Slideshow Real World Evidence: 10 Benefits for Providers, Payers and Pharma

  • May 18 2015, 11:10pm EDT
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Real World Evidence: 10 Benefits for Providers, Payers and Pharma

Real-world evidence (RWE) is the medical equivalent of big data. It makes use of very large data sets to determine how new drugs perform beyond the scope of clinical trials.

Using electronic medical records (EMRs), administrative claims data and other data sources, pharmaceutical companies, healthcare providers and payers can determine the effectiveness, safety and cost benefit of a medicine by tapping the records of tens of thousands of patients.

Here we present 10 important benefits of combining real-world data with big data analytics.

1.tDetermine outcomes based on much larger data samples

As opposed to the much smaller and narrower range of patients who typically participate in traditional clinical trials, RWE makes use of the medical data gleaned from tens of thousands of patients in real time. In addition to claims files, electronic medical and electronic health records as well as pharmacy data, data sources can be as varied as doctors’ notes, patient forums, social media and blogs.

This gives life science companies, medical providers and insurers a vastly larger and more accurate data sample on which to base their conclusions, allowing them to ascertain the effectiveness and ROI of a medication as it’s actually prescribed and used by real doctors and patients in real clinical settings.

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2.tLink data across disparate sources

RWE allows providers, payers and pharma companies to integrate data from multiple sources. This can include clinical data from EMR or EHR records, transactional data from claims files, pharmacy data from various databases and unstructured data from handwritten records and social media sites.

Linking this data can yield new insights—such as discovering that a slightly less effective but much less expensive medicine is more cost effective for a given population. It also increases data reliability—since different sources for the same data can be compared against one another—and consistency. For example, data on the same patient can be reconciled even though it was generated by different systems (e.g. private insurance versus Medicare) and stored in different databases.

3.tSatisfy payer demands for cost-effective medicines

Drugs represent roughly 10 percent of the cost of health care or around $270 billion annually. That has led payers — including private insurers, Medicare, Medicaid and other government programs—to require data that demonstrates the cost-effectiveness of a medicine before agreeing to pay for it.

RWE can convincingly provide that data by conducting comparison studies with previously approved medications. The studies are based on claims data along with clinical data generated at the point of care.

4.tReduce costs and improve the efficiency of clinical trials

Small, narrow data sets and misleading or irrelevant results can reduce the reliability of clinical drug trials, further increasing R&D costs that are already sky-high.

Using RWE, drug researchers can integrate multiple sources of data and simulate trials based on actual patient outcomes. This gives them a much stronger basis on which to decide whether a trial design will yield meaningful results, saving substantial time and money.

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5.tPrevent false starts and accelerate time to market

Along with reducing clinical trial time, RWE can shave significant time off of basic compound research by tying that research to market requirements. By steering potential product development with near real-time feedback on market requirements, life science companies can rapidly zero in on the most promising avenues of research in terms of both scientific and commercial potential. This approach reduces false starts and the development of orphan drugs with limited clinical application.

6.tRespond faster to adverse developments

By collecting post-trial information about a drug in real time, RWE helps researchers and providers to quickly identify side-effects, negative reactions and medication errors, thereby limiting potential harm. The information gathered can also be used to improve recommendations for how best to use the medication—like taking it with food or on an empty stomach.

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7.tIncrease personalization of drug therapy and treatment

By scouring large numbers of patient records and tracking patients over time, RWE makes it practical to identify subsets of patients who can most benefit from a particular medicine due to their genetics, the particulars of their illness, environmental and other factors. Potential side-effects and contraindications can also be identified much more quickly.

This helps pharma companies and healthcare providers decide which members of a given population to target with a particular medicine, and makes it easier for insurers and other payers to justify the cost.

8.tUnearth new indications for existing treatments

RWE greatly enlarges the clinical sample against which data is collected allowing researchers to identify patterns that were obscured by or not in evidence with smaller samples. These patterns can reveal additional indications for medications already in widespread use.

For life science companies this is a huge advantage, since it allows them to leverage previous R&D investments to capture new revenue streams with minimal development costs. A classic example is Botox, which was first approved by the FDA in 1978 as a treatment for strabismus. It wasn’t approved as a treatment for wrinkle smoothing until 2002. If its makers had had access to doctors’ medical notes, media reports, online forums and discussion groups, they could have identified the drug’s more lucrative market much more quickly.

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9.tIdentify new markets and underserved patient populations

Using population data on disease trends and medical outcomes, pharmaceutical makers can gain insights into epidemiological trends, treatment patterns, patient adherence and disease management opportunities. These can be used to identify underserved markets and treatment inefficiencies.

These real-world insights can inform the development of new products and therapies for which there is strong market demand and ready payer acceptance.

10.tWin payer acceptance for expensive new treatments

New drugs can be very expensive, costing a single patient tens of thousands of dollars a month. While many of these medicines prolong lives, it may be difficult using conventional trial data alone to demonstrate that they provide real value relative to their cost.

Using RWE, pharmaceutical companies can work with payers to determine exactly who benefits from these expensive therapies. When the evidence shows that a specific group of patients will receive outsized benefits from a particular medicine, then insurers are willing to cover it.