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`
`Copay programs' increased value to manufacturers is matched by rising criticism
`
`
`
`Copay programs’ increased value to manufacturers is
`matched by rising criticism
`
`January 15, 2014
`
`Despite proven medical value, coupon and copay offset programs continue to draw re from
`insurers; meanwhile, will the programs extend to ACA insureds?
`
`Suzanne Shelley, Contributing Editor
`Coupon or copay-offset provisions are aimed at the “out of pocket”
`(OOP) expenses of commercially insured or cash-paying patients.
`When such a discount program is used, the drugmaker pays the
`differential between what the patient’s insurance plan will pay for
`that drug, and the wholesale price plus dispensing fee paid back to
`the pharmacy. The goal is to ensure that the patient’s nal OOP cost
`is capped by the dollar gure offered by the coupon or copay-offset
`program. “When a patient can use a coupon or copay-offset card to
`pay a lower rate than a top-tier copay, they are much more apt to ll
`that prescription,” says Devin Paullin, EVP at Physicians Interactive (Marlborough, MA).
`
`Coupons and copay-offset programs are currently available for nearly 400 branded products, with the majority
`being for chronic conditions for which drug treatment could be expected for several months or more and can
`easily cost hundreds if not thousands of dollars per month.
`
`In one study of more than 10 million prescriptions for over 5 million patients, researchers found that when
`patients had copays of $50, their prescriptions were three times more likely to be abandoned at the pharmacy
`than when there were no OOP costs, and over twice as likely to abandon the prescription when they had a copay
`of $25. [1]
`
`Today, a conuence of factors is driving the deployment of copay-offset programs. One big driver that has made
`many medications less affordable for nancially strapped patients is tier creep—“whereby Tier 2 drugs no longer
`carry a $25 copay, but a copay closer to $35–$75—resulting in lower medication adherence,” says Chris Dowd,
`Exhibit 1102
`SVP for PSKW (Bedminster, NJ).
`IPR2017-00807
`ARGENTUM
`Copays and the copay differential between tiers continue to grow. In 2012, copays for retail pharmacy generic
`and traditional brand prescriptions grew between 10% and 13% while specialty copays grew by 26% (from $84 to
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`$106 average for a 30-day supply), in an effort to keep pace with the rapidly increasing cost of specialty drugs,
`according to the Pharmacy Benet Management Institute (PBMI; Plano, TX).
`
`Tighter economic conditions and competitive pressures from other in-class products are also driving demand:
`Manufacturers are realizing that “remaining competitive in their respective markets if other products in the
`class already offer copay programs is an important factor,” notes Tracy Foster, president of Lash Group, an
`AmerisourceBergen Consulting Services company (Charlotte, NC).
`
`Pharma marketers have a variety of resources for managing copay-offset programs. Dedicated vendors include
`PSKW, Physicians Interactive, Opus Health (a unit of Cegedim, Bedminster, NJ), Trialcard (Cary, NC), Lash Group
`(Charlotte, NC, a unit of AmerisourceBergen Consulting Services), Triplen (Scottsdale, AZ; now a unit of H.D.
`Smith Medical Solutions), McKesson Patient Relationship Solutions (Scottsdale, AZ), Medimedia Health (Yardley,
`PA) and QPharma (Morristown, NJ). Various copay-assistance programs are available from the many operators of
`patient assistance programs; and vendors of consumer-oriented, retail patient services such as Catalina Health
`(now a unit of Adheris) and Inmar, Inc. (Winston-Salem, NC).
`
`Formulary ght
`Where the insurance industry cries foul is with the longstanding argument that the very existence of these
`copay programs undermines the formulary-tier-designation efforts that are so strenuously negotiated with
`drugmakers. This has the potential to undermine the insurer’s bottom line in two ways: (1) By allowing physicians
`to prescribe outside the tiered formulary system, thus forcing insurers to reimburse for more costly branded
`drugs when cheaper, on-tier drugs (both branded and generic) are available, and (2) by denying insurers rebates
`(contracted with drugmakers as part of the tier-designation negotiations) that might have been available had an
`on-tier therapy been prescribed. The formulary model is a key cost-containment initiative used by payers.
`
`“With these offsets, some brand teams who might never be able to win a preferred formulary bidding process
`can get directly to the patient and pay no rebate to the insurer, which changes the balance of power in the
`negotiating process,” says Mason Tenaglia, managing director at Amundsen Group (Burlington, MA).
