Budget Analysis of Addition of Riociguat for PAH and CTEPH

Results of a budgetary impact model study showed that the addition of riociguat to treat patients with pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH) offers US health plans an additional treatment for these conditions that is safe, effective, and associated with minimal economic impact [Am Health Drug Benefits. 2014;7(9):479-487].

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Riociguat is a first-in-class oral soluble guanylate cyclase stimulator approved by the FDA since October 2013 for the treatment of PAH and inoperable, persistent, or recurrent CTEPH. Evidence from previous randomized trials showed that riociguat can increase hemodynamic and exercise capacity in these patient populations.

In this study, Chakkarin Burudpakdee, PharmD, principle, IMS Health, Fairfax, Virginia, research assistant professor, University of North Carolina, Charlotte, and colleagues used a budget impact analytic model to estimate the budgetary impact of adding riociguat to the formulary of US healthcare plans to treat patients with PAH or CTEPH. This was the first study to examine this.

The budget impact analytic model was based on an interactive, decision analytic tool developed to provide an estimate of the effect of adding riociguat on Medicare and non-Medicare health plans on a per-member, per-month (PMPM) and per-member, per-year (PMPY) basis.

The investigators used data on 1 million insured lives, published estimates of the prevalence of PAH and CTEPH, patients with PAH and CTEPH eligible for drug treatment, administration costs, and monitoring costs related to pharmacotherapy to calculate the hypothetical economic impact of adding riociguat. Wholesale acquisition costs were used to determine drug costs and all costs were reported in 2013 US dollars without taking into account any discounting of future cost. Claims data from Truven Health MarketScan® and Medicare 2013 Clinical Diagnostic Laboratory Fee Schedule and Physician Fee Schedule were used to determine costs.

Using the model, the study found that 9 patients (7 with PAH and 2 with CTEPH) out of 1 million plan members would be suitable for drug treatment. A total of 3 patients (1 with PAH and 2 with CTEPH) covered by commercial insurance and Medicare were receiving riociguat.

When adding riociguat to the formulary for these patients under a non-Medicare plan, the estimated total annual expenditure rose from $328,807 to $600,654. This cost impact to the health plan of adding riociguat based on a per-member calculation was $0.02 PMPM and $0.27 PMPY.

When adding riociguat to the formulary for these patients under a Medicare plan, the estimated annual expenditure rose from $329,382 to $601,800. The cost impact on the health plan based on per-member was the same as the non-Medicare plan.

“The findings from this budget impact model suggest that adding riociguat to a formulary plan, either Medicare or a non-Medicare plan, offers a new treatment option for managing patients with PAH and CTEPH with a budget increase estimated at $0.02 PMPM and $0.27 PMPY,” according to Dr. Burudpakdee and colleagues.

The authors suggested further research to examine the use of real-world evidence on the real-world budget impact of adding riociguat in this setting to validate these hypothetical results.

The investigators caution that interpretation of the study’s results should include recognition of the study limitations, including restricting the study population to patients ≥18 years of age, a lack of specific US prevalence estimates of PAH and CTEPH, a lack of consideration of other costs related to disease monitoring, and the exclusion of costs to members.—Mary Beth Nierengarten