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Pharmaceutical Executive Digital Edition - August 2011

As Big Pharma struggles through an endless cycle of market churn, a strategic question is whether the concept of an "emerging market" is a dated one. Many of these markets are no longer 

 with the C-suite placing big bets on them as growth centers against diminished earnings over the next few years from the old mainstay markets of the US, Europe, and Japan. Drawing on insights from a May 31 roundtable with experts from IMS Health, our third-annual survey of the "pharmerging 17" adds some grouch to the gloss, concluding that profitability—the metric that counts—depends on how well companies deploy their portfolio strengths to separate themselves from the pack, drop that HQ comfort-zone mentality, and anticipate a growing list of built-in risks.       

Like any passion play, the potential for big returns depends on the level of engagement, the cost of which is rising. Creating infrastructure, cultivating relationships, preserving a reputation for quality, and building a ground presence by mobilizing a large and conspicuous sales force is not cheap. At the same time, such investments don't mean that local payers—assuming you can identify them—will automatically pony up to pay for expensive brand drugs. The consensus is that "expensive"—in terms of commercial investment, portfolio positioning, and drug pricing—is an increasingly relative concept, dependent on a host of factors unique to each particular country. Making a decision about which emerging markets to enter requires as much of a studied self-examination of company assets and culture as it does an understanding of the market forces at work within a specific country. Going forward, it will take more than just showing up to make money.  

The traditional selling model for US- and European-based companies has been to launch innovative products at a premium price, which can be more or less maintained through the lifecycle of the drug. Following on that model, biologics and specialty drugs targeting orphan diseases—priced at an even higher premium, to make up for smaller patient populations—have been a winning strategy for many companies in mature markets, where healthcare spending is backed by a critical mass of affluence. 

This is not necessarily so in the emerging markets. While India is said to have the world's largest middle class, annual household income for this segment is still only between $5,000 and $22,000, a modest amount in relation to what middle-class patients are able to pay for a typical innovative medicine in the West. In addition, that Indian middle class usually has to pay the full cost of a drug out of pocket, due to the absence of any government safety net. While other governments might pay for innovative treatments, most of the highest growth geographies start at a low base, and favor generics over brand drugs. Big Pharma has had some success in emerging markets by sticking to the brand and muscling out generic competitors, but that window is closing as governments start intervening to curb drug prices and promote the interests of local generics companies. "China is planning to benchmark brand drug prices to the local generic, even if the brands are on the essential drug list," said Marc Benoff, vice president, IMS Consulting Group. Russia and South Africa are two other examples of countries where government has said it will extend healthcare and drug reimbursement to greater swaths of the population, says Benoff, but it's unclear how these initiatives will be financed without significant European-style austerity measures.  

Despite healthy growth forecasts for many of the 17 emerging markets surveyed by IMS, a closer look at the numbers may staunch initial enthusiasm: It's worth noting that market growth and pharma company growth is not the same thing. Spending on innovative brand drugs is expected to decrease across the board, with any gains offset by patent losses. Even though the global pharmaceutical market is predicted to cross the $1 trillion mark in 2015, approximately $400 billion to $430 billion, or 39 percent, will come from the sale of generic drugs. In 2010, generics accounted for just 27 percent of the global drug market.  

To capitalize on the skyrocketing generics spend, top pharmas have dusted off brands with expired patents and rejiggered them for emerging markets, often with the help of local generics players. In India alone, partnerships have been forged between Merck and Sun Pharmaceuticals, AstraZeneca and Torrent Pharmaceuticals, Bayer and Cadila Healthcare, GSK and Dr. Reddy's Laboratories, and Abbott paid $3.7 billion for key parts of Piramal Healthcare last year. But the branded generics game is not without risk; while some patients in emerging markets are willing to pay extra for the prestige (or presumed safety) that comes along with a drug manufactured by a Pfizer or a Merck, the margins necessary to make a deal worthwhile are beginning to face a crunch, as local governments intervene in negotiations or try to scale back reimbursement coverage. 

Latin America, which represented 6 percent of the $856 billion global pharmaceutical industry in 2010, provides an example of the growing pains for pharma. Drug spending in the region is expected to rise by between 11 percent and 14 percent in the next five years, to as much as $82 billion by 2015. Brazil leads Latin America in terms of spending on drugs, and while that spending will increase, brand drugs will take a hit, despite a relatively large original brand market, says Michael Kleinrock, research director, IMS Institute for Healthcare Informatics. "Government policies will have longer-term impact on brand growth over the next five years ... a lot of the growth is essentially going to be volume-driven," he says.   

Indeed, brand drug prices in Latin America have been driven down by the adoption of international price referencing, where the lowest price wins. "Brazil's international price referencing significantly impacts the rest of Latin America," said John Brennick, director, worldwide market access, Janssen Global Services, at a panel at the Drug Information Association's (DIA) annual meeting in June. "Brazil takes the lowest price reference available," based on nine reference countries including Australia, Canada, France, Greece, Italy, New Zealand, Portugal, Spain, and the US or the drug's country of origin, said Brennick. That price can then represent "your product's maximum price for its entire patent life on the market in Latin American countries." Brand growth is also hampered by the fact that 79 percent of drug costs in Brazil are paid for out of pocket; Mexico's out-of-pocket percentage is even higher.  

Some traditionally innovative drug-oriented companies have opted to buy in to Brazil's generics market. Last October, Pfizer bought 40 percent of Teuto, a Brazillian drug company, for $238 million. Sanofi bought Medley, and its portfolio of 189 generic products, for €500 million in 2009, although the deal was held up for a year by antitrust concerns.  

Many of the growing pains present in Latin America hold true for other emerging market countries. Generic drug buy-ins are likely to continue, particularly with the shift in the profile of disease caused by things such as urbanization, diet, smoking, and rising life expectancy. "By 2030, the burden of disease in the emerging markets will look very similar to the burden in terms of chronic conditions in mature markets, "says David Campbell, senior principal, IMS Consulting Group. As the bulk of drug spending moves from acute disease to chronic disease, R&D-driven organizations are increasingly considering a play in branded generics, or pure generics sales. As an illustration of the pricing pressures in Brazil, and the appeal of generic buy-in, consider the following case presented at DIA by Alexandre Schiola, head of regional market access for Latin America at Bayer. Elan and Biogen Idec's Tysabri received regulatory approval in August 2008, and was eligible to be classified as a category 1 drug by the Brazilian Health Ministry. The wholesaler price in August 2008, as well as the accepted international price, was $2,400 per dose. The expected price in Brazil, with taxes and margins, was $3,900. But the price that received approval was $2,219. 

Examples like the one above can be impossibly frustrating. But challenges in pricing and market access have a way of weeding out companies without a stomach for change and innovation. Where some companies see a prohibitive set of circumstances, others see opportunity. In some cases, product process can be the source of innovation.  

"If you don't have a vision of how a drug is going to be reimbursed, you don't really have a drug," said Alberto Grignolo, corporate vice president, Parexel Consulting, at the DIA conference. There are ways to improve a drug's chances of gaining reimbursement, the first of which begins in the developmental stages. According to Raj Long, head of international regulatory, AMAC, GEM, Latin America, at Novartis, the onset of historically Western diseases, such as type 2 diabetes, hypertension, and cancer, demands mass-market access, which in turn generates a demand for affordable and reimbursable healthcare. A key mistake, says Long, is made when comparative effectiveness research (CER) is conducted during the final stages of product approval, in Phase III or later. Long says that the result of late-stage CER reflects a developed market gold standard, which becomes non-comparable in the local context. 

"You can demonstrate superiority, and that's fine, you might get approval, but you won't get reimbursed, because the products you compared aren't available" in a given emerging market, Long tells 

 Additionally, the dose titration target for mature markets may not jibe with emerging market standards, says Long. By commencing CER on dosage, safety, and efficacy during Phase II, sponsors can better identify payer-oriented endpoints, seek and combine payer/regulator/sponsor input, and identify local practices and medical standards, Long says. This helps to create a "local system" value, rather than just claiming marginal improvements in efficacy in terms of global value. 

