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Access with evidence development explained

At a recent reception, the chair of Health Economics at the Leeds Institute of Health Science explained risk sharing schemes

At a reception hosted by Bridgehead Consulting on June 24, Professor Christopher McCabe, chair of Health Economics at the Leeds Institute of Health Sciences and director of the Academic Unit of Health Economics, addressed an audience from the pharmaceutical, biotechnology and financial sectors about access with evidence development (AED), more commonly referred to as risk sharing schemes. 

Professor McCabe described AED as an umbrella term for schemes that support market access when standard decision rules decline reimbursement. He stated, however, that the trend is towards this happening even when the standard decision rules support reimbursement. 

The advantages of AED are that it meets the demand for access to therapy while protecting the process, allows for controlled implementation and the creation of additional knowledge when existing evidence is poor. Professor McCabe also points out several long- and short-term risks, however. In the short term, he cautions, such schemes may not deliver new knowledge or appropriate access, while in the long term they could remove incentives for manufacturers to undertake research that informs reimbursement decisions, lower the evidence hurdles for reimbursement and licensing, and inappropriately divert resources towards “high-tech” healthcare, ie set up a system of bias towards one type of healthcare over others. This threatens the sustainability of public healthcare systems by introducing a two-tiered healthcare system, he said.

According to Professor McCabe, the age of licensing driven R&D in healthcare is passing, with how well a drug works for its cost mattering now. Bodies such as NICE realise that the situation today is very different from the one that existed when pipelines were decided and R&D initiated 10 or so years ago, and that a mechanism is needed to tide this period over. AED caters to this requirement and thus should not be viewed as a long-term strategy or new model, but rather as a short-term mechanism to bridge the gap as imperatives surrounding the provision of healthcare continue to shift. 

Steps are underway to define the core principles and desirable characteristics of AED in a move towards standardisation, while the US Food and Drug Administration (FDA), UK National Institute for Health and Clinical Excellence (NICE) and their European counterparts are engaged in dialogue regarding future trial designs.

1st July 2009

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