The role an unmet need plays in driving innovation

As healthcare budgets tighten and patients' expectations increase, pharma must go beyond simply supplying the pills and work to provide services and technologies that address broader unmet needs.

Historically, pharma innovation tended to be focussed at a pharmacological level, with assets typically developed from a company's preferred research areas which were then, hopefully, approved. These were then (hopefully - given the long time frame involved) matched to a remaining 'unmet' patient need at a price point that (hopefully) healthcare systems/payers were willing/able to pay.

But what happens when, by the time of launch, unmet needs have been largely satisfied, or are difficult to meet? Factor in the increasing pressures at a financial, political and patient demand level and you have one of the most fundamental challenges the industry has faced.

Companies must re-assess exactly what is meant by 'unmet need' now, and in the future at launch, in order to develop products which really deliver innovation.

So what are the pressures?

The financial pressures are the most obvious, especially in light of the economic uncertainty facing large parts of the world. Healthcare systems can't afford to 'just find the funds' for new treatments simply because they are new, without considering what they are getting for their money, especially considering the number of 'me too' therapies and cheaper generics available. When every amount invested in one product or therapy area needs to be balanced with a dis-investment somewhere else, additional services designed to get the most from every penny or cent are increasingly demanded.

"Governments may be unwilling to directly criticise the industry, but a lack of positive government support conveys a powerful message nonetheless"

At a political level, particularly in government-funded health systems, such as that in the UK, the focus (and perhaps blame) has begun to shift from the system's lack of willingness to pay (or ability to afford because of lack of funds) towards the industry's perceived 'profiteering from the sick'. Governments may be unwilling to directly criticise the industry, but a lack of positive government support conveys a powerful message nonetheless. The impacts of campaigns such as that by Breakthrough Breast Cancer in the UK, Demand a Fair price for life-extending drugs, have raised the political game by suggesting that the UK Government is a driving force in reducing the costs of drugs demanded by the industry from the NHS.

Closely linked to the political drive is the influence of the individual patient, patient groups, parents and carers who want and expect more from the healthcare system and therefore, inevitably, the industry. Patients expect to be able to access the very latest, most innovative treatments that they perceive offer them the greatest benefit.

What can the industry do but keep up, offer more? It has to demonstrate genuine improvements in patient outcome, and real value for money, while also being politically acceptable. At the heart of this is re-defining what is meant by real unmet patient or healthcare system need and recognising that there is more to improving patient outcomes than simply developing a newer, better drug.

When thinking around real unmet patient need extends beyond the purely pharmacological and becomes more holistic, it opens up areas that focus on ensuring that maximum pharmacotherapy benefits can be realised by the greatest number of patients. These considerations range from supporting patient compliance/adherence in different, more stringent ways, through to creating a more aware and empowered patient and clinician through engagement and education programmes. Above everything, it should demonstrate improved 'value for money', bearing in mind that this, in itself, is a subjective concept.

When considering value for money the UK NHS is looking at outcome more than input and the industry is already offering a number of innovative schemes to drive better outcomes. These include Smartphone apps, which track patients taking their medication at the right time and in the right way, and 'smart' packaging which tracks when patients open blisters of high-cost drugs requiring strict adherence and compliance to regimens.

Similarly, innovation is also improving diagnostic approaches and tests (such as biomarkers) as well as patient monitoring. These offerings have helped pharma to demonstrate a commitment to both a therapy area and, more broadly, the healthcare system itself, while also helping maximise the full benefits promised by the drug itself.

"Patients expect more than ever before and, if the last drug they took came with a support package that they felt benefitted them, then they will want at least as much from the next therapy they are prescribed"

When it comes to patients, the choice of one particular therapy over another may be decided by the whole package offered, either to patients directly or to the healthcare system in which they are treated. This, in turn, may influence their physician to recommend one treatment over another. Patients expect more than ever before and, if the last drug they took came with a support package that they felt benefitted them, then they will want at least as much from the next therapy they are prescribed.

Just as the industry needs to evolve 'beyond pharmaceuticals', it must be willing to go beyond its current understanding and limitations. Broader understanding of 'unmet need' will allow pharma companies to innovate appropriately and provide a firm foundation to keep finding better ways to be 'best in class' as judged by providing genuine improved patient outcomes. The end result should be an even more positive future.

About the author:

Cassandra Rix is a market access specialist and applies her in-depth market access and marketing knowledge with diverse therapy area expertise to solve complex organisation, asset and portfolio business challenges.

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