How to prevent ‘agg spend’ sunburn

Implementation of the Physicians Sunshine Act may require you to begin data gathering by Feb. 25, but questions remain over the law’s details, from data to dollars

By Bob Sperber for Pharmaceutical Commerce.

The reelection of Pres. Barack Obama assured that the Patient Protection and Affordable Care Act (PPACA or ACA), signed into law on March 23, 2010, will move forward, and with it, the Physician Payment Sunshine Act provisions.

Interpretation_of_dataIt goes by lots of names. Officially named the Transparency Reports and Reporting of Physician Ownership or Investment Interests section, it also goes by the “Sunshine Act,” aggregate spend law or simply “agg spend.” By any name, it will require pharma, device and medical supply manufacturers to submit reports of spending on physicians and teaching hospitals to a database maintained by the Centers for Medicare and Medicaid Services (CMS). Reports must include “payment or other transfers of value” (POTVs) exceeding $10 for everything from small meals to consulting fees, to speaking and research fees, to stock ownership.

Manufacturers can’t begin collecting data for strict compliance until the final rule is published. The latest news at presstime is that CMS completed the final rule, and on Nov. 27, sent it to the White House Office of Management and Budget for review. Expectations are that within 90 days of OMB’s receipt, CMS rule will be issued as final. If so, manufacturers could be required to begin data gathering on Monday, Feb. 25, 2013, for their 2014 agg spend report submissions.

Will you be ready when(ever) the law comes? Penalties as proposed range from $1,000 for an unreported item to a maximum $1,000,000 for knowingly failing to submit an annual report. Considering that the price of instituting compliance processes and IT solutions can reach into the hundreds of millions, might some companies find deliberate noncompliance an option? “It sure as heck would be cheaper,” one Big Pharma manager told Pharmaceutical Commerce, “but that’s not the approach we believe in.”

Most manufacturers already have some program in place to meet the reporting requirements of several US states—Minnesota, Colorado and several New England states, among others. Comparable reporting requirements are coming into force in the European Union, and some companies are attempting to build a global reporting database to meet current or future requirements worldwide.

Fear and uncertainty

Not knowing exactly how CMS will incorporate industry comments into the final rule, companies remain fearful over the many yet-unknowns, from dates to data points.

One big issue: “context.” Under the proposed law, when a manufacturer reports a research grant to a teaching hospital, it includes total dollar amount and other identifiers, including the identity of the principal investigator. Of course, the investigator doesn’t get the money, the institution does, “and that institution has to pay 50 people, run a laboratory, do patient testing, and all kinds of other things with that money to conduct that clinical trial,” says Marjorie Powell, senior assistant and general counsel with the Pharmaceutical Research and Manufacturers of America (PhRMA), which has lobbied to add clear, nontechnical explanations to public spend reports.

Asked whether they favor a public, searchable database of all physician-industry relationships, a 2012 survey of 110 US-based physicians and 223 executives from life sciences companies, conducted for Deloitte by Forbes Insights, found that 68% were, most of them agreeing “as long as patients understand how to interpret the data” (Fig. 1). The last point speaks directly to the issue of context.

State regulations add further complexity. The federal law will set the baseline, but states are free to enact further restrictions. Massachusetts and Vermont ban spending on gifts; Vermont bans meals and requires reporting on clinical transactions and disclosure of all free product samples that do not apply under Section 6004 of the ACA. Minnesota maintains spending limits, which the federal proposal does not.

Massachusetts, Washington, D.C., West Virginia and Colorado also have state agg spend laws. There are signs that some of these and perhaps the rest of the states are looking forward to letting Uncle Sam do the bulk of the heavy lifting. Maine had a law, but repealed it on June 29. Massachusetts eased restrictions a month later and partially repealed its 2008 Pharmaceutical and Medical Device Manufacturer Code of Conduct, then in September, issued an “emergency regulation” to address a legislative change “to allow companies to provide ‘modest meals’ to physicians outside of their offices as part of an educational event, such as a speaker program or conference seminar,” says PhRMA’s Powell.

Other states, though, backed off on laws that would exceed the proposed federal law, which will preempt state laws only to the extent of “setting the floor,” says Natasha Thoren, attorney with Epstein Becker Green (New York). “States may choose to enact statutes or regulations that require reporting and disclosure of additional information and/or information from individuals or institutions not covered under the federal law,” she adds. “It will be interesting to see what states will do after the ACA regulations are finalized.”

Another area of ambiguity is the very fundamental identification of physicians. CMS expects healthcare providers (HCPs) to be identified by their National Provider Identification (NPI) number, but not all doctors have one because it’s limited to physicians serving federally funded insurance programs. “So, a plastic surgeon doing cosmetic surgery, for instance, wouldn’t be in the Medicare or Medicaid system,” says Bill Buzzeo, GM of global compliance solutions at Cegedim Relationship Management (Bedminster, NJ).

 Speculative solutions include expanding the NPI to all physicians, or perhaps expanding the DEA ID, which authorizes the prescribing and dispensing of controlled drugs, but the agency has in the past nixed the idea. “Am I 100% confident that there still won’t be gray areas in the final rule? No,” says Buzzeo. But he says regulators have been in contact with industry stakeholders, and that “CMS is listening.”

It’s about process, not technologyCegedimSurvey

For Bristol-Myers Squibb (BMS), the key to a successful compliance solution is “thinking of the project as a business problem in terms of process and not necessarily as an IT or system solution first,” Antionette Brock, director of business projects & planning, told attendees at a June user conference held by IT vendor Pegasystems (Cambridge, MA). The company’s system establishes a single set of processes, common roles/rights workflows and procedures that will ultimately roll out across global operations.

