CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tryvio (aprocitentan) — Coverage Criteria for Resistant Hypertension

Covers authorization and renewal criteria for Tryvio (aprocitentan) used to lower blood pressure in adults with resistant hypertension under the Medicaid scope of this payer.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTryvio (aprocitentan) — Coverage Criteria for Resistant Hypertension

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date05/2025

Next Review Date02/2026

Key ActionSubmit prior authorization with documentation of age, eGFR, baseline blood pressure, pregnancy status, specialist involvement, and evidence of clinical response for renewals.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3minitial authorization duration

12mrenewal authorization duration

12.5mgquantity limit

Medicaidscope

Coverage Criteria for Tryvio (aprocitentan)

Initial Therapy

Covered when ALL of the following are met:

Initial authorization: Patient is an adult (>= 18 years); documentation of eGFR >= 15 mL/min; patient is not pregnant; documentation of baseline blood pressure on current therapy; prescribed to lower blood pressure in a patient not adequately controlled on other drugs; prescribed by or in consultation with a specialist experienced in resistant hypertension (e.g., cardiologist, nephrologist, endocrinologist).

Definition of resistant hypertension or alternatives

Resistant hypertension diagnosis: Patient has a diagnosis of resistant hypertension (takes three antihypertensive medications with complementary mechanisms including a diuretic and does not achieve BP control defined as systolic BP >= 140 mmHg, OR BP control is achieved but requires at least four medications).
Use in combination:

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTryvio (aprocitentan) — Coverage Criteria for Resistant Hypertension

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date05/2025

Next Review Date02/2026

Key ActionSubmit prior authorization with documentation of age, eGFR, baseline blood pressure, pregnancy status, specialist involvement, and evidence of clinical response for renewals.

SourceLink

On This Page

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Continuation Therapy

Covered when ALL of the following are met:

Renewal authorization: Documentation that the patient has achieved or maintained a positive clinical response to treatment as evidenced by a reduction in blood pressure from baseline; the requested drug will continue to be used in combination with at least three other antihypertensive agents at maximally tolerated doses (a combination product containing two different BP‑lowering agents counts as two), unless the patient is unable to tolerate or has a contraindication; patient does not have contraindications or risks that would preclude use (e.g., pregnant or planning to become pregnant).

Authorization, Documentation, and Prescribing Requirements

Denial Risk

Documentation missing

If required documentation listed below is not submitted with the prior authorization request, the request may be denied.

Documentation Required

Required documentation

Providers must submit the following documentation with the prior authorization request: age of the patient; baseline blood pressure on current therapy; baseline eGFR (mL/min); pregnancy status (pregnant, planning pregnancy, or not pregnant); documentation of diagnosis of resistant hypertension or rationale for use; evidence of prior trials and reasons for failure/intolerance of other antihypertensive agents; current medication list showing the requested agent will be used in combination with at least three other antihypertensive agents at maximally tolerated doses (note: a combination product containing two different BP‑lowering agents counts as two agents); and for renewals, documentation of clinical response (reduction in BP from baseline) or maintenance of response.

Age of the patient
Baseline blood pressure on current therapy
Baseline eGFR (mL/min)
Pregnancy status
Diagnosis of resistant hypertension or rationale for use
Evidence of prior trials and failure/intolerance of other antihypertensive agents
Current medication list showing combination with ≥3 other antihypertensive agents at maximally tolerated doses (combination product with two agents counts as two)
For renewals: documentation of clinical response (reduction in BP from baseline)

Step Therapy

Requirement for combination therapy

The requested agent must be used in combination with at least three other antihypertensive agents at maximally tolerated doses unless the member has documented contraindication or intolerance preventing such therapy. A combination product that contains two different blood pressure‑lowering agents will be counted as two antihypertensive agents. Exceptions (and supporting documentation) are required when the patient cannot tolerate or has contraindications to specific agents. For initiation, documentation that the patient is taking three complementary antihypertensive medications (including a diuretic) without achieving BP control, or that BP control requires ≥4 agents, should be provided.

Must be used with ≥3 other antihypertensive agents at maximally tolerated doses
Combination product with two agents counts as two agents
Documented contraindication or intolerance permits exception but must be provided
For initiation: evidence of resistant hypertension (3 agents including a diuretic without control, or control only on ≥4 agents)

Background

Resistant hypertension refers to elevated blood pressure despite the use of multiple antihypertensive agents. This policy supports use of Tryvio (aprocitentan) for adults with resistant hypertension when criteria are met because the drug is intended to lower BP in patients not adequately controlled on other drugs or who require complex combination therapy.

The clinical rationale for a staged approval approach is that initial therapy requires demonstration of the resistant hypertension phenotype or equivalent treatment history (for example, use of three antihypertensive agents including a diuretic or requirement of four or more agents to control BP) and proof of appropriate baseline testing and specialist involvement, while renewals require documented maintained clinical response (a reduction in BP from baseline) and continued combination use with at least three other antihypertensive agents at maximally tolerated doses unless the patient cannot tolerate them.

OpenPayer

Tryvio (aprocitentan) — Coverage Criteria for Resistant Hypertension

Coverage Criteria for Tryvio (aprocitentan)

Clinical Eligibility Key Data

Authorization, Documentation, and Prescribing Requirements

Background

Key Definitions