Why the Life Science and Pharmaceutical industries won’t survive without real-world evidence

How does a disease impact on a patient's life and who are the people most qualified to answer this question?

More and more healthcare users are living with chronic conditions. Healthcare professionals can diagnose, explain and prescribe, but only patients can know what it is like to live with their condition day to day. Many people managing long-term health problems are experts about their condition - they should be treated as such.

To achieve strategic advantage in this tightly regulated industry, health organisations must harness this expertise. In doing so, the life sciences and pharmaceutical industry will not only ensure that it meets the right challenges –according to buyers and patients – but will also achieve an accurate evaluation of its own offering within the market. In the UK, cost-effectiveness is determined by NICE, but government regulatory efforts are often put under pressure through media and public scrutiny – cancer treatments and anti-dementia drugs are two examples.

Continual monitoring of real-world patient outcomes evidences real-world value and efficacy of devices and treatments to both NICE and to the public. If industry is not asking every patient about how their treatments are affecting their lives day to day, it is not responding to this need.

In 2016 GSK used real-world evidence in the Salford Lung Study, which was the first trial of its kind to apply rigorous clinical trial methodologies in a real-world setting.
The tightly controlled conditions of a randomised controlled trial (RCT) are of course vital to verify the science, but understanding how a patient uses a treatment in the real world and its impact on their specific disease is the only way to show the actual value of that drug or treatment in the context of a complex public healthcare system.

“We are moving into a period when health data will be seen as the next revolution in healthcare.”
Mike Thompson, CEO of the Association of the British Pharmaceutical Industry

Through the trial, GSK evidenced that their inhalers were easier for patients to use and thus provided a more cost-effective treatment in the long term by increasing adherence and treatment effect. Patients with better asthma control will present to A&E less (if ever) and suffer fewer complications from their condition.This is industry adding value in different parts of the treatment pathway; highlighting how collaboration leads to insight, leads to strategy, leads to better outcomes for all stakeholders.

Value can no longer be associated with price alone but must instead be identified as opportunities to deliver better healthcare throughout the entire system. With twice then umber of companies competing for the same buyers, evidencing real-world efficacy, outcomes and value is vital for any healthcare organisation to survive what Mckinsey calls the ‘fragmentation’ of the market.

Viewing patients as partners throughout the product life cycle provides vital understanding and strategic insight. Tactical planning must now necessarily be patient-centric if larger organisations are to innovate and survive against the smaller, more agile biotechs. Buyers and clinicians, of course, remain important stakeholders, but ignoring real-world patient experience and outcomes will result in missing out on the key evidence that demonstrates efficacy and value which public health care systems increasingly demand.

Patients can have a vital role in co-creation along the entire development pathway for new devices and treatments - from the design and scope of clinical trials and patient support programmes (PSPs), to providing insights on competitors, to evidencing real-world value against generic treatments or devices.Furthermore, seeking to understand every patient’s experience and outcome not only ensures that buyers gain maximum value and therapies meet the patient’s needs, but also builds mutual trust between industry and the people who suffer from the healthcare problems they treat.

Prevention and management of disease is now as important for life sciences as producing new pills, devices and systems. Mike Thompson, CEO of the Association of the BritishPharmaceutical industry recently stated in the Financial Times that “we are moving into a period when health data will be seen as the next revolution in healthcare.”

It is this data which must be used to direct and inform strategy and to demonstrate the value of any new intervention -to patients, payers, clinicians and regulators.

In an increasingly highly-regulated and budget-restricted market, slick sales packs and a big name alone will no-longer deliver the margins. Real-world value must be demonstrated, and monitoring real-world evidence is vital to do this.