The company shared its challenges: underestimation of time and cost; the need to navigate competing priorities; team member “swapping”; training and the sheer number of integration points. These included 11 internal systems (e.g., master database of item costs, global product master data, geographic data), as well as five, which were external vendor systems (e.g., the logistics, T&E and other vendors).

The transparency preparedness efforts to date for Sanoti US have focused on a combination of existing state requirements, as well as the statute and federal proposed rule and PhRMA comments. “Every organization will have its own strategy,” says Gus Papandrikos, director, transparency operations, US medical affairs (Bridgewater, NJ), “but we all have a common theme: We all use multiple source systems that host data, such as enterprise resource planning, financial, sales, procurement, research and others.”

Regardless of the IT architecture, “all companies will need to capture data out of these systems and ultimately aggregate it into one reporting solution,” he adds. For its system, Sanofi chose a major vendor to remotely host and maintain data and the application. Users access it through secure Internet connections.

There are many paths to compliance. The most common method, IT-wise, is to minimize the investment with a manual spreadsheet-based system, followed by in-house applications, third-party solutions, and then sheet avoidance or noncompliance, Cegedim research indicates (Fig. 2). Many companies often start with HCP lists from one or more vendors (e.g., Cegedim, MedPro, Health Market Science) to complete their existing databases; 47% of company data come from third parties per Cegedim research. Many such vendors also partner with other firms to offer full compliance reporting, validation and software solutions. For instance, MedPro has partnered with Porzio Life Sciences Services and an allied law firm to offer a full software-and-regulatory solution. In terms of third-party offerings, these can be based in-house or outsourced via SaaS to a provider who will keep data and systems up-to-date as regulations evolve. R-Squared (Princeton, NJ) is an example of a vendor that offers systems both in-house and remote.

AdvantageMS (Fort Washington, PA) combines its verified HCP databases with a partnership with Concur Technologies (Redmond, WA), whose travel and expense-management solutions are widely used by sales organizations. Compliance Implementation Services (Media, PA) provides consulting on setting up and administering agg spend systems.

No matter the IT strategy, companies need to follow the same fundamentals—collect, standardize, cleanse and validate data to ensure accurate reporting of the following: physician name, address, specialty, NPI, or perhaps an improved identification scheme, as well as the value, form, date, and name of the drug. “Form” refers to the correct entry of the transaction across 18 categories:

1. Gift
2. Food
3. Entertainment
4. Travel
5. Honoraria
6. Research funding
7. Education
8. Research
9. Profit distribution

  10. Charity contribution
11. Consulting fees
12. Faculty or speaker fee
13. Investment interest
14. Royalties
15. License fee
16. Speaking fees
17. Dividends
18. Stock or stock options

According to Acquis Consulting Group (New York), roughly 80% of HCP transactions are recorded in the expense system, but these comprise only 20% of the total HCP spend. This underscores the need to integrate many systems from many departments, including finance, compliance, legal, IT, sales and marketing meetings and events, and travel departments. Not only do systems from these departments need to be integrated into a single reporting database, companies need to have a clear road map for doing so, from the top down. A steering committee must identify a project leader, who must assemble a cross-functional team, which must develop clear departmental business processes, all the while working with IT to ensure that standard terminology, codes and other details are used. The right data from the right systems in the right departments must be mapped into a unified whole.

Companies, department by department, may need to budget more time and resources than initially expected for data cleansing, augmentation and validation processes. “Because the more they start getting into data cleansing, as they ‘overturn more stones,’ companies often find that not all of the data is being collected, or being collected properly,” says David Kaufman, managing partner at Acquis. “In some cases, they’ve been aware that there were some inconsistencies, but now that they will be reporting under a federal law, the effort takes on a new urgency.”

Once a system is in place, a system should let users link a transaction directly to one or more physician records by selecting the appropriate attendees when planning an event, for instance, as well as inputting details needed to list expenses and exporting the relevant data to a unified agg spend data warehouse.

The business case for compliance

Spectrum_IntegrationsBesides giving manufacturers a better view of their own spending limits, public reporting of data will allow them to track others’ spend data. In fact, they should do this, “because that’s exactly what journalists are going to be doing, and the government’s going to be doing,” says Mandy Klosterman, COO for Regulatory Clinical Research Inc. (Minneapolis), a clinical research organization (CRO) that also provides agg-spend consulting for medical device development.

If, for example, Big Pharma Company A is spending $5,000 a year per physician, Company B is spending $50,000, and Company C is spending $500,000—and you’re with Company C—you can expect to get some attention in the media and by the government, and not the kind you want.

Such benchmarking will take time to become entrenched. In the Deloitte-Forbes Insights survey, 49% of respondents said they were considering or planning to use public data from other companies for strategic purposes, while only 13% had developed significant plans to do so, and 25% “didn’t know.”

Aside from sizing up the competition, there are additional areas where the cost of compliance can be at least partially mitigated, however, there are limits to expense-targeting.

“In general, people have thought about ways to use their information in addition to reporting,” says Sanofi’s Papandrikos, himself having started in sales and marketing. “But in terms of making allocation decisions based on their business impact? That’s something we steer very, very clear of, as does every other pharmaceutical company.” Rather, agg spend compliance systems are for compliance and “to limit overspending on any one individual based on a set of rules that you establish within your organization, sometimes based on limitations set by statute or state regulation, such as in Minnesota.”

Still, the data can be used elsewhere for predictive analytics, promotional analysis, marketing analysis, strategic planning—and to provide “great ROI down the road,” says Eric Newmark, program director of IDC Health Insights’ Life Sciences practice. So far, discovery and due diligence efforts have “led to many companies uncovering huge inefficiencies in their organizations that they didn’t even know about.” He cites one that uncovered nearly 40 different third-party speakers bureaus across divisions, “then consolidated to roughly five and instantly saved millions.”

