CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tryvio (aprocitentan) — Coverage Criteria for Resistant Hypertension

Covers authorization criteria, quantity limits, and renewal requirements for Tryvio (aprocitentan) when used to treat resistant hypertension in adult patients within Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTryvio (aprocitentan) — Coverage Criteria for Resistant Hypertension

Policy CodePolicy N/A

Change TypeMaterial revisions (authorization durations, quantity limit, specialist requirement)

Effective DateMay 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization with documentation of diagnosis, baseline BP on current therapy, eGFR ≥15 mL/min, and specialist involvement; initial approval up to 3 months, renewals up to 12 months.

SourceLink

POLICY UPDATE CHANGES

Specific authorization durations: 3-month initial authorization and 12-month renewal criteria for Tryvio.

Quantity limit set: Tryvio 12.5 mg tablets, 1 tablet per day.

Requirement that Tryvio be prescribed by or in consultation with a specialist experienced in resistant hypertension.

3 monthsinitial authorization duration

12 monthsrenewal authorization duration

1/dayquantity limit (Tryvio 12.5 mg)

≥18

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Coverage Criteria for Tryvio (aprocitentan)

Initial Therapy

Covered when ALL of the following are met for initial authorization (3 months):

Initial authorization (3 months)

Demographics and safety: Patient is >=18 years of age; not pregnant; eGFR >= 15 mL/min; Tryvio not contraindicated
See chunk 0.
Diagnostic documentation: Documentation of baseline blood pressure on current therapy; diagnosis of resistant hypertension (patient takes three antihypertensive medications with complementary mechanisms including a diuretic and does not achieve BP control [systolic BP >= 140 mmHg], or BP control requires >=4 medications)
See chunk 0.
Antihypertensive regimen requirement: Either: (1) requested drug will be used in combination with at least three other antihypertensive agents at maximally tolerated doses (combination products count as two agents), OR (2) patient is unable to take such a combination due to intolerance or contraindication
See chunk 0.
Spironolactone criteria: Either: (1) patient is currently taking spironolactone plus at least three other antihypertensive agents and has not reached BP control after three months of concomitant treatment, OR (2) patient has experienced intolerance to spironolactone, OR (3) patient has a contraindication prohibiting a trial of spironolactone3 months of spironolactone without control
See chunk 0.
Specialist involvement: Tryvio is prescribed by, or in consultation with, a specialist (e.g., cardiologist, nephrologist, endocrinologist) experienced in the treatment of resistant hypertension
See chunk 0.

Continuation Therapy

Covered when ALL of the following are met for renewal authorization (12 months):

Renewal authorization (12 months)

Clinical response: Documentation that the patient has achieved or maintained a positive clinical response to treatment as evidenced by a reduction in BP from baseline
See chunk 1.
Ongoing regimen: Either: (1) requested drug will continue to be used in combination with at least three other antihypertensive agents at maximally tolerated doses (combination products count as two agents), OR (2) patient is unable to take such a combination due to intolerance or contraindication
See chunk 1.

Pregnancy or planned pregnancy is a contraindication to Tryvio (aprocitentan). The policy excludes use in patients who are pregnant or who are planning to become pregnant; providers must confirm non-pregnant status before authorization is granted.

Tryvio is considered not medically necessary when used outside the documented resistant hypertension population or without required background therapy. Specifically, use is not covered for patients who do not meet the policy definition of resistant hypertension, for those who lack documentation of the required antihypertensive regimen (three complementary agents including a diuretic, or four agents overall at maximally tolerated doses), for pregnant patients or those planning pregnancy, or for patients with insufficient renal function. Providers must document age ≥18 and an eGFR ≥ 15 mL/min to meet baseline safety requirements.

Key Clinical Parameters and Coding

Minimum age

Minimum patient age>= 18 years

Applies toInitial authorization (3 months)

Documentation requiredProvider must document age ≥18 in initial request

Renal function

Required renal functioneGFR >= 15 mL/min

Applies toInitial authorization (3 months)

Documentation requiredProvider must document eGFR ≥ 15 mL/min

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior authorization and quantity limit

Prior authorization is required. Initial approvals may be granted for up to 3 months when initial criteria are met; renewals may be granted for up to 12 months when renewal criteria are met. Quantity is limited to Tryvio (aprocitentan) 12.5 mg tablets, 1 tablet per day.

Step Therapy

Step therapy: spironolactone requirement

Patient must have failed or be unable to use spironolactone. Approval requires either: (1) the patient is currently taking spironolactone plus at least three other antihypertensive agents and has not reached BP control after three months of concomitant treatment, or (2) the patient has intolerance or a contraindication to spironolactone.

Documentation Required

Background and Rationale

Resistant hypertension, for the purposes of this policy, is diagnosed when an adult patient remains uncontrolled despite use of three antihypertensive medications with complementary mechanisms (including a diuretic) — defined here as systolic BP ≥140 mmHg — or when BP control is achieved only with four or more medications. The policy requires documentation of baseline blood pressure on current therapy, confirmation that the patient is on the required background regimen at maximally tolerated doses (combination products may count as two agents), and, when applicable, evidence of a trial of spironolactone (at least three months of concomitant therapy) unless the patient is intolerant or has a contraindication.

Definitions

Resistant hypertension

DefinitionDiagnosis made when a patient takes three antihypertensive medications with complementary mechanisms (including a diuretic) but does NOT achieve BP control (systolic BP ≥ 140 mmHg), OR when BP control is achieved but requires at least four medications.

Clinical implicationRequires documentation of baseline blood pressure on current therapy for authorization

Relation to treatmentTryvio intended for add-on therapy in patients meeting this diagnosis

Maximally tolerated doses

DefinitionDoses of antihypertensive agents increased to the highest dose tolerated by the patient; combination products count as two agents when containing two BP-lowering drugs.

Use in criteriaRequirement that concomitant antihypertensive agents be at maximally tolerated doses for initial and renewal authorization