Cardiology - Tryvio
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This policy governs Cigna benefit coverage and prior authorization for Tryvio (aprocitentan) in adults with hypertension. Coverage is medically necessary only for the FDA-approved indication when the patient meets the specified age and prior antihypertensive-treatment criteria.
The hypertension criterion was revised to require that each of at least three previously tried or currently used antihypertensive agents be used for at least 1 month.
Medical Necessity Criteria
FDA-approved indication: hypertension
Tryvio is considered medically necessary for the FDA-approved indication of hypertension when BOTH criteria A and B are met.
FDA-approved hypertension indication
- Age: Patient is at least 18 years of age.≥ 18 years
Prior antihypertensive therapy
- Qualifying pharmacologic class: Angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB).
Examples include benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, ramipril, trandolapril, azilsartan, candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan, and valsartan.
- Qualifying pharmacologic class: Nondihydropyridine calcium channel blocker.
Examples include diltiazem and verapamil.
- Qualifying pharmacologic class: Dihydropyridine calcium channel blocker.
Examples include amlodipine, felodipine, isradipine, nicardipine, nifedipine, and nisoldipine.
- Qualifying pharmacologic class: Diuretic.
Examples include thiazide, loop, and potassium-sparing diuretics.
- Qualifying pharmacologic class: Mineralocorticoid receptor antagonist.
Examples include eplerenone and spironolactone.
- Qualifying pharmacologic class: Beta blocker.
Examples include acebutolol, atenolol, betaxolol, bisoprolol, carvedilol, metoprolol, nadolol, nebivolol, pindolol, propranolol, and timolol.
- Qualifying pharmacologic class: Alpha-adrenergic blocker.
Examples include doxazosin, prazosin, and terazosin.
- Qualifying pharmacologic class: Central alpha-adrenergic agonist.
Examples include clonidine, guanfacine, and methyldopa.
- Qualifying pharmacologic class: Direct vasodilator.
Examples include hydralazine and minoxidil.
- Qualifying pharmacologic class: Direct renin inhibitor.
An example is aliskiren.
Tryvio is considered not medically necessary for any use other than its covered FDA-approved indication of hypertension.
Blood Pressure Classification and Treatment Thresholds
Authorization, Documentation, and Denial Risks
Prior Authorization Required
Prior authorization is required for benefit coverage of Tryvio. Approved requests are authorized for the policy-specified duration of 1 year.
- Prior authorization required before coverage of Tryvio.
- Approval duration: 1 year.
Three-Class Antihypertensive Trial
Document that the patient has tried, or is currently receiving, at least three other antihypertensive agents from at least three qualifying pharmacological classes, with each agent used for at least 1 month. A combination product containing two or more classes counts as an alternative from each applicable class.
- ACE inhibitor or angiotensin receptor blocker (ARB)
- Nondihydropyridine calcium channel blocker
- Dihydropyridine calcium channel blocker
- Diuretic
- Mineralocorticoid receptor antagonist
- Beta blocker
- Alpha-adrenergic blocker
- Central alpha-adrenergic agonist
- Direct vasodilator
- Direct renin inhibitor
Non-Covered Use
Tryvio is covered for the FDA-approved indication of hypertension. Use for any other indication is considered not medically necessary.
- Covered indication: hypertension.
- Other uses: not medically necessary.
Failure to Meet Clinical Criteria
Coverage approval requires both that the patient is at least 18 years of age and that the required prior or current antihypertensive therapy is documented. Requests may be denied when the patient is younger than 18 or has not tried, or is not currently receiving, agents from at least three qualifying antihypertensive classes for at least 1 month each.
- Patient must be ≥ 18 years of age.
- Must have tried or currently receive at least three antihypertensive agents from at least three pharmacological classes.
- Each qualifying agent must be used for at least 1 month.
Missing Covered Codes
Submit the applicable covered diagnosis and/or procedure code(s) with the claim. Claims not accompanied by covered code(s) under the applicable policy may be denied as not covered.
- Use the most appropriate codes in effect on the submission date.
- Missing applicable covered code(s) creates a claim denial risk.
Therapy Overview
Tryvio (aprocitentan) is an endothelin receptor antagonist indicated for the treatment of hypertension in adults whose blood pressure is not adequately controlled with other drugs. It is used in combination with other antihypertensive medications. The policy describes its role within guideline-based hypertension treatment, including escalation for resistant hypertension and use as an alternative when mineralocorticoid receptor antagonists cannot be tolerated or are contraindicated.
Key Terms
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