CurrentCignaPolicy N/A

Pulmonary Arterial Hypertension - Endothelin Receptor Antagonists Preferred Specialty Management Policy

Cigna preferred specialty management policy specifying preferred vs non-preferred endothelin receptor antagonists (ambrisentan, macitentan, bosentan / brand and generics) for treatment of pulmonary arterial hypertension (WHO Group 1), prior authorization and non-preferred product exception criteria, documentation requirements, and 1-year approvals.

Policy Summary

PayerCigna

PolicyPulmonary Arterial Hypertension - Endothelin Receptor Antagonists Preferred Specialty Management Policy

Policy CodePolicy N/A

Change TypeAnnual revision — no criteria changes

Effective DateN/A

Next Review DateN/A

Key ActionPatient must meet the standard Pulmonary Arterial Hypertension - Endothelin Receptor Antagonists Prior Authorization Policy criteria before approval.

POLICY UPDATE CHANGES

Annual Revision, Summary of Changes = No criteria changes.

4Products mentioned (preferred + non-preferred)

1 yearApproval duration

DocumentationBrand exception evidence

Coverage Summary

Cigna preferred specialty management policy specifying preferred vs non-preferred oral endothelin receptor antagonists (ambrisentan, macitentan, bosentan — brand and generics) for treatment of pulmonary arterial hypertension (WHO Group 1).

Medical Necessity / Exception Criteria

General Policy Statement

Program encourages use of Preferred Products; prior authorization and trial of generic preferred required. Approvals provided for 1 year.

ALL of the following

Patient required to meet the respective standard Pulmonary Arterial Hypertension - Endothelin Receptor Antagonists Prior Authorization Policy criteria
Patient required to try the equivalent generic Preferred Product (when applicable)
All approvals for Preferred and Non-Preferred products are provided for 1 year
If patient meets standard PAH ERA prior authorization criteria but has not tried respective generic Preferred Product, approval for the generic Preferred Product will be authorized
Documentation is required for use of Letairis and Tracleer tablets as noted in criteria; documentation may include chart notes, prescription claims records, prescription receipts, and/or other information
Documentation required

Non-Preferred Product Exception Criteria - Letairis (brand ambrisentan tablets)

Approve for 1 year if the patient meets BOTH of the following (A and B):

ALL of the following

A: Patient meets the standard Pulmonary Arterial Hypertension - Endothelin Receptor Antagonist Prior Authorization Policy criteria
B
- i: Patient has tried generic ambrisentan tablets
- ii: Patient cannot continue to use generic ambrisentan tablets due to a formulation difference in the inactive ingredient(s) (e.g., difference in dyes, fillers, preservatives) between the Brand and the bioequivalent product which, per the prescriber, would result in a significant allergy or serious adverse reaction
  Documentation required

Non-Preferred Product Exception Criteria - Tracleer (brand bosentan tablets)

Approve for 1 year if the patient meets BOTH of the following (A and B):

ALL of the following

A: Patient meets the standard Pulmonary Arterial Hypertension - Endothelin Receptor Antagonist Prior Authorization Policy criteria
B
- i: Patient has tried generic bosentan tablets
- ii: Patient cannot continue to use generic bosentan tablets due to a formulation difference in the inactive ingredient(s) (e.g., difference in dyes, fillers, preservatives) between the Brand and the bioequivalent product which, per the prescriber, would result in a significant allergy or serious adverse reaction
  Documentation required

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required

Patient must meet the standard Pulmonary Arterial Hypertension - Endothelin Receptor Antagonists Prior Authorization Policy criteria before approval.

Step Therapy

Step / try generic first

Requests for non-preferred products require trial of the equivalent generic preferred product unless there is documented intolerance or allergy to the generic's inactive ingredients.

Documentation Required

Documentation for brand exceptions

When requesting Letairis or Tracleer (brand tablets) as non-preferred exceptions, documentation is required to support inability to use the generic due to formulation differences in inactive ingredients that per the prescriber would result in a significant allergy or serious adverse reaction.

Chart notes
Prescription claims records
Prescription receipts

Billing Rule

Approval duration

All approvals for Preferred and Non-Preferred products are provided for 1 year.

Background & Evidence

Letairis (ambrisentan), Opsumit (macitentan), and Tracleer (bosentan) are oral endothelin receptor antagonists indicated for treatment of pulmonary arterial hypertension (PAH) World Health Organization (WHO) Group 1.

Letairis and Tracleer traditional tablets are available as generics; the policy designates preferred products (generic ambrisentan, Opsumit tablets, generic bosentan tablets, and Tracleer tablets for oral suspension) and non-preferred products (Letairis tablets and Tracleer tablets).

Clinical intent: these agents are used to improve exercise ability and to reduce the risk of disease progression and hospitalization for worsening PAH, with specific indications noted for each agent (e.g., Letairis to improve exercise ability and delay clinical worsening and in combination with tadalafil to reduce progression/hospitalization; Opsumit to reduce risk of progression/hospitalization; Tracleer to improve exercise ability and decrease clinical worsening).

Source	Reference
Prescribing information references	Tracleer PI Feb 2024; Letairis PI Aug 2019; Opsumit PI Mar 2024

Preferred Products: Medications designated by the program as preferred; members are expected to try these agents first. Listed preferred products include generic ambrisentan, Opsumit (macitentan) tablets, generic bosentan tablets, and Tracleer tablets for oral suspension.

Non-Preferred Products: Brand products that are not preferred and require exception criteria to be met for coverage. Listed non-preferred products include Letairis tablets (brand ambrisentan) and Tracleer tablets (brand bosentan). Requests for non-preferred products generally require trial of the equivalent generic preferred product or documentation of inability to use the generic due to inactive ingredient differences causing significant allergy or serious adverse reaction.

	generic ambrisentan (Preferred)
	Opsumit tablets (macitentan) (Preferred)
	generic bosentan tablets (Preferred)
	Tracleer tablets for oral suspension (Preferred)

OpenPayer

Pulmonary Arterial Hypertension - Endothelin Receptor Antagonists Preferred Specialty Management Policy

Coverage Summary

Medical Necessity / Exception Criteria

Relevant Products / Code Groups

Provider Actions & Prior Authorization

Background & Evidence

Revision History

	Letairis tablets (brand ambrisentan) (Non-Preferred)
	Tracleer tablets (brand bosentan) (Non-Preferred)