It's also important to remember that innovative drugs do get reimbursed in some emerging markets, particularly the most innovative therapies. Bayer was able to gain reimbursement on Nexavar, an innovative cancer drug, in Korea, a notoriously difficult reimbursement environment, earlier this year. Compelling evidence relevant to the disease profile for kidney cancer in Korea as well as an aggressive clinician outreach strategy helped do the trick.  

Another way to gain reimbursement favor in emerging markets is to invest in local manufacturing, as the political preferences for homegrown products pile up. Perhaps the most famous call for local production over the last year came from Russian Prime Minister Vladimir Putin, who, according to a report in the 

 said he wanted "90 percent of Russia's vital medicines, and 50 percent of its medical equipment to be domestically produced by 2020." 

 IMS panel agreed that local investment can sometimes help to open reimbursement doors. "There are discussions around setting up bio parks to stimulate new industry [in Russia], says Campbell, but that presents new challenges, since Russia doesn't have established Good Manufacturing Practices (GMP). "A lot of organizations don't want to manufacture in Russia, because you can't export out" without GMP compliance. "Other organizations are making decisions about whether to build manufacturing plants, hedging on the fact that government may mandate local manufacturing to be included on its central drug list for any new national drug insurance scheme that goes forward," says Campbell. But that's a risky bet, since it could turn out that local manufacturing isn't mandated, but instead receives preferential pricing, which could in turn be offset by importation taxes. 

For IMS's tier 1 and 2 markets—China plus Brazil, Russia and India—"making some direct investment, I think, has a real impact," said Benoff. But for the 13 tier 3 markets—which include Argentina, Egypt, Indonesia, Mexico, Pakistan, Poland, Romania, South Africa, Thailand, Turkey, Ukraine, Venezuela, and Vietnam—"the ability to drive local investment is much less significant," since "the tradeoffs aren't as strong."   

One of the crucial aspects of selling in the pharmerging space is the assets in a company's portfolio, and how it changes from market to market. "The opportunity in each of the individual pharmerging markets is very different depending on portfolio," says Campbell, adding that GlaxoSmithKline, and several other companies, have a "very localized portfolio in India versus their global portfolio," a strategy primarily due to the prevalence of out-of-pocket payment from patients. "The opportunity depends on whether you're trying to sell high-priced innovative products ... or branded or unbranded generics."  

Aside from portfolio customizing for specific markets, industry must also prepare itself for some volatility in how countries see this squaring with their own priorities. "Companies are essentially realigning their definitions to match this [emerging markets] basket approach, which mitigates some of the risk," says Kleinrock. "We've seen growth performance swings in China of 10 percent or 12 percent in a single year. Companies are increasingly talking about putting these countries together, to curb variable growth trends. That's helpful in terms of investment return." Nevertheless, marquee growth rates among local players in emerging markets can drum up artificially high performance expectations at headquarters, and some of the multinationals fail to achieve similar growth rates, adds Kleinrock. A long-term perspective and tolerance of the occasional launch failure is the best way that HQ can overcome this trend. It is also important to agree on just where HQ should set benchmarks for progress—measuring performance against local firms is not always the right indicator to chart success.  

Leveraging the portfolio successfully should also recognize rates of disease morbidity and mortality unique to a given market, since disease prevalence can vary dramatically between countries. In Russia, for instance, cardiovascular disease and metabolic disorders represent the most pressing health concerns; in India, infectious diseases are top of mind; and in Brazil, China, and Mexico, neuropsychiatric disorders represent the largest healthcare costs.  

So, how is the C-suite responding to growth opportunities in emerging markets? "Most companies start out with a legacy footprint—countries where the parent organization has been strong in the past—but now the local affiliates are saying, 'Okay, we are beating the competition in Brazil so can we launch in other Portuguese-speaking markets?' Or, 'We're in Asia; are there other markets in Asia that have similar demographics and disease profiles that  we can move into?'" says Campbell.  "Everyone is chasing China," but beyond that, it depends on the company and its management.   

In terms of organization, many companies have elected to combine the emerging markets into a single entity that reports up to the CEO, taking leadership out of the regions, says Benoff. "But a lot of the tier 3 pharmerging countries still stay in the regions, and to me, that's a signal of where efforts are the most focused." In this scenario, "you're seeing the four BRIC countries, plus maybe Turkey or Mexico, getting most of the attention" from top brass, he says. Chris Nickum, vice president, IMS Consulting Group, says companies are still configuring internal reporting structures for the smaller emerging markets. "I think all companies have good intentions of trying to take commercial best practices from around the globe and putting them into use in those markets," says Nickum. "They're still working out accountability for some of the Tier 3 markets: Who makes what decision, in what order, and under what workup for allocating resources?" 

In terms of expertise on the ground, "the local general manager is going to know the most about the market," according to Nickum. "But they may not see everything else the company is doing commercially, around the rest of the world. What we see a lot of times is that the GM is doing one thing, headquarters is doing another, and they don't meet in between." If global multinationals are serious about maintaining a long-term presence in emerging markets, they will need to start incorporating local talent in to the executive ranks. Much like politics, all business is local.  

In summary, for a successful launch in an emerging market, Nickum says organizational alignment is No. 1, followed by a clear value proposition, which may include pharmacoeconomic data and CER, patient assistance programs, and a commitment to diagnostic testing. It is equally important to use the asset provided by a distinct offering through the portfolio to build currency with local stakeholders.  

Big Pharma leadership has demonstrated a desire to learn about new markets, and to do their homework, says Campbell, but they haven't yet shown a "desire to innovate in terms of the commercial model." Nickum says true innovation often requires "new systems and capabilities;" some of these are beginning to get rolled out. "You're starting to see some of the big multinationals roll out global centers of excellence for things such as e-detailing or tele-detailing," he says. 

Long-term success in emerging markets thus requires a unique skill set, one that requires agility and the willingness to adapt to new conditions on the ground. Consider the following levers of influence before executing your strategy in each market:  

 Are you focusing investment primarily on manufacturing, R&D, or promotion? Local government, of course, can drive the decision on all three of these options, but once the decision is made, make sure the investment correlates with stated objectives.  

 The best way to succeed in emerging markets is to understand the core strengths and value proposition your company can bring to the table. Organize your portfolio to meet the demands of each market. 

 Don't assume that physicians are the key to decisions about what drug gets prescribed, or purchased. Patient decisions and reimbursement coverage may function independently. Cultivating government and the state-owned organizations that often surround it is another useful point of introduction to the decision set.  

Understand the information needs of the market.

 Endpoints, comparative effectiveness research, health equity, and observational research typical of mature market drug launching may not align with emerging markets standards. For example, an economic study produced in the US or Europe to demonstrate how use of a drug reduces hospitalization costs may be irrelevant in Russia, where daily hospital charges are sometimes lower than the cost of out-patient treatment with an innovative drug. Build contacts with local academic institutions familiar with health practices and link up with payers as early as possible to establish the threshold for evidence. 

 Success in one market does not guarantee expertise in another. Give local affiliates a seat at the table to avoid blind-siding local expertise when key decisions are being made at HQ. Make sure key business support functions like manufacturing are not "US-centric" or "Euro-centric" but are properly aligned globally and thus can address any special needs in the emerging markets.  

A strong reputation is a major business asset.

 In many emerging markets, Big Pharma brands are associated with quality. Maintaining that association is vital to long-term success. Forging a local identity as a local company by partnering around issues such as quality and prevention is another tool that can counter the growing tendency toward bias in government polices to promote the commercial interests of home-based companies.  

Columns

When it comes to the emerging markets, executing a few key elements of success are more important than ever.

Is the 'Emerging Market' a Dated Concept?

Healthcare professionals have been fighting an endless equivalent to the inspirational Rocky Balboa parable—with the exception that in this epic the ending remains unscripted.  

Getty Images: spxChrome (Foreground  gloves) / Aaron Cobbett (Background Frame)			

A first glance at the current data screen actually suggests that patient adherence is getting worse, not better. New data from the Center for Health Transformation claims the annual cost of patients not taking their medicines as prescribed is nearly $300 billion, with approximately 125,000 patients dying each year due to poor adherence—that's 342 people every day. But the engagement of new stakeholders, tighter focus on wellness and prevention, and the development of better performance metrics to drive internal support for adherence programs could be adding the bulk the healthcare industry needs to finally make it a fair fight. 

