Non-adherence to therapy is widely recognized as an ever-present problem in healthcare generally and the pharma industry specifically, which forgoes some $250 billion annually in lost sales. The picture is changing, somewhat, from past years, as health systems now have incentives (through Medicare’s Star program of financial incentives and penalties for health outcomes) to improve patient adherence. In the specialty pharmaceutical arena, manufacturers now have substantial incentives to improve adherence and outcomes, through the expansion of value- or outcomes-based contracting.

Leveraging data from off-label prescribing

Patient-support and hub service providers assist their manufacturer clients in running adherence programs, and manufacturers are reaching out to the specialty pharmacies that they work with for assistance as well. For the most expensive specialty products, it’s not hard to justify the expense and effort of “high touch” personal interactions with patients, via care coordinators or pharmacy technicians. The trend now, though, is to use technology to automate some or all of adherence programs, thereby getting better results at lower overall cost.

There are two aspects to the technology trend: developing better analytics to predict patient behaviors during therapy; and establishing a line of communication through the latest digital technologies, notably smartphone apps, to reach patients “where they are at” in their day, or in their patient journey.

“Historically we’ve been very hypothesis-driven around adherence — we create a hypothesis and then a solution and then we measure whether the solution worked,” says John Doyle, SVP@IQVIA. However, with advances in the breadth and depth of real-world data and real-world experience available today and advanced modeling and machine-learning analytic techniques, stakeholders “don’t necessarily need to start with a hypothesis. We can now look for patterns and then use inductive reasoning and run models to test the impact of newly identified trends.” For instance, he notes that the search for factors impacting adherence should integrate not just the usual healthcare data sources, such as payer and pharmacy databases, EHR and patient registry data, but financial data sources as well (such as de-identified credit scores). “This can shed light on how socio-economic challenges may further impact adherence trends, thereby allowing more-tailored interventions to be created.”

Adheris Health LLC, a Syneos Health Company, partners with large branded phama companies to deliver targeted adherence-support information and motivational messaging directly to patients and physicians, via the EHR system (at the point of care) and the retail pharmacy (at the point when prescriptions are picked up). Using proprietary analytical methodologies to gain insight into patients’ behaviors, needs, and emotions, the messaging and outreach can be tailored as needed, allowing for improved clinical outcomes and brand performance.

“Today we have insight into more than half of all retail prescriptions written,” says Michael Occhipinti, VP, Analytics. “Working with our EHR vendor partners and retail pharmacy partners, we have direct access to 295,000 prescribers, 197 million patients, 2.25 billion prescriptions per year dispensed from 26,500 pharmacies, so we are able to support the patient through the most critical moments of care to ensure they stay on their prescribed therapy to maximize both brand and patient performance.” He notes that the company routinely use several years’ worth of patient longitudinal data to help decide where and when to intervene with the most appropriate outreach (in terms of messaging and timing) for the biggest impact.

Adheris Health also uses data analytics (and randomized test controls) to assess the effectiveness of any brand-specific outreach efforts, so the adherence-related behaviors of patients exposed to the campaign can be assessed, and the program finetuned going forward, he adds. Using logic that is incorporated into the pharmacy workflow, the company also generates the familiar, targeted drug- and disease-specific messaging printed in the information packet that is stapled to the prescription bag, with messaging that may be related to not only the prescription being picked up, but to other diseases the patient may be managing, as well.

Upwell Health, a company that works primarily with pharmacies and insurers to support patients, makes use of direct shipment, telemedicine and educational support tools, according to Alison Wistner, CEO. Upwell also provides a variety of high-touch, wraparound services, helping patients work with pharmacies and insurance companies to ensure access to all of their medications at the lowest possible OOP costs, and curates and shares informative content, including news, videos, reports and research, through its website, to help patients remain informed and engaged.

The adherence challenge becomes more acute when the condition is asymptomatic and patients “feel fine” without their medications — until an episode occurs — despite the known threat that poor adherence poses to their long-time prognosis and overall health outcomes. “Each solution being explored today has its own strengths and weaknesses, but it’s important that patients arrive at a point where they view taking prescribed medications as an important part of their overall health — rather than a burden,” says Sub Datta, CEO of CompanionMx, a spinoff launched in late 2018 from voice-analysis company Cogito. “If patients are engaged through a more holistic program, they feel empowered as an active and critical part of the process. Then we can meet them where they are through digital applications, clinician dashboards or other interventions.”

CompanionMx’s Companion smartphone app uses voice-analysis technology with weekly check-ins with patients; patented algorithms analyze the voice recording to assess patient status, which can then be shared with a care team. In a preliminary six-month study of more than 100 patients with diagnosed mood disorders, CompanionMx found that 86% of survey responses were taking their medications as prescribed — “a rate that is significantly higher than typical medication adherence statistics for mental health, which is a reflection of increased patient engagement through the platform,” says Datta.

Groove Health offers an interactive mobile app that combines existing healthcare data, patient-generated input and predictive analytics to provide more personalized engagement. The company’s mobile app not only streamlines medication management (with automatic reminders, alerts to potential drug-drug interactions and more), but features an AI-powered chatbot, dubbed Maxwell. “As Maxwell interacts with the patient, it learns more about the patient’s particular barriers to adherence and can respond with tailored content, in order to spur behavior change among patients,” says Andrew Hourani, CEO and Co-Founder of Groove Health. Besides the information forwarded to the patient, the chatbot collects voice data “provides a unique view into the types of barriers the patient may be facing and build a more-detailed profile of that patient so that someone on their care team can take provide tailored support.”

