Guidelines and Experts Recommend Upfront ERA + PDE5i Therapy1,2
For treatment of patients with idiopathic, heritable, or CTD-associated PAH, based on risk assessment or other health conditions
2022 ESC/ERS
EVIDENCE-BASED Guideline for Upfront Therapy1
Low or intermediate risk
Dual Therapy
ERA +
PDE5i
(Class I)High risk
Triple
TherapyERA + PDE5i + IV/SC PPA
(Class IIa)Cardiopulmonary comorbidities
Monotherapy
ERA or PDE5i (Class IIa)
2024 7TH WSPH
Expert Consensus Opinion for Upfront Therapy2
Not high risk
Dual Therapy
ERA + PDE5i
High risk
Triple
TherapyERA + PDE5i +
IV/SC PPA
Analysis of trends in upfront dual therapy utilization3,4
CLAIMS DATA
PROPORTION OF PATIENTS WITH PAH RECEIVING ERA + PDE5i THERAPY WITHIN 90 DAYS OF TREATMENT INITIATION
to SEP 2022
23%
OFPATIENTS
to SEP 2024
28%
OFPATIENTS
<1/3
Less than one-third of patients are receiving upfront dual therapy
Methodology
- Using the regimen table, patients were selected for the cohort with a first-line treatment on or after October 1, 2021 for PAH
- Treatment was flagged using a grouping based on ERA/PDE5i/Other
- Using a 90-day look-forward window (from first-line start date), additional lines of therapy were considered for patients
- If a patient is ever receiving a dual-/triple-/quadruple-combination therapy (defined by regimen table) containing ERA + PDE5i on first-line or within 90 days, they are considered dual-combination therapy with an ERA + a PDE5i
Limitations
- Claims data analyses are limited to claims processed for insurance purposes therefore uninsured patients are not captured
- Although the database (Supercharge) captures a large portion of lives in the US (~300 million), not all payers are captured
- Administrative claims data are subject to potential coding errors and inconsistencies
- Presence of a claim for a dispensed prescription does not indicate that the medication was taken as prescribed
- Information such as some clinical parameters (eg, hemodynamics) and laboratory results and disease-specific parameters such as risk score are not available in claims data
- Identification of PAH patients in our analysis relied upon ICD-10-CM diagnostic codes for PH and a prescription for a PAH medication
- PDE5is may also be used for erectile dysfunction (ED) and therefore steps were taken to eliminate these patients. However, these methods cannot eliminate all non-PAH patients who receive PDE5is
Data source
Komodo/SHS US Patient Claims from October 2021-September 2024.
- Clinical guidelines provide evidence-based management strategies to optimize patient care1
- Expert consensus is opinion-based guidance and may not consider all available evidence5
| Definition | Wording to use |
|---|---|
| CLASS I: Evidence and/or general agreement that a given treatment or procedure is beneficial, useful, and effective. | Is recommended or is indicated |
| CLASS II: Conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of the given treatment or procedure. | |
| CLASS IIa: Weight of evidence/ opinion is in favor of usefulness/ efficacy. | Should be considered |
| CLASS IIb: Usefulness/ efficacy is less well established by evidence/ opinion. | May be considered |
| CLASS III: Evidence or general agreement that the given treatment or procedure is not useful/ effective, and in some cases may be harmful. | Is not recommended |
| Levels of evidence | |
|---|---|
| Level of evidence A | Data derived from multiple randomized clinical trials or meta-analyses. |
| Level of evidence B | Data derived from a single randomized clinical trial or large nonrandomized studies. |
| Level of evidence C | Consensus of opinion of the experts and/or small studies, retrospective studies, and registries. |
Compare OPSYNVI® (macitentan/ tadalafil) dosing regimen
to loose-dose combination therapy