TRYVIO (aprocitentan)

TRYVIO (aprocitentan)

Self-Administration-oral tablets

Diagnosis considered for coverage:

Hypertension: Indicated in combination with other antihypertensive drugs, for the treatment of hypertension, to lower blood pressure (BP) in adult patients who are not adequately controlled on other drugs.

Coverage Criteria:

For diagnosis of resistant hypertension:

• Diagnosis of hypertension; AND

• Patient has not achieved target blood pressure (e.g., systolic blood pressure [SBP] less than 130 mmHg) after treatment with ALL of the following antihypertensive medications from different classes for an adequate duration (minimum 4 weeks each) at a maximally tolerated dose: 

  • One of the following: 

    • Angiotensin converting enzyme (ACE) inhibitor (e.g., captopril, enalapril) 

    • Angiotensin II receptor blocker (ARB) (e.g., candesartan, valsartan) 

  • Diuretic (e.g., hydrochlorothiazide, chlorthalidone) 

  • Calcium channel blocker (e.g., amlodipine, nifedipine) 

  • Mineralocorticoid receptor antagonist (MRA) [e.g., eplerenone, spironolactone]; AND 

• Provider attests other causes of hypertension have been excluded (e.g., secondary causes, white coat effect, medication nonadherence); AND 

• Used as an adjunct to lifestyle modification (e.g., dietary or caloric restriction, exercise, behavioral support, community-based program); AND

• Requested drug will be used in combination with at least 3 antihypertensive medications from different classes; AND

• Prescribed by or in consultation with a specialist experienced in the treatment of resistant hypertension (e.g., cardiologist, nephrologist) 

Reauthorization Criteria:

For diagnosis of resistant hypertension:

• Patient demonstrates positive clinical response to therapy (e.g., systolic blood pressure [SBP] less than 130 mmHg); AND

• Patient continues to use Tryvio in combination with at least 3 antihypertensive medications from different classes and is adherent to therapy; AND

• Requested drug will continue to be used as an adjunct to lifestyle modification (e.g., dietary or caloric restriction, exercise, behavioral support, community-based program); AND

• Patient has been previously treated with ALL of the following antihypertensive medications from different classes for an adequate duration (minimum 4 weeks each) at a maximally tolerated dose: 

  • One of the following: 

    • Angiotensin converting enzyme (ACE) inhibitor (e.g., captopril, enalapril) 

    • Angiotensin II receptor blocker (ARB) (e.g., candesartan, valsartan) 

  • Diuretic (e.g., hydrochlorothiazide, chlorthalidone) 

  • Calcium channel blocker (e.g., amlodipine, nifedipine) 

  • Mineralocorticoid receptor antagonist (MRA) [e.g., eplerenone, spironolactone] 

Coverage Duration:

• Initial: 6 months

• Reauthorization: 1 year

Dosing:

For diagnosis of resistant hypertension:

• The recommended dosage of TRYVIO is 12.5 mg orally once daily, with or without food.

Authorization is not covered for the following:

• The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• Tryvio is the first endothelin receptor antagonist (ERA) approved for the treatment of hypertension.

• ERAs cause hepatotoxicity and liver failure. Measure serum aminotransferase levels and total bilirubin prior to initiation of treatment and repeat periodically during treatment and as clinically indicated.

• No head-to-head data are available Tryvio vs other antihypertensives in resistant hypertension, including spironolactone, which is currently recommended as a preferred add-on therapy.

Policy Updates:

• 12/01/2024 – New policy for Tryvio approved by WHA P&T Committee. (P&T, 11/21/2024)

References:

1. Tryvio Prescribing Information. Idorsia Pharmaceuticals US Inc. Radnor, PA. April 2024. 
2. Carey RM, Calhoun DA, Bakris GL, et al. Resistant Hypertension: Detection, Evaluation, and Management: A Scientific Statement From the American Heart Association. Hypertension. 2018;72(5).