“Human interaction and empathy are the hardest to replicate — you will never really be able to fully replicate a trained medical professional interacting directly with a person,” says Hourani. “But maintaining dedicated staffing is costly, and even if a pharmacist or coach talks to a patient once or twice when the patient is initiating treatment, there will be long stretches of time that the patient has no interaction with that specialist.” For a typical patient living with Type 2 diabetes, “you can count the time spent with a doctor in terms of a few hours in any given year — yet the need to properly manage medications and side effects and symptoms of disease progression is happening every single day,” he adds. “The Maxwell chatbot offers a great complement to that, by collecting and delivering the best information to answer any question that arises for the patient.”

The initial commercial-scale versions of the Groove Health platform have had a disease-specific focus (targeting patients with cardiovascular disease (CVD), diabetes, high blood pressure or high cholesterol) developed in conjunction with several hospital and payer systems, with the specific goal to reduce readmission rates through improved adherence. These drug-agnostic platforms help patients to overcome adherence challenges, no matter what medications have been prescribed. The company is also in the process of developing partnerships with several pharma companies and hub providers to configure its adherence-improvement app.

HealthPrize Technologies has put its money on another behavioral strategy — gamification, an interactive offering that combines education, encouragement and rewards with proven gaming techniques — to improve medication adherence. Gamification-based efforts aim to counteract what behavioral economists call “present bias” — that is, one’s preference for immediate short-term rewards over longer-term (but more nebulous) gains. This is particularly important when it comes to asymptomatic conditions that require a lifelong commitment to therapy yet the perceived long-term gains (say, staving off a heart attack or stroke, or reduce the risk of progressive limb loss or blindness) may seem abstract today. “Because there is little in the way of instant gratification in the lonely, burdensome process of daily medication, apps that are based on gamification aim to provide fast, fun and engaging feedback to overcome present bias,” says Tom Kottler, CEO.

Importantly, gamification has been proven effective with people across all age, gender and education-level demographics, and have been proven across many disease states, drug types and drug-administration routes. “We address medication adherence by addressing the psychological barriers many patients have, and we support habit change by rewarding patients for engaging in healthy activities, such as verifying prescriptions, reporting compliance and engaging with positive educational experiences like quizzes, surveys and videos,” says Kottler.

HealthPrize claims over one million patient users, and half of the top 20 pharma companies as clients.

Diabetes has proven to be a dynamic therapy area for raising patient adherence. In mid-2017, Roche acquired mySugr GmbH, the creator of a gamification-based mobile app to help patients with diabetes. The mySugr platform already had a million users in 52 countries at the time. Through this partnership, the app is now integrated with Roche’s existing Accu-Chek brand of blood glucose meters and test strips) and other forms of patient support (such as access to advice from certified diabetes coaches). Roche is now collaborating with Novo Nordisk, the world’s largest insulin provider, to integrate dosage information from Novo’s “connected pen” dispenser with Roche’s digital therapy-management platform.

Novo Nordisk also made headlines in 2017 when it partnered with Glooko, a diabetes data-management platform, and IBM Watson Health, to further expand its existing digital health offerings, enabling patients with diabetes to use their smart phones to sync their blood glucose measurements and self-reported activities, and integrates the data with up-to-date clinical content and resources and the company’s personalized support program.

HealthPrize is notable among adherence-technology providers for forging relationships with other parts of the drug-delivery ecosystem, specifically West Pharmaceutical, which manufactures syringe components and full-fledged prefilled syringe systems, WestRock, a compliance-packaging vendor, and Noble, which develops patient-training and education tools.

“Patients who are able to get hands-on practice with auto-injection and inhalation devices not only gain experience and muscle memory, but increase confidence while reducing anxiety about administering their medications at home,” says Joe Reynolds, research manager for Noble. Noble’s Smart Injection Practice Pad is an error-correcting trainer that uses proprietary electronics, smart sensors, audio, LED and tactile simulation to make patients aware of their errors in real time.

In a recent longitudinal study, Noble studied three patient cohorts that received different training stimuli during the14-day “decay” period following initial treatment in the doctor’s office. Among the group that had received no training (only written instructions), 56% made mistakes on critical steps during self-injection. By contrast, those who received basic training (using a resettable autoinjector training device and injection pad plus written materials) with or without an interactive training video, the combination of practice and mental preparation resulted in 100% successful completion of critical steps.

“We’ve put a lot of thought into how we design our training devices, in terms of human factors engineering, how people learn, how they forget and more, so our devices can most closely mimic the patient’s experience at home,” says Reynolds. Today, Noble has more than 30 different training devices on the market (each married to a specific branded therapy), and works closely with many major device manufacturers (including BD Safety Systems and SHL), to develop training devices and materials to ensure proper injection of medications for chronic, acute or episodic (emergency) therapies.

Articles

The longstanding adherence problem is yielding to new technology

Improving medication adherence with technology

As the US healthcare system continues to shift its reimbursement model from volume-based (fee for service) to value-based (fee for outcome), the landscape for specialty care is becoming increasingly complex. At the same time, a growing number of innovative specialty drugs with novel mechanisms of action are receiving approval from the FDA—typically with small patient populations and high price tags.

At the intersection of the patient’s treatment and reiMany of these therapies promise to deliver significantly better outcomes for patients than existing treatments—but given their costs, they may also face resistance from payers, who are reluctant to reimburse for a product that is still viewed as unproven against less expensive alternatives.