`
`A 2011 white paper by the Pharmaceutical Care Management Assn. (PCMA; Washington, DC) set off alarm bells
`for many industry observers by stating that drug coupons and copay-offset programs “could raise prescription
`drugs by $32 billion over the next decade,” and offering a stinging indictment of the pharma industry for
`pursuing such subsidy programs.
`
`“Many payers—including Express Scripts as a PBM—while supportive of programs to facilitate patient access for
`high-cost specialty drugs, are not supportive of these programs as a mechanism to undermine formulary
`placement,” says Kevin Cast, VP, global pharmaceutical business development, at United BioSource, an Express
`Scripts company (Blue Bell, PA). “This incurs additional expenditures with no additional health benets for the
`patient.”
`
`In response, Cast says, “Some payers are allowing members to ll their prescriptions only at pharmacies that
`don’t accept copay cards; another payer tactic to counter their use in competitive drug classes is to remove
`those medications from the formulary altogether.”
`
`However, coupon advocates say that the payers’ portrayal of copay-offset programs is not always fair or
`accurate. “The problem with the PCMA paper, which generated a lot of media attention, is that it is not backed
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`up by a single analysis of actual data in any therapeutic class,” says Tenaglia. “There are studies that show that
`the combined medical and pharmacy costs for such debilitating conditions as cancer, rheumatology-related
`disorders and multiple sclerosis can actually be reduced when patients remain on therapy. And it is clear in all
`those classes that copay support increases adherence.”
`
`After conducting several years of empirical analysis through a variety of longitudinal studies, the Amundsen
`Group asserts that copay-offset program usage is not correlated with lower generic utilization in any of the
`major drug classes, and points out that most of the money invested by US brand teams goes into offset programs
`that are aimed at the extremely high-dollar-value specialty, biologic and orphan drugs—such as TNF inhibitors,
`therapies for multiple sclerosis, HIV, Hepatitis B and C, oral oncology products and so on—for which there are
`no alternatives available (generic or otherwise), and for which the OOP cost for patients can easily run into
`hundreds or thousands of dollars per month.
`
`“Insurers can argue that these offset programs drive patients to use more costly branded drugs (in lieu of
`cheaper branded options or generics), but studies have shown that more than 40% of the time, in the absence of
`a copay-offset program, if the patient cannot pay the OOP expenses, they won’t switch to a cheaper drug—they
`will simply forgo the medication,” says Mick Kolassa, managing partner of Medical Marketing Economics (MME)
`LLC (Oxford, MS). “The insurance industry will end up losing considerably more money over the long run, in
`terms of covering related medical expenses that arise when the patients don’t control their conditions through
`the use of medication.”
`
`Even the Pharmacy Benet Management Institute conceded this point. In its “2012–2013 Prescription Drug
`Benet Cost + Plan Design Report,” the organization writes: “Plan sponsors must develop effective strategies
`beyond higher cost-sharing for managing specialty drug spend given the detrimental effect that further copay
`increases for specialty drugs are likely to have on medication adherence.”
`
`“We’ve done the analysis across many therapeutic classes, and there is no clear data that shows that there is
`higher branded drug utilization in classes that have generics, but this is what the insurance continues to assert,”
`adds Tenaglia of the Amundsen Group.
`
`According to a 2013 study published in the New England J. of Medicine, less than 8% of copay assistance cards or
`coupons are for products for which there is a generic available. [2]
`
`Today, pharmacy spending currently accounts for roughly 10% of healthcare costs. Supporting the idea that
`prudent use of drug therapies pays its own dividends, a recent Congressional Budget Ofce study [3] notes that
`every dollar spent on pharmaceuticals saves two dollars in overall healthcare costs. “The converse of this is that
`every dollar not spent on pharmaceutical interventions costs the industry $2 in healthcare costs, and the
`numbers used in that CBO study were very conservative,” says Kolassa. He asserts that copay assistance is
`actually “helping to subsidize the health insurance industry” itself.
`
`Meanwhile, the claim that copays exist primarily to inuence prescribers, is dubious at best. “A coupon would
`not likely be the reason any doctor would write a prescription,” says Paullin of Physicians Interactive. “But once
`the physician has selected the therapy, the coupon can help increase both affordability and adherence for the
`patient.”
`
`“Even payers, who are largely critical of such programs, understand that affordability impacts adherence,” says
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`Foster of The Lash Group.
`
`Copay programs' increased value to manufacturers is matched by rising criticism
`
`Coupons under the ACA
`While Pharma may not like the situation, it has long accepted that patients in Medicare, Medicaid, Veterans
`Administration (VA) programs or other federal healthcare programs are not eligible to use pharma coupons,
`copay-assistance cards or similar subsidy-type programs, because they are viewed as illegal inducements that
`have the potential to violate the federal anti-kickback statute (AKS).
