1.1. Study Question
“What is the incremental cost per quality-adjusted life-year (QALY) gained, from a provincial government payer perspective for Adempas compared with placebo for the management of chronic thromboembolic pulmonary hypertension (CTEPH) in Canadian patients in World Health Organization functional class (WHO FC) II or III with inoperable CTEPH, or patients with persistent or recurrent pulmonary hypertension following pulmonary endarterectomy, over a patient lifetime horizon (maximum 20 years)?”
(Manufacturer’s submission,1 page 57.)
1.2. Treatment
An individual dose titration of between 0.5 mg and 2.5 mg, orally, three times a day.
1.3. Comparators
Placebo or bosentan (generic) and Tracleer (brand-name bosentan). According to the clinical expert, 60% to 80% of the indicated patient group are on off-label treatment, bosentan being the most commonly used, although not approved by Health Canada. As such, it is appropriate to consider bosentan as the most appropriate comparator in the cost-utility analysis (CUA). Please refer to Table 3 for the proportion of brand-name versus generic bosentan across provinces and drug plans.
1.4. Type of Economic Evaluation
A CUA was undertaken and is appropriate according to the Canadian Agency for Drugs and Technologies in Health (CADTH) guidelines. The primary perspective utilized in the model is that of the Canadian public payer.
In addition, a cost-consequence analysis (CCA) was conducted when the costs and consequences of the alternative treatments are listed separately in a disaggregated format. A summary of the CCA is presented in Appendix 3.
1.5. Population
The population comprised adult patients (≥ 18 years old) with 1) inoperable CTEPH, or 2) persistent or recurrent pulmonary hypertension after pulmonary endarterectomy.
