year when ALL of the following are met:

FDA-Approved Indication Criteria

A) Patient is ≥ 18 years of age;
B) Patient has a history of sustained (≥ 20 minutes) paroxysmal supraventricular tachycardia;
Sustained duration requirement clarified: ≥ 20 minutes.
C) The medication is prescribed by or in consultation with a cardiologist or electrophysiologist.

Cardamyst (etripamil nasal spray) is approved only for the FDA‑labeled indication of conversion of acute symptomatic paroxysmal supraventricular tachycardia (PSVT) in adults and is covered only when the policy's specific clinical criteria are met. Use of Cardamyst for any indication beyond the FDA‑approved indication is not medically necessary. The policy will be updated as new published evidence becomes available.

Explicit non‑coverage: Cardamyst is not medically necessary for indications other than paroxysmal supraventricular tachycardia (PSVT). Requests for Cardamyst to treat diagnoses or clinical circumstances outside the FDA‑approved PSVT indication will be denied as not covered.

Coding and Clinical Thresholds

Covered/Relevant Codesmixed

No codes listed

Duration of sustained PSVT required for approval — clinical threshold value

Required duration of sustained PSVT historyDocumented history of sustained (≥ 20 minutes) symptomatic PSVT episodes

Supporting trial eligibilityPhase III RAPID trial enrolled adults with sustained, symptomatic PSVT (≥ 20 minutes) documented by ECG

Documentation standardSustained episodes should be documented by electrocardiogram (ECG) per clinical trial methods

Policy change noteOperational language clarified to specify sustained episodes ≥ 20 minutes for PSVT history requirement

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization is required for Cardamyst for prescription benefit coverage. Approvals are provided for the duration noted in the policy; when duration is expressed in months, 1 month = 30 days. Because specialized skills are required for evaluation, diagnosis, and monitoring, Cardamyst must be prescribed by or in consultation with a physician who specializes in the condition being treated (cardiologist or electrophysiologist).

Prior Authorization required
Prescriber requirement: cardiologist or electrophysiologist
Approval durations follow policy (months = 30 days)

Step Therapy

Step Therapy / Treatment Sequence

The policy does not impose an explicit step therapy requirement prior to approval. Clinical guidelines recommend attempting vagal maneuvers and/or IV adenosine as first-line acute management of PSVT; these guideline-recommended acute measures are clinical best practices but are not required by this policy as formal step therapy.

Background on Cardamyst (etripamil)

Background: Cardamyst (etripamil nasal spray) is the intranasal formulation developed for acute conversion of symptomatic paroxysmal supraventricular tachycardia. Efficacy evidence and detailed clinical context are described in the full policy; coverage is limited to the FDA‑approved PSVT indication and will follow the policy’s clinical criteria and prior authorization requirements.

Definitions

Paroxysmal Supraventricular Tachycardia (PSVT) — definition and requirement for sustained (≥ 20 minutes) symptomatic episodes

Definition of PSVTParoxysmal Supraventricular Tachycardia (PSVT): recurrent, abrupt-onset supraventricular tachycardia for which Cardamyst is indicated to convert acute symptomatic episodes to sinus rhythm in adults

Symptom-duration requirementPolicy requires a history of sustained (≥ 20 minutes) symptomatic PSVT episodes documented in adults for consideration of Cardamyst

Age requirementApplies to adults aged ≥ 18 years

Prescriber requirementMedication must be prescribed by or in consultation with a cardiologist or electrophysiologist

Clinical contextCardamyst demonstrated efficacy in RAPID where self-administration converted PSVT more frequently and faster than placebo