"I refer to this as the silent disease in America because of the large amount of non-adherence to medications, routinely in acute care situations but even more specifically in chronic disease," said Dr. Lyle Bootman, Dean and Professor at the University of Arizona School of Pharmacy in a recent adherence teleconference. "Not only is this a clinical problem in terms of [patient] outcomes ... it has serious economic consequences for this country. That $300 billion cost of non-adherence is in the same category and level of severity as heart disease and cancer, which are in the range of $250 billion to $350 billion to manage and diagnose. So, indeed, adherence, when looked upon as a disorder, is a very serious clinical and 

What is the true issue driving non-adherence? Shouldn't patients—especially those with chronic or more severe diseases—

 to take their medication and feel better? Consensus is proving elusive; a variety of excuses exist. Patients start to feel better so they stop taking their scrips as often; they can't handle the unpleasant side effects; the copays are too expensive; or they just forget. 

HealthPrize—an organization that provides pharmaceutical companies and other organizations with online adherence-incentive programs—scoffs at these factors as excuses that mask the true root of the problem. Its blunt and rather frightening conclusion is that medication non-adherence is often intentional. "Upon greater digging, it becomes clear that forgetfulness can also serve as a convenient excuse rather than a true reason," reads HealthPrize's recent white paper, "Medication Non-Adherence: An Ancient Problem in Need of Modern Solutions." "There are many deeper cultural reasons ... such as: taking medication is not a high enough priority; taking medication makes a person feel old; it reminds a person that they have a 'condition' or that they're a 'patient;' they don't trust their doctor; or they just don't like the idea of taking a pill." 

If there's any doubt as to the validity of such a statement, consider the vast number (more than 20 percent according to a study from Harvard Medical School last year) of patients who receive a first-time scrip from their physician and then never even make it to the pharmacy to fill the initial prescription. These patients have made an active decision not to take a medication—despite a recent appointment and discussion with their doctor, whose advice they presumably willingly sought out to manage their condition. 

A survey and white paper—"Patient Adherence: The Next Frontier in Patient Care"—from Paris-based Capgemini Consulting found that "on average, adherence levels drop over the course of the patient journey from 69 percent of patients filling their first prescription to 43 percent continuing their treatment as prescribed after six months." Additionally, the paper says, "It is also estimated that non-adherence results in an average per-drug loss of 36 percent in potential sales for a pharma company." 

DIMENSIONS OF PATIENT ADHERENCE (Source: Capgemini Consulting)			

Patient cost is also a theme, one that remains largely unspoken. A survey conducted in September 2010 by MDLinx and parent company M3 revealed that 95 percent of the nation's oncologists reported a rise in their patients' concerns over treatment costs in the six months prior to the survey. Of the 106 US oncologists surveyed, 84 percent said they had invested more time and effort into the financial planning of patients' treatments than they ever had before. Additionally, 67 percent of those who responded reported that their patients were rationing medications and/or forgoing treatment due to financial and insurance coverage concerns.  

Internal alignment within drug companies that strengthens the case for investing in adherence programs is another challenge; efforts that are disaggregated and fail to show a link between investment and outcome are victim to being seen as just another public relations exercise that makes the programs targets for budget cutters. "Patient adherence initiatives often lack a thorough understanding of the root causes of discontinuing treatment, or fail to engage patients sufficiently and to address the issue holistically," says the Capgemini white paper. "Individual tactics are tried by different brands and then discontinued as budgets and priorities shift, before their impact is known." 

Source: Integrated Benefits Institute (EE = Employees)			

FICO's Health Care Practice division is now taking the same demographics tracking and analytics it has used since 1958 to come up with credit scores and applying those skills towards calculating non-adherence risk.  

- Daria Blackwell, Founder, Knowledge Clinic			

"FICO has, for the past 10 years or so, been providing data-based marketing solutions in the healthcare space," explains Todd Steffes, vice president of healthcare practice at FICO. Over the last few years, Steffes says, FICO's healthcare clients have been more focused on consumer marketing, and on how to better understand patients—including their reasons for non-adherence. "That's where this idea came from," says Steffes. "Could we apply our predictive modeling skill sets and the methodologies around how we do the credit scores toward the pharma space and help answer those kinds of business questions?" 

The process of creating a Medication Adherence Score (MAS) began by partnering with pharmacy benefit manager MedImpact, which has access to claims data for patients across the country. Because the information from MedImpact is strictly demographic, it's all de-identified and HIPAA-compliant. FICO then used that data to determine which mixes of demographics were adhering to their medication in certain therapeutic areas. After a base study of 12 months, FICO can now use that data to predict the likelihood of adherence in other patient groups with similar mixes of demographics. 

"What you're doing is looking at those initial patients—how they actually adhere and actually perform—and then analyzing their attributes and identifying which mix of those attributes is really predictive towards how they performed. That creates a scorecard that allows you to do the same analysis—using just publicly available data—for future patients," explains Steffes. 

The upshot? FICO can then take this predictive data to pharmaceutical marketers, managed care organizations, and eventually physicians—all those who are at crucial points of contact with the patient—to help develop strategies to target the specific patient populations that are least likely to adhere.  

Another novel approach is leveraging the industry's educational mission for professionals to relate directly to the patient experience. With that goal in mind, Daria Blackwell—entrepreneur, 2011 Healthcare Businesswomen's Association (HBA) Star, and 2004 HBA president, recently founded Knowledge Clinic in Ireland. 

Blackwell has been involved with medical marketing and medical communications for most of her career. But it was while working for Roche that Blackwell got the idea of creating some sort of continuing medical education (CME) for patients. "I started developing resources for physicians to help them understand how patients think, because patients coming from different backgrounds all think very differently about Western medicine and what physicians tell them," she explains. "So eventually we arrived at the thought that there really needs to be a separate discipline that helps patients accept the fact that they are responsible for their own health and that they have to partner with their healthcare professionals." 

From there, Knowledge Clinic was born. Currently, Blackwell is in the middle of organizing what she calls a "pilot trial" of medical education via webinars and other learn-from-home options, "where people are recruited—as soon as they are diagnosed with a chronic disease—into an educational program where they will learn at their own pace and pass a couple of simple tests that will acknowledge what they've learned." 

A big part of non-adherence is lack of patient education, says Blackwell. For example, she says, most people who are diagnosed with hypertension are asymptomatic. "And the doctor just tells them, 'Here, take this pill.' Most of the time the patient doesn't realize they're going to be on this for life. Most of the time they don't realize that if they discontinue it, there could be very serious problems. They don't realize that hypertension leads to problems down the line that could include stroke and heart disease." 

Not only do patients not realize the consequences of non-adherence; they also don't place enough value on their medications. "AARP did a survey a few years ago that revealed more people were willing to spend money on cable television than on life-saving drugs," reiterates Blackwell. 

The idea behind Knowledge Clinic, according to Blackwell, is that patients will learn how to manage their own health—including the value of medication adherence—in a way that is easy to understand, personalized, and is cognizant of cultural and religious differences. Additionally, rewards for completing educational workshops at Knowledge Clinic will help keep patients motivated. "Once they've passed a test, patients will get a certificate, which is redeemable for different rewards and products from different partners that will be participating with us who have a stake in the management of that particular health condition," Blackwell says. For example, patients with heart disease might redeem points for free classes at health centers or for workshops to reduce stress levels; asthmatics might redeem their points for products such as air purifiers and allergen-reducing mattress covers. 

Adherence, says Blackwell, is not a responsibility that can rest solely on the shoulders of patients, or on the pharma manufacturers. "It's going to take everybody," she says. "People have been working on compliance and adherence for a long time, and nobody's quite figured all of it out. It makes sense that the more different factions cooperate towards improving adherence, the more successful we will be." 

Like Knowledge Clinic, the people behind HealthPrize recognize the value of cooperation when it comes to putting on the gloves and going up against patient non-adherence. At first glance, the company's website seems a bit too ... 

 ... to be taken seriously as a contender in the adherence fight. But such an approach might be just the motivation patients need. In a world of boring lectures about medications, overbearing reminders to talk to your health professional, and promotional DTC, HealthPrize's simple idea of offering money and rewards for adherence gets right to the point in a way patients can understand. 

