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•Effective Use of Health Technology Assessment to Maximize Market Access: Start Early and Update Often

By: ICON

"It's always too early to evaluate a technology… …until suddenly it's too late." ~Professor Martin Buxton, Brunel University, London, UK [Buxton's Law]

We all know that the face of drug discovery and the market for new pharmaceutical products (and medical devices/diagnostic technologies) is changing. The era of the blockbuster appears to be over, the cost of bringing a new product to market has skyrocketed and when a new product is eventually licensed, sceptical payers are increasingly demanding evidence, not only of the product's effi cacy, but also its value for money. This demand on the part of payers for evidence of value has led to an increasing need for health technology assessment to support reimbursement and market access strategies.

The drug development pyramid is a familiar concept to those working in clinical research. With so many candidate substances screened for development just to support the launch of a single product, it would be tempting to see it as folly to embark on a formal assessment of potential value for a product prior to launch – before it has even been shown whether the product works.

However, as the quote above suggests, to wait for successful demonstration of efficacy before thinking about demonstrating value, risks coming to market totally unprepared, with the consequent danger that the successfully licensed product will fail to ‘hit the ground running.' Furthermore the formal assessment of value early in a product lifecycle has much more to offer than helping a fast exit from the starting gates for those products that do make it through clinical development.

A retiring vice-president of one of the world's leading pharmaceutical companies was asked what, looking back over his career, would he have done better were he to be given his time over again. ‘To have the confidence to call an end to failing products earlier' was his reply. The implication was clear – that pharmaceutical companies generally spend too long persisting with clinical development of products that have a very low chance of making it to market. When you consider the costs involved in the clinical development process, this is true folly. And this is where formal techniques of health technology assessment – in particular economic analysis – can help.

Using the very tools that reimbursement authorities use to assess value, cost-effectiveness models, employed early in the lifecycle, can help identify the ‘road to value' – the chain of evidence required to take something in early human studies (or even pre-clinical studies) through to showing a measureable impact on health. Of course there will be uncertainties – and the earlier in the development process you start, the greater those uncertainties will be – but it is precisely in quantifying those uncertainties that the value of the exercise is obtained.

Once the uncertainties are mapped out, strategies to reduce those uncertainties can be developed and the appropriate research studies commissioned. Once those studies report, the world becomes that bit clearer and a new strategy can be developed.

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•Effective Use of Health Technology Assessment to Maximize Market Access: Start Early and Update Often