In light of these challenges, more and more drug developers are negotiating outcomes-based reimbursement contracts— also known as risk-sharing contracts—with payers. Through these contracts, the drug is only reimbursed if the patient achieves certain clinical milestones.

According to a recent report from the Common Wealth Fund [1], pharmaceutical companies and payers have engaged in outcomes-based pharmaceutical contracts for more than 25 high-cost, brand-name drugs that treat heart disease, diabetes, osteoporosis, multiple sclerosis, rheumatoid arthritis, hepatitis C and cancer.

One of the first well-publicized examples is Harvard Pilgrim’s 2017 outcomes-based agreement with Spark Therapeutics, for Luxturna, a one-time gene therapy treatment for retinal dystrophy which costs upwards of $850,000.

Per the contract, Spark Therapeutics would measure patient sight improvements at 30- to 90-day intervals, and after 30 months on therapy. The contract calls for the drug’s efficacy to be measured using clinical benchmarks for light sensitivity. If a Luxturna treatment fails, then Harvard Pilgrim would receive a rebate from Spark.

Another high-visibility example involved sacubitril/valsartan (Entresto), a drug introduced by Novartis in 2015 to treat congestive heart failure. Novartis created agreements with multiple payers, including Harvard Pilgrim, Cigna and Aetna, in which it committed to reduce the price of Entresto to payers, if the rate of heart failure hospitalization of patients taking the drug were to exceed a pre-specified threshold. In return, Entresto was given preferred formulary status.

Other well-known examples of outcomes-based contracts include Amgen’s evolocumab (Repatha), a low-density lipoprotein (LDL) cholesterol-lowering drug with a list price of over $14,000 per year, and Eli Lilly & Co.’s GLP-1 drug Trulicity at around $7,500 per year.

As more risk-sharing contracs are adopted, the pharma industry has greater ownership for the outcomes patients achieve when taking their therapies. As a result, pharma companies are looking beyond the first prescription fill and asking how they can help patients strictly adhere to therapies, and how they can support patients in reaching both short-term and long-term clinical outcomes.

That’s where patient services hubs are playing a bigger role. While still evolving, the patient education and adherence support programs managed by hubs have been clinically shown to improve outcomes. In one recent example, a 2017 ISPOR poster presentation [2] delivered by Cardinal Health Specialty Solutions demonstrated that one hub’s implementation of a customized Medication Therapy Management (MTM) compliance program helped drive medication possession rates (MPR) among patients taking an oral oncolytic therapy for leukemia. Among the 144 patients who participated, 62% reported MPRs above 80%, compared to 42% of patients who didn’t receive the MTM intervention from the hub. For the most adherent in the group, 46% reported MPRs above 90%, versus just 28% of patients who did not receive the MTM intervention.

In addition, health care providers recognize the positive impact these services can have on outcomes, when they’re implemented well. In a 2018 study conducted by Cardinal Health Specialty Solutions [3] among 57 medical oncologists/ hematologists, 89% of those surveyed indicated that they agreed that patient support services such as education and adherence programs (including brochures, videos or reminder call programs) can help improve outcomes for patients managing chronic diseases.

In that same study, 38% of respondents said that pharma-sponsored education and adherence programs are essential, although those respondents also indicated that they felt these programs can be highly variable in regard to ease-of-use and effectiveness. The same percentage of respondents indicated that hub services programs, as currently available, would need to be significantly improved in order to be valuable. Not

surprisingly, these results indicate that the patient services hubs that are able to make their programs clinically beneficial for patients and those that demonstrate the most consistent ability to support improved patient outcomes, are the most likely to earn traction in the market.

As risk-based contracts become more common, many pharma companies are looking to their patient services hubs to play a significant role in helping patients achieve the clinical milestones, and in collecting data to support the fulfillment of the contract. Below are three ways hubs are changing in the era of value-based care.

Delivering more frequent patient follow up

Historically, it has been difficult for the pharma industry to track patients taking their medicines because they have had limited

access to patient data. With the emergence of outcomes-based contracts, tracking patients has become a requirement for reimbursement—and drug companies are leaning on their hubs to drive these efforts. Hubs are being asked to provide clinical support services to patients at 30, 60 and 90 day-intervals following the initial prescription fill to provide education and adherence support. It’s this more frequent contact that enables outcomes data to be more frequently be collected and reported in aggregate back to the payer.

In the effort to collect more complete patient data, hubs are also being asked to look beyond pharmacy dispensing data, which—by itself—can paint an incomplete picture of patient persistency. Simple changes like a patient filling a prescription at another pharmacy can result in lost compliance data – and when value-based contracts are involved, that lost data can directly lead to lost reimbursement dollars. Additionally, approximately 20% of Americans change insurance plans annually, which can also lead to disruption in data collection. Tracking patients as they switch pharmacies and plans requires the kind of tailored approach hubs specialize in. By reaching out directly to patients, hubs can help pharma companies to close the data gaps and better identify when patients are at risk of falling off therapy.

The collection of patient data is key to the successful implementation of outcomes-based contracts—and hubs are ideally positioned to collect it. Beyond simply documenting whether a patient is still taking their medication, hubs can collect information on disease-specific and general quality-of-life details, patient satisfaction scores, disease symptoms, adverse events, depression scores and other measurements for a health utilities index. Today, many hubs can also incorporate lab and diagnostic test results into their patient databases, enabling pharma companies to construct a more complete picture of the patient experience.