"Medication adherence can be viewed in the same light as other 'healthy behaviors' like exercise or healthy eating, where an 'on-again/off-again' pattern is common," says the HealthPrize white paper. "Most adults are educated enough to know that it's a good idea to exercise regularly. And most adults have access to free forms of exercise, like walking. Yet, how many adults still have trouble following through?"  

The concept is simple: Patients find out about the HealthPrize website through their physician or pharmacy, and sign up to play educational games, earning points that are redeemable for physical objects, gift cards to top retailers, and the chance to enter sweepstakes for cash prizes. The idea here is that patients will respond to immediate, short-term satisfaction items such as gift cards, while at the same time learning more about their condition and the importance of taking their medicine as directed. "What we're trying to do is leverage concepts and lessons learned from consumer marketing and behavioral economics ... and make the process engaging and fun for the patients so that they remain on therapy for a longer duration of time," explains John Ruvane, VP of sales and business development for HealthPrize. 

"There is fundamentally a value problem at the heart of the medication adherence crisis," says the white paper, echoing Blackwell's perspective on the subject. "In other words, patients don't take their medication enough because they don't value it enough. High value—or more accurately, high perceived value—is what makes a person remember to brush their teeth every morning (they don't want bad breath at work), or remember to catch their favorite television show every week at the right time (they enjoy it), or pay cash out of pocket for their dog to visit the veterinarian (unconditional love is treasured)." 

To tie in with HealthPrize's goal of teaching patients to value their medication, the company recently announced a partnership with PSKW, a marketing company that focuses on brand loyalty and provides patient copay assistance programs for its pharmaceutical clients. "PSKW has great power in getting physicians to write scrips for branded medications that have a copay card associated with them," says Tom Kottler, CEO of HealthPrize. 

"I believe the physician will intrinsically feel good about providing the prescription with a copay card because they know how important copay is to the patient, so they feel like they're providing something of value to the patient," explains Steve Freeman, chief operating officer of PSKW. Once PSKW provides the copay discount program and the physician prescribes the drug, the patient then opts in to use the discount card. Through the PSKW/HealhtPrize partnership, the next step at the point of contact (either the physician's office or the pharmacy) is for the doctor or pharmacist to make the patient aware of HealthPrize. In theory, PSKW's discounts will get the patient to fill the initial scrip, and driving them to HealthPrize from there will motivate them to stay adherent, filling subsequent scrips regularly. 

Round 4: Center for Business Intelligence

The Center for Business Intelligence (CBI) has long recognized the merits of direct intervention geared to the patient. It holds an annual conference and awards ceremony each April devoted entirely to coming up with innovative ways to tackle the problem. 

The focus at the 2011 conference was on shaping patient behavior, says Christen Smith, program manager at CBI. "The best way to do that is to find the key points of intervention with the patients and train those people who are having the most influence with the patient to institute more practices to improve adherence." 

One of the biggest potential influences, according to the speakers at the conference, is pharmacists. A great deal of emphasis is being put on the pharmacist/patient interaction, she says, "to get the patient to explain more about why they aren't picking up their prescriptions on time, or not at all, or if they're taking them incorrectly." 

Like Blackwell, Smith and others at CBI recognize the value of collaboration when it comes to facing an opponent such as non-adherence. "There was quite a bit of talk at the conference on those different partnerships," she says.  

Going forward, Smith says, changes in the industry—including healthcare reform—will change the way pharma and other stakeholders approach adherence. "With providers being incentivized to improve outcomes and not just continually treat patients [through ACOs, for example], physicians and managed care are going to have a greater stake in adherence. They're not exactly penalized, but they may make less money or get less reimbursed if they don't improve patient outcomes. And one way to really improve those outcomes is through better adherence." 

Also making a new play to drive better patient adherence is the National Consumer's League (NCL). In May, NCL joined with US Surgeon General Dr. Regina M. Benjamin to launch a public education campaign to raise awareness among patients about the consequences of not taking medication as directed.  

The campaign, "Script Your Future," features a website that offers "tools to support patient efforts to adhere to their prescribed medication, including text massage reminders, medication charts and lists to keep track of medications, and fact sheets on common chronic conditions," according to a NCL press release. The campaign is supported by a coalition of close to 100 public and private partners and sponsors, including healthcare professional groups, chronic disease groups, health insurance plans, pharmaceutical companies, consumer groups, and government agencies. 

Script Your Future is focusing on three common chronic conditions: diabetes, cardiovascular (which includes high blood pressure and high cholesterol), and respiratory (which includes asthma and COPD). 

"One way we're approaching this, based on the research that we've done, is that patients don't always understand their condition, and they don't always understand the consequences of not taking their medication," says Rebecca Burkholder, vice president of health policy for the NCL. "We conducted focus groups across the country with patients that had these chronic conditions. And what seemed to be effective for them was focusing on the consequences, on the impact that not taking your medication can have on not just you, but your family. If you don't take your medication as directed, you might not be around for your family—to enjoy moments together or to help take care of them." 

Over the next three years, the campaign will provide materials through partnerships with pharmacies, hospitals, medical offices and clinics, and health insurance plans; host community events and health fairs; and evaluate medication adherence awareness through research.  

Features

Why does the match against medicines compliance always seem to end in an easy knockout?

The Adherence Fight: A TKO?

Innovation is the issue of the moment in Big Pharma, with a fierce debate raging about whether the capacity to "do it" is waning, as companies grow bigger and seek new opportunities around a platform of portfolio diversification. To obtain some answers, 

 Editor-in-Chief William Looney took this question up with the biggest of Big Pharma—Pfizer—in a wide ranging interview with Executive Vice President Kristin Peck, who holds a dual leadership portfolio focused on serving as the company's chief innovation officer as well as business development strategist. Peck outlines what Pfizer is doing to transform the "art of invention" into executable innovations, with new products and services that address the needs of a changing customer base. Her biggest challenge? Convincing both colleagues and the world outside that innovation is not something serendipitous and ad hoc but a deliberate process that is tightly managed, forward-looking, complex, partner-driven—and risky. True innovation poses a challenge to the organization, but it must be embraced without fear, because as traditional commercial boundaries fray, there is no alternative.  

Getty Images: John Foxx (Background image) 			

In addition to coordinating the business development function at Pfizer you are responsible for "innovative business model activities." This latter assignment is not a defined role in most other biopharmaceutical companies, at least at the executive-leadership level. What makes you different?

 I occupy a position that is in some ways unique to the industry. On business development, we have deep roots in all of the Business Units (BUs) and work closely with their management to identify and assess opportunities around acquisitions, divestitures, and licensing, as well as leveraging the equity partnering capabilities of our in-house venture capital operation that is also part of my group. The innovation part is not an add-on but complements business development by creating new pathways in which these partnerships with external players can take root. We try to answer the question: "Where are the new or untapped opportunities for partnering that will put us in that 'blue ocean' position where we are out in front of the competition?"  			

In contrast to the BUs, we look at everything in the context of the entire company—the "Pfizer Inc." perspective, you might call it. But we are not the sole source and outlet for innovation initiatives. Each BU has a mandate to work here as well. Where we lead is in looking at truly disruptive innovation, which we define as substantial "game changers" that carry an impact on the whole company. This big-picture space has become more important as Pfizer has grown through some sizeable acquisitions. The rationale is that a BU might walk away from a disruptive idea because it might not be aligned with its strategy or hurt its quarterly returns. In contrast, our job is to say that is 

 a reason in itself to avoid working on a project. Instead, we try to champion ideas that cross BU lines and could benefit Pfizer Inc. Someone in an organization with more than 100,000 employees has to be thinking about that.  

To do that and maintain trust with the BUs, we must collaborate. I also emphasize that I do not run a "skunk works" or serve as an ivory-towered think tank. We are firmly embedded in all key parts of the business. Much of my day is spent on teams geared to building trust. Trust is the currency of our goodwill account with the business. It's a transaction that has to work both ways.  

Innovation is a very broad term—so broad that it risks becoming a cliché. Why has Pfizer opted to dedicate resources and visibility to this function as a strategic driver in the company's long-term business plan?

