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- W1986647572 abstract "The Committee for the Assessment of Hospital Drugs, led by the Catalan Agency of Health Information Assessment and Quality, has provided evidence-based information to regional health care decision-makers in Catalonia about the added therapeutic value (ATV) of centralized approved drugs fit into the orphan or advanced therapies category or have conditional approval or were approved in exceptional circumstances. This study describes the committee's activity since its creation. Systematic reviews of efficacy, safety and cost-effectiveness are conducted upon request from the Pharmacy Directorate and results are appraised by expert panels. A total of 22 drugs (24 indications) for an estimated population of 1.100 patients have been assessed. Most drugs were granted approval for two major therapeutic areas: onco/hematological (41%) and metabolic diseases (32%). Orphan designation had been given to 70% of all indications. Only 8 indications were given positive opinion based on 2 clinical trials. Most pivotal studies were randomized phase III trials and were considered to have moderate (63%) to high (25%) risk of bias. Placebo was the most frequent comparator in controlled studies but was only considered appropriate in half. Primary endpoint was a surrogate/intermediate endpoint in 94% of studies. Relevance of efficacy results was difficult to interpret due to design flaws, small samples and short-term follow-ups. Scarce or no data on effectiveness was available. Information on comparative safety was also scant and limited by short-term follow-ups. At time of assessment cost-effectiveness data was missing in 66% of the indications. Reported base-case incremental cost-effectiveness ratios from manufacturers ranged from 16.000-565.000£/QALY. Defining ATV of new entities at the time of introduction proved a challenge because of low quality studies and lack of information about relative effectiveness. Registers and/or risk-sharing schemes may be an alternative to gather more information new about drugs and establish their real ATV while facilitating access." @default.
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- W1986647572 date "2011-11-01" @default.
- W1986647572 modified "2023-10-18" @default.
- W1986647572 title "PHP57 Centralized Drug Assessment in Catalonia: Where We Have Gone so Far?" @default.
- W1986647572 doi "https://doi.org/10.1016/j.jval.2011.08.608" @default.
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