Pharma Digital IQ Study

The pharmaceutical industry is disconnected regarding digital marketing to physicians. The industry spends an estimated $27 billion marketing to doctors and other healthcare professionals
(HCPs).1 However, while physician time spent on the internet for clinical practice has quadrupled since 2002, less than one percent of HCP marketing spend is allocated to digital channels.2
The explosion in clinical use of smartphones and other portable devices has led to even greater imbalance. Even as doctors increasingly turn to digital, the majority of pharma dollars continue to flow to the industry’s increasingly constrained and extraordinarily expensive sales forces.

Digital IQ = Shareholder Value
Our thesis is that digital competence is inextricably linked to
shareholder value in the pharmaceutical industry. Key to managing
and developing a competence is an actionable metric.
This study attempts to quantify the digital competence of 70
U.S. pharmaceutical brands across ten disease states and their
efforts in using digital platfoms to reach HCPs. Our aim is to
provide a robust tool to diagnose digital strengths and weaknesses
and help brands achieve greater return on incremental
investment.
Like the medium we are assessing, our methodology is dynamic,
and we hope you will reach out to us with comments that improve
our approach, investigation, and findings.

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The Consumerization of Healthcare

HealthConsumersOnline_InfographiThe systemic change in US healthcare delivery has been called many things, but they all refer to one thing: the future of healthcare will be in the hands of the consumers. Today, consumers are better able to make choices about their healthcare needs, because the majority of medical information formerly held by a select group of people is now available to anyone with internet access. People can research conditions, symptoms, treatment options, and best practice information before even calling a doctor. This enables patients to take an active rather than traditionally passive role in their personal healthcare.

As the roles continue to change, the future consumer-driven healthcare system will most likely see drastic changes in three main areas:

Outcomes

In a new dynamic of healthcare, the patient visit will increasingly be outcome-based. The traditional fee-for-service model incentivizes activity rather than outcome, which means that patient results are low priority. In order to improve outcomes in healthcare, the way doctors communicate with their patients needs to change. Studies consistently find that health outcomes improve when patients better understand their physician and are a part of the treatment/management process.

A systematic review of patient communication interventions in clinical trials revealed that principal outcomes (effects of the intervention on the process of the consultation) favored the intervention groups in 74% of cases, and positive health outcomes (a positive effect on any health outcome) were found in 80% of cases, significantly so in 44%. (Griffin et al. 2004).

Technology

The healthcare system will become increasingly reliant on technology to improve outcomes and cut costs while increasing coverage. The US government fully supports the move to technology-driven healthcare, and is subsidizing hospitals that make the switch to electronic health records (EHRs) for Medicare/Medicaid patients, while penalizing those who do not, beginning in 2015.

The growth of mobile health in the past few years has been exponential.  Manhattan Research found that 62% of US physicians own a tablet in 2012, up from 31% in 2011, and 50% of tablet owning physicians have used their device at the point of care. Meanwhile, 90% of patients want to self-manage their healthcare leveraging technology (Accenture, 2012). As the goals and actions of the physician and patient align, technology can play a much greater role in reaching those goals.

Cost 

Managed care reimbursement cuts are creating more industry competition for the patient’s dollar, which means physicians will have to start competing for those dollars. Up until now, the clinic visit hasn’t been based on much choice beyond location. Insurance dictates which doctors you can see, and whether the doctors are any good or priced fairly has been a total black box. All trends indicate that the current system will become a relic of the past. If patients are able to make a decision based off more than just insurance acceptance, they will likely choose the best doctor with the fairest price. Increasing demand for better price and quality can significantly improve the supply of hospitals and physicians who meet these criteria.

The consumerization of healthcare is just that – the consumers taking an active role in how healthcare delivery benefits them. The gears are shifting, and it is up to consumers to influence where they shift to.

The Future of Pharma Marketing is Mobile, Unless…: …FDA’s “Enforcement Discretion” Remains Unclear

The Future of Pharma Marketing is Mobile, Unless…
…FDA’s “Enforcement Discretion” Remains Unclear
By John Mack

You don’t need a crystal ball to know that the future of media is mobile.