`
`But a far more grey area has been the lingering question of whether or not coupons and copay-offset programs
`would also be barred from being used in the health exchanges established by the Patient Protection and
`Affordable Care Act (ACA, or Obamacare), which—according to one side of the argument—could be construed as
`federal programs, given that there is some level of federal subsidy involved in the exchanges.
`
`Specically, all stakeholders have been holding their breath, waiting to see whether or not previously uninsured
`patients, now nally insured through healthcare exchanges under the ACA, would be allowed to use coupons
`and copay-offset cards that are aimed at making certain medications more affordable. As of press time, the
`answer remains far from clear.
`
`In late October, Kathleen Sebelius, HHS Secretary, attempted to resolve this question in a letter to Congressman
`Jim McDermott (D-WA), but critics of the copay assistance programs say that her characterization of the
`situation was both misguided and misinformed and will have no legal standing over the long run.
`
`Specically, the Sebelius letter says that HHS does not consider qualied health plans purchased through the
`ACA insurance exchanges to be “federal healthcare programs” for the purpose of the federal anti-kickback rules.
`
`“Given the recent conicting guidance from HHS and CMS around Qualied Health Plans, manufacturers should
`be very cautious with their approach to providing cost-sharing assistance to patients enrolled in these plans,”
`says Scott Dulitz, VP, product support, at UBC. Mark Merritt, president and CEO of the PCMA, went farther in a
`statement: “Now regulators need to take the next step and formally determine what everyone already knows:
`That federal anti-kickback laws apply to the ACA.”
`
`Some in Congress agree. Senator Chuck Grassley (R-IA) wrote to Sebelius and the Dept. of Justice, saying it was
`“extremely disturbing” that the HHS Secretary is “intentionally attempting to strip away these vital protections
`by administrative at.”
`
`“It is unclear exactly who has the authority to declare whether exchange plans purchased with federal subsidies
`are federal healthcare programs,” says Kevin McAnaney, a Washington, DC-based attorney and former HHS
`executive who specializes in anti-kickback and Stark laws. He notes that the only agency with jurisdiction over
`the AKS “would appear to be the Dept. of Justice (DOJ),” saying: “While HHS has regulatory authority to create
`safe harbors for conducts that otherwise might violate the AKS statute, nothing the Sebelius letter said is
`binding and HHS can reverse their position at any time, and DOJ can reverse it through rulemaking.”
`
`Proponents of drug coupons and copay-offset programs say that it is a cruel twist of fate that previously
`uninsured patients—once enrolled in one of the ACA health exchanges—would still be denied access to the
`coupons and copay offsets that are already available to patients with private insurance.
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`Copay programs' increased value to manufacturers is matched by rising criticism
`
`“How do you tell patients in the ACA that they are not entitled to the same discount coupons that aim to make
`certain drugs more affordable as patients who already enjoy private-sector insurance plans are entitled to?” says
`Derek Rago, VP and GM of McKesson Patient Relationship Solutions. “Under ACA, it should be all about trying to
`nally provide uninsured Americans with some form of health insurance, with the ultimate goal of improving
`patient outcomes.”
`
`And Sebelius’ position has possible political signicance, as well. The Obama administration “cannot come out
`and say that the exchanges operated under the ACA are ‘a federal program’—people would scream ‘socialized
`medicine’ or ‘a government takeover of healthcare,’” says Kolassa of MME. “It was especially important for
`Sebelius to reiterate that the ACA establishes a broad private/commercial insurance market—not a government
`program—and thus, by denition, the potential to violate the AKS statute would not apply.”
`
`“If that distinction were to ultimately be reversed, the issue will become so much bigger than just copay cards
`alone,” he adds.
`
`Best practices in program development
`While they may be under re, it’s clear that coupon and copay-offset programs are here to stay. Experience in
`the early years has brought to light several ways in which drugmakers can make these programs as effective and
`valuable as possible, for both the pharma brand team and the patient.
`
`At the end of the day, the price at the pharmacy counter is not the sole motivator for patients to be healthy and
`stay on therapy, and simply lowering the cost of medications does not necessarily provide enough of a support
`mechanism to improve compliance and long-term health outcomes
`
`“It’s important for brand teams to recognize the different types of barriers that can lead to low drug
`compliance,” adds Rago of McKesson. He notes that nancial barriers can be addressed by coupons and copay-
`offset programs, and clinical barriers—related to, say, side effects or lack of efcacy—can be addressed through
`greater physician and pharmacy support and branded and unbranded educational materials provided by the
`drug manufacturer and other entities.