Physician relations

“Physicians need to know what’s coming at them…like a freight train,” says Klosterman of RCRI. Without the chance to review spend data before it goes public, she adds, “You can imagine what kind of impact that’s going to have on the manufacturer’s relationship with physicians, if you don’t prepare them for the public reporting.”

Physician Ford Vox, MD, called the agg spend proposal “good legislation overall,” in a recent column for The Atlantic (“The Devil’s in the Details used for Doctor Transparency”), but still admits he backed out of tentative plans to attend a manufacturer’s educational event, “when I realized my attendance would be reported as a gift from the company.” His prescription to docs and hospitals is to create their own websites to “proactively tell the world…before ProPublica starts calling you.”

The American Medical Assn. voiced concerns at and since a Sept. 12, 2012, Senate roundtable discussion, chiefly that the public will mistake the agg spend law for a regulation on ethical conduct rather than simply an accounting of industry practices, and also that the proposed rule “would deny physicians due process to review, dispute and correct inaccurate reporting,” wrote James Madara, AMA CEO, to CMS Administrator Marilyn Tavenner on Oct. 10.

As it stands, manufacturers have a 45-day window to make corrections after submitting reports. CMS suggests—but doesn’t require—that they allow physicians access during this period or perhaps earlier in a “pre-submission review.” But how? The options generally focus on some type of secure Web portal that lets physicians log in to verify what goes into reports. A single portal would be ideal for the manufacturer.

BMS designed such a portal into its system as early as 2010, when one source at a company presentation noted how the effort “takes a lot of manpower,” including setting up a call center, a mechanism for sending letters inviting the doctor to come online and review reports, and hiring a staff of case managers.

If companies face challenges with single-country databases and systems, that’s not stopping leading companies planning regional solutions for the Americas, EMEA (Europe, Middle East and Africa) and Asia-Pacific. A “few true, groundbreaking leaders,” Cegedim’s Buzzeo says, have committed to global transparency projects. Cegedim’s 2012 industry survey on agg spend found that 87% consider global capabilities when choosing an aggregate spend solution. Success will hinge on a single global, corporate instance for systems, such as enterprise resource planning, travel and entertainment, customer master, and disclosure.

Beyond corporate global standards, some hope for globalization of transparency standards. In turn, the European Federation of Pharmaceutical Industries and Associations has begun a multinational initiative that targets spend reporting as early as 2016. If it succeeds, it could pave the way for global standards harmonization, which “may prove more elusive than the lost city of Atlantis,” says IDC’s Newmark.

Such utopian standards are worthy of support; however, for the time being, the US industry is still preoccupied with investing in systems to comply with a law that has yet to be published.

With coupons, pharma is saying ‘Let’s make a deal’ to consumers

Pharma marketers become adept at refining coupon and voucher programs, while technology options multiply. Meanwhile payer criticism mounts

By Bob Sperber; posted @ Pharmaceutical Commerce.

While sampling has been the traditional method of getting patients to try new therapies, the use of coupons or vouchers—often targeted directly to consumers rather than physicians—are on the increase. PillsPurchased” target=”_blank”>In these difficult economic times, such financial incentives are attracting more consumer interest, and the availability of these consumer discounts is being magnified by Web-based promotions in addition to conventional print media. In parallel, coupons and vouchers are demonstrating value in raising or maintaining patient adherence to therapy—a good thing from most healthcare payers’ perspective—but are attracting more criticism from them when the incentives are plainly directly at countering higher-co-pay, higher-cost second- or third-tier formulary positions. The contention is that pharma marketers are circumventing the plans’ goals in steering patients to lower-cost drugs.

IMS Health told the New York Times, in an article published at the beginning of this year, that use of coupon programs has tripled since 2006. Coupon programs are even figuring in pharma companies’ Wall Street presentations: during J&J’s quarterly conference call in October, CFO Dominic Caruso told analysts that, in order to recover lost market share from its recent product recalls and competition from private-label OTC products, “our marketers are very good at knowing what they need to do to attract consumers [with] a mix of brand marketing and expenses, couponing, innovation, etc.—a surround-sound impact to get consumers back,” according to Bloomberg News.

Paul Kandle, VP and GM of Opus Health, a division of Cegedim Relationship Management (Bedminster, NJ). Opus was one of the first companies to capitalize on the “secondary adjudication” steps that were put into claims-processing systems at pharmacies, once a copay had to be linked not only with a specific health plan, but also with the identity of the drug being prescribed. Since then, it has run over 1,000 programs for manufacturers, and says that it has 250 programs currently. “These claims-processing systems allow manufacturers to overcome two obstacles to patient assistance: the complexity and difficulty of getting samples into the hands of patients after a prescription has been written, and the ability to provide a refund at the point of sale, rather than taking actions like mailing a coupon and receipt into a fulfillment center.” Vouchers (which figure primarily in getting free samples dispensed) enable the prescription to be filled at the pharmacy—and to be documented in the claims processing system—as opposed to being handed out by the physician; however, Kandle notes that there is still a perceived value by physicians in being able to hand out a sample directly.

On the copay side, the original need was to ensure that the pharmacist “would be made whole” financially if a discount on a copay were transacted; the secondary adjudication ensures that that happens. As these details were worked out, the overall economics of running coupon and voucher programs became more positive.

