Initial combination therapy for patients with pulmonary arterial hypertension (PAH): a budget impact analysis from the perspective of the Italian national healthcare system

ABSTRACT

Background: Initial combination therapy in patients with pulmonary arterial hypertension (PAH) WHO functional class (FC) II or III has demonstrated clinical benefits over initial monotherapy. The objective of this study is to compare the financial impact of initial combination therapy with initial monotherapy for incident patients with PAH in Italy.

Methods: A 3-year budget impact model compared a ‘status quo’ scenario of initial monotherapy with an endothelin receptor antagonist (ERA), phosphodiesterase 5 inhibitor (PDE5i) or prostanoid, with a ‘new’ scenario involving initial combination therapy, using Italian national healthcare system (NHS) data for incident patients with PAH WHO FC II or III. The hospitalisation hazard ratio (HHR) from the AMBITION study and expert panel advice on therapy use were employed. Univariate sensitivity analyses were performed.

Results: A difference in costs of €16,070 favouring the ‘new’ scenario (initial combination therapy) was observed, and attributed to 101 fewer hospitalisations over 3 years. Sensitivity analyses showed that costs were driven by the proportion of patients receiving ERAs versus PDE5i, hospitalisation costs and prostanoid dose.

Conclusion: Initial combination therapy instead of monotherapy could reduce the number and cost of hospitalisations without an increase in the total costs to the Italian NHS.

KEYWORDS:

• Cost
• hospitalisation
• initial combination therapy
• pulmonary arterial hypertension

Declaration of interest

Editorial assistance was provided by Clare Slater, PhD, of Fishawack Indicia Ltd and funded by GlaxoSmithKline. C Albera received honoraria from Bayer and GlaxoSmithKline for participation on advisory boards. R Carignola has received consulting fees for advisory board participation for GlaxoSmithKline, Actelion, Bristol Myers Squibb, and Italfarmaco. M Dalto has received consulting fees for advisory board participation for GlaxoSmithKline, Actelion, Bayer, and United Therapeutics. S Ghio received consulting fees from Bayer, GlaxoSmithKline (for advisory board participation) and United Therapeutics. His Institution has received grants by Pfizer to lead a Regional Network Project on Pulmonary Hypertension in Region Lombardia over the last three years. M Mulè received honoraria from GlaxoSmithKline for participation on advisory board. P Vitulo received consulting fees for advisory board from GlaxoSmithKline and Bayer. Travel fees by Actelion, Bayer, Dompé, GlaxoSmithKline, and Pfizer. His institution (ISMETT) has received educational grants sponsored by GSK, Actelion and Dompé. CD Vizza received honoraria for participation in advisory boards for GlaxoSmithKline, Bayer, MSD, Pfizer, UTEL. His institution received fees for sponsored study from GlaxoSmithKline, Actelion, Bayer, UTEL. M Vighini, R Silvestri, and W Zamboni are all employees of GlaxoSmithKline; M Vighini and R Silvestri don’t hold stock ownership in the company whereas W Zamboni hold stock ownership in the company. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Additional information

Funding

Funding for this study was provided by GlaxoSmithKline.