Having a robust data management system is key to the hub’s ability to support outcomes-based contracts, particularly as each contract is different and may require unique data sets. Clarifying the actual data stipulations is critical before embarking on a new outcomes-based contract. Not only is it important to determine which outcomes will be tracked, it’s also imperative to consider factors such as how long patients will be followed, where the data be stored, who can access the data and how the data will be analyzed.

Selecting a hub services provider that focuses the team on outcomes and data gathering is another important consideration. Using a quality assurance (QA) tool that monitors how successfully hub teams track results and engage patients reinforces the importance of such initiatives. A strong collaboration between QA and Training further cements the value each hub brings to the process.

Generally speaking, patients engaged in their own healthcare are more compliant, and compliant patients experience better outcomes. As risk-based contracts become more prevalent, keeping patients engaged in managing their own health continues to become more important. While healthcare providers including pharmacists, physicians, nurse practitioners and nurses play a central role in answering patient questions and providing education, hubs are increasingly able to support patient engagement by leveraging their clinical teams to conduct proactive patient outreach and provide informed responses to incoming patient questions.

With medications that can cost six digits for a single dose, the financial stakes in value-based contracts are high – and all players in the healthcare system are eager to see rapid results.

Patient services hubs—with their primary focus on patient support—are well positioned to develop user-friendly, effective processes for providing patient education and support services that drive compliance and effectively leverage the mountains of patient data that is collected in the process.

https://www.commonwealthfund.org/publications/issue-briefs/2017/sep/outcomes-based-pharmaceutical-contracts-answer-high-us-drug

https://www.cardinalhealth.com/content/dam/corp/email/ documents/2019/2019_02/cardinalhealth-oral-oncolytic-adherence.pdf

The Impact of Patient-Centered Care in Community Oncology Practice, November 2018, Cardinal Health Specialty Solutions

Tara Herington is VP of Cardinal Health Sonexus™ Access and Patient Support where she provides strategic direction on hub offerings to address business challenges and drive improved patient access. She began her career as a registered nurse and transitioned to the pharmaceutical industry, leading patient services, reimbursement and copay support

A changing role for hubs in collecting critical data, raising adherence

The outcomes-based reimbursement environment

Welcome to our 5th annual report on patient support / hub services. Pharmaceutical Commerce has been highlighting this part of the life-sciences service universe for two reasons: one trivial and one profound. The trivial reason is that the topic fits so well with our publication’s focus on commercialization. Commercialization is something that, most of the time in media, gets talked about as the activities around sales reps knocking on physicians’ doors, and direct-to-consumer advertising. In our worldview, distribution channels, trade relations, and patient medical and financial support are equally important to commercialization, if not more so. We’re proud to be the exponents of this view.

The more profound reason—and the one you should pay attention to—is the impact of patient support and hub services on the delivery of healthcare. Healthcare, in the US, has become a more structured service, as providers and payers struggle with the its ever-growing cost. The most obvious example of this is the requirement, upon contacting a doctor’s office or entering a hospital, is to be asked about insurance plans. Ditto with picking up prescriptions at the pharmacy. So much of healthcare is gated: if you have the right passkey, you’re in; without it, you’re knocking on doors and hoping for the best.

Patient support is something that the pharma industry offers, mostly out of its own pocket, to help patients navigate the healthcare system. Part of this is simple necessity: the nature of many specialty pharmaceuticals today demands more complicated care of the patient, and the medical/hospital complex has adjusted to that poorly, if at all. And part of it is, clearly, self-serving the pharma industry’s own interests: getting patient on therapy sooner, getting better adherence, means more pharma sales ultimately.

What gets overlooked, though, is that the end result of all this is better outcomes for patients, and a better experience in dealing with the rigors of many drug-based therapies. The care coordinators at the hub providers described in this report (and the many more that work at pharma companies directly) are a helping hand, and the benefits of their services are documented in the better outcomes patients are experiencing.

By our estimate, there are now some 10,000-20,000 care coordinators employed directly or indirectly by the pharma industry, taking care of patients every day. (It’s kind of amazing that there appears to be no professional organization for these workers—an indicator of its lack of recognition.) We salute these unsung heroes of modern healthcare. We’re also excited about the technology that hub providers are bringing to the patient journey. Together, the two activities are bringing healthcare into the 21st century.

Uplifting the patient care continuum

There are at least 26 bills, roughly evenly split between the House and Senate, already filed in the 116th Congress that point at the pharma industry. And because there is an unusual consensus among Democrats, the White House, and most Republicans, to address drug pricing and reimbursement policy, there is a strong likelihood that some of this legislation will pass. The fact that various Democrats have declared their presidential intentions (along with some Republicans who would potentially go up against President Trump), only adds gasoline to this simmering fire.

Introducing bills is, of course, merely the first step in the legislative process, and some of these bills were floating about in the previous Congress. One—the CREATES Act that would clear away the spurious practice of withholding innovator’s comparator drugs for when a generic manufacturer is attempting to win FDA approval—is likely to pass in some form; the practice is a black eye on the pharma industry and wouldn’t, itself, dramatically change overall drug pricing.

According to press reports, the pharma industry (one of the powerhouses in Washington lobbying) is not sitting idly by. For years, it has fought against drug importation, and is carefully aligning itself with President Trump and his HHS Secretary, Alex Azar, in their push to change the rebate practices of pharmacy benefit managers. But the issue that is likely to garner the most headlines during presidential campaigning—various versions of “Medicare for All”—is, surprisingly, something that PhRMA and BIO finds themselves in alignment with insurance companies, hospital administrators and many medical associations: They are against it. These groups are all part of a relatively new organization, the Partnership for America’s Health Care Future, and their basic stance is: Fix what needs fixing in the Affordable Care Act, but do not expand Medicare to a wider group of covered lives.

