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Defining value: has anyone asked the patient?

The real-world challenges they face give patients unique views on 'value'

Pharma pricing transparency value 

ASCO has once again opened up the Pandora's Box of high-cost medicines. The annual congress is not only a must for anyone with an interest in clinical oncology, but it also shows how developments around high-profile cancer innovations can be used as a barometer for market access challenges facing expensive treatments across all therapy areas.

The recent 2016 meeting was entitled 'Collective Wisdom' - and it focused on the 'future of patient-centred care and research'. How ironic. Because at present, the 'collective wisdom' is that a single value framework could solve all the ills of oncology pricing - yet the frameworks being proposed appear to exclude the patient from the value discussion. That cannot possibly be right.

In April this year, a Journal of Clinical Oncology (JCO) editorial, Walking the Tightrope Between Treatment Efficacy and Price, evaluated the relative merits of value frameworks currently being proposed in the US. It concluded, like much of the debate before it, that a single value framework is the best way forward. Discourse at ASCO 2016 has only perpetuated that view. However, while the single system is an understandable suggestion, I don't believe the proposals are either possible or workable.

The ASCO value framework, rather like those proposed by The European Society for Medical Oncology and The National Comprehensive Cancer Network, is a laudable attempt to develop policy that provides Americans with equal access to high-quality care at the lowest cost. It's no surprise that many emerging platforms designed to determine value - such as the DrugAbacus referenced by PB Bach in his JCO editorial - place the key parameters of the ASCO framework at the centre of their algorithms. However, in limiting its value evaluation to a narrow focus on clinical benefit, safety and cost, the ASCO framework fails to capture the most valuable perspective of all: the patient's. The framework's greatest strength - its objectivity - is also its biggest weakness.

Patient empathy
In the complex world of cancer care, objective analysis from eminent oncologists and health economists, can never truly empathise with the real-world challenges patients with cancer face. Patients have entirely different definitions of value that fluctuate as their disease progresses and their treatment options evolve. If future frameworks are to be effective, we must find a way of - responsively - adding these crucial perspectives to the value discussion, rather than pursuing a one-size-fits-all framework based solely on objective measures.

The value of life is a personal viewpoint; we each have our own value system that reflects our life experience and socioeconomic circumstances. Yet none of the current value framework proposals make any provision for patient preference - they are purely based on efficacy, toxicity and cost. Moreover, they each propose single solutions that cannot flex to suit individual needs. Fundamentally, a single value framework cannot meet the needs of an entire society. Moreover, any system that deprives patients of their right to choice goes against the fundamental principles enshrined in the US declaration: life, liberty and the pursuit of happiness.

The JCO editorial reflects the bi-polar symptoms within US healthcare. It argues that cost-effectiveness should not get in the way of how medicine is practiced, yet goes on to state that US healthcare 'cannot afford to build a large pool of people receiving expensive maintenance treatments'. The qualifier - that no-one wants to prevent life-saving therapies reaching the people who need them - only underlines the challenges we face. These challenges are not limited to the US, they're resonating in every developed market and beyond. What's more, they're not only dictating the standards of cancer care, they're influencing patient outcomes across all known diseases.

In the EU, manufacturers are being forced into providing dramatic discounts to achieve cost-effectiveness. Meanwhile, in the UK, NICE has now adopted the new Cancer Drugs Fund and will officially begin to apply it from July. Under the new framework, therapies where cost-effectiveness is not proven are being formally reviewed so that cancer patients may still gain access to treatments that could prolong life. Manufacturers have two years to gather evidence and prove value. If they are successful, they can have secured funding. If they're not, and value for money is not proven, therapies will be dropped from the list.

In the US, the current approach to evaluating medicines places a disproportionate emphasis on efficacy at the expense of cost-effectiveness criteria. As a result, costs are rocketing. Conversely, HTA systems, similar to those used in Europe, have created a beautified version of rationing medical resources. The result? Patient choices are limited.

A patient preference value framework
So what's the solution? The US healthcare system should be able to provide a basic framework for payer coverage, based on the WHO's recommended threshold level (three times per capita GDP). This could be supported by a more flexible value framework to inform patients' individualised choices. Treatments that meet agreed criteria would be covered by insurance as a legal requirement, whilst drugs that don't would dictate a higher patient co-pay. Determining whether a drug can be used in treating cancer should be subject to a second framework - a 'patient preference value framework'. Through this, data around the cost, risk and benefit of a treatment can be described to patients through HCP interaction and followed up with a patient questionnaire. Analysis of this questionnaire can generate a personalised scoring system that reflects preferences, ranks options and informs choices.

The benefits of a patient preference value framework are manifold. Fundamentally, patients' individual preferences will be accurately reflected and inform treatment choice. Secondly, with basic needs be covered by the payer framework, society will not have to pay much to satisfy individual preferences. Importantly, innovation will be rewarded; all FDA-approved treatments will have a place in the market, even if they fail to meet standard CEA evaluation. Manufacturers who fail to meet CEA evaluation are directly subject to market competition, meaning 'willingness-to-pay' is decided by the actual consumer. Ultimately, market forces will determine the 'right' price for a drug.

Current value framework proposals are a positive step towards achieving equitable and effective healthcare in the US. However, to progress we must move away from one-size-fits-all models and develop value frameworks that respond to individual patient preferences.

Article by
Claire Gillis

CEO of WG US

17th June 2016

From: Sales

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