Clinical Policy: Aprocitentan (Tryvio)
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Defines medical necessity and prior authorization criteria for aprocitentan (Tryvio) for treatment of hypertension in adults within Health Net/Centene-affiliated plans.
No material clinical or coverage changes in this revision.
Coverage Criteria
inv-01: Initial Therapy
Covered when ALL of the following are met:
Provider must submit documentation (e.g., office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
inv-18: Initial Approval
Initial coverage criteria for hypertension:
See Appendix B for example antihypertensive classes. Providers must submit supporting clinical documentation.
Non–FDA approved indications are not authorized under this policy unless there is sufficient documentation of efficacy and safety and the request is supported by the applicable off‑label use policy (see CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid) or by the member’s evidence of coverage.
When state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Refer to the applicable state Medicaid manual for specific coverage rules applicable to Medicaid members.
Requests for indications that are not FDA‑approved and are not supported by the referenced off‑label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or by the member’s evidence of coverage will be considered not a covered benefit and are not authorized under this policy.
Initial Therapy — Authorization Requirements
inv-01: Initial Therapy
Covered when ALL of the following are met:
Provider must submit office chart notes, lab results or other clinical information supporting that member has met all approval criteria.
Continuation Therapy — Ongoing Authorization
inv-02: Continuation Therapy
Covered when ALL of the following are met for continuation:
May be subject to continuity of care regulations per state/product; provider should submit supporting clinical documentation (e.g., chart notes, BP measurements).
inv-19: Continuation
Criteria for members already receiving therapy:
Continuity of care provisions may apply in certain states/products; providers must supply documentation supporting continued benefit.
Provider Actions and Documentation
Prior authorization required — demonstrate diagnosis and listed clinical criteria
Prior authorization is required. Requests must demonstrate a diagnosis of hypertension and that all listed clinical criteria are met, including age ≥18 years, recent blood pressure ≥140/90 mmHg, adherence to a prior antihypertensive regimen, concurrent use limits, and dosing limits (≤12.5 mg/day).
- Diagnosis of hypertension; age ≥18 years
- Documentation of recent (within 30 days) BP ≥140/90 mmHg
- Adherence ≥4 weeks to a regimen of at least three antihypertensive drug classes at maximally tolerated doses
- Dose does not exceed 12.5 mg (1 tablet) per day
- Not prescribed concurrently with other endothelin receptor antagonists
Step/therapeutic positioning — concurrent 3+ drug classes
Tryvio must be prescribed concurrently with an antihypertensive regimen containing three or more drug classes unless clinically significant adverse effects or contraindications prevent use of those classes.
- Concurrent regimen must include THREE or more antihypertensive drug classes (see Appendix B for examples)
- Exception allowed if clinically significant adverse effects experienced or all classes are contraindicated
Step therapy — use only with ≥3-class antihypertensive regimen (or documented intolerance)
Step therapy requirement: Tryvio must be used with an antihypertensive regimen containing ≥3 drug classes, unless the member has documented intolerance or contraindication to those classes.
- Requirement applies to initiation of Tryvio
- Documented intolerance or contraindication to the ≥3 drug classes must be provided to support exception
Required documentation — submit chart notes, labs, and clinical information
Providers must submit supporting clinical documentation with the authorization request, such as office chart notes, laboratory results, or other clinical information showing the member meets all approval criteria.
- Include recent BP measurements (within 30 days)
- Include evidence of adherence to prior antihypertensive therapy for at least 4 weeks
- Include medication history showing concurrent use of required antihypertensive classes
Denial risk — insufficient documentation may trigger denial
Insufficient or missing clinical documentation (for example, absence of recent BP readings, adherence evidence, or prior medication trials) may result in denial of the request.
- Recent BP readings within 30 days must be provided
- Evidence of adherence and prior regimen trials must be documented
Prior authorization process not specified in these sections
The policy text establishes coverage rules but the cited sections do not specify separate prior authorization procedures beyond the coverage criteria requirements.
- Coverage criteria are detailed in the policy, but prior authorization process steps are not specified in these chunks
Proprietary policy — unauthorized use prohibited
This clinical policy is the property of the Health Plan; unauthorized copying, use, or distribution of the policy or its contents is strictly prohibited and providers, members, and representatives are bound by its terms.
- Providers, members, and representatives are bound to the policy terms when providing services or submitting claims
Professional judgment reminder — policy is informational, not prescriptive
This clinical policy is informational and does not replace professional medical judgment; providers remain responsible for diagnosis and treatment decisions.
- Policy is not intended to dictate how providers practice medicine
- Providers are expected to exercise independent professional medical judgment
Coding and Clinical Thresholds
Step Therapy Requirements
| Step | Requirement | Notes |
|---|---|---|
| 1 | Tryvio (aprocitentan) must be prescribed concurrently with an antihypertensive regimen containing three or more drug classes | Requirement waived only if clinically significant adverse effects are experienced or all drug classes are contraindicated; see Appendix B for example drug classes |
| Documentation of recent (within the last 30 days) blood pressure ≥ 140/90 mmHg | Provider must submit office chart notes or other clinical information showing recent BP measurements | |
| Member has been adherent for at least the last 4 weeks at up to maximally tolerated doses of an antihypertensive regimen containing at least three different antihypertensive drug classes | Adherence and prior regimen details should be included in submitted documentation | |
| Dose limit: does not exceed 12.5 mg (1 tablet) per day | Per product availability: tablet strength 12.5 mg |
Quantity Limits
Definitions
Background
Aprocitentan (Tryvio) is an endothelin receptor antagonist approved to lower blood pressure in adults with hypertension when used in combination with other antihypertensive agents. The product is available as a 12.5 mg tablet and is indicated for adult patients with hypertension inadequately controlled on other therapies.
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