A recent story in the Wall Street Journal recounted how a Comcast cable customer wanted to jettison TV service and keep just the Internet connection plus phone. Presumably such people prefer to get their TV via their smartphones.

This is the future — where we will access all our media through our smartphones and mobile tablets. Unfortunately, companies like Comcast are trying to thwart this natural progression by bundling services and charging extra for unbundling. In the case cited in the WSJ, the consumer would pay $20 extra a month if she just wanted Internet without the TV.

“We live in a world where one of the most pervasive and fastest growing channels by which we consume health content is mobile,” said Mark Bard, co-founder of the Digital Health Coalition (DHC). “Pharma has to get to a world where we see branded drug ads on these mobile devices that have become part of our lives.” Bard made these comments during a Pharma Marketing Talk LIVE podcast where he discussed some of the key findings of the DHC 2012 Executive Landscape Study (listen to the podcast here).

While pharmaceutical companies may not yet be advertising on mobile devices as they do on TV, websites, and magazines, they are developing health “apps” that run on Droid smartphones, iPhones and iPads. According to a recent presentation by the FDA to the Regulatory Affairs Professional Society there are now 17,828 health and fitness apps and 14,558 medical apps (see The FDA and Medical Apps: Where Are We?).

All this has tremendous implications for the pharmaceutical industry. which is trying not to be caught flatfooted when it comes to mobile marketing. Unfortunately, a majority of respondents to the DHC survey feels that the pharma industry lags behind other industries as far as having a mobile strategy is concerned (see figure below).

FDA’s Looming Regulation of “Mobile Medical Apps”
One of the factors that may be holding back pharma in its pursuit of a mobile strategy is the “loomimg” sepecter of FDA regulations. The agency issued draft guidelines on July 21, 2011 (see here). It accepted public comments through October 19, 2011 and has of yet not issued final guidance.

PhRMA, the drug industry trade group, cited (here) a Washington Times op-ed piece that suggested the FDA guidance will require apps such as medication prescription renewal reminders and blood glucose level tracking functions to be regulated as medical devices. In a report, Deloitte said: “Given the additional monetary costs and time associated with designing implementing and maintaining an FDA-compliant quality system, regulating these applications could undermine the advancement of the technology, and thus, limit the benefit to the public” (see “Regulatory implications of mobile applications in the life science industry“).

Recently, I debated this issue as part of a pharmaHOTSPOT topic: “Should Pharma reconsider its mobile application approach with FDA guidance looming?” My point of view is that the pharmaceutical industry has to police itself with regard to development of medical apps regardless of what the FDA does (view video below).

A “counterpoint” was offered by Dr. Chetan Vijayvergia, PhD, Director of Medical Strategy, Ignite Health. Dr. Vijayvergia’s point was “The apps that are currently being created in the Pharma space don’t have a predicate in the FDA database. Pharma needs to reconsider the mobile approach to actively help the FDA shape industry guidance” (see here).

Vijayvergia contends that the current FDA draft guidance for MMAs “casts a very wide net” and if pharma app developers are not careful, their apps can get “dinged as an MMA [mobile medical application]” and be subject to regulation as a medical device.

What Is and Is Not an “MMA”?
The fear that FDA is casting too “wide a net” over health apps is a major concern. It is important, therefore, to understand the FDA’s perspective on what is and what is not an MMA.

FDA has co-opted the term “mobile medical app” to refer to health apps requiring regulation as medical devices. Unfortunately, this confuses the discussion, which up until now used MMA to describe any health-related app that a physician or patient might use. This may be why PhRMA and other drug industry spokespeople are so fearful of FDA regulations hampering innovation within the “mobile health app” arena (see, for example, “Mobile Regulatory Fears“).

In an attempt to clarify what is and what is not an MMA, FDA uses a schematic “Mobile medical apps Proposed Scope for Oversight” pyramid divided into three parts:

DrugWonk Peter Pitts summarized FDA’s description of these parts of the pyramid (here) :

  1. The top of the pyramid includes mobile medical apps that are traditional medical devices or a part or an extension of a traditional medical device. Clearly within the scope of being regulated as medical devices.
  2. The middle section includes patient self-management apps and simple tracking or trending apps not intended for treating/adjusting medication. This is the area, as defined by CDRH, for enforcement discretion
  3. The bottom section are devices that are not deemed “mobile medical apps” and, as such, have no regulatory requirements.

