Etripamil (Cardamyst) for PSVT
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Defines medical necessity and coverage criteria for Cardamyst (etripamil) nasal spray for conversion of acute symptomatic paroxysmal supraventricular tachycardia (PSVT) and related authorization rules for affected QualChoice lines of business.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial Therapy — Paroxysmal Supraventricular Tachycardia
Covered when ALL of the following are met:
Approval duration: 12 months (up to 4 nasal spray devices per month)
Continued Therapy — Paroxysmal Supraventricular Tachycardia
Covered when ALL of the following are met:
Approval duration: 12 months (up to 4 nasal spray devices per month)
Other diagnoses/indications
If requested use is not covered under initial/continued criteria or recent label change applies:
See policy cross-references for commercial, marketplace, and Medicaid lines of business.
Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety per the applicable off‑label use policies or evidence of coverage documents. Refer to CP.CPA.09 for commercial plans, HIM.PA.154 for Health Insurance Marketplace lines of business, and CP.PMN.53 for Medicaid when considering non‑label uses.
Use of Cardamyst (etripamil) for off‑label indications is not authorized under this policy in the absence of adequate supporting documentation. Providers seeking coverage for non‑FDA uses must submit evidence meeting the criteria in the referenced off‑label use policies for the member's line of business.
Coding, Dosing, and Quantity Limits
Provider Actions and Authorization Requirements
Prior authorization required — demonstrate all initial PSVT criteria
Prior authorization is required. The provider must demonstrate that all initial PSVT approval criteria are met, including ECG-confirmed diagnosis, prescription by or consultation with a cardiologist/electrophysiologist, age ≥18, history of sustained symptomatic PSVT, required prior hospitalization/ED/urgent care in last 12 months or current oral preventive therapy (with concurrent prescribing if applicable), consideration of catheter ablation, absence of listed contraindications, and adherence to device and dose limits.
- ECG-confirmed diagnosis of PSVT
- Prescribed by or in consultation with a cardiologist or electrophysiologist
- Age ≥ 18 years
- History of sustained, symptomatic PSVT
- Either (a) hospitalization/ED/urgent care for PSVT in last 12 months or (b) currently on oral preventive pharmacologic therapy
- If on oral preventive therapy, Cardamyst prescribed concurrently
- Provider attestation that catheter ablation was considered and is not appropriate
- No contraindications listed (WPW, LGL, manifest pre-excitation, Mobitz II or higher AV block, NYHA II–IV heart failure, sick sinus syndrome without permanent pacemaker)
- Request ≤ 4 nasal spray devices/month and dose limits not exceeded (≤140 mg and ≤2 devices in 24 hours)
Step elements for initial approval — hospitalization/ED OR concurrent oral preventive therapy
Initial approval requires one of two step elements: either the member had a PSVT episode requiring hospitalization/ED/urgent care within the past 12 months or the member is currently receiving oral pharmacologic therapy for prevention of PSVT (and Cardamyst must be prescribed concurrently in that case).
- Option A: ≥1 PSVT episode requiring hospitalization or ED/urgent care within last 12 months
- Option B: Currently receiving oral preventive pharmacologic therapy (examples listed in policy); if so, Cardamyst must be prescribed concurrently with that therapy
Required clinical documentation to support approval
Submit clinical documentation supporting that the member meets all approval criteria. Acceptable documentation includes office chart notes, laboratory results, ECG evidence, and any notes confirming specialist consultation, prior hospital/ED visits, current oral preventive therapy, and provider attestation regarding catheter ablation.
- Office chart notes documenting PSVT history and symptoms
- 12-lead ECG showing PSVT diagnosis or absence of contraindicating findings
- Records of hospitalization, ED, or urgent care visits within past 12 months if applicable
- Medication records showing current oral preventive therapy when claimed
- Provider attestation about consideration of catheter ablation
Denial risk if required documentation not provided
Lack of submitted documentation demonstrating the member meets all approval criteria may result in denial of the authorization request.
- Missing ECG confirmation, specialist consultation notes, proof of prior hospitalization/ED visit, or medication records increases denial risk
- Failure to attest that catheter ablation was considered may also trigger denial
Definitions
Background
Etripamil (Cardamyst) is an intranasal calcium channel blocker approved for conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) in adults. The product is supplied as a 70 mg nasal spray device (one spray in each nostril); a second device may be administered after 10 minutes for a total of 140 mg in 24 hours. Symptoms of PSVT can include palpitations, chest discomfort, shortness of breath, lightheadedness, dizziness, anxiety, and neck pulsations.
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