`Even more vexing, says Rago, are the so-called “cognitive challenges” that must be overcome in order to ensure
`maximum compliance with the drug regimen. “These include such issues as the patient not truly understanding
`the severity of the disease (which is especially common for chronic conditions such as high blood pressure or
`high cholesterol that are asymptomatic), not understanding the role of the medication or the importance of
`taking the full course of drugs according to their label instructions,” he says.
`
`Industry experts in patient-assistance programs agree: The goal of any brand team should be to offer more than
`just the copay-offset card itself. A range of other support tools such as rell reminders, educational outreach to
`the copay-assistance program via patient opt-in mechanism and followup from call centers will help the patient
`get stay on therapy and experience sustained improvements in outcomes. [4]
`
`With the understanding that patients voluntarily opt in to copay programs, the pharma industry benets by
`having a direct link to the patient. With this, manufacturers can provide targeted, actionable information right
`from the beginning, to make sure patients understand why they are being prescribed the medication, to explain
`the side effects and provide tips for managing them, to stress the importance of taking the entire course of
`treatment and so on.
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`These can be as simple as sending the patient a reminder message (via text or email) once the prescription is
`submitted electronically, to remind them to pick up the prescription, or to bring their copay-assistance card if
`necessary.
`
`“With just three to ve strategically worded questions at the opt-in stage, the brand team can accurately
`characterize which patients are highly likely to be adherent and which are not,” says Rago of McKesson, and that
`can help the team to customize the patient-support outreach that follows once the patient starts the
`medication.
`
`Advanced programs will use such information to create personalized and customized messages, based on what
`type of information the patient wants to see, in the preferred format, from the onset of being in the program, to
`help them get past some of the hurdles and stay on therapy.
`
`There is no one-size-ts-all approach here, says Rago of McKesson. For instance, higher-touch models are
`appropriate for complex diseases or specialty medications with complicated administration requirements. For
`these cases, it is often appropriate to establish contact centers with live patient-support representatives “who
`can have a rich, two-way dialogue with patients who may be likely to fall off therapy and have other barriers to
`adherence,” he says. Since high-touch programs always have higher costs associated with them, their ROI must
`be justied brand by brand.
`
`Apply analytical rigor
`Pharma companies already devote considerable effort to negotiating rebate terms to attain preferred status or
`access through contracts with managed care companies. According to Amundsen Group’s Tenaglia, they need to
`apply the same level of business sense and analytical rigor when it comes to designing and deploying copay-
`offset programs—to project the actual costs, analyze the ROI of the effort, and understand the impact of the
`program on patients.
`
`Again, offering a one-size-ts-all approach is not an option. Rather, it’s important to deploy these programs
`where they are needed most, not necessarily across the board, using both geographic and brand considerations.
`“You want to design copay programs that make sense—ones that save patients who might abandon their
`prescription and ones that will not subsidize patients who would have lled their prescription anyway,” says
`Tenaglia. “Savvy brand teams will analyze how costs associated with copay-offer programs differ in different
`regions, and analyze those against costs already associated with rebates provided under existing managed-care
`contracts and use this insight to guide program development.”
`
`For instance, if a given insurance provider is dominant in a given region, and you’ve already paid signicant
`rebates to lower the patient’s drug cost through that formulary program, it does not make sense to heavy up on
`copay cards in that region at the same time, he says.
`
`Tenaglia suggests that brands can minimize erosion of prot margin by focusing on allocating offset cards to
`those geographic areas with the greatest price sensitivity (where such assistance really matters)—to support
`patients who may otherwise simply forgo treatment without such support. For instance, when brand teams
`conduct studies to analyze anonymous patient longitudinal data (APLD), they can drill down even more precisely
`into patient price sensitivity, at both the initial prescription pickup and at each subsequent rell. These data can
`help program designers to identify critical threshold values for OOP costs, after which patients will start to
`abandon their prescriptions, and tailor their programs accordingly.
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`Copay programs' increased value to manufacturers is matched by rising criticism
`
`“This level of analytical rigor currently only happens in a handful of companies, but it is necessary, because in
`some cases, copay-offset programs may end up costing more than the rebates given to retain preferred tier
`status,” he says. “When companies don’t get this right, they end up paying for the same drug three times—
`through rebates to managed care, through offsets to the patients, and by incentivizing the reps to tell doctors
`about the copay-offset offering.”