“Manufacturers always had pressure to reduce costs overall, but the pressure’s much greater today,” says David Merkel, senior vice president of business solutions for J. Knipper and Co. (www.knipper.com), Lakewood, NJ-based multi-channel marketing services firm. “Rightly or wrongly, pharmaceutical companies have been painted as the bad guys…and are being expected to absorb much of the costs.”

Beyond sampling
Free-trial vouchers, started as an alternative sampling vehicle to help contain those costs, says Merkel, “but have led to other components from direct mail to longer-term vehicles to promote patient persistency with other forms of patient co-pay assistance.”

And yet physician sampling programs are still a starting point for patient outreach, with 85% of manufacturers distributing trial samples directly to physicians through their sales reps or via direct-to-practitioner (DTP), according to a survey report presented in September by TGaS Advisors (www.tgas.com), and the PDMA Alliance (www.pdmaalliance.org) at September’s PDMA Sharing Conference in San Antonio. Kevin Sharp, director with TGaS, says trial vouchers are “generally utilized to address ‘white space’ concerns and facilities that do not receive physical samples. These particular channels have seen growth as pharmaceutical companies have changed the structure and size of their sales forces.”

Still, with the downturn in the economy and years of pharmaceutical mergers, prescription drug manufacturers are “looking for ways to do more with less. And because there are fewer reps out there, there’s less sampling going on than in the past,” says John Khantzian, senior principal, LifeLink Solutions, IMS Health (www.imshealth.com), Danbury, CT. “And where that sampling that does still exist, it’s being done based on priorities developed through physician and patient segmentation analyses.” So, for example, if there’s a managed care influence in a certain area, the manufacturer may modify their sampling tactics based on its formulary status. This helps to ensure that the physician will have its drugs on hand in the sample closet to provide until the patient fills an initial prescription.

While hand-delivered samples still dominate according to the TGaS study, those sampled – primarily drug-makers sample-accountability and PDMA compliance professionals – are also exploring other options at high levels: 90% of respondents use coupons; 76% use vouchers; 24% use a pre-paid card; and 17% offer co-pay assistance.

The most confusing aspect of analyzing these results is trying to discern the definitions of these vehicles – something that won’t soon be answered.

“There aren’t any consistent definitions across the board for coupons, vouchers, pre-paid cards and co-pay cards,” Sharp concedes. As a result, the survey listed those promotional options and asked respondents to check which method they used. On on end of the spectrum are one-time free trials; on the other are longer-term co-pay-assist card programs that foster loyalty. Given these parameters, it may be possible to discern what promotional vehicle works best for the drug maker-marketer.

IMS studied the success of three kinds of patient card programs for one branded pharma company’s (unnamed) chronic therapy (Fig. 1) for which there were a mix of branded and generic alternatives, with generics representing a significant percentage of market TRx (prescriptions written) volume:

• A multi-use co-pay card for use with multiple prescription fills per year, with a guaranteed maximum level of co-pay or patient out of pocket expense;
• A limited-use savings card program that guaranteed lower patient out of pocket costs to a fixed dollar amount and
• A free-trial voucher program for one free prescription fill.

The objectives of the three programs were to increase the flow of new-to-brand patients and drive brand loyalty. Patients selected were new to the brand, either newly diagnosed or switched from other medications) The result? Multi-use program patients purchased 61% more pills over a six month observation period, while limited-use savings card program patients purchased 28% more pills than the control group.

Interestingly, the free-trial voucher program resulted in lower sales than the control program. The drug may have carried unwanted side effects, but such speculation fell outside of the research, says Greg Mastrogiovanni, engagement manager, Commercial Services, IMS Health. He avoids such speculation, offering that this isn’t an uncommon occurrence, and that “a good percentage of patients try the product once because its free but never convert to paid therapy.” Beyond that, he didn’t speculate on why those who tried the free trial didn’t continue on the drug as often as the control group.

Such studies provide very useful data through the identification number printed on each voucher or card, which upon redemption is run through an anonymized, HIPAA-compliant patient-level database, explains Khantzian, providing data on “patient XYZ123… which tells us they used a coupon, voucher or co-pay card. That’s what allows us to create test groups and control groups to the measure adherence, compliance etc., of patients who get the card versus those who don’t. This way, a pharma company can evaluate the results of two different promotions for effectiveness and ROI.”

While pharma companies factor in costs, and ROI in promotional vehicles remain confidential to the brand, “The measurements around them – how they’re distributed and the ancillary materials – can be so remarkably, incredibly different,” says Tom Foley, director of business development for RxHope, one of the integrated multi-channel sampling and marketing companies of Triplefin (www.wearetriplefin.com), Cincinnati, OH. He says no “one size fits all” strategy can be applied to define a media mix or ROI; an osteoporosis drug for elderly women won’t use the same mix of tools and media as an erectile dysfunction drug; likewise, how a co-pay card or free trial will work depends on the drug, the patient population and when and how it’s deployed in the lifecycle.

Ned Finn, VP pharmacy at Inmar Corp. (www.inmar.com, Winston-Salem, NC), notes that coupon programs vary not only by therapeutic area, but also by the healthcare objective. “To drive better patient adherence, it may make sense to provide coupons to reduce copay for patients that have proven adherent to therapy. This can have a huge impact on patient clinical outcomes. If the goal is to cross-promote, there are opportunities to use coupons to promote OTC therapies or foods that address the side effects experienced by patients taking prescription drugs for specific health conditions. For example, an online coupon for moisturizers could be offered to someone searching for information on ways to manage side effects of chemotherapy; an online coupon could be offered for foods that address specific health conditions or lifestyle products such as smoking cessation products.” The company, which handles the equivalent of over $6 billion in coupons annually from a wide variety of consumer-goods companies, prints, distributes and then reimburses for coupons used in print media and online.