As always with FDA regulation, there’s a substantial gray area devoted to “Enforcement Discretion.” This is why experts such as Dr. Vijayvergia suggest that pharma “help the FDA shape industry guidance” to narrow the discretionary gray area. The following are some comments submitted to the FDA that addresses the industry’s general concerns about FDA’s intentions and specifically about which types of health apps the FDA should and should not regulate. You can access all the comments on the regulations.gov site here.

Risk of “Squashing” the Startup Mobile Medical Industry
A few commentators, including Qualcomm, a wireless technology company, expressed fear that FDA regulations might have a negative impact on the nascent mobile app industry and innovation. “Many apps are developed by garage entrepreneurs,” said Qualcomm, “including individual doctors or clinicians, that work from their home.” Qualcomm estimates that nearly two-thirds of “all mobile apps” are developed by individuals (30%) or small companies (34%). An anonymous commentator put it this way: “The FDA risks squashing the startup mobile medical industry if they require full investigative study for each mobile application.”
The Focus Should Be Solely on Apps that Involve Significant Risk to Patients
Another recurring theme in comments submitted to the FDA was that final guidance should be narrowly-tailored to focus solely on those intended uses that involve significant risk to patients. Roche Diagnostics commented that “in determining classification of software that provides clinical decision support functionality, FDA should consider the extent of control, level of risk associated with a wrong decision, and the degree to which the software drives the decision… If the risk associated with a wrong decision is high,” said Roche, “and the level of control the software has over that decision is high, then the software would be considered high risk.”

“Who is the judge?”, asked Michael Kremliovsky, Chief Software Architect at Hospira, on the Digital Health LinkedIn discussion group. “FDA favors approach based on risk analysis and mitigation. This approach sounds like very reasonable with one caveat: who is the judge? It is always a convenient position that allows Agency to declare that a risk is underestimated.”

Whatever! Generally, the Coalition for 21st Century Medicine — which includes “some of the world’s most innovative diagnostic technology companies, clinical laboratories, venture capital companies, and patient groups” — said that the “focus of oversight for software that support medical devices, mobile or not, should be based upon the manufacturer’s intended use of the product.”

Who’s Responsible for Recalls?
The FDA draft guidance states that “mobile medical app manufacturers are required to report to FDA any corrections made to a mobile medical app to reduce a risk to health posed by the mobile medical app.” Roche, however, requested more guidance on working with Applications distributors [e.g., the Apple iTunes/App Store] regardig recalls. “We appreciate FDA’s concern regarding distributor cooperation in recalls,” said Roche. “Roche believes, as a practical matter, that this will be very difficult to enforce unless FDA holds distributors accountable… Applications distributors have standard terms and conditions in on-line form agreements that a designer acknowledges to access the development platform. These usually are not open to negotiation.”
Depends on What FDA Means by “Health and Wellness”
“The term ‘Health and Wellness’,” said the Coalition for 21st Century Medicine, “lacks clarity and may be too limiting. Patient accessible tools, mobile apps, and websites that exist to help guide patients to ask appropriate questions to their physician, encourage them to see a physician, describe various treatment options, or identify potentially appropriate clinical trials are important patient education tools and support patient-centered health care. Because these applications often include patient-specific inputs, it is critical that FDA clarify that they should not be considered FDA regulated devices/medical applications.”
Mobile Apps Based on Websites
According to Novo Nordisk, “the guidance does not address websites that provide applications that are the same as or similar to some mobile apps. We recommend that the Agency consider situations where a mobile app has been developed that directly parallels materials on a website (e.g. identical diagnostic information, interactive algorithms, calculator for standard parameters) and state if the mobile app and website require FDA approval. Should the mobile app and website be submitted simultaneously for premarket clearance to FDA?”
Clarify the Scope of FDA’s “Enforcement Discretion”
Merck believes that the FDA should take following actions to “clarify the scope of its enforcement discretion: (1) provide more specific categories and examples of apps for which it intends to exercise enforcement discretion; (2) specify the factors and/or guiding principles it plans to consider in determining whether certain apps qualify for enforcement discretion; and (3) clarify the circumstances under which it may choose not to exercise enforcement discretion with respect to these apps.” For example, enforcement discretion is appropriate for health and wellness apps that allow patients to log, track, and graph specific health goals and provide patients reminders or alarms based on generally accepted and established medical standards or parameters. In addition, Merck suggests that “drug dose calculator apps that use an algorithm to automate dosing rules based on the approved labeling for a specific drug are subject to enforcement discretion. Merck believes that enforcement discretion is appropriate for such apps. To the extent that FDA’s statements elsewhere in the guidance create uncertainty regarding the regulatory status of such products, we encourage FDA to clarify this point.

