CurrentCignaPolicy N/A

Pulmonary Arterial Hypertension - Uptravi Prior Authorization Policy

Prior authorization policy for coverage of Uptravi (selexipag tablets) for treatment of pulmonary arterial hypertension (WHO Group 1) for Cigna-administered health benefit plans; includes documentation requirements, prescriber specialty requirement, initial and continuation approval criteria, and noncovered combinations.

Policy Summary

PayerCigna

PolicyPulmonary Arterial Hypertension - Uptravi Prior Authorization Policy

Policy CodePolicy N/A

Change TypeClarified

Effective Date10/09/2024

Next Review Date

Key ActionPrior Authorization is recommended for Uptravi tablets; ensure documentation of right heart catheterization confirming WHO Group 1 PAH and that prescribing is by or in consultation with a cardiologist or pulmonologist.

POLICY UPDATE CHANGES

No material clinical or coverage changes were made in the latest revision; clarification added that the right heart catheterization requirement refers to an RHC prior to starting therapy with a medication for WHO Group 1 PAH.

1Approval duration (initial)

1Approval duration (continuation)

WHO Group 1Covered Indication

Concurrent prostacyclin useDeclared not appropriate

Coverage Summary

Coverage summary: Uptravi (selexipag tablets) is covered with criteria for treatment of pulmonary arterial hypertension (WHO Group 1) to delay disease progression and reduce the risk of hospitalization. The drug is an oral prostacyclin receptor agonist indicated specifically for WHO Group 1 PAH.

Diagnostic and documentation requirements: PAH must be confirmed by right heart catheterization (RHC). RHC diagnostic thresholds required are mean pulmonary artery pressure (mPAP) > 20 mmHg, pulmonary arterial wedge pressure (PAWP) ≤ 15 mmHg, and pulmonary vascular resistance (PVR) > 2 Wood units. Documentation of the RHC and results is required for initiation and continuation of therapy; for patients already receiving Uptravi, the RHC requirement refers to an RHC performed prior to starting therapy.

Coverage stance: This policy stance is covered_with_criteria — Uptravi is approved when the specified clinical criteria, documentation, and prescriber specialty requirements are met (approvals provided for the durations noted in the policy).

Policy key values

Approval duration (initial)1 year

Approval duration (continuation)1 year

Covered IndicationWHO Group 1 PAH

Declared not appropriateConcurrent prostacyclin use (combination with oral, inhaled, or parenteral prostacyclins)

Prior PAH medication trial duration>= 60 days on each referenced oral agent

FDA‑Approved Indication — Coverage Criteria

FDA-Approved Indication

Uptravi (selexipag tablets) is covered as medically necessary when criteria below for WHO Group 1 PAH are met. Approvals provided for durations noted.

Approve if ONE of the following (A or B) is met

A) Initial Therapy. Approve for 1 year if ALL of the following (i, ii, iii, and iv) are met:
- i: Patient has a diagnosis of World Health Organization (WHO) Group 1 pulmonary arterial hypertension (PAH).
- ii
  - a: Patient has had a right heart catheterization [documentation required].
    Documentation may include chart notes and catheterization laboratory reports; documentation provided for a prior PAH medication review is considered to meet this requirement.
  - b: Results for the right heart catheterization confirm the diagnosis of WHO Group 1 PAH.
- iii
  - a: Patient has tried or is currently receiving at least one oral medication for PAH from each of the three different categories (one phosphodiesterase type 5 [PDE5] inhibitor, one endothelin receptor antagonist [ERA], or Adempas [riociguat]) each for ≥ 60 days (either alone or in combination).≥ 60 days on each referenced oral agent
    Examples: PDE5 inhibitors = sildenafil, tadalafil; ERAs = bosentan, ambrisentan, macitentan; Opsynvi is a combo product containing tadalafil and macitentan.
  - b: Patient is currently receiving, or has a history of receiving, one prostacyclin therapy for PAH.
    Examples of prostacyclin therapies include Orenitram (treprostinil tablets), Tyvaso (treprostinil inhalation), Tyvaso DPI, Ventavis (iloprost inhalation), treprostinil injection, and epoprostenol injection.
- iv: The medication is prescribed by, or in consultation with, a cardiologist or a pulmonologist.
B) Patient is Currently Receiving Uptravi. Approve for 1 year if ALL of the following (i, ii, and iii) are met:
- i: Patient has a diagnosis of World Health Organization (WHO) Group 1 pulmonary arterial hypertension (PAH).
- ii
  - a: Patient has had a right heart catheterization.
    This refers to a right heart catheterization prior to starting therapy with a medication for WHO Group 1 PAH.
  - b: Results of the right heart catheterization confirm the diagnosis of WHO Group 1 PAH.
- iii: The medication is prescribed by or in consultation with a cardiologist or a pulmonologist.

