TREPROSTINIL CAP,INHL

Clinical Criteria Summary

Care provided by a VA or VA Community Care provider experienced in the management of PAH

Definitive PAH confirmed by right-heart catheterization and hemodynamic diagnosis
Mean pulmonary artery pressure greater than 20 mmHg
Pulmonary capillary wedge pressure 15 mmHg or less
Pulmonary vascular resistance greater than 2 Wood units

World Health Organization (WHO) Group 1 PAH
Unacceptable or deteriorating clinical status on PAH-directed therapy with, or not a candidate for, an endothelin receptor antagonist (ERA) and phosphodiesterase-5 inhibitor (PDE5i)
Efficacy established in patients with NYHA Functional Class III symptoms

Nebulized solution preferred if patient requires more than one cartridge or capsule per dose using the DPI (e.g., >64 mcg of TYVASO or >106 mcg of YUTREPIA)
Dry powder inhalers (DPIs) reserved for patients with documented inability to use the nebulized product

Individual cases that are exceptions to inclusion/exclusion criteria should be adjudicated at the local facility level per P&T committee and pharmacy services policy/procedures
Product information should be consulted for detailed prescribing information

Care must be provided by a VA or VA Community Care provider experienced in the management of pulmonary hypertension (PH).

Definitive, confirmed diagnosis of interstitial lung disease (ILD) (e.g., diffuse parenchymal lung disease on chest CT).
Examples of ILD include idiopathic interstitial pneumonia, combined pulmonary fibrosis and emphysema, connective tissue disease, and chronic hypersensitivity pneumonitis.
Definitive, confirmed diagnosis of WHO Group 3 PH associated with ILD.

Nebulized solution is preferred for patients requiring more than one cartridge per dose using the dry powder inhaler (DPI) (e.g., >64 mcg of TYVASO or >106 mcg of YUTREPIA).
DPI should be reserved for patients with a documented inability to use the nebulized product.

All inclusion criteria must be met.
Individual cases that are exceptions to exclusion/inclusion criteria or require formulation preference adjustments should be adjudicated at the local facility level per P&T Committee and Pharmacy Services policies/procedures.

Pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability
Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability

WHO Group 1 PAH patients who are either prostacyclin naïve and on ≤2 nonprostacyclin oral PAH agents, or transitioning from stable doses of nebulized treprostinil
Patients with PH-ILD (not specifically evaluated in clinical trials but considered for use)
May be useful for patients who are unable to use DPIs that require strong inhalation due to low inspiratory effort requirement

Treatment naïve: Initiate at 26.5 mcg four times daily
Target maintenance dose: 79.5 to 106 mcg four times daily
Transitioning from treprostinil nebulized inhalation solution (TYVASO): Dose determined by current TYVASO breaths per dose (≤5 breaths = 26.5 mcg; 6–8 breaths = 53 mcg; 9–11 breaths = 79.5 mcg; 12–14 breaths = 106 mcg; 15–17 breaths = 132.5 mcg requiring 2 capsules; ≥18 breaths = 159 mcg requiring 2+ capsules)
Doses exceeding 106 mcg require two capsules and double the cost

Monitor for common adverse events: cough, headache, throat irritation, dizziness
Discontinuation due to adverse events observed at 12% in clinical trials
Assess risk of symptomatic hypotension (vasodilator effect)
Assess risk of bleeding (platelet aggregation inhibitor)
Monitor for bronchospasm, with increased risk in patients with asthma, COPD, or other bronchial hyperreactivity
Adjust/monitor for CYP2C8 inhibitor co-administration (increased exposure) and CYP2C8 inducer co-administration (decreased exposure)

Considered an alternative to treprostinil inhaled nebulized solution (TYVASO) or TYVASO DPI for PAH and PH-ILD
Approved based on demonstration of safety and tolerability rather than efficacy
Requires administration via a specialized capsule-based inhaler; device discarded every 7 days