This stance is counterintuitive, in that the pharma industry was an early supporter of ACA—whose primary purpose was to expand governmental healthcare insurance. After Sen. Bernie Sanders announced his candidacy in February, the Partnership’s executive director, Lauren Crawford Shaver, commented, “Whether you call it Medicare for All, Medicare buy-in, single-payer or a public option, when Americans learn the facts about government-run health care proposals, majorities oppose it.” In broad terms, the Partnership will argue that there’s a necessary choice between Medicare for All and private insurance, but that belief itself will be argued over.

Presidential campaigns only magnify an already intense debate

Healthcare and drug policy take center stage in Washington

The business of providing outsourced patient support and hub services is growing in lockstep with the growth of specialty pharmaceuticals, which are now approaching nearly half of pharma spending in the US. Specialty pharmaceuticals are not only growing in number, but also in cost, with the latest cellular and genetic therapies reaching a half-million dollars or more for a dose.

Even so, the hub business is extraordinarily dynamic, with businesses merging at the same time as others are opening their doors, with competing loci of patient attention from specialty pharmacies and from service providers to healthcare systems, and—crucially—a riskier element of regulatory compliance, as government regulators look more closely at industry practices. Yet another factor is the ebb and flow of pharma’s own interest in owning the patient experience, through in-sourcing some or all patient support activities.

Through it all, the outsourced hub providers are expanding staff, facilities and technology assets, and expanding the range of their offerings to manufacturer clients. Even though only a handful of the buzz-generating cellular and genetic therapies (CGTs), such as Gilead’s Yescarta and Novartis’ Kymriah, have reached commercialization, some hub providers are already building service bundles in anticipation of this next wave of therapies.

“Ten or 15 years ago, the specialty pharmaceutical space was a handful of drugs costing $5,000 per year so, and the rest were mass-market products. Now, you can’t just say “specialty,” because the market is segmenting and realigning—there’s a real transformation occurring in the industry,” says Shawn Seamans, president of the newly reorganized McKesson Life Sciences unit, which includes their traditional hub and patient-support offerings. According to Seamans, different specialty pharma products call for distinct patient-support offerings, ranging from automated patient contacts to healthcare services delivered in the patient’s home.

Most hub providers have claimed highly individualized support programs; as Scott Dulitz, VP of strategy for TrialCard puts it, “if you’ve seen one hub, you’ve seen one hub.” But now, according to Seamans and others, the industry will see different categories of patient support providers, with competitive offerings more attuned to sectors of the specialty pharmaceutical arena.

Here are some of the business actions that have occurred in the past 12 months or so:

 There have been at least five rollups in recent months: Eversana now incorporates the assets of Dohmen Life Sciences Services and Triplefin (a former unit of HD Smith), among other acquisitions; CareMetx has acquired Biosolutia (another hub provider) along with Virmedica, a provider of electronic benefit verification (eBV) services; ConnectiveRx, formed in 2016 from a variety of patient service assets, added a consulting firm, Macaluso Group in 2018; and McKesson has completed its integration of RxCrossroads, acquired in 2017 from CVS Health.

 Cardinal Health Specialty Solutions, which acquired the hub provider Sonexus Health several years ago, has opened an additional facility in Louisville, TX. Trialcard added a facility in Oakland, CA. Asembia has added a fourth location, Trevose, PA, to its other sites of patient support centers. In addition, ConnectivRx is about to open its own noncommercial pharmacy, as is CareMetx.

 The new year has seen the launch of a new hub provider, Diligent Health Solutions; and it’s roughly the one-year anniversary of another entrant, PharmaCord.

It’s worth noting that all these organizations, as well as the hundreds of pharmacies now accredited as specialty pharmacies (SPs), operate in the spaces around the major pharmacy benefit managers (Express Scripts, CVS Health, Optum and Prime Therapeutics [partnered with Walgreens]), each of which has its own large mail-order pharmacy, and offer some level of patient support. The PBM channel dominates in market share; however, many pharma companies will include other pharmacies in their distribution network, and, for some rare diseases, use an independent specialty pharmacy exclusively. The general rap against the PBM patient-support services is that they occur in the context of the PBMs hardball negotiating over drug prices and rebates; and a fraught dynamic is set up between the manufacturer, the PBM, and the insurer over who gets medications, and how they’re reimbursed.

“There’s never been a better time to provide the industry with the right people and the latest technology to best serve their needs and those of the people they serve—patients, caretakers, and health care professionals,” says Mary Anne Greenberg, president of Diligent Health, upon launching her company in January. Greenberg, was former president, North America, of Ashfield, a global pharma services firm.

In that both hub providers and SPs interact directly with patients, there is a natural competition between the two, at least when it comes to fees for services that the pharma industry might pay. Hub providers have a more or less clear pathway in this regard, since they are simply acting as agents of the manufacturer; the relationship with SPs is less easy to navigate, in part due to compliance issues regarding bona fide service fees (more about this later). The leading independent SP, Diplomat, set up a “firewalled” hub service, Envoy Health, in 2014 specifically to provide bona fide services separately from its SP. (Diplomat also set up its own PBM, CastiaRx, a year ago, thus positioning itself more strongly against the big PBMs; now that those PBMs are for the most part divisions of insurers, this aspect of healthcare delivery is going to be different, in uncertain ways, going forward.)