`
`The funds devoted to copay and offset programs can be a vital part of
`overall pharma marketing budgets. “Because brand teams can
`measure and manage these programs, they can be as effective as any
`major promotional avenue at a fraction of the cost,” points out Dowd
`of PSKW. At Physicians Interactive, Paullin notes that, “Another
`important advantage of e-coupons is that they provide a mechanism
`for small and mid-tier pharmaceutical companies to deliver cost-
`savings programs to physicians all over the US without the burden of
`a costly sales force.”
`
`Fig. 2. PSKW’s analysis of claims data shows a “halo
`effect” on prescribers who will increase scrips for a
`drug with a coupon, regardless of actual use of that
`coupon. Credit: PSKW
`
`Copay-offset programs are equally valuable at launch, and later in the
`product lifecycle, to help speed market penetration and make new
`drugs more affordable during the initial period when a new
`medication would likely have a Tier 3 copay before the manufacturer can establish the contract with the
`drugmaker.
`
`PSKW’s Dowd notes that there is a “halo effect” with physicians simply because of the existence of patient
`support. Non-coupon patients (i.e., patients whose plans do not have high copays) are more likely to be
`prescribed a drug that the physician is aware of through the existence of the program. (Fig. 2).
`
`The e-prescribing environment
`Traditionally, coupons were paper documents, often handed over by the rep during a physician visit, along with
`samples. Sometimes the physician remembered that a coupon exists for a prescription; sometimes not;
`sometimes, the paper coupons are locatable in the sample closet; sometimes not. These logistical difculties are
`being addressed both by e-prescribing and electronic health record (EHR) systems now in wider use by
`physicians, and by online sample closets where physicians order samples directly from manufacturers.
`
`With the growth of EHR systems, the capability of creating an electronic coupon, accessible (or present) at the
`point of prescribing, is on the rise. Savvy consumers are also aware of online sites that aggregate coupons from
`many manufacturers.
`
`The home run in this environment is when an electronic coupon is coupled with the electronic prescription, and
`both the patient and physician are aware of it at the point of prescribing. But getting there is not a simple task.
`PSKW’s Dowd notes that the EHR market is highly fragmented (there are estimates of more than 500 EHR
`vendors) with varying degrees of system interoperability. He notes that all stakeholder groups must working to
`address these challenges in order to optimize the capabilities of e-coupon programs.
`
`At Physicians Interactive, Devin Paullin notes that “Clinicians are very open to receiving select services from
`pharma manufacturers within their mobile devices and EHR—if it adds value and is relevant to their workow
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`and to the delivery of quality care, they will use it.” A recent Physicians Interactive study of 2,300 physicians,
`nurse practitioners and physician assistants revealed that medication vouchers and coupons were “the most
`requested pharma resources to have access to directly within the EHR software.”
`
`Some EHR vendors have open access to marketing information from manufacturers, and inclusion of a coupon
`program is fairly straightforward. Another evolving channel is online drug information databases offered by
`vendors like PDR Network, Epocrates and others; prescribing information for drugs can be accompanied by a
`discreet reminder that a coupon is available. The watchword in all this is not to interfere with the physician’s
`“digital workow” of navigating an EHR system. Properly designed, the electronic coupon is a welcome
`component; poorly designed, it becomes an irritation.
`
`“We’re still in the rst generation of integrated products that will improve adherence and outcomes, and we are
`still learning, but—as an industry—we’re all approaching this very responsibly (in terms of clinical, legal and
`regulatory requirements) and there are rules in place in all of these EHR systems to minimize commercialism,”
`says Paullin.
` 
`
` 
` 
`References
`[1] Ford ES, Ajani UA, Croft JB, Critchley JA, Labarthe DR, Kottke TE, Giles WH, Capewell, Explaining the
`Decrease in U.S. Deaths from Coronary Disease, 1980–2000; N Engl J Med, 2007).
`[2] Joseph S. Ross, MD, and Aaron S. Kesselheim, MD, JD, MPH, N Engl J Med 2013; 369: 1188–1189, September 26,
`2013, DOI: 10.1056/NEJMp1301993).
`[3] Offsetting Effects of Prescripton Drug Use on Medicare’s Spending for Medical Services,
`www.cbo.gov/publication/43741.
`[4] Shelley, S., “Pharma Struggles to manage the complexity of its Patient Assistance Programs,” Pharmaceutical
`Commerce, March/April 2013, p. 1.
` 
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`Copay programs' increased value to manufacturers is matched by rising criticism
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`Posted in Brand Marketing / Communications | Tagged JANUARY/FEBRUARY 2014
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