Interactive Healthcare Marketing Needs To Get Innovative

Interactive Healthcare Marketing Needs To Get Innovative

Posted by Darika Ahrens on August 22, 20

A few years ago, a barrister told me a story about an open-and-shut court case involving a burglar caught red-handed by police as he was carrying a television through the window of a house he’d just broken into. After the evidence had been presented, the jury made a request – would the prosecution present the forensic evidence they’d taken from the scene tying the burglar to the crime? “It’s the CSI effect,” the barrister lamented. You see, the general populace has watched a lot of crime shows on TV and now think they’re experts in how and when legal evidence should be gathered and presented.

When it comes to health and well-being, there’s something even bigger than a top-rated TV show influencing consumers – the Google effect. We all turn to the Web at the first sign of a cough and are happily diagnosing or researching our ailments daily. There’s even a word for people who diagnose themselves mistakenly from the Web: “cyberchondriacs.”

As the classic connected “Gen Xer,” I’m constantly Googling symptoms and cures when I’m unwell. So despite my previously limited knowledge of marketing healthcare, I sought to answer these questions: Just how big is the digital opportunity for healthcare brands, and what are brands doing to take advantage?

The research showed what you’d expect. Opportunity = huge, execution = limited. Healthcare brands across pharma, medical devices, over-the-counter (OTC), and consumer health are spending conservatively (compared to both offline marketing and other industry sectors, such as financial services). We also picked up that there was a frustration in the lack of innovation taking place.

What do I mean by innovation? It’s not about jumping on the latest social media platform (*cough* Pinterest *cough*) but, as one interactive health marketer I spoke to described it, innovation is really about relevancy – understanding customers and servicing them in ways that suit them. For today’s customer, more and more, that means that customers need to be serviced with smart use of digital technologies and marketing practices.

One outstanding example we use in the report is a brand re-evaluating its classic search campaign. Product promotion was mapped to the wrong patient life-cycle phase. The brand was buying search ads and optimizing content educating customers on the illness. Evaluating customer behavior showed that consumers already relied on high-quality free information available online that the brand was wasting spend on competing with. What the consumer really needed to convert to a customer was to be able to locate a retailer easily while out and about on a mobile phone. The brand optimized mobile search to drive sales and saw a much better ROI.

As more customers, both consumer and professional, turn to the Web for health products and services, it makes sense that this is where brands in this space must follow.

What’s stopping them? Yeah, regulations for pharma/medical/OTC can be a barrier, but as one leading agency told us, “There’s almost nothing that pharma and healthcare can’t do; there’s just additional considerations and planning.” 

My new report, “Innovate Interactive Healthcare Marketing Without Rocking The Boat,” addresses interactive healthcare marketing in four ways;

  1. Provides research into the digital opportunity for health and wellness and some benchmarks on customer behavior and industry spend
  2. Clearly pinpoints the barriers (beyond the obvious) so that organizations can look at where and how they need to problem solve
  3. Recommends the three values healthcare needs to adopt today to activate innovation within their organization’s interactive marketing
  4. Provides a process and planning framework that digital marketers in this industry can use to develop their campaign strategies (we’ve even made this a downloadable planning matrix for you to use or adapt)

As always, a lot of the credit goes to those already innovating in the healthcare industry today who were willing to share their thoughts, learnings, ideas, and experiences. A big thank-you to those who contributed to the report: Across Health, British Medical Association, Cambridge BioMarketing, Digitas Health, Edelman Digital Health, GSW, Novartis, and Philips Healthcare.