 The simple fact is that innovation—involving both products and business processes—is the way companies in our sector compete. Today, innovation, more than price, is the most important source of competitive advantage in the pharmaceutical business. This automatically makes innovation a strategic factor in how we respond to the enormous transition taking place in how medicines are discovered, developed, and marketed around a more diverse customer base. Simply put, innovation is the mindset that allows us to keep pace with market change.  

 Fundamentally, it is the move from a world in which our regulatory-approved medicines were paid for routinely, without question, to one where our customers are insisting that we build therapies around a lower cost structure, are clinically differentiated from existing products, and add significant incremental value to the entire healthcare system. A business model based on the proposition, "You should just pay," is not sustainable for any player in healthcare, public or private. Responding to the revolution in payer expectations is a challenge to any healthcare provider, but it is particularly acute for our industry, because in most health systems medicines are a "siloed" resource, with scant information available on how appropriate use of medicines contribute to cost efficiencies in funding.   

Market change is also creating rich opportunities for companies alert enough to recognize them. One driver of change is the growth of the middle class in emerging countries, which means more discretionary income to meet the significant unmet demand for better healthcare. Innovation in how we relate to this new customer segment is vital, as the old business model focused on the most affluent top tier of patients is only going to deliver diminishing returns.   

In what ways is the Pfizer business model being recast to ensure the company is not left behind by market change?

 Over the years, Pfizer was regarded as the poster child for the blockbuster drug. Our focus was on medicines that served large, undifferentiated blocs of patients, mainly in primary care. We were enormously successful at that approach, in so far as our offerings delivered major public health gains in the struggle against chronic disease. Nevertheless, returns from this strategy have slowed due to the fact that off-patent generic medicines are now the standard of care for many chronic diseases. There is a general trend toward a loss of exclusivity for many of these blockbuster medicines; for Pfizer, the gap in revenue will be particularly acute over the next two years.     

To fix that, our CEO Ian Read has a blueprint geared to preserving and building our "innovative core." It consists of three main elements: improving the cost efficiency of in-house R&D around new medicines that customers will want to pay for; restructuring of our eight Business Units to limit bureaucracy, build accountability, foster a proper balance between risk and reward, and allow for faster, better decisions on the ground; and becoming a better business partner to ensure we can seize the best new external opportunities, ahead of the competition.  

On R&D, we are spending less and outsourcing more, building stronger ongoing relationships with the academic research community, and pursuing new approaches to the conduct of clinical trials. Our pipeline portfolio has been reshaped to emphasize potential-breakthrough, well-differentiated products like crizotinib for non-small-cell lung cancer (NSCLC) that can show real clinical benefit for patients with no alternatives against the current standard of treatment (see 

, July 2011). Overall, the measure of success is in offering a solution relevant to the customer; whether that solution is in the traditional form of a product or a new process or application will depend on how well we can read the market, which is where my group plays a key role. It certainly demands a different approach, one that is sensitive to the desire to show a link to improved outcomes, not only for the individual patient, but for the healthcare system as a whole.  

 Is There a Constituency for In-house Innovation?

Is it possible to retain the high margins Pfizer is used to by adhering to a "total health solutions" approach? Are you not taking on potentially costly responsibilities that go beyond that of simply selling a pill?

There is little future for us in the healthcare system if we only focus on selling a drug like a commodity—health is not just about the kind of medicine you take. The emphasis we place is on being a good partner, and what that means is we have an ongoing obligation to ensure our medicines are safe as prescribed and promote adherence to therapy and ultimately to good health. That proposition justifies our margins—it does not undercut them—because providers will pay a premium for value. It's the partnering that drives new business and brings us together. In that sense, we position ourselves as 

A key driver in innovation is the explosion of health information and data—not only has the breadth and volume of information increased, it is more accessible to outsiders. The challenge is making sense of this abundance and leveraging it to encourage the uptake of the best new medicines. How is Pfizer responding?

Information is the pillar that allows participants in the healthcare system to show how a given treatment improves outcomes. So, building a coherent approach to managing the information flow is one of my most important priorities. Pfizer collects, evaluates, and stores an enormous backlog of data about our products, but equally there is much more information now available to our external stakeholders, including competitors, which can be used and interpreted in different ways. We have claims data from insurers, scrip data from pharmacists, hospital admissions and discharge data, clinical trials data, and adverse event reporting data—but none of this is really captured beyond the different silos they rest in. The challenge is establishing "connectivity"—where information is aggregated and applied to target our development and marketing efforts, [and] delivering more choice to the patient and informing actions throughout the healthcare system. Information alone is not sufficient to provide the integrated solutions we need; it must be transformed into knowledge. Knowledge, in turn, creates the evidence that is the basis for good decision-making. More important, the source of this information must come from a "real-world" rather than hypothetical setting. It's not going to have any practical value to payers unless it is.  

The regulatory community understands this and is insisting on a higher standard of disclosure from our industry, particularly once a new medicine is on the market. But are we ready yet to engage? One of our priorities is that Pfizer has a seat at the table when regulators pose fundamental questions about clinical benefit, access, and cost for a new drug. Getting to the right answer requires the ability to amass a fully integrated data set, rather than bits and pieces. My fear is that no one is operating with that full data set to really know what the right answer is. Practically, it means that insurers only know what the lowest cost should be for reimbursing a new drug; there is no capacity to extend this to how much the healthcare system might save by providing access.  

Pfizer is taking an industry leadership role to increase the "connectivity" around information. My Executive Leadership Team (ELT) colleague and Chief Medical Officer Freda Lewis-Hall sits on the board of the new Patient-Centered Outcomes Research Institute (PCORI), which is a step in the right direction, for Pfizer and the industry. We are also working with Pfizer board members like Dennis Ausiello of Harvard Medical School to explore ways to collaborate with hospitals and other outside players in building that fuller data set. Finally, we are making the point to regulators of the need for flexibility in incorporating real-world observational data in the decision-making process. At present, the industry is barred from promoting its products on the basis of anything other than the standard randomized clinical trials we submit for registration. Insurance companies and other payers are under no such limit, which is why we think it's important to get them to acknowledge that good information must strike a balance between the cost of the drug itself against the total cost of the therapy in managing an episode of disease.  

What is the ultimate objective of the internal effort you are leading to integrate the information flow to deliver more value to the customer? Will you seek to engage other companies around a shared platform? I am frequently told by insurers that they desire cooperative efforts with multiple drug companies rather than just one. 

 Pfizer believes this serious issue requires an equally serious commitment. The objective is to build more connectivity around the separate streams of data that govern behavior of all parts of the healthcare system. That is why we are reaching out to groups and constituencies—not just insurers, but the physicians and pharmacists who prescribe and dispense our products, or the hospital chains that purchase drugs in bulk. We want data that is able to "speak" to a diverse group. This involves agreeing on what kinds of data should be tracked and assessed and then building the technology applications to allow it to be shared. We have a number of promising initiatives around this joint approach, with Keas and Quest Diagnostics, for example, to help us relate more directly to the patient and his or her primary care physician, through new communication tools to help provide for timely information about their condition.  

Are there other examples of where Pfizer is working to accommodate new business models based on a health solutions approach?

As I noted, the manner in which health services are delivered is changing; boundaries are falling fast due to the impact of information technologies and an empowered customer base. To get ahead of these changes, Pfizer is exploring a direct-to-patient marketing strategy that would allow us to provide medicines to patients who need them, with less reliance on the traditional intermediaries. Innovations we are exploring to "operationalize" this goal include ATM-like drug dispensing machines; live, interactive Web portals for targeted patients with chronic disease; and a virtual Internet pharmacy operation that allows men with erectile dysfunction to obtain Viagra without visiting a pharmacy in person.  

We are also looking carefully at how our marketing expertise in the over-the-counter (OTC) business we acquired from Wyeth can be applied to soften the blow from loss of exclusivity. A prime example is seeking OTC or "behind-the-counter" status for our cholesterol-lowering franchise. The idea is, a consumer can go to his pharmacist, get a quick check for blood lipids, and then purchase one of our off-patent statins directly from the pharmacist—no doctor visit or prescription required. We have a number of products where this basic strategy could work, saving healthcare systems a great deal of money. There are real opportunities for this in emerging markets. 

Is it difficult to incorporate a strong commitment to finding and funding innovation in an organization as big and unwieldy as Pfizer?

