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Aims: Hidradenitis suppurativa (HS) is a chronic skin condition causing inflammatory lesions, pain, scarring, and impaired mobility. Treatment options are limited and often lack success implying the need for additional/improved treatments. This research aimed to estimate the potential economic value of a treatment candidate, explore drivers of cost-effectiveness, and highlight economic evidence requirements for successful future value assessments., Materials and Methods: An early cost-effectiveness model was developed to assess the cost-effectiveness (cost per quality-adjusted life year (QALY) gained) of a treatment candidate compared against the only authorized biologic, adalimumab, for moderate to severe HS, from a UK National Health Service and Personal Social Service perspective. A targeted literature review of clinical and economic references and previous health technology assessments (HTA) was performed for development and validation of the early economic model used to present sensitivity analyses accompanying the base case cost-effectiveness results., Results and Limitations: Base case results revealed the candidate not to be cost-effective compared to adalimumab when considering a formal cost-effectiveness threshold of £30,000 per QALY gained. Scenario- and threshold analyses highlighted that reducing dosing or drug price by half improved the cost-effectiveness of the candidate. Cost-effectiveness was highly sensitive to health states' utility values, treatment discontinuation, and resource utilization, in line with existing HTA evidence. The paucity of economic studies and uncertainties around the candidate presented methodological constraints that were addressed through sensitivity analyses., Conclusions: Key costs and health effects drivers were highlighted to contextualize under which circumstances a treatment candidate for moderate to severe HS would reach acceptable cost-effectiveness levels. This early economic evaluation suggested promising economic perspectives for treatment candidates in HS. Exploring novel ways to use clinical endpoints to simulate the patient pathway and clinically meaningful treatment achievements in future research will facilitate the value demonstration of candidates in disease areas with high unmet care need.

Background and Aims: Epilepsy is the most common serious neurological disorder worldwide. Approximately 40% of patients with focal epileptic seizures remain uncontrolled with antiepileptic drug (AED) monotherapy or polytherapy. Lacosamide has been recently approved by the European Medicines Agency as monotherapy for the treatment of focal seizures. The aim of this study was to estimate the cost-effectiveness of lacosamide compared with zonisamide as first-line treatment of focal epilepsy in patients with epilepsy aged ≥ 16 years to inform clinical decision-making in Greece., Methods: A discrete event simulation model was adapted to reflect treatment pathways and resource use within the Greek national healthcare system, as specified by clinical experts. The model captures time-varying events and patient characteristics. Clinical inputs were sourced from pivotal trials and a network meta-analysis comparing lacosamide with other AEDs. The model predicts disease progression and seizures, relevant and most common adverse events, withdrawal due to lack of efficacy or adverse events, and epilepsy-specific and all-cause mortality over a 2-year time horizon. Unit costs were retrieved from published Greek sources. Health outcomes were measured as quality-adjusted life years (QALYs); secondary outcome was the cost per seizure avoided. Robustness of the results was tested with univariate and probabilistic sensitivity analyses., Results: The lacosamide treatment pathway was associated with higher costs (i.e. €1,064) and an additional 0.119 QALYs when compared with zonisamide, resulting in an incremental cost-effectiveness ratio of €8,938 per QALY gained. The sensitivity analyses demonstrated that the results are most sensitive to the efficacy and utility estimates., Limitations: There are a number of limitations which stem from the process of model adaptation and lack of local real-world evidence., Conclusions: Lacosamide is a cost-effective option at a willingness-to-pay threshold of €30,000 per QALY, representing a valuable monotherapy treatment option for patients with focal epileptic seizures in the Greek setting.