“We’ve seen the patient-support services growing at other SPs, but if I were a manufacturer, I’d look under the covers to ensure there are firewalls because there have been so many legal actions it would be reckless not to do so,” says Derek Cothran, SVP at Envoy Health. Relative to a free-standing hub provider, Envoy benefits from the technology platforms operating across the company, and from the financial backing that the parent provides, he says; these translate into higher levels of service for patients and, ultimately, the manufacturer clients.

There’s no regulatory requirement to set up a separate business unit at an SP for patient services, as long as what the service provider does passes regulatory muster, and this is, in part, how Senderra Rx, a Dallas-based SP that now operates nationally, with other locations in North Carolina and Michigan. “We compete against hubs for patient-support services,” says Win Purifoy, CEO. “We believe that because we have a more robust service offering than hubs, and because we get the prescription first, we will win on this front.”

Bob Wilburn, Senderra Rx’ SVP, phama business development, elaborates on Senderra’s approach: “Senderra is physician-centric. While we can provide a range of prescription products, we specialize in high-value drugs for rheumatology and some related conditions. A provider who works with us sends the prescription, and we take care of everything else—prior authorization, reimbursement and patient followup. We take care of all of this, so that the physician can focus on taking care of patients.” He adds that the company “will stay within its lane” of the specialty products and specialty physicians that represent its core value.

Overall, hubs and SPs are accustomed to working cooperatively with each other; “There’s room for both,” is how numerous industry sources characterize the relationship. Many hub providers have a so-called a noncommercial (“closed door”) pharmacy to handle free product dispensed to the indigent, or for fast-fill programs that provide a drug even as benefit verification or prior authorization are being worked out; but for the most part, they stay away from dispensing. On the SP side, the business model is mostly to make revenue as a percentage of the dispensed medication, but to provide patient followup to the extent that refills are part of the therapy. Being able to keep patients on therapy is a concern of the hubs and the SPs, and, ultimately, the manufacturer.

A bigger challenge than SPs to hub providers is, potentially, the desire by manufacturers to keep some or all of the service in-house. Hubs have grown as manufacturers recognized the risk of HIPAA violations, and to keep arm’s length from financial assistance like copays or free goods; but with ultrarare diseases, each patient becomes almost its own project. Manufacturers can also take technology-driven measures to de-identify patient records, even when dealing with patient populations as a whole.

Helio Health, a compliance and auditing consulting firm that specializes in patient support activities, did a survey last year across 28 pharma companies on the mix of insourced, outsourced and SP-sourced services (Fig. 1). Results show that hub providers are most frequently used to manage patient onboarding, benefit verification and prior authorization, but also across the growing range of all types of services. Insourcing was highest for patient education, patient assistance programs and copay assistance. SPs’ involvement was highest for benefit verification and prior authorization.

“The trend is for activities involving financial support, such as copay programs, to be managed by the outsourced provider, while patient education might be handled internally,” says Minna Bak, senior manager at Helio. “The overriding question is, what is a bona fide service as defined by HHS regulations? There are safe harbor arrangements where a service can be offered by an independent third party, but the appropriateness of this is determined almost on a case-by-case basis.”

Regulatory actions involving patient support were headline news in 2018, most notably in California, where the state insurance commissioner, Dave Jones, drafting on a whistleblower lawsuit, filed an insurance fraud compliant against AbbVie, alleging $1.2-billion in fraudulent payments for its Humira biologic by private insurance in the state. Besides “classic kickbacks” (as the commissioner’s news release put it) for dinners and gifts to prescribers, the suit claims that AbbVie “nurse ambassadors” (as AbbVie calls them) influenced patients’ use of Humira while downplaying side effect risks. Further, says Jones, “At no cost and considerable gain to the physician’s office, AbbVie nurses provide pharmacy and insurance authorization assistance, open enrollment resources, paperwork help, advice on insurance products, and other services, all of which provide a substantial value and save physicians’ time, money, and resources.”

Calling it the “largest health care fraud case in department history,” the state wants to claw back the $1.2 billion (there might also be a multi-billion-dollar multiplier penalty). AbbVie has not responded publicly to the filing, even though its stock took a hit the day the action was announced. What is notable about the fraud claims is that, on the surface, all these actions are conventional and widely-practiced components of hub programs.

In December, related whistleblower cases were the subject of an unusual Dept. of Justice motion that federal courts should throw out 11 whistleblower suits that were brought by individuals supported by an organization, the National Healthcare Analysis Group, in district counts around the country. According to a Forbes article, that group is “limited liability [company] set up by investors and former Wall Street investment bankers” expressly to win False Claims Act settlements. After examining the cases, DoJ found that “the allegations to lack sufficient merit to justify the cost of investigation and prosecution” and should be dismissed.

The outcome of both the DoJ motion and the California suit remain to be seen; if nothing else, the actions highlight how carefully manufacturers need to operate in their interactions with providers and patients. There are multiple safeguards that manufacturers, and their outsourced hub providers, can do to minimize the risks of regulatory issues, according to Helio Health and others in the field. The primary concern is to restrict protected health information (PHI—an official category of information as defined by HIPAA rules) to where they belong, and use a variety of de-identification technologies in cases where patient data is aggregated, such as for monthly reports. Manufacturers can ensure more-favorable consideration from regulators simply by the outsourcing process itself (on the assumption that PHI doesn’t pass from the hub to the client).