 It depends on the kind of innovation you are talking about. Making incremental improvements to adjust to payer expectations is actually something that large organizations do quite well because it is ongoing and requires scale. But truly disruptive innovation is hard to accept in any institution, of any size. That kind of innovation poses a direct challenge to the business model—it's a signal blow to the status quo. Seeing it coming often requires you act on the basis of gut instinct rather than facts. Without the standard metrics, it is often harder to move a "game-changing" initiative forward through the organization.  

How do you create a management culture that promotes and encourages in-house innovation?

 Pfizer has a history of leadership in product innovation—it is written in our DNA. The struggle for any large enterprise like Pfizer occurs where innovation is perceived as disruptive, challenging the status quo in some fundamental way. Overcoming that and embracing change requires significant persuasive efforts from top management. This includes laying forth a clear vision of why change is necessary so everyone understands that their future depends on acknowledging it. At Pfizer, we've done that by having CEO Ian Read and all top management reinforce three fundamental truths: company R&D structure and investment flows will not be the same in five years as it is today; the commercial "go-to-market" model will need to adapt to a much more stringent environment, dominated by price-sensitive payers; and that the bottom line depends on furnishing evidence that our products improve clinical outcomes for the patient and support objectives in public health. Ian Read has been deliberately explicit about this.  

The second element is providing employees with the tools that enable them to suggest and then execute a good idea. A good example is the Innovative Communities initiative we launched in cooperation with Microsoft in September 2010 (see sidebar). It allows a colleague to put a proposal together, solicit the support of other colleagues, and create a community—a constituency—to declare, "We think there is an opportunity here." The group then drafts a business plan and is required to obtain the endorsement of a member of the ELT, who becomes the initiative's champion and agrees to fund it. You might see this as a bit process-oriented, and I concede it is. But people forget that innovation requires discipline as well as creativity. A good idea is nothing unless you can execute to produce a result.  

Your experience suggests that an innovation platform must be grounded on the ability for sponsors to build internal coalitions for change that will attract the support of senior management. A program built around the colleague "suggestion box" is doomed to failure.

Yes, this is a critical point. We had an earlier program called 

 that gave colleagues the opportunity to suggest changes in process and pitch ideas, to which others could react to in real time. This did not really work because there was no mechanism for follow-through; it became a bin for the collection of best practices but nothing more. It actually made innovation seem like a diversion from business fundamentals and fostered an impression among many colleagues that the company was not serious about embracing change. It is frustrating to come up with a good idea, invest in the background work, and then discover there is no channel to take it forward. The Innovative Communities project is designed to rectify this imbalance.  

Another criterion for a strong innovation culture is distinguishing between a genuine innovation—the game-changer—and something that is more incremental: what we call "continuous improvement." For example, we might hear from colleagues who want to eliminate unnecessary forms or requirements for approvals. This we would refer to our Six Sigma teams under the rubric of what I call the "just do it" category. Winning support and then implementing a real innovation—one that might pose a painful adjustment for some part of the business—is a far more complex task.   

How do you define success in your role on the Executive Leadership Team? What do you expect to have accomplished in the next two to three years?

 We are all about strategy—defining the themes and building the platforms that bring us to the next stage of growth. In that regard, our first priority is fixing what Ian Read calls our "innovative core." That means finding creative ways to develop first-in-class drugs, tap our existing therapeutic portfolio to address unmet medical needs, and ensure all patients across geographies and incomes obtain access to our products. So we have to innovate around things like cooperation with academia to generate new drugs and complementary technologies like diagnostics; to build new approaches to reimbursement based on an integrated evidence base responsive to demands from payers for more clinical differentiation; and to invent new delivery and distribution systems that inform clinicians and patients and speed access to the patient, at lower cost.  

In addition, we have to strengthen our awareness of how we interact with other parts of the health system, particularly once our medicines are out on the market. In what ways do our medicines shape the patient experience? Is partnering the best way to stay relevant here? Answering these questions well will be the basis for our success, particularly if we can continue to find and execute good deals with other companies.   

Internally, it's a function of keeping our BU leaders and chief science officers happy while not relinquishing the role of advocate for the best interests of the full organization. It's a careful balancing act. And today is a great time to be a leader because change is irrevocable in this industry. It has to be embraced as a positive. Showing fear and sowing pessimism is not a management skill that is going to work in the years ahead.  

A Q&A with Kristin Peck, the drugmaker's Executive Vice President, Worldwide Business Development and Innovation.

Innovation at Pfizer

One of the fears that the Big Pharma trade associations sow among a distracted membership is that without a common front on key issues the industry will end up as a "public utility." But do companies really have to act badly to avoid this outcome? Evidence is mounting that it may happen whatever course PhRMA and its counterparts in the big markets for Europe and Japan choose to take. 

The near term suddenly carries the conditions for a "perfect storm" for the industry. Patent exclusivity losses are already under way. Although pharma pipelines, by many accounts, are headed out of the trough, a major revenue gap is expected to hold for the next two years due to expiries and the slow uptake of new products. Industry has little choice but to embrace major cost-cutting measures, including layoffs, outsourcing, consolidations, and divestitures. 

What industry has not anticipated is a looming deficit and debt crisis of governments in the key mature markets, led by the US, on which the industry uniquely depends. This coincides with the industry's growing reliance on public-sector financing of drug purchases and health care overall. In the US, the government's share of total healthcare spending is facing a dramatic rise: by 2020, 49 percent, or $2.28 trillion, of that spend will come out of Uncle Sam's pocket, up from 45 percent in 2010, according to data just published by the journal 

The key strategic question is where will those additional dollars come from, when the US government's capacity to fund basic entitlements is already in arrears? The issue is compounded by deficit crisises abroad; austerity measures in Europe and elsewhere target drug spending outlays by necessity. Their cost-cutting tool of choice is a dramatic expansion of cross-border reference pricing, which is promoting a global "race to the bottom" as governments vie to be the lowest cost purchaser and force others to follow suit.  

No one doubts the importance of health expenditures in the social context, but then, euros, like dollars, don't grow on trees. Given the magnitude of healthcare spending in countries everywhere, any attempt to bring costs under control prohibits the kind of negotiation by handshake "ring-fencing" that industry has enjoyed in the past. The stakes around the US deficit talks that will linger long after the Aug. 2 deadline for extension of the federal debt ceiling will determine whether the US remains the "world's medicine chest" or ends up joining the ranks of countries that treat the industry as a credit machine that can be tapped when—oops—their global budget ceiling for health doesn't add up. Will physicians finally get hit with scaled-back reimbursement rates from government, a proposal endlessly (and easily) postponed in years past? Will biologic exclusivity periods get shortened from 12 to seven years? Will CMS begin to negotiate drug prices under Part D, or receive newly mandated rebates from pharma on dual eligibles in Medicaid? Will the drug advertising tax deduction, or the tax repatriation holiday, get permanently canceled? With the US's credit—and US politicians'—reputation at stake, the deficit debacle has overtaken the entire dialogue around "innovation."  

Likewise, deep cuts in discretionary federal spending will constrain the efforts of FDA to address gaps in a new globalized supply chain and keep abreast of the drug information explosion, making it more risk averse. Industry should promote cooperation across national borders, to help build a more harmonious global regulatory environment. 

The point here is that the confluence of a public deficit crisis and the internal industry revenue gap created by genericization, a slower uptake in the market for new drugs, lackluster pipelines, a risk-averse FDA, means one thing: Big Pharma must choose its battles wisely.  

One major issue is which horse to back in responding to this tightening market for medicine: private insurance or the US government? The proposed merger of pharmacy benefits managers Express Scripts and Medco will give private payers more leverage in drug pricing negotiations. Institutions like Kaiser Permanente amd the Cleveland Clinic are writing the book on managing medication costs. In many ways, they are becoming no different in their singular approach to cost control than that global symbol of single pay, the UK National Health Service.   

On the other hand, healthcare reform is expected to bring 30 million new customers into the system, primarily through an expansion of Medicaid and other federal subsidies—and pharmaceutical companies will want a piece of that action. But will the legislation's new Independent Payment Advisory Board (IPAB) sharpen its teeth on pharma industry coffers? Will individual product pricing become irrelevant if IPAB has the power to set a global budget and basically peg any increase in health spending to the rise in CPI? Where in that remit is the "premium" for innovation?   

