October 22, 2013
Important changes are occurring in the way pharmaceutical companies test and assign value to their existing drugs and those in the pipeline. With these changes come new challenges for health-care PR practitioners.
The old metrics, which the FDA established and used for half a century to determine whether a drug can come to market, focused on safety and efficacy, as demonstrated in tightly regulated, randomized clinical trials.
But just as an aircraft designer wants assurance that a new wing will operate at 40,000 feet as well as it performs in a wind tunnel, pharma companies and payers are now asking if a drug performs as well in the real world as it does in the closely monitored world of clinical trials.
This new real-world evidence (RWE) standard means that PR and marketing professionals working for health-care companies have to design messages about the old safety and efficacy standards, but they also need to consider how to build relationships with physicians, insurance company executives and consumers about this new approach. It requires a new way of speaking about economic outcomes, data mining and population studies.
Navigating this new world may mean the difference between a successful medicine and one that is as difficult to swallow as a horse pill.
“Real-world evidence isn’t a business strategy in and of itself; rather, it is part of the proof a pharmaceutical company gathers to demonstrate that it is meeting the needs of the new realities of health care,” says Caroline Stern, managing director of Insocius, a global strategic communications firm based in the United Kingdom. “As payers — whether private insurance companies, governments or individuals — become increasingly price sensitive, companies have to recalibrate their messages. Real-world evidence is one of the areas health-care companies are increasingly investing in to do this.”
RWE is the medical equivalent of Big Data — the use of massive data sets to see how medicines perform outside the tightly corseted world of clinical trials. While clinical trials traditionally restrict participation to select patients, RWE looks at massive blocks of information from patients of every hue and stripe.
Using electronic medical records, administrative claims data and other sources, pharmaceutical companies, insurance companies and other interested parties can look at the effectiveness, safety and cost benefit of a drug by using the records of tens of thousands of patients as opposed to a handful of people. 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 thousands 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.
Payers — such as insurance companies, Medicare and Medicaid in the United States, and government-run agencies in European countries — are applying the brakes to runaway costs by requiring data that show the drugs actually make a difference before green-lighting new, expensive treatments. While drugs are responsible for only about 10 percent of the cost of health care, even this modest fraction means we are paying some $270 billon annually.
Smart pharmaceutical companies are realizing that rather than opposing limits on what payers will cover, a better strategy is to partner with payers to determine exactly who benefits from pricey therapies. If evidence shows that a specific subset of patients are prime candidates for a medicine, then insurance companies and other payers should be eager to cover payment for it. Instead of the drug company struggling to compete for a large share of the pie, it may be happy to settle for a smaller portion, but without the marketing costs and payment hassles.
While it would have been impractical to examine outcomes from large patient groups previously, it is now possible, thanks to the development of high-capacity computer programs that scour electronic health records and administrative claims data to determine patterns of drug use and specific medical outcomes.
RWE will help us determine subsets of patients who can most benefit from a medicine, based on their genetics, social factors and disease variations. RWE may help us decide where the most pressing medical needs are and help drug companies pull the plug on drug candidates that are not going to effectively comply with existing therapies. It also means that we can pick up “safety signals” much quicker, thereby alerting companies and the public to the dangerous side effects of certain medicines.
There are important communications issues that companies must address on the inexorable march toward reliance on RWE. These include:
Communicators must keep the following items in mind if they are to establish credibility as part of an RWE team:
Companies are only now formulating their RWE strategies. Internally, you should interview the people who are concerned about this evidence to decide precisely how you can contribute to the team.
RWE may be important to a health-care company evidence strategy, but at its core, it is a mechanism for determining the drug benefits to the public as a whole and for helping payers make wiser decisions. Keeping this broad perspective in mind is crucial as one engages in this new approach.
The payer is an emerging audience for marketing communications. PR and marketing programs focused on these stakeholders cannot simply be bolted onto existing plans. Rather, thoughtful and realistic communications programs attuned to payers’ needs are vital.