The new gold standard in healthcare

© Shutterstock
© Shutterstock

In the past 50 years, the planet’s population has doubled, survival rate has been augmented by 40% and these numbers do not cease to increase, mainly due to the continuous innovations brought by pharma industry but, at what cost?


Healthcare expenditures have increased exponentially with life expectancy reaching, nowadays, percentages of gross domestic product (GDP) hard to sustain in most countries. The high costs of a better and longer life come as a real hurdle especially in the current economic context.


Facing the struggle of facilitating patients’ access to treatments at a sustainable price, governments found themselves in a position that gave them no other choice but to become more selective when it comes to reimbursing medicines. Consequently, pharma industry needs to adapt its business model to the new constrains in order to not only recover their investments but continue to provide more performant solutions.


As the sole evidence of treatment effectiveness is not enough, disease is no more a problem per se as the quality of a patient’s life under the treatment is. In other words, randomized clinical trials (RCT) are not sufficient anymore to prove that a drug is worthwhile. Stakeholders are looking for more. They are not satisfied with results provided by pre-selected, pre-screened samples that actually exclude patients with comorbidities, whom will in the end represent the majority of those using the new drug. Therefore, Health Technology Assessment (HTA) puts under a question mark the applicability of RCT outcomes at a large scale, in the real world.


There is however a complement to RCT, able to wave away the uncertainty amongst payers and stakeholders, a complement that might, just as well, become the new ‘gold standard’ of healthcare: Real World Evidence (RWE).


RWE can be outsourced from hospital databases, medical records, product registries, and can offer a large palette of information from prescribed treatment to certain patient typology, reasons for drug switch, treatment response and side-effects, undergone hospital procedures, type of physicians involved, even behavioral data and their repercussions on outcomes and costs. Needless to say, that the complexity and the holistic approach, implied by RWE, have started to seduce doctors. A study, conducted worldwide by Ipsos in 2013, revealed that RWE on drug safety and performance was considered by 87% of oncologists most of the time or always when prescribing a treatment. The same study also confirms the increasing importance accorded to life quality improvement, an aspect prioritized by 94% of oncologists and seconded by affordability and product cost (65% of oncologists).


However, REW is still immature and often insufficient for pricing and market access purpose as not all sources are accessible at any given time, not all information is complete, governance models vary across countries and it requires a solid methodology to centralize, analyze and transform data into actionable insights. Current alternatives are represented by “syndicated patient records’ studies” that are able to generate really complex evidence about patient flow, drivers and barriers of certain treatment decisions, the impact in terms of treatment outcomes and costs for both the patient and the healthcare system. Another solution, proposed by IMS Consulting Group, to meet the increasing need for RWE would be partnering up with payers. Such partnerships can provide a better understanding of unsatisfied needs within a disease area and implied market access limitation, as well as contribute to development of drugs both clinically and economically viable and even establish market leadership.


Nonetheless, efforts are being made to facilitate tapping into the real potential of RWE by digitalizing healthcare information: medical records are started to be computer registered; new electronic tools for collecting, centralizing and analyzing data are being developed; full operational access that allows variable modeling and generates pertinent data, at an affordable cost and time, is seeked to be obtained.


Considering all the above, as the evolution trend of nowadays healthcare sector is more clearly depicted, RWE becomes the new “healthcare currency”. Consequently, pharma industry is in full process of business remodeling with great emphasis not only on revolutionary R&D but also on the importance of RWE use and HTA collaboration in early stages of a product’s life for successful market access.