The other major regulatory concern is almost anything touching financial or reimbursement matters involving patients, under federal and state anti-kickback statutes. According to Helio’s 2018 survey, 55% of manufacturers use a third party to manage free goods dispensing; however, a sizable fraction of them do not monitor the programs’ actions, and an even larger proportion do not audit results (monitoring and auditing being two defensive measures manufacturers can take). Worrisomely, a significant number of Big Pharma names—including Alexion, J&J, Pfizer, Lundbeck’s US subsidiary and United Therapeutics—have made multimillion-dollar settlements with DoJ over patient assistance allegations, some of which involved financial support, funneled through charitable organizations, for patients on Medicare.

Lash Group, the AmerisourceBergen unit that was one of the pioneering firms in the patient support field (see interview on p. 16), puts a significant effort into regulatory compliance as part of its overall quality control, according to Tommy Bramley, Lash president. Fully 100 of its more-than 3,000-person staff operates within a Quality Center of Excellence, and that group is segregated physically from the rest of the staff. Quality checks include periodic monitoring of patient interactions, and extensive training on care coordination and regulatory compliance, says Bramley.

A near-universal objective of organizations involved in patient support is to collect more data, and to perform more advanced analytics on that data, to achieve accurate, actionable results for patients and health outcomes. Some of this is coming from the current trend toward value- or outcomes-based contracting—someone needs to keep score if a manufacturer’s products are to be reimbursed based on improved health. But the data/analytics drive was accelerating even before value-based contracts appeared. Hub providers are scored on how well they are managing patients; hub providers are looking to sophisticated behavioral analyses to both minimize the need for, and cost of, human intervention in patient care, and to ensure that, when that intervention is called for, it is being directed in a meaningful way.

“There’s a need for automating enrollment and reimbursement tasks, and our focus is to move away from the need for significant human capital and balancing that with automation,” says Shabbir Ahmed, chief commercial officer at CareMetX. “We’re taking a very deliberate approach to automation, with more granular programs in adherence and compliance, and using analytics to provide intelligence back to those who are touching the patient.”

Quite a few hub providers contacted for this report have built or installed a relationship-management system based on Salesforce.com’s platform, which is then customized with workflows and dashboards to meet the hub’s requirements. Cardinal Health worked with Converge Health, a unit of Deloitte, to build its platform, ConnectSource, all of which is standing on the SalesForce platform. “ConnectSource has been a big lift for us,” says Tara Herington, VP, Cardinal Health Sonexus Access and Patient Support. Besides providing significant internal advantages—being able to access data, generate reports, initiate analytics and the like—the system provides a fast way to onboard clients. “We had a client who had to start up a program in less than 30 days, and we were able to turn that around,” she says. That timeline would have been impossible in the recent past.

Unusual among hub providers, ConnectiveRx not only has a proprietary IT system that it touts, but it also licenses the software out to pharma companies that insource their patient support activities. Through its acquisitions, the company has a long history of managing copay programs and providing medical information directly to physicians (The Prescribers Desk Reference is a longstanding go-to resource for prescribers) and with its latest acquisition of the Macaluso Group, can provide comprehensive reimbursement support for buy-and-bill prescribing, something that many physicians’ offices depend on. “We built our software to be very flexible and modular,” says Josh Cordle, SVP of product and client solutions. “A biopharma client can turn on and off different features, or manage a hybrid program.” Called BrandHub, the platform integrates product procurement, inventory management, trade support, patient access EHR integration, prior authorization, among other features. “Biopharma companies want to own the patient experience, and need an infrastructure to do that,” he says.

Other SalesForce-based systems in the industry include Lash Group’s Fusion platform, Health At Work, Conduent’s system, and the in-house system for Diligent Health Solutions. McKesson’s Seamans says the company is on a pathway to unify the data-generating platforms of its various units (RxCrossroads, Biologics SP, and its existing Specialty Health and Patient Relationship Solutions units); SalesForce.com will be the underlying platform. One plus for these platforms is that they integrate well with SalesForce platforms in use at pharma companies themselves.

However, other hub providers are sticking with home-grown systems, claiming to provide a better client experience by avoiding “commoditized” platforms. Envoy Health uses a home-grown system called eNAV, which Cothran says is geared to rapidly develop content (i.e., the care program designed for a specific drug, and then the patient data gathered by it). TrialCard touts the fact that its proprietary system has just passed ISO 27001 certification, a fairly rigorous process, reviewed by an outside auditor, that can provide the highest levels of privacy protection for patient data. PharmaCord’s platform, called CORsend, was developed with a global IT services company, EXL; the two are partnering in offering healthcare data management services to phama.

Mention of EXL brings up another pathway toward comprehensive data management: use of a third-party data aggregator that collects data from the hub provider and/or SPs, and combines it with other data sources (which the pharma client might possess) to provide a more complete picture of the patient journey. Such companies include ProMetrics (now a unit of Symphony AI), LiquidHub (now a unit of Cap Gemini), Integrichain, ValueCentric and Shyft Analytics (now a unit of Medidata Solutions), among others. (Healthcare data aggregation is a fast-expanding field in healthcare generally; the abovementioned companies have experience in working directly on commercial specialty-pharmaceutical projects.)

“Digital enablement” is the term Siddhartha Sharad, GM for Pharma and Life Sciences at Conduent, uses for his company’s push into data aggregation. The company, which was divested from Xerox in 2017 (not long after Xerox purchased the Patient Solutions hub business of what was then inVentiv Health), provides direct patient support, as well as enterprise-level patient-services aggregation, including linking ordering processes for drugs and medical procedures at pharmacies and health systems. Fifteen of the top 20 pharma companies are current clients, either for commercial activities around patient support, or for clinical services and phamacovigilance. Sharad says that his group now has over 1,000 employees in locations around the world, working primarily for US and European patient-support programs.

