Objective: Chronic lymphocytic leukaemia places a considerable economic burden on the Spanish National Health System. This study estimated the direct costs of chronic lymphocytic leukaemia oral targeted therapies from 2011 to 2025, inclusive, in a scenario with fixed  treatment oral targeted therapies and in a scenario without them. Method: The clinical course of adult chronic lymphocytic leukaemia patients  was represented by a Markov model with four health states: watchful waiting,  first-line treatment, relapse, and death. The treatment pattern was defined  according to patient type by disease status or situation, age, presence or  absence of deletion in the short arm of chromosome 17, immunoglobulin heavy  chain mutation status, and year of treatment. The treatment algorithm  was simulated from 2011 to 2025, and included therapies funded by the  Spanish National Health System and their use in routine clinical practice,  validated by leading experts. A single treatment option was assumed for each  type of patient and time period (the most widely option used at each time  point). Direct costs were included: pharmacological, administration, tests  performed, routine visits, hospitalizations, and adverse events. Results: From 2011 to 2025, there would be a mean annual chronic  ymphocytic leukaemia prevalence of 16,436 patients in the scenario without  fixed treatment oral targeted therapies and 16,413 in the scenario  with  in the scenario without fixed treatment oral targeted therapies would be €4,676.7 million and in the scenario with fixed treatment oral targeted therapies they would be €4,111.8 million. Thus, the introduction of fixed treatment oral targeted therapies would entail a saving of €564.9 million (12.1% of the total cost of care of chronic lymphocytic leukaemia patients during the period assessed). In this period, the total cost per patient would decrease from €266,019 in the scenario without fixed treatment oral targeted therapies to €236,852 in the scenario with fixed treatment oral targeted therapies, representing a saving of €29,167 per patient.

Conclusions: This study estimates that, between 2011 and 2025, the introduction of fixed treatment oral targeted therapies for the treatment of chronic lymphocytic leukaemia would entail €564.9 million cost savings for  the Spanish National Health System (12.1% of the total cost of care of chronic  lymphocytic leukaemia patients during the period assessed).

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