Whatever choices pharma makes, it will need a voter-friendly strategy to avoid becoming the lender of first resort to health systems awash in unfunded obligations to an aging population. People vote—but institutions pay.  

No one doubts the importance of health expenditures ? but then, euros, like dollars, don't grow on trees

Mind the Gap!

Shaking off its dead tree past, today's reinvented press release is packed with a number of social media elements that make it much more interactive, or as the digital evangelists would say, more "viral ready."			

Readers accustomed to posting their opinions in blogs, on Facebook, Google+, and the like can now do the same on social media-enabled press releases, which sport their own "comments" sections—right on the release. 

Info junkies, who regularly bookmark and share interesting news and other items on the dozens of social bookmarking sites such as Digg, StumbleUpon, Reddit, and dozens of others, are given tools with a social media-enabled press release that enable them to quickly bookmark the release with a service of their choice. 

And bloggers, who thrive on arcane tools like "permalinks" and "trackbacks" to make it easier for the blogosphere to seamlessly discuss breaking news, are pleasantly surprised to find that social media-enabled press releases have these tools built in.

 Free online media tools like "AddThis"-just look for the white plus sign, surrounded by orange-to enable you to simultaneously offer links to dozens of social bookmarking services			

Arch Biopartners' recent press release on hiring a new investment relations firm, for example, offers social media-conversant readers the ability to report the news to more than 300 news-sharing services, as well as a handy button they can click to spread the word even further on Twitter. Aptalis offers similar social media enhancements on a recent press release. 

Pfizer and PRWeb bring social media enhancements a step further by offering videos, a handy RSS News Feed signup, and countless sharing tools, from Twitter and Linkedin to Digg and Delicious. 

"There has been a sea change in how the press release is viewed and utilized," says Paolina Milana, executive vice president, global marketing, at Marketwire. "The once 400-word all-text release has evolved into an interactive tool that incorporates multimedia elements, social media tags and bookmarks, in-release performance stats, and feedback mechanisms."			

Brian Solis, principal at Altimeter Group, a new media advisory firm, agrees: "It's something that combines the best of traditional [press releases]and new and social media, and helps package a story in a way that works for different writers and users." 

You can hire Marketwire, PRWeb, or a similar firm to create your own Web 2.0-enabled press release. Or you can simply put one together yourself.  Here are the key elements you'll want included: 

 Enabling readers to post comments on your press release—the same way they post comments on a blog—can give the announcement more legs. A journalist or blogger who posts a comment on your release, for example, may in turn attract other journalists, bloggers, and readers to your release, and so on. 

The feature also works as a "consumer tool, which makes it easier for the public to identify and share interesting content in the social networking communities," says Deirdre Breakenridge, author of "PR 2.0" and president of PFS Marketwyse, a PR firm. 

 There's an entire subculture of info and news junkies on the Web who regularly categorize and bookmark items of interest for themselves on free bookmarking services.  Adding quick links to these bookmarking services, which members use to store and share their links with others, offers your press release another opportunity to reach a wider audience.  Free tools like "AddThis" enable you to offer quick links to more than three dozen social bookmarking services. 

 This tool makes it effortless for a journalist, blogger or other reader to link to your press release from another Web site, article on blog. I regularly link to press releases, company .PDFs and similar company info on the Web in the articles I write.   

  Most pharma companies understand the power of word-of-mouth referrals on the Web, and have been using this tool on other pages of their Web site. Including this tool on every Web-based press release also helps. 

				 This is a fancy term for a link that will never be changed or moved. It's the perfect solution for companies that like to feature new press releases on their home pages (a temporary location), while simultaneously storing the same press release in their archives (a permalink location).  Journalists, bloggers, and other opinion-shapers like to include permalinks in their work on the Web, since they can be reasonably confident that those links will last indefinitely.   

You can include a permalink to your press release by simply establishing a press release archive for long-term storage of your press releases. 

 A product of the blogosphere, trackbacks are little snippets of code that let you know people are talking about your press release on another blog. In practice, the commenter—usually a blogger—cuts and pastes your trackback code into his blogging program, and the comment alert is sent back to your company press center. You can find a detailed description about trackbacks at "How Trackbacks Work." 

				 There's never been a better time to feature links to the supporting digital images and video for a press release.  The mainstream media is always hungry for news images; bloggers are even hungrier. Besides offering the standard links to images of corporate executives, you can also offer links to Web video associated with the press release, and to related Web videos you've posted on YouTube. 

				 A quick link to your company's press release domain makes it easier for journalists and bloggers to easily dig deeper into your company's story. 

				 Offering an easy way for readers to get to the heart of your company's publicity apparatus is another no-brainer. 

				 A significant percentage of news hounds and info junkies now gather much of their news off the Web with RSS—or Really Simple Syndication—readers.  An RSS reader is a lot like an e-mail reader, only it's generally tougher to spam, which is why many info junkies prefer the technology. Your Web designer will know how to quickly code your press release for RSS. Or, you can auto-code a press release yourself in about five minutes with Ice Rocket's free RSS Builder tool (

 is a New York-based media consultant. He can be reached at 					

Social media now gives companies a plethora of creative ways to digitally spread recent company news and keep customers informed

Giving Press Releases New Legs

In the past, mentioning electronic health records (EHRs) to pharma industry marketing departments would mostly elicit, if anything, yawns and conversation-stoppers. They're too costly to install and maintain, and therefore most physician practices aren't using them. In 2008, when the 

Journal of the American Medical Informatics Association

 (JAMIA) published a case study from Pfizer's healthcare informatics group, which examined how EHRs might support business functions, the primary conclusions were that EHRs could potentially be valuable in some areas, such as drug safety and surveillance or clinical trial recruitment. The assumption was that EHRs could provide patient data and contribute to a more robust database for drug monitoring, but again, without widespread physician adoption, the benefits of EHRs for pharma seemed limited.  

Then, in 2009, the Obama Administration earmarked a whopping $19.2 billion for EHRs as part of the American Recovery and Reinvestment Act (ARRA), and put new incentives in place for adoption; the Congressional Budget Office (CBO) estimates that healthcare information technology (HCIT) spending could top $36 billion. Under the well-known "meaningful use" provision of the ARRA, sticks have now emerged, in addition to the carrots, for EHR adoption and e-prescribing. Physician practices stand to receive up to $44,000 per physician over a five-year period if they adopt EHRs in 2011, direct from the Centers for Medicare & Medicaid Services (CMS). Penalties for non-adoption begin in 2015. Some physicians jumped on board soon after the incentive program was announced, but the vast majority did not. In 2009, approximately 153,000 physicians were using EHRs in their practice, and in 2010, that number increased to 171,000. Beginning this year, however, adoption rates are expected to grow exponentially, with 254,000 physicians using EHRs in 2011, and 376,000 in 2012. By 2013, roughly 70 percent of physicians, or 557,000, are expected to be using EHRs. The CBO predicts that 80 percent, or 726,000 physicians, will be using EHRs by 2019. 

While the biggest providers of EHRs, such as Epic, Allscipts/Eclipsys, and NextGen, are well established, and medium-size players such as Cerner, Sage, Greenway, and AthenaHealth have made headway with early adopters, there haven't been, until recently, EHR providers that offer a clear way in for pharma.   

"With the exception of Practice Fusion"—a free, ad-supported EHR provider—"there are no real pharma regulatory or marketing services available in electronic health records," says Ed Fotsch, CEO at PDR, publisher of the Physicians' Desk Reference, a drug reference service. "EHRs were developed ignoring the pharmaceutical industry." As sales forces shrink, and direct access to physicians becomes increasingly difficult, Fotsch says there's a need for the provision of basic services that physicians and pharmaceutical companies find valuable. "Whether you have a pharma regulatory goal or a marketing goal, either one requires engagement with physicians, ideally at the point of care," he says. To that end, a new crop of EHR providers such as Practice Fusion, PDR, and, most recently, Epocrates, are stepping up to the plate, in an attempt to give pharma marketers access to physicians, without disrupting their workflow. Fotsch, a physician, says "the traditional goal of pharma, when I was practicing, was to disrupt my workflow with pizzas, coupons, great-looking drug reps, and so on, and while that was pleasant, it didn't exactly help my patient volume throughput."  

