Imagine: Your pharmaceutical or medical device has been tested in carefully designed clinical trials and shown to meet required standards of efficacy and safety. It has gained regulatory approval and has gone to market. Now you want to know, does it measure up to its promise when used in the real world? Does it materially improve patient outcomes? Does it outperform alternative therapies? Does it achieve these outcomes at an appropriate value? Do you know which patients are most likely to benefit from it? Can you prove it, with statistical rigor?
As the health care system moves toward a patient-centric, value-based approach, questions such as these are getting heightened scrutiny from all angles from regulators, payers, providers and patients. And they should. Real-world evidence (RWE) can provide new insight into the benefits, risks and cost effectiveness of medicines and medical devices in actual use evidence that can enable life sciences companies to develop better therapies, prove the value and differentiate the brand in the market.
RWE lets investigators see how medicines perform without their training wheels on how doctors use them in the frantic setting of primary-care offices, and how patients use them when they are not screened for age, weight, education levels and willingness to comply with instructions.
Several factors have aligned to make RWE imperative and practical. The steep rise in the cost of drugs, pitted against finite health-care budgets, keeps payers tossing and turning nightly. New medicines some for life-threatening diseases cost tens of thou- sands of dollars a month. Many of these medicines prolong lives, but in many cases, the data from conventional trials are ambiguous, and it is hard to determine if the medicines are providing real value relative to their stratospheric costs.
You could knock heads with insurance companies trying to oppose their coverage limits for such treatments, or you could partner with them to determine exactly which patients will benefit and make a compelling case. Prove the value, and youre in. The most successful life sciences companies will be the ones that can convince their customers patients, health care professionals, government authorities and health plans that new treatments are the most effective and provide true value compared with alternatives. Using medical treatments more effectively could save hundreds of billions of dollars a year by some estimates. Providers and payers will take notice.