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Objectives: The Tunisian National Authority for Assessment and Accreditation has published in 2018 its first HTA report, aimed at informing the national payer on the effectiveness and cost-effectiveness of trastuzumab, the first agent targeting HER2 positive breast cancer, representing its biggest budgetary expenditure since 2008. Methods: A systematic litterature review of recent clinical practice guidelines on management of breast cancer was performed to extract best available evidence on effectiveness and risks related to trastuzumab. The recommendations of the Tunisian Society of Oncology were compared with SIGN and NICE guidelines. A benchmark of ex-factory prices of trastuzumab in different countries was carried out along with a survey among INAHTA members to collect prices' information, reimbursement and treatment management modalities. To determine the cost effectiveness of trastuzumab at the 2018 selling price, an adaptation of a Latin American cost-effectiveness study was conducted, followed by a sensitivity analysis and the estimation of the cost effectiveness price. Results: Trastuzumab significantly improves DFS and OS compared to chemotherapy alone, however it increases the risk of congestive heart failure. According to the benchmark, the 2018 ex-factory price of trastuzumab in Tunisia remains higher than most of high income countries. From the ministry of health's perspective, the ICER of trastuzumab was 49 670,67 USD/QALY, representing 4,5 times the 3 GDPPC/QALY threshold suggested by WHO. From the national payer's perspective, the ICER was 75 386,18 USD/QALY, representing 6,8 times the threshold. Probabilistic sensitivity analysis showed 0 % probability of trastuzumab being costeffective considering the same threshold. A discount of 78% on trastuzumab's acquisition price is required to reach cost-effectiveness threshold. These results provided a set of recommendations for the payer and informed the negociation of the biosimilar's price. Conclusions: This first INEAS HTA report clearly illustrates the central role of HTA at informing decision-makers in terms of price negotiations and reimbursement decisions.

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OBJECTIVES: Treatment options for patients with advanced NSCLC (aNSCLC) are rapidly expanding. The iTEN model was developed to support medical decisionmaking by predicting aNSCLC patient survival and associated costs, from a Canadian healthcare system perspective. METHODS: A discrete event simulation was developed to estimate survival and costs, dependent upon patient characteristics (histology, biomarker, performance and smoker status). Treatment sequencing and eligibility were derived from a modified Delphi process with Canadian clinical experts. Published KaplaneMeier progression free and overall survival data were fit with parametric functions to estimate treatment efficacy and applied based on statistical and visual fit. Progression and death events were randomly assigned for each patient, using the estimated parametric functions. Treatment history was assumed to have no impact on the efficacy of subsequent therapies. Costs included were: drug acquisition and administration, monitoring, imaging, physician visits, end-of-life, best supportive care and adverse events. Analyses were based on 100,000 simulated patients. Model survival predictions were validated against published real-world estimates from the Ontario Cancer and Austrian (TYROL) registries and a retrospective analysis of US medical records (Nadler et al., 2018). RESULTS: The Ontario Cancer registry, TYROL registry and US medical records study reported overall survival for patients receiving two-lines of chemotherapy, up to five-lines of treatment with chemotherapy/targeted therapies or up to threelines of treatment with PD-1 inhibitors/chemotherapy/targeted therapies, respectively. One-year survival rates for these studies were 67%, 38% and 49%. iTEN estimated one-year survival, after restricting the treatment pattern to match each study, was: 61%, 39% and 60%. Based on the Canadian (2017) treatment algorithm, the estimated one-year survival and per-patient cost of treating aNSCLC were 46% and $89,899. CONCLUSIONS: Survival estimated by the iTEN model approximates published real-world data. Further validation is planned; however, the model may reasonably estimate the clinical and cost consequences of treating aNSCLC.

A509cost of each stage of kidney disease according scheduled visits in each condition, and, therefore, to calculate the economic burden of one year dialysis for the Spanish Health System, to check the advantage of a treatment that could delay the disease progression of ADPKD. Methods: The model was based in normal practice of a specific hospital, selected for it's expertise within ADPKD. To build the model the following figures were provided: Hospital costs (number of expected healthcare provider visits, analytics, image diagnosis), and other expected costs (such ambulance transport and concomitant treatments for hypertension, hypercholesterolemia, hyperuricemia, pain, infections, and haematuria). In addition to this, costs from the patient's perspective, namely medication and transport costs were also analysed. Results: The annual cost for dialysis patients in Hospital La Paz, and Madrid Province, in general, is 56,028 euros (43,980.00 € for Hospital costs, up to 600 € for medication, and 11,448 € for ambulance transport) , while the rest of Chronic Kidney Disease stages (CKD stages 1-4) range annually between 809-1.551 € (Hospital costs and medication). Therefore, avoiding 1 year of dialysis will represent around 54,800 € savings. ADPKD patients cover additional expenses (up to 350 € for medication and 8-195 € for transport, annually). ConClusions: Dialysis extensively increases the economic burden of ADPKD, this is mainly seen in the healthcare system. ADPKD patients are faced with medication costs and travel expenses, as well as other incommodities and non-calculated indirect costs. Therefore, a treatment able to delay the disease progression represents an important step towards patient wellbeing and big savings for the Health System PUK9 Do Socioeconomic ineqUalitieS imPact the Social coSt of chronic KiDney DiSeaSe in italy?