CurrentCignaPolicy N/A

PREFERRED SPECIALTY MANAGEMENT POLICY

Cigna Preferred Specialty Management program directing preferred use of Tyvaso and Tyvaso DPI over non-preferred Ventavis for PAH (WHO Group 1) and pulmonary hypertension associated with interstitial lung disease (WHO Group 3); prior authorization required and non-preferred products require exception criteria. Approvals provided for 1 year.

Policy Summary

PayerCigna

PolicyPREFERRED SPECIALTY MANAGEMENT POLICY

Policy CodePolicy N/A

Change TypeAnnual review (no criteria changes)

Effective Date

Next Review Date

Key ActionPrior authorization is required for all inhaled prostacyclin products; patients must meet the standard Pulmonary Arterial Hypertension - Inhaled Prostacyclin Products Prior Authorization Policy criteria.

SourceLink

POLICY UPDATE CHANGES

Annual Revision, Review Date = 10/02/2024; summary states No criteria changes.

Annual Revision, Review Date = 10/11/2023; summary states No criteria changes.

3Products listed

1 yearApproval duration

VentavisNon-Preferred

Coverage Summary

Overview: This Cigna Preferred Specialty Management program directs use of Tyvaso and Tyvaso DPI as the preferred inhaled prostacyclin products and identifies Ventavis as a non-preferred product (exception criteria apply) for treatment of pulmonary arterial hypertension (WHO Group 1) and pulmonary hypertension associated with interstitial lung disease (WHO Group 3). Prior authorization is required for all inhaled prostacyclin products under the applicable PAH prior authorization policy. Requests are reviewed under the program rules and non-preferred product exceptions; approvals are provided for 1 year.

Prior Authorization / Exception Criteria

Non-Preferred Product Exception Criteria (Ventavis)

Ventavis is covered as medically necessary when the non-preferred product exception criteria are met. Any other exception is considered not medically necessary. See separate prior authorization policy for the detailed medical necessity criteria.

Included Products / Codes

Included Products (by drug name)mixedCovered

Tyvaso	treprostinil inhalation solution (United Therapeutics) - Preferred Product
Tyvaso DPI	treprostinil inhalation powder (United Therapeutics/Mannkind) - Preferred Product
Ventavis	iloprost inhalation solution (Actelion/Janssen) - Non-Preferred Product (exception criteria apply)

What Providers Must Do

Prior Authorization

Prior authorization required

Prior authorization is required for all inhaled prostacyclin products; patients must meet the standard Pulmonary Arterial Hypertension - Inhaled Prostacyclin Products Prior Authorization Policy criteria.

Prior Authorization

Non-preferred product exception requirements (Ventavis)

To approve Ventavis (non-preferred) for 1 year, the patient must meet the standard PAH prior authorization criteria AND meet one of: established on Ventavis, tried Tyvaso or Tyvaso DPI, or already possesses the Ventavis device. Approval duration = 1 year.

Documentation Required

Approval duration

All approvals are provided for 1 year; documentation should support ongoing medical necessity for annual renewal.

Billing Rule

Preferred product trial

Prior to approving a non-preferred product, documentation must show the patient tried a preferred product unless an exception applies.

Background & Evidence

Tyvaso, Tyvaso DPI, and Ventavis are inhaled prostacyclin vasodilators indicated for pulmonary arterial hypertension (PAH), WHO Group 1. Tyvaso and Tyvaso DPI are also indicated for pulmonary hypertension associated with interstitial lung disease (WHO Group 3). The program encourages use of the preferred products (Tyvaso and Tyvaso DPI), requires that patients meet the respective prior authorization criteria, and directs patients to try a preferred product prior to approval of a non-preferred product; non-preferred requests are reviewed using exception criteria.

Source	Reference
Tyvaso prescribing information - United Therapeutics	May 2022
Ventavis prescribing information - Actelion/Janssen	March 2022
Tyvaso DPI prescribing information - MannKind and United Therapeutics	November 2023

Preferred Specialty Management program: Program developed to encourage use of Preferred Product(s) and require preferred product trial prior to non-preferred approval; applies alongside standard prior authorization criteria.

Revision History

10/02/2024clarifiedLatest

Policy reviewed annually with no clinical criteria changes as of 10/02/2024.

10/11/2023clarified

Previous annual review on 10/11/2023 with no criteria changes.