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OBJECTIVES: To assess the potential number of EU PICOs based on EUnetHTA 21 guidance and to explore further evidence-based opportunities to produce more predictable and workable EU PICOs. METHODS: The consolidated EU PICOs of two future hypothetical medicines in first line non small cell lung cancer (1L NSCLC) and third line multiple myeloma (3L MM) were derived using published HTA reports of two recent medicines in similar indications based on EUnetHTA 21 proposed guidance. Sensitivity analysis assessed the impact of additional PICO requests. The number of analyses requested was estimated. RESULTS: In 1L NSCLC and 3L MM, six and nine EU Member States (MS), respectively, had published HTA reports. PICO consolidation resulted in 10 PICOs for 1L NSCLC and 16 PICOs for 3L MM, increasing to 14 and 18 PICOs respectively when England's NICE scope was included to proxy remaining MS. A minimum of 280 and 720 analyses would be requested, exponentially increasing as additional outcome measures and subgroups are requested. CONCLUSIONS: The PICO approach outlined by EUnetHTA 21 results in a significant number of analysis requests and substantial resources. Use of complementary analyses alongside evidence-based methods to derive PICOs and engaging with the health technology developer throughout the process, would create a workable EU PICO that is predictable and most impactful for the EU, resulting in a timely and high-quality assessment report that is more usable at a MS level.
RESUMO
Background: This study aimed to assess the broader environmental, healthcare and societal impacts across the entire asthma pathway from diagnosis to treatment in the UK. Methods: A comprehensive cost-of-illness framework was developed considering the effects of the full asthma patient pathway, including greenhouse gas emissions generated from inhalers, National Health Service (NHS) costs, health-related quality of life and productivity losses. The model was based on published literature and clinical expert opinion to accurately estimate, in monetary terms, the net present value of the asthma pathway impacts for 2022-2031. Results: The estimated net present value of the environmental, healthcare and societal impacts of the asthma pathway was £47 billion over the 2022-2031 period in the UK. Loss of disease control was a key contributor to higher greenhouse gas emissions and NHS costs. In 2022, a patient with non-severe uncontrolled asthma was estimated to incur 22% higher NHS costs than a patient with controlled asthma, while generating 0.1â t more of CO2 equivalent emissions. In the same year, the total direct impacts per patient with severe asthma were four times higher than for a patient with non-severe controlled asthma, with 0.54â t CO2 equivalent of greenhouse gas emissions. Moreover, as much as 77% of the total economic impact was driven by worsening health-related quality of life and productivity impacts occurring when patients' symptoms were uncontrolled. Conclusions: Uncontrolled asthma significantly impacts patients, the economy and the environment in the UK. Our results emphasise the need for a holistic approach in controlling asthma and should be carefully considered when developing policies to mitigate the overall burden of the disease.