Other parties, besides EHR providers, have recognized the value of EHRs. Hospitals are now actively purchasing EHR platforms for physician practices, assuming that a systems alignment between a physician group and a hospital will boost referrals—a safe bet, according to Fotsch. "If the EHR platforms are in sync, and really accessible, between a physician's office and the hospital, so that dictations, lab results, and so on can be freely exchanged, [the physician] is much more likely to refer to that hospital," he says. Hospitals such as Advocate in Chicago, Sisters of Charity of Health System in Cleveland, Long Island Jewish Medical Center in New York, and others have committed "tens of millions of dollars" to bolstering referral lines through EHR purchases, says Fotsch. Asked whether pharmaceutical companies could see a positive ROI on purchasing EHRs for doctors, Fotsch says part of the reason that pharma has been left out of EHR design to date is that pharma "can't legally give away EHRs; that would be a broad inurement issue."  

With EHRs, disruption of a physician's "chat, chart, and charge" workflow is unnecessary, says Fotsch. Physicians will use EHRs during an exam with patients, and if they can find valuable services one click away, or embedded within the EHR technology—easy access to patient education materials, coupons and other financial assistance, or samples—they'll use them, or their office managers and nurses will use them. Rose Crane, CEO at Epocrates, is also targeting the physician's workflow with that company's EHRs. Crane says the four criteria used by Epocrates when developing its EHRs were affordability, ease of use, a focus on the patient encounter for the physician-facing template, and uninterrupted workflow. "We are admittedly coming late to the [EHR] market, but I'd say that we've learned from a lot of the current EHR providers out there, and what physicians find problematic," says Crane. Epocrates announced the first phase of its EHR roll-out on July 27. The company will target small physician practices, rather than compete with the companies mentioned above. 

The other major development within the new crop of EHR providers is access: PDR and Epocrates, both of which made their bones initially as a drug reference for physicians, have kept up with shift in technology platforms used by physicians, beginning with smartphones and now tablets. As such, the companies' EHR offerings utilize mobile and SAAS technology, which lets physicians bypass much, if not all, of the hardware installation, a key barrier to adoption. Additionally, drug updates, such as black box warnings, risk, and REMS information, are updated live in real-time. "The fact that box warnings aren't surfaced real-time in EHRs, and that EHRs don't contain the full updated FDA-approved labeling, is kind of astounding," says Fotsch, adding that with EHRs only recently being underwritten by the federal government, it's perhaps not 

 astounding. After talks with FDA in April, PDR, with its partners, launched an adverse events reporting service in June, which is incorporated into the EHR platform. Fotsch says physicians don't have time to report every adverse event they encounter with patients through the traditional channels, which is typically a phone call to a pharmaceutical company. In her keynote address at the PDR-sponsored PharmEHR Summit last April, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at FDA, advocated for not only adverse events reporting through EHRs, but also talked about incorporating REMS programs into EHRs. "REMS are very clunky, and not well integrated into the physician's workflow ... I think [REMS] can be integrated into the workflow through EHRs and electronic prescribing, and can have much more value for everyone." Woodcock said EHRs can provide a fail-safe for prescribers: "You shouldn't get your warfarin refilled for the first time if you haven't had an INR test in the intervening month," for example. It would also be useful, said Woodcock, to provide pharma-sponsored support services like financial assistance through EHRs. 

It's important for brands to "skate toward the puck," in terms of creating a strategy for EHRs, says Fotsch. Pharma companies that get involved now can say, "Here are my samples, coupons, copay cards, warnings, etc., and they're available within your EHR, and my competitor has nothing," says Fotsch. 

It's a work in progres among EHR providers to offer a clear bridge between pharma and physicians.

An IOU to Big Pharma Regarding EHR

 presents its third-annual review of opportunities in the emerging market countries, still touted as the most fertile seedbed for industry sales growth as key patents expire and a bleak deficit winter settles over the US, Europe, and Japan. In a slightly contrarian point of view, Senior Editor Ben Comer and our panel of IMS experts conclude that while the revenue curve in the "pharmerging 17" is straight up, the trajectory for sustainable profits is craggy. Smoothing out the kinks depends on the capacity of Big Pharma to perform consistently around a locally grounded strategy defined by doing just a few things well. 

» an adequately resourced commitment to each market, for the long-term;			

» a business plan focused on competitive differentiation through a good understanding of local health practice patterns and unmet medical need; and 			

» a simple value proposition that neutralizes the growing bias of government toward domestic "national champions" in the life sciences.  

But success in emerging markets is not solely a consequence of framing the right business plan. There is a broader, industry-wide dimension geared to shaping the structural design of the healthcare system itself. The next five years provides a window of opportunity for Big Pharma to apply its deep exposure to healthcare practices around the world to help that business model thrive in these emerging markets—where the global future is being set today.   

A good way to start is to develop core principles around a basic question: 

What's the best way to finance the path toward better health?

 access to healthcare ought to be declared a national development priority and be enfolded in planning targets for GDP growth.  

 financing for publicly sponsored healthcare must be sustainable over time. This requires a mandate through permanent legislation that allocates to health a specific revenue-raising source not subject to amendment through the annual budgetary cycle or the fickle streams of foreign aid. Health provision is never sustainable if it has to compete with other, more short-term budget priorities.  

 a "level playing field" between public and private approaches to financing care is vital in emerging markets. Evidence from the US and Europe indicates that a combination of insurance schemes promotes economically productive competition and allows patients to exercise choice on the basis of medical need and income. It also complements the dialectic of demand in emerging countries, in which the market for health services is complex, divided among the urban and rural poor, dependent on the informal sector; middle-class workers, who rely on employer-subsidized care; and the truly affluent, with the capacity to pay directly out-of-pocket. Government neglect or bias against the latter two population segments can induce higher public-sector deficits and lead to a deterioration of care overall.  

 regulation of health insurance needs to avoid contracting bias, by allowing for the transparent and prompt registration of private plans that can address the diverse needs of middle-income and affluent consumers. This is particularly true in providing cover for supplemental health services such as pharmaceuticals. Capital reserve requirements for private insurers are important to guarantee the solvency of plans, but should not be imposed in a way that limits returns to private investors, especially in comparison to public provision.  

 allowance for diversity and choice in the structure of funding for healthcare is not only good for business, it is good for society. It plants the incentive for innovation by granting more leeway to local medical entrepreneurship and the growth of academic centers of excellence where the conduct of clinical trials funded by pharmaceutical companies carry an important spinoff effect. Emerging market countries can leverage opportunities in this sector to diversify and avoid the pitfalls of relying too heavily on the "boom and bust" cycle of commodities.   

What Big Pharma fails to see is how engagement in health policy is the biggest of reputation builders: it fosters equity; creates stronger institutional roots by moving people away from the unregulated, under-taxed informal segment of the economy; decreases the "democratic deficit" by establishing the legitimacy of good governance; and, through the expansion of access to proven technologies such as modern medicine, delivers better outcomes to patients.   

From the Editor

What Big Pharma fails to see is how engagement in health policy is the biggest of reputation builders

Options for Paying for Health—The Right Way

It was a boom year for pharma at the Supreme Court of the United States. Right up to the end of June, the Justices addressed key issues involving free speech, federal preemption, and patents—many, but not all, in favor of manufacturers. Rulings involving other parties also promise to affect how drugmakers do business, as do Court decisions to reject certain cases (see sidebar).  

A number of important decisions from the Supreme Court will affect drug marketing, research, and regulation

Pharmaceutical Executive-08-01-2011

Pharmaceutical Executive Digital Edition - August 2011

Is the 'Emerging Market' a Dated Concept?

The Adherence Fight: A TKO?

Innovation at Pfizer

Mind the Gap!

Giving Press Releases New Legs

An IOU to Big Pharma Regarding EHR

Options for Paying for Health—The Right Way

The Supremes Shape Pharma

Congressional Investigations: What Every Exec Should Know

Serbia: Ready to Flourish

Employers: Fighting Non-Adherence

Europe in HTA Gridlock

Cure for the Common Cold Chain Break

Google+ and Pharma