Tech serves brand experience
Opus Health, Knipper, Triplefin, Inmar and companies like PSK&W (www.pskw.com, Bedminster, NJ), Trialcard (www.trialcard.com, Cary, NC), Group DCA (www.groupdca.com, Parsippany, NJ) offer a variety of platforms and programs directed at consumers. Programs have evolved from distributing paper coupons to online, print-on-demand coupons, or loyalty cards that are used at the retail pharmacy to obtain an on-the-spot discount for copays. PSK&W has built out a system that integrates coupon distribution with relationship management tools (the DIVO platform) that it says provides a more complete interaction with patients. Most recently, the company linked up with HealthPrize, which is applying gaming technology to the patient adherence problem (Pharmaceutical Commerce, July/Aug 2010, p. 8) to power up its adherence offering.

Group DCA, for one, connects with the order-entry and reimbursement systems run by McKesson’s Relay Health unit to effect that on-the-spot discount with minimum workflow issues for pharmacists. Catalina Marketing (www.catalinahealthresources.com) says that it has 18,000 pharmacies, within a network of 50,000 retail outlets overall, through which it can manage copay assistance and adherence programs. (The company also runs CouponNetwork.com, said to be the largest print-on-demand coupon system in the world.)
Meanwhile, the growth of electronic health record (EHR) and e-prescribing systems at doctors’ offices and pharmacies is creating a new channel for electronic couponing. OptimizeRx Corp. (www.optimizerxcorp.com; Rochester, MI), now about a year old, is hoping to ride the EHR wave by integrating sampling and coupon programs with these e-prescribing systems, and has a partnership with Allscripts (Chicago) to bring pharma manufacturers’ programs into that channel. The company says that it has processed almost 70,000 coupons in the past year.

NationalPatientMedicare and other government-funded programs are ineligible for coupon programs, but Medicare Part D, and its infamous “doughnut hole” that requires patient payment up to a set level annually, has created an opportunity for patients. In helping to subsidize prescription drug costs by mandating a secondary payer field in the electronic claims process, the theory goes, Part D “gave manufacturers greater ability to offer financial assistance with new immediacy,” says Rick Randell, president of Triplefin’s National Patient Services (NPS). Because in contrast to old-fashioned snail-mail vouchers and the like, “the immediacy of on-the-spot secondary payer discounts at the pharmacy, and access to current multi-channel technology services, gave manufacturers the ability to finally make offers they needed to offset the expenses of being a non-formulary product, right at the point of sale.” While vouchers, coupons, co-pay cards and the like were already gaining popularity, the secondary payer field could be used not just for Medicare but for all transactions (Fig. 2).

It’s part of a tech explosion, he contends, that has brands more interested in tying and tracking promotional activities to Internet and mobile communication technologies. With consumer electronics and the Web now mainstream communication channels, and with patients actively managing their own Health Savings Accounts, more patients are taking to the Web where, says Randell: “A coupon isn’t just a coupon anymore. It’s an opportunity to communicate and work with the patient.”

Likewise, a website isn’t a website anymore. Beyond static display of information or perhaps printable coupons, brand sites can serving much of the informational role today as family doctors and neighborhood pharmacists did in days of yore. For example, Eli Lilly and Co.’s site for Effient (http://www.effient.com), for instance, offers a plain-English Esstential Habits program to help patients with stents adjust their diets and lifestyles in addition to offering a card that covers the portion of a patient’s co-pay over $25 up to a maximum of $20 each for the next 11 refills.

And Bristol-Myers Squibb’s website for Abilify (www.abilify.com), a treatment for depression, BMSOnlinebipolar disorder and schizophrenia, guides visitors to identify the disorder for which they’re interested, state their informational needs as a patient, caregiver or information-seeker, and invites them to join its “ABILIFYAssist”  (www.abilifyassistprogram.com) program for a free trial and “continued savings” with promotions for the healthcare provider, pharmacist, insured patient and uninsured patient (Fig. 3). Also, there’s a cost-and-coverage calculator, refill reminders and prior authorization assistance where the brand collaborates to help complete documentation and facilitate authorization.

“You can go on any brand’s website today and there will likely be a link to some sort of card program,” says IMS’ Mastrogiovanni, adding the prevalence of “relationship management programs” of the type illustrated above, where, beyond financial promotions, “there are patient education fulfillment materials and ongoing contact or touch-points via phone, e-mail, direct mail, et cetera – and we definitely see an increased trend in the industry toward these programs.”

In fact, any Internet, communication or media channel can be part of the mix, from TV commercial “ask your doctor” prompts and website “click here to print-out our coupon” features to opt-in email and text messaging elements, even mobile apps, which are emerging. (In September, Triplefin launched a new Innovations Mobile business to fill that need.) For some, this will beat the frustration calling a plan’s phone tree, although even that’s changing as new-generation IVR (interactive voice response) systems offer 24/7 services offering assistance with similar granularity to websites.

Given all these content-rich and personally tailored services, patients are much more likely to consider a brand’s value beyond the co-pay to build loyalty, or in the case of free trials, increase the value of the offer due to the trust the marketer builds using all of these technology-assisted services.

PBMs temper pharma zeal
It’s hard to manage a prescription drug promotional campaign when success when putting the brakes on a promotion can be as important as being proactive to patients’ needs. Viewed from one angle, that’s what happens when a pharma company offers too heavy a discount without offering also-deep discounts to the plans that would rather sell generics. But this is a simplistic view of a much more complicated set of considerations that make promoting prescription drugs a complicated affair.

