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TRYVIO Prior Authorization with Quantity Limit Program Summary

Policy Number: PH-91238

 

This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.

POLICY REVIEW CYCLE                                                                                                                                            

Effective Date

Date of Origin   

04-01-2025           

04-01-2025

FDA LABELED INDICATIONS AND DOSAGE

Agent(s)

FDA Indication(s)

Notes

Ref#

TRYVIO™

(aprocitentan)

tablets

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. 

1

See package insert for FDA prescribing information:  https://dailymed.nlm.nih.gov/dailymed/index.cfm

CLINICAL RATIONALE

Hypertension

The 2020 International Society of Hypertension Global Hypertension Practice Guidelines include the following as hypertension pharmacotherapy options:(2)

  • ACE-inhibitor
  • Angiotensin Receptor Blocker (ARB)
  • Calcium channel blockers
  • Thiazide and thiazide-like diuretics

The choice of pharmacotherapy is dependent on patient characteristics. Spironolactone, amiloride, doxazosin, eplerenone, clonidine, or beta blocker can be added on as additional therapy to triple therapy of the above. Beta blockers can also be considered for patients with specific indications which benefit from beta blocker therapy, such as heart failure, angina, post-myocardial infarction, atrial fibrillation, or younger women who are pregnant or planning pregnancy. The treatment target blood pressure is to be less than 130/80 mmHg, although for the target should be individualized for the elderly based on frailty. (2)

Efficacy

TRYVIO was evaluated in a multipart, phase 3, randomized, double-blinded, multicenter study in 730 adults with systolic blood pressure of greater or equal to 140 mmHg who were prescribed at least three antihypertensive agents. Prior to the placebo run-in period, all participants were switched to triple therapy with an angiotensin receptor blocker, a calcium channel blocker, and a diuretic, which were continued throughout the study. Patients on beta-blockers continued beta-blocker therapy throughout the study. Efficacy was evaluated at 32 weeks. TRYVIO exhibited statistically significant (p=0.0043) decrease in systolic blood pressure at week 4 of -15.4 mmHg vs. placebo's -11.6 mmHg. TRYVIO's persistence in blood pressure lowering was demonstrated at 40 weeks where participants were re-randomized to either 25 mg TRYVIO or placebo. Participants re-randomized to TRYVIO maintained blood pressure lowering compared to placebo.(1)

TRYVIO is not approved for use at a 25 mg dose. The 25 mg dose did not demonstrated a meaningful improvement in blood pressure reduction compared to the 12.5 mg dose, but did demonstrate an increased risk of edema/fluid retention.(1)

Safety

TRYVIO has the following boxed warnings:(1)

  • TRYVIO can cause major birth defects if used by pregnant patients
  • In patients who can become pregnant, obtain a negative pregnancy test prior to initiation of TRYVIO and counsel patients to take monthly pregnancy tests during treatment and one month after discontinuation of TRYVIO
  • To prevent pregnancy, patients who can become pregnant should use acceptable methods of contraception before the start of, during, and for one month after stopping treatment
  • Because of the risk of birth defects, TRYVIO is only available through a restricted program called the TRYVIO Risk Evaluation and Mitigation Strategy (REMS)

TRYVIO has the following contraindications:(1)

  • Pregnancy
  • Hypersensitivity

REFERENCES                                                                                                                                                                           

Number

Reference

1

Tryvio prescribing information. Idorsia Pharmaceuticals Ltd. June 2024.

2

Unger T, Borghi C, Charchar F, et al. 2020 International Society of Hypertension Global Hypertension Practice Guidelines. Hypertension. 2020;75(6):1334-1357. doi:10.1161/hypertensionaha.120.15026

POLICY AGENT SUMMARY PRIOR AUTHORIZATION

Target Brand Agent(s)

Target Generic Agent(s)

Strength

Targeted MSC

Available MSC

Final Age Limit

Preferred Status

Tryvio

aprocitentan tab

12.5 MG

M ; N ; O ; Y

N

POLICY AGENT SUMMARY QUANTITY LIMIT

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

QL Amount

Dose Form

Day Supply

Duration

Addtl QL Info

Allowed Exceptions

Targeted NDCs When Exclusions Exist

Tryvio

aprocitentan tab

12.5 MG

30

Tablets

30

DAYS

CLIENT SUMMARY – PRIOR AUTHORIZATION

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Client Formulary

Tryvio

aprocitentan tab

12.5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

CLIENT SUMMARY – QUANTITY LIMITS

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Client Formulary

Tryvio

aprocitentan tab

12.5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

Initial Evaluation

Target Agent(s) will be approved when ALL of the following are met:

  1. ONE of the following:
    1. The requested agent is eligible for continuation of therapy AND ONE of the following:

Agents Eligible for Continuation of Therapy

TRYVIO
      1. The patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR
      2. The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed OR
    2. BOTH of the following:
      1. ONE of the following:
        1. The patient has a diagnosis of hypertension AND ONE of the following:
          1. The patient is still not at blood pressure goal while on triple agent therapy with 3 different antihypertensive therapy classes OR
          2. The patient is unable to be on triple antihypertensive therapy with 3 different antihypertensive therapy classes OR
        2. The patient has another FDA labeled indication for the requested agent and route of administration AND
      2. If the patient has an FDA labeled indication, then ONE of the following:
        1. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
        2. There is support for using the requested agent for the patient’s age for the requested indication AND
  2. If the patient has a diagnosis of hypertension, t​​he patient will continue therapy with another antihypertensive agent in combination with the requested agent AND
  3. The patient does NOT have any FDA labeled contraindications to the requested agent

Length of Approval: 3 months

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

 

Renewal Evaluation

Target Agent(s) will be approved when ALL of the following are met:

  1. T​he patient has been previously approved for the requested agent through the plan’s Prior Authorization process [Note: patients not previously approved for the requested agent will require initial evaluation review] ​​​​​​
  2. The patient has had clinical benefit with the requested agent AND 
  3. ONE of the following:
    1. The patient has a diagnosis of hypertension, then BOTH of the following:
      1. The patient is currently treated with another antihypertensive agent AND
      2. The patient will continue therapy with another antihypertensive agent in combination with the requested agent OR
    2. The patient has another FDA labeled indication for the requested agent and route of administration AND
  4. The patient does NOT have any FDA labeled contraindications to the requested agent

Length of Approval: 12 months

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

Quantity limit for the Target Agent(s) will be approved when ONE of the following is met: 

  1. The requested quantity (dose) does NOT exceed the program quantity limit OR
  2. The requested quantity (dose) exceeds the program quantity limit AND ONE of the following:
    1. BOTH of the following:
      1. The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND
      2. There is support for therapy with a higher dose for the requested indication OR
    2. BOTH of the following:
      1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
      2. There is support for why the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does NOT exceed the program quantity limit OR

Length of Approval: up to 12 months

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.

Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

 

 

 

Commercial _ PS _ Tryvio__PAQL _ProgSum_ 04-01-2025