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Defining value: has anyone asked the patient?

The real-world challenges patients face give them unique views on ‘value’
Defining value: has anyone asked the patient?

ASCO has again opened up the Pandora's Box of high-cost medicines. The congress, which focuses on clinical oncology, also provides a barometer for the access challenges expensive treatments face across all therapy areas.

ASCO 2016, entitled Collective Wisdom, explored the 'future of patient-centred care and research'. How ironic. Because at present, while the 'collective wisdom' is that a single value framework could solve the ills of oncology pricing, the frameworks being proposed exclude the patient from the value discussion. That cannot be right.

Value frameworks
In April, the Journal of Clinical Oncology (JCO) evaluated the value frameworks being proposed in the US and concluded that a single framework is the best way forward. ASCO 2016 reinforced that view. However, current proposals are neither possible nor workable.

The ASCO framework, like those recommended by the European Society for Medical Oncology and the National Comprehensive Cancer Network, attempts to give US citizens equitable access to high-quality care at the lowest cost. However, in limiting evaluation to a narrow focus on clinical benefit, safety and cost, it fails to capture the most valuable perspective of all: the patient's.

Clinical oncologists are inherently objective. It's a major strength. However, such objectivity means they can never truly empathise with the real-world challenges cancer patients face. Patients have different definitions of value that fluctuate as their disease progresses. If future frameworks are to be effective, we must find a way of adding these perspectives to the value discussion, rather than pursuing one-size-fits-all frameworks based on objective measures.

The value of life is a personal viewpoint; we each have our own value systems that reflect life experiences and socioeconomic circumstances. Yet current proposals make no provision for patient preference - they're purely based on efficacy, toxicity and cost. Moreover, they advocate single solutions that cannot flex to suit individual needs. Fundamentally, a single framework cannot meet the needs of an entire society. Moreover, any system that deprives patients of their right to choice goes against principles enshrined in the US declaration: life, liberty and the pursuit of happiness.

Current proposals make no provision for patient preference - they're purely based on efficacy, toxicity and cost

Cost vs care
JCO's editorial reflects bipolar symptoms within US healthcare. It argues that cost-effectiveness should not impede how medicine is practised, yet it also says the US 'cannot afford to build a large pool of people receiving expensive maintenance treatments'. Its qualifier - 'no-one wants to prevent life-saving therapies reaching the people who need them' - only underlines the challenge.

These issues resonate everywhere. In the EU, manufacturers are being forced to offer dramatic discounts to achieve cost-effectiveness. The UK's new Cancer Drugs Fund means that where cost-effectiveness is not proven, patients may still gain access while a therapy is formally reviewed. Manufacturers have two years to prove value. If they are successful, they will attain secured funding. If they're not, therapies will be dropped from the list.

In the US, evaluation places a disproportionate emphasis on efficacy. Consequently, costs are rocketing. The resultant HTA systems, like those in Europe, have created a beautified version of rationing medical resources. Patient choices are limited.

Patient preference
The solution? US healthcare should be able to provide a basic framework for payer coverage, based on the WHO's recommended threshold. This could be supported by a flexible value framework to inform individual patient choices. Treatments that meet agreed criteria would be covered by insurance as a legal requirement, while drugs that do not 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 cost, risks and benefits can be given to patients through HCP interaction and followed up with a patient questionnaire. Analysis of this can generate a personalised scoring system that reflects preferences, ranks options and informs choices.

The benefits would be significant. Primarily, patients' individual preferences would be accurately reflected and would inform treatment choice. Secondly, with basic needs covered by the payer framework, society wouldn't have to pay much to satisfy individual preferences. Importantly, innovation would be rewarded; all FDA-approved treatments would have a place in the market, even if they don't meet standard CEA evaluation. Brands that don't 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.

Current proposals are a positive step towards achieving equitable healthcare. 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

is CEO, WG US

1st August 2016

From: Healthcare

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