Before the drug-maker can promote its drug, it has to establish its a preferred position in a drug plan by offering a sufficiently large rebate – in plain talk, discount – to pharmacy benefit managers (PBMs). PBMs administer prescription drug plans for patients through the group health plans to which they subscribe through self-funded employer or labor union plans, health insurance plans, and Medicare Part D.

Those rebates act as a discount that’s factored into the formulary process to offset the cost of the drug, and they go “directly to the ultimate payer, such as the employer group, to offset their plan cost,” says Brent Eberle, VP of clinical services for Navitus Health Solutions (www.navitus.com), a PBM based in Madison, WI.

Once a manufacturer secures pricing and a preferred (or any) position, it then can turn to promotions such as patient co-pay assistance programs. Unlike samples and free-trial offers that don’t incur costs to anyone but the manufacturer, co-pay discounts are generally disliked by PBMs. The reason simple: A more expensive Tier 3 drug can appear to the patient to cost the same as a preferred Tier 2 drug when in fact its cost to the plan is almost always higher. Eberle says situations like this – aggressive marketing that crosses the formulary line – is “something we factor that into formulary decision making.

“If we feel a manufacturer’s marketing practices are too aggressive, that’s a manufacturer we typically going to be manufacturers we won’t partner with for that drug,” says Eberle. “There have been situations where we’ve been unhappy with a product’s marketing, and that has resulted in putting it in a non-preferred position with fairly aggressive ‘prior auth’ restrictions – even while we have other products of theirs that are in preferred positions.”

Integrating coupon/voucher/adherence programs with electronic medical records (EMR) systems will be the next frontier for these programs, says Opus Health’s Kandle. Currently, a contest is being waged between the EMR vendors and the patient-assistance providers over the cost of allowing a presence in the EMR network. At the same time, the EMR vendors are competing for share of mind with physicians and healthcare networks, so there’s going to be some equilibrium to be reached between the cost of having a presence in the network and the value to the EMR vendor for customer acceptance.

 

Social Media: An Irresistible Force Colliding With an Unmovable Object

Following FDA’s punt of regulations for social media, industry is scratching its collective head over how to utilize these channels

By Bob Sperber for Pharmaceutical Commerce.

socmediaTake one of the most dynamic transformations in any form of media occurring right now—the rise of social media like Facebook, Twitter and the rest—and factor in that marketing and advertising agencies themselves are heavily vested in exploiting the possibilities of the new, digital cornucopia. Then layer in the reality that almost month by month, the “norms” of social media (if such a concept can be recognized) are changing. Now throw this tidal wave against the careful, deliberate traditions of FDA regulation of healthcare communications.

The result: a lot (a LOT!) of sound and fury, but relatively little movement by pharma companies into the social sphere. FDA, without coming right out and saying so, has postponed providing rules on pharmacos’ use of social media (and has indicated that it is likely to provide “guidance” rather than actual rules). In turn, pharma marketing and communications leaders are dabbling around the fringes of the social media movement, while mostly building more websites and buying banners through online marketing networks. Behind the scenes, though, pharmacos appear to be quite active in monitoring online discussions and commentary—itself an evolving type of marketing service for themselves.

Living without guidelines
In 2009, FDA’s Div. of Drug Marketing, Advertising and Communications (DDMAC) held public hearings over online marketing and communications (Pharmaceutical Commerce, Nov/Dec 2009, p. 6), which brought out many thought leaders among online companies, public interest groups and manufacturers. DDMAC hoped to use the commentary to develop communication standards in 2010, but at the end of that year, delayed them to this year. Social media, as such, were somewhat on the periphery then; a lot of the discussion revolved around getting fair balance into banners (which, it turned out, has become fairly easy to do). But one issue that was prominent then—and remains so today—is whether manufacturers are obliged to handle product complaints that might be expressed anywhere on the Web as reportable adverse events (AEs).

In January, the agency dropped online drug promotion, including social media, from its Guidance Agenda publishing plans for 2011, leading industry watchers like John Mack, the blogging “Pharmaguy,” to ask, “Is this supposed to be the promised guidance we’ve all been waiting for?”
For its part, DDMAC is keeping its cards close to the chest. “It is difficult to provide a timeframe for the issuance of our guidances or related ‘milestones’ due to the extensive work and review process, or GGPs [good guidance practices],” DDMAC announced in a letter. “Our goal is to provide well vetted, meaningful, and useful guidances articulating our current thinking on various topics related to Internet/social media promotion.”

Asked whether he thinks the FDA has given-up on the effort to produce guidelines, James Musick, director of social media and web communications for Genentech, says “the more I dig into social media, the more I find that it’s extraordinarily complex. So I don’t think it’s so much a back-burner issue for the FDA as it is that they’re realizing what we have realized, which is that it’s not easy to do.”

For now, he says the company is taking a “letter-of-the-law approach,” even he’s left wondering which letters to which laws to follow. Like most pharmacos, Genentech has a public statement of principles, based on parent Roche (see box, p. 34). Most of the rules are not specific to social media, except to note that comments posted in a seemingly local or private site have a way of ricocheting around the world.

Marketing agency leaders say that it’s just as well that DDMAC hasn’t come out with rulemaking, simply because the medium is changing so quickly. In just the past few months, for example:

• Google announced that it was shutting down Google Health, an early effort to get electronic health records (EHRs) organized for consumers; at the same time, it has started up Google+, its answer to Facebook.
• Microsoft, which has a service, Health Vault, that competed with Google Health, has gone ahead and acquired FDA registration for the service as a medical device.
• In April, Facebook announced that it would no longer allow users to disable comments, a rule that already affects new Pages and coming to existing pages by August 15, according to numerous agency sources. Matthew Snodgrass, director of social media for San Francisco-based agency WCG, was one of the first to dissect pre-announcement details and note the exceptions that will apply to pharmaceutical companies:

• Pages that promote, talk about, or support prescription drugs or devices
• Pages that focus on a disease state where there is only one prescribed treatment (even if the Page doesn’t mention the treatment)
• Disease-state/therapeutic area Pages that have the PI/ISI on the Page This means that corporate Pages, general disease awareness Pages, and unbranded campaign Pages will have their comments re-enabled for their Walls, photos, and videos.

