4. Clinical effectiveness assessment in HTA
1. Clinical effectiveness assessment in HTA
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Clinical effectiveness assessment
At the heart of HTA lies the evaluation of the effectiveness of a new medicine.
In general, evidence from (multinational) randomised controlled trials is used as a basis, which must then be interpreted in the local context and be supplemented by additional information. It can’t be assumed that the available information desirable for an ideal HTA is comprehensive and contains all aspects. This means that different sources of information must be pieced together to provide a picture for HTA bodies/decision-makers. The required information may be published in scientific journals, available through regulatory assessment reports for marketing authorisation of medicines, or obtained directly from companies that develop and/or market a medicine. While some HTA bodies will commission or conduct their own research, most HTA bodies use work done by others.
Clinical effectiveness assessments compare the effect of a new technology on the health of patients in a standard clinical setting to the current standard of care. The impact that a technology has on health is usually analysed through a further examination of health outcomes beyond the assessment of efficacy and safety (benefit-risk) done by regulatory authorities. Assessing the impact of any health technology requires comprehensive information that reflects what is likely to happen in a health system or society. High quality analysis requires the use of expert advice and methods from associated disciplines that are used as sources.
In particular, the evaluation of clinical effectiveness is carried out with the methodology borrowed from epidemiology and medicine .
There are four underlying steps of clinical effectiveness assessment which are frequently followed:
1. Seeking information
2. Asking relevant questions
3. Understanding differences
4. Valuing differences.