Experimental / Unproven Uses

Experimental, Investigational, or Unproven Uses / Not Appropriate Combinations

Uptravi (selexipag tablets) is considered experimental, investigational, or unproven for any other use including the following:

Concurrent use with Orenitram, inhaled prostacyclin products, or parenteral prostacyclin agents used for pulmonary hypertension is not appropriate (use in combination is considered unproven).

Examples of medications include Tyvaso (treprostinil inhalation solution), Tyvaso DPI, Ventavis (iloprost inhalation solution), epoprostenol intravenous infusion, and treprostinil subcutaneous or intravenous infusion (Remodulin, generic).

Denial Risk

Combination therapy exclusion

Concomitant use of Uptravi with certain prostacyclin therapies is considered not appropriate and may be denied as experimental/unproven. Examples include oral treprostinil (Orenitram), inhaled prostacyclins (Tyvaso, Tyvaso DPI, Ventavis), and parenteral prostacyclin agents (treprostinil injection, epoprostenol).

Examples from code groups/criteria: Orenitram (treprostinil tablets); Tyvaso (treprostinil inhalation solution); Tyvaso DPI (treprostinil inhalation powder); Ventavis (iloprost inhalation solution); treprostinil injection; epoprostenol injection.
Policy language: Concurrent use with Orenitram, inhaled prostacyclin products, or parenteral prostacyclin agents is not appropriate (combination use considered unproven).

Provider Actions & Authorization

Prior Authorization

Prior authorization required for Uptravi tablets

Prior authorization is required for coverage of Uptravi tablets. Approvals are provided for the durations noted in the policy; initial and continuation approvals are provided for 1 year.

Documentation Required

Right heart catheterization documentation required

Documentation of right heart catheterization and results confirming WHO Group 1 PAH is required for initiation and continuation of Uptravi. Documentation may include chart notes and catheterization laboratory reports. For patients currently receiving Uptravi, the RHC requirement refers to an RHC performed prior to starting therapy with a medication for WHO Group 1 PAH.

Acceptable documentation: chart notes and catheterization laboratory reports.
RHC must have been performed prior to starting therapy (clarification applies to patients currently receiving Uptravi).

Documentation Required

Specialist prescriber requirement

Uptravi must be prescribed by, or in consultation with, a cardiologist or a pulmonologist.

Background

Background and mechanism: Uptravi (selexipag) is an oral prostacyclin receptor agonist indicated for treatment of pulmonary arterial hypertension (WHO Group 1) to delay disease progression and reduce the risk of hospitalization. The agent acts on the prostacyclin pathway and is used to slow progression of PAH and reduce PAH-related hospitalizations.

Indication and use: Uptravi is indicated for WHO Group 1 PAH and is covered when the policy criteria are met, including specialist prescriber requirements and appropriate prior medication or prostacyclin therapy history as applicable.

Diagnostic criteria by RHC: Diagnosis of WHO Group 1 PAH must be confirmed by right heart catheterization demonstrating mPAP > 20 mmHg, PAWP ≤ 15 mmHg, and PVR > 2 Wood units. Documentation of RHC and catheterization results is required for initiation and continuation of Uptravi; for patients currently receiving Uptravi the RHC requirement refers to an RHC performed prior to starting therapy.