In the recent past, these IT systems, whether within a hub itself, or from a data aggregator, were used to manage interactions with patients, and to report cumulative data to the client. The basic set of performance indicators included such data as:

but this list could rise to dozens more items. For some programs, pharma clients want daily updates in a push toward “real time” reporting. For a traditional limited-distribution specialty drug, which might involve a dozen specialty pharmacies, the hub would aggregate these data and report them to the pharma client. All that being said, the data-aggregation field is moving on, says Yash Shah, executive director at ProMetrics.

“Collecting the SP data is a given now,” says Shah. “Now the challenge is how to integrate these operational data with other data sources, such as claims data and EHR systems, or the ability to apply behavioral science algorithms on patient profiles, in order to predict adherence.” He says that some pharma clients have sought to perform such analysis even pre-launch (which would preclude obtaining operational data from hubs) as a way of predicting drug takeup patterns once the product is launched. ProMetrics has worked with pharma clients that bring clinical data they possess into the mix of data ProMetrics is gathering, in order to better understand patient journeys.

Mention of electronic health-record (EHR) data brings up what seems to be the front line in patient support analytics: integrating the entire patient journey, after initial diagnosis and prescribing, and through to multi-year outcomes. The fact that most health systems now have fairly complete EHR systems that generate (among other things) claims data and care episodes, will ultimately give manufacturers (and insurers and healthcare providers) a more complete picture of the effectiveness of a therapy.

There is, however, a mixed message currently about how possible, or how meaningful, the hub-EHR data integration can be. According to some sources in the patient-support field, EHR integration remains a bridge too far, due to interoperability problems among EHR systems, and the quality of data therein. Conduent’s Sharad, however, says that his company, through its role as a data services provider to pharma and to health systems, is able to fulfill this goal.

There are links between the services that patient-support providers deliver, and EHR systems, but most of them are oriented toward providing coupons or medical information at the point of prescribing, in a doctor’s office (more about his later). The topic comes up, also, in the context of value-based contracts, something that more pharma companies are engaging in with insurers and health systems (see article on p. 18).

Another aspect of hub services that is rapidly evolving is also something that was routine mainstay in past years: managing benefit verifications (BVs), and handling the prior authorization (PA) paperwork that insurers impose when most specialty pharmaceuticals are prescribed.

All hub providers are positioned to handle BVs and PAs—it is a critical service to overworked, time-constrained physicians’ offices. Some have developed their own database of necessary forms and contacts with insurers; others rely on one of several companies that have grown in recent years to do the process electronically. One of the more prominent is CoverMyMeds, now owned by McKesson (but separate from McKesson Life Sciences).

CoverMyMeds has spent a decade, and the efforts of hundreds of staff, to create links to some 700,000 physicians and to 94% of the payer segment, according to Erica Conroy, VP of specialty at the firm. Physicians and pharmacies use the service for free; payers and manufacturers pay CoverMyMeds for the service.

For manufacturers, the main concern is to ensure that a drug, once prescribed, will actually be dispensed to the patient. PAs can vary from quite routine to quite complex, with rejections necessitating intervention. CoverMyMeds’ ePA processes cut out as much of the phone calling and faxing that goes on between physicians’ offices and payers, thereby reducing the effort to get the PA approved, and speeding up the time to a patient receiving the therapy. Notwithstanding CoverMyMeds’ (and others’) efforts, the company’s just published 

 reports that half of all PAs are still handled by faxes from doctors’ offices.

CoverMyMeds has since branched out to eBV services (much of which it says can be completed in real time), including a version called RxBenefit Clarity, which combines the patient’s benefit check with prescription-cost information from another McKesson service, RelayHealth. The combination enables prescribers to provide ready access to the cost of a prescription at the point where it is prescribed. (CoverMyMeds has extensive linkages into EHR systems, enabling convenient information access to the prescriber.)

An ePA competitor to CoverMyMeds tries to do that organization one step better by ensuring that the PA is completed and (to the extent that this is controllable) approved: PARx Solutions. Dan Rubin, CEO, says that his company’s advantage is to take the PA process out of the doctor’s hands to the extent possible. “PAs can be very confusing to doctors; we inject ourselves between the prescriber and the payer, reviewing the submission, ensuring its accuracy and submitting it.” The result, he says, is a higher percentage of successfully approved PAs, and ultimately, a higher proportion of patients on therapy.

PARx is also notable for partnering with ZappRx, a company that is providing automated tools for handling PAs and other tasks, but is doing so one therapy class at a time. PARx provides the ePA resource for ZappRx customers.

A competitor to CoverMyMeds in the eBV arena is Virmedica, now a unit of CareMetX. Virmedica’s eAccess Provider solution, geared toward serving specialty pharmacies, speeds up the benefit investigations process within the pharmacy’s workflow. With CareMetX opening up a noncommercial pharmacy, the company will be able to provide starter prescriptions even as the eBV and ePA processes are being carried out.

The goal of producing meaningful data is driving industry progress

Pharmaceutical Commerce - March 2019

Improving medication adherence with technology

The outcomes-based reimbursement environment

Uplifting the patient care continuum

Healthcare and drug policy take center stage in Washington

Patient support / hub services continue to evolve