CurrentCignaPolicy IP0713

Tryvio

Defines medical necessity criteria, coverage duration, and exclusions for Tryvio (aprocitentan tablets) for treatment of hypertension in adults for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyTryvio

Policy CodePolicy IP0713

Change TypeNew policy

Effective DateFeb 1, 2025

Next Review Date

Key ActionPrior authorization required; approve for up to 1 year when FDA-approved indication criteria and prior therapy requirements are met.

POLICY UPDATE CHANGES

New policy established for Tryvio with effective date 02/01/2025.

1Approved Indication

≥3Required prior antihypertensive classes

1 yearInitial approval duration

Coverage Summary

Defines medical necessity criteria, coverage duration, and exclusions for Tryvio (aprocitentan tablets) for treatment of hypertension in adults for Cigna-administered health benefit plans. Coverage stance: covered_with_criteria. Effective date: 02/01/2025; last review: 02/01/2025.

Medical necessity: Tryvio is approved for adults (≥ 18 years) with hypertension who have tried or are currently receiving at least three other antihypertensive agents from at least three different pharmacologic classes; approve for 1 year if criteria are met. Any use other than the FDA‑approved indication is considered experimental/investigational and not covered.

Continuation Therapy Criteria

Approve for up to 1 year when initial criteria are met; reauthorization requires documentation that the patient remains ≥ 18 years of age and continues to have the indicated diagnosis and that prior therapy requirements (trial or current use of at least three antihypertensive agents from at least three pharmacologic classes) have been met.

Provider Actions

Prior Authorization

Prior authorization and approval duration

Prior authorization required; approve for up to 1 year when FDA-approved indication criteria and prior therapy requirements are met.

Approval duration: up to 1 year

Documentation Required

Document prior antihypertensive therapies

Provider must document age ≥18 and that the patient has tried or is currently receiving at least three antihypertensive agents from at least three pharmacologic classes (combination products may count for multiple classes).

Document age ≥18
List of prior antihypertensive agents and classes
Combination products may count for multiple classes.

Denial Risk

Experimental/Unproven uses not covered

Any use of Tryvio other than the FDA-approved indication for hypertension is considered experimental, investigational, or unproven and is not covered.

Clinical Evidence

Evidence sources cited: Tryvio prescribing information (Idorsia, March 2024); guideline references include the 2017 ACC/AHA high blood pressure guideline and the 2018 AHA scientific statement on resistant hypertension. No quantitative trial metrics were provided in the brief.

Background

Tryvio (aprocitentan) is an endothelin receptor antagonist indicated in combination with other antihypertensive medications to lower blood pressure in adults whose hypertension is not adequately controlled on other drugs. It is intended for adults who have trialed multiple antihypertensive classes and fits within guideline discussions of resistant hypertension. Current hypertension guidelines (2017 ACC/AHA) recommend thiazide diuretics, calcium channel blockers, and ACE inhibitors or ARBs as first-line agents; the 2018 AHA resistant hypertension statement defines resistant hypertension as above-goal BP despite concurrent use of three antihypertensive classes (or controlled with four or more agents) and discusses use of mineralocorticoid receptor antagonists and stepwise addition of agents with complementary mechanisms.

Definition and scope

TermResistant hypertension

DefinitionAbove goal BP despite concurrent use of three antihypertensive drug classes at maximum or maximally tolerated doses, or controlled BP requiring four or more agents.

Scope summaryDefines medical necessity criteria, coverage duration, and exclusions for Tryvio (aprocitentan tablets) for treatment of hypertension in adults for Cigna-administered health benefit plans.

SubjectTryvio (aprocitentan) for hypertension