Jonathan Richman, group director of insights and planning at WPP’s interactive agency arm, Possible Worldwide(www.possibleworldwide.com) notes that “whitelisting” will apply and gives a detailed explanation at his blog, www.doseofdigital.com.

Listening in
So what happens after August 15? Some pharma companies may ditch Facebook as a channel, but that’s not necessary, says Joe Doyle, interactive director at Austin, TX-based agency HCB Health (www.hcbhealth.com), because the social manager will likely be using a software tool like Radian6 (www.radian6.com), or any of the dozens of competing offerings such as Nielsen’s BuzzMetrics, ThoughtBuzz, Lithium, which scan the Internet with special emphasis on social elements for all mentions of a brand and allow companies moderate, monitor and correct statements that put the company at regulatory risk because with or without DDMAC guidelines or a formal rule, the rules of engagement are “very black and white. We all know what our boundaries are, what we can and can’t say regarding standards such as fair balance and off-label content.”

One of the more recent developments from Radian6 is a partnership with Asentech (http://beta.asentechllc.com), whose new, combined system trolls a claimed 330 million sites every five minutes to offer ratings like other systems, with a difference: The partners have added a staff of physicians and pharmacists to mediate the data for pharma brand manger users before pulling the trigger on weekly or monthly reports.

Even companies who shy away from social media due to regulatory fears should still be aware of what people are saying about them. Monitoring, or as some call it, “listening,” assisting companies in their marketing and overall in pharmacovigilance efforts that can help prevent or mitigate situations that can lead to adverse events, improper off-label use and warning letters—whether or not the FDA ever offers guidance or formal rules.

Existing rules will do
“I think the longer it takes the less likely we are going to see rules from FDA,” says David Ormesher, CEO of Chicago-based agency closerlook (www.closerlook.com). He says the agency “has more to lose” by publishing regulations because “it is balancing a lot of interests, and have gotten a lot of heat over the years for even opening-up direct-to-consumer advertising TV. They’re already getting a lot of heat from people for the amount of promotion that pharma does on the web as it is. So I think they like this tension they have from Pharma right now.”

Eileen O’Brien, director of search and innovation at siren Interactive (www.sireninteractive.com), a Chicago-based agency specializing in rare disorders, says she was “very optimistic two years ago” that DDMAC would issue guidelines, but is not sure they’re needed today: “We’re still waiting for guidance for using the Internet, but that hasn’t stopped anybody from doing a website.” Pharmacos seem to be coping by following existing guidance for TV and print media promotions.
“It’s easy to get distracted by a shiny, new object,” says O’Brien, who stresses that social media aren’t a strategy “but a tactic that has to tie back to larger marketing and brand objectives. It’s not right for every brand.” Companies should first attend to higher-priority interactive tactics such as a creating a compelling, frequently-updated website and search-optimized e-mail campaign that reaches key audiences.

In the face of the evolving if amorphous nature of social networking, statistics aren’t everything; even Manhattan Research, a New York market-research company specializing in tracking new media, is sidestepping some of the frothier parts of the social media buzz. Monique Levy, VP of research, says that the firm routinely finds itself doing “a lot of explanation to contextualize the data” revolving around social media activity and that business models are still evolving. For the time being, she says, the more significant activity is focused on mobile technology at a time when consumer and physician mobile apps are surging and the research firm estimates that 91% of US physicians are using some type of smartphone, and that 75% of all physicians own some form of Apple device, such as an iPhone or iPad. The firm is now conducting a study on physicians’ opinions of sales-rep presentations using digital media.

Web or mobile Web, there’s plenty of opportunity for pharma social networking despite regulatory restrictions, as hundreds —thousands—of online social connections attest. But where to start?

Ben Curtis, a strategist at Cary, NC- based healthcare agency MicroMass Communications, (www.micromass.com), starts with a “pure definition” of social networking as “getting a community of people engaged with one another and having, for our purposes, discussions about the brand. It’s really no different than word-of-mouth marketing just that it’s happening online.” This starting point leads him to help clients facilitate one-on-one communication between two patients, “where all the pharma is doing is connect them so they can speak outside of the pharma network. One way to do this is to partner with associations to build communities, facilitating patient-to-patient or patient-to-doctor communications, as well as a “good relationship between the association and the pharmaceutical company.”

Going forward, social networking may or may not become an easily measured media segment to track. It’s not that market shares and data are top secret, but that it’s difficult to get accurate audience data beyond users and “likes” on publicly accessible sites, or–more importantly—tracking physicians on targeted, registration firewall-protected physician-only sites like Medscape Physician Connect (http://www.medscape.com/connect), Sermo (www.sermo.com) or Ozmosis (www.ozmosis.com), or any of hundreds more health-related venues. User counts don’t measure active users, nor do total user counts for which there’s likely to be plenty of overlap.

NightNurse“A marketer is better off reaching physicians in a closed community because even if they’re on Facebook, they’re not consuming pharma information there,” says Tim Lewis, director of strategy for interactive and relationship management for Chicago-based healthcare agency AbelsonTaylor. Because every rule seems to have an exception, AblesonTaylor has found one group of healthcare providers using Facebook: 2600 night nurses in hospital nurseries who have special needs and can be overlooked in the nursing world. AblesonTaylor created this presence for Abbott’s Similac brand. Lewis’ associate, Bekah Locker, manager of social marketing, notes that this is “a community space where night nurses could come together, engage in conversation and connect with each other on topics they find relevant.” Abbott doesn’t push the brand, but has provided “an authentic place for that type of engagement.” The moderator shares relevant information for sleep disorder, working with patients and the challenges of working at night.

The content isn’t on the brand so much as the cause—which is exactly what prescription drug marketers say is the easiest way to build audience affinity. Lewis says “the FDA has never issued a warning letter for letting people talk about a brand on any social space. The warning letters have been associated with not providing fair/balance” when a site is controlled by a brand. And on this Facebook site, over the past tens of thousands of posts, only removed two posts have been removed. Says Lewis: “We want authentic conversation. If that authentic language includes criticism of something we posted, so be it.”

The same applies to prescription drugs: “One of the easiest ways for a brand to get involved in terms of the social space is to do cause marketing.” Pharma marketers typically gain access, and then only some, on closed physican sites, depending on their level of sponsorship, and so, Lewis says, “it’s harder to have an ongoing dialog [in a closed community that’s sponsored.” That also goes for custom sites and pages created using platforms by custom developers such as within3 (www.within3.com). But opinions diverge on such topics because the “social” market may never be a market segment that can be as easily measured as more monolithic channels.
Even mobile platforms are easier to measure, despite “huge regulatory issues,” says Manhattan Research’s Levy: “Every screen is different; fair/balance is different; platforms are different—it’s a whole other beast. People are already tackling that within pharma. It’s a bigger priority than social this year.”

Even if social becomes a stepchild to mobile, social media won’t fade into the woodwork so much as become part of the architecture of the Web. “Things are changing so rapidly,” says Genentech’s Musick, “that in 5 to 10 years, it will be increasingly difficult to make the distinction from social as distinct from Internet media. There will be socially enabled features everywhere online, as well as mobile.”

Big (Pharma) Brother?
However, there is already a debate building over online listening, which makes it one of the agenda items of the newly formed Digital Health Coalition (DHC). Founded by Mark Bard (former president of Manhattan Research), DHC brings together many leading pharma companies with Google, Epocrates (an online medium for physicians) Health Central and Digitas Health. The group is seeking to build consensus within the manufacturer community, and interact with FDA and other regulators. Bard says that the debate on behavioral tracking and digital privacy “is a major issue” to all advertisers, not just in healthcare. “There are voices out there that are saying the very premise of behavioral tracking is a bad thing. That has impact on every industry and it can also have a significant impact on the pharmaceutical industry.”

However the privacy/behaviorial tracking/mobile communications discussions play out, one thing seems certain: a year from now there will be yet other new issues bubbling out of the social media mix. PC

BOX: ROCHE’S PRINCIPLES FOR ONLINE ACTIVITY

Codified in late 2010, Roche’s guidelines apply worldwide, and are an example of how pharma companies are grappling with the changes in communications media. The company also has a Social Media Advisory Board to address new issues. The following is excerpted from the company’s website, roche.com.

I. Personal online activities
1. Be conscious about mixing your personal and business lives. There is no separation for others between your personal and your business profiles within social media. You must be aware of that. Roche respects the free speech rights of all our employees, but you must remember that patients, customers and competitors as well as colleagues may have access to the online content you post …
2. You are responsible for your actions. … Anything that brings damage to our business or reputation will ultimately be your responsibility. This does not mean that you should refrain from any activity, but that you should use common sense …
3. Follow the Roche Group Code of Conduct. When “speaking”, be compliant with the Roche Group Code of Conduct, as well as all other Roche Positions, Policies & Guidelines (i.e. Protection of Privacy, Rules on Insider Trading, etc.) …
4. Mind the global audience. Even if you are posting on a “local” platform, the information may be accessed globally. This is particularly important in our regulated business …
5. Be careful if talking about Roche. Only share publicly available information. You are not allowed to talk about the revenue, future plans, or the share price of Roche as this may have serious legal repercussions for you and the company.
6. Be transparent about your affiliation with Roche …
7. Be a “scout” for sentiment and critical issues. … If you come across positive or negative remarks about Roche or its products online that you believe are important, consider sharing them by forwarding them to your local communications department. This is most important in the case of so-called “Adverse Events”…

II. Professional online activities
The following principles outline what to consider when representing Roche as an official online spokesperson:
1. Follow the Roche Group Code of Conduct and Communication Policy. In the core of all communication engagements is our commitment to transparency, balanced information and equal treatment of all parties …
2. Approval processes for publications and communication. … Given the interactivity and speed of the new medium, however, it is not realistic to have each response undergo full approval by communications, legal and regulatory. Therefore, you should establish with your usual approval partners a common agreement on a bandwidth of topics and instances that may not require the normal process. …
3. Mind copyrights and give credit to the owners.
4. Use special care if talking about Roche products or financial data. Communication about the revenue, future plans, or the share price of Roche as well as statements about our products (“promotional information”) is reserved to experts in the field who have been trained to do so …
5. Identify yourself as a representative of Roche.
6. Monitor your relevant social media channels. Make sure you know what is being discussed, so that you can respond when issues arise. Have rules in place to deal with potential Adverse Event reports or potentially inappropriate or illegal content … Also, be mindful of any obligations to preserve data that may be subject to a legal hold.
7. Know and follow record management practices. … Keep records of our interactions in the online social media space. Because online conversations are often fleeting and immediate, it is important for you to keep track of them when you’re officially representing Roche.