Value- or outcomes-based contracting is the buzz of the moment in specialty pharmaceutical marketing. Interest in it is driven by the (typically) high cost of the therapies, and payers’ desire to ensure that they’re getting something for the money expended, In the single-payer systems in Europe, generally speaking, these issues are addressed by health technology assessments; in the US, with its decentralized, pay-as-you-go practices, the value-based contract (VBC) is becoming a viable practice.

Essential to a rational VBC is the ability to track the outcomes or continued health of patients. Where does this outcomes data come from? For the most part, it seems that the payers or health systems engaged in VBCs are using claims records and data from electronic health records (EHRs) to verify outcomes. EHR data figures in many of the prominent efforts to generate real-world data and real-world evidence (RWE) as well.

So far, all good. There are limitations and constraints on RWE from claims and EHRs (mostly, because they’re set up for handling reimbursements, and not for outcomes directly); lots of smart people are working on that. But here’s the twist: apart from the extraordinarily expensive cell/gene therapies, most RWE work seems to be focused on clinical trials, both leading up to and after a drug’s approval. This is due, in part, to the 21st Century Cures Act, which opened the door wider for FDA to consider observational data (which includes RWE) as part of a drug’s application.

We would like to highlight another source of RWE, and one that could play into a much wider range of VBCs: the pharma industry’s hub and patient-support providers. As the 

 details, hubs routinely gather data from patients. In some cases, they are in touch with them daily, not just for medical data, but scads of data on patients’ moods, emotions and concerns.

Surprisingly, all of the outsourced hub providers interviewed for the Overview say that collecting data for VBCs is “not here yet, but coming soon.” We suspect that the reason for this is pharma companies’ siloing of the patient data in commercial or market-access functions; over in the R&D sector, researchers are unaware of the value of these data (or, perhaps, simply don’t recognize it as research-grade).

 from the Institute for Clinical and Economic Review (ICER) is that RWE will become a more central part of their analyses. The RWE contractor that ICER will work with runs a blog on its website named “The Evidence Hub.” That “hub,” and all the RWE researchers, would do well to connect with the actual hubs gathering valuable data every day.

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Hub providers can be the source of the best real-world evidence

Download the 2020 Patient Support Vendor Directory.

2020 Patient Support Vendor Directory

CareMetx was founded in 2011 by two longtime industry executives, Bob Dresing and Mark Hansan, who started in the patient support field in the 1980s. Dresing is now chairman; Hansan is CEO. In 2018, it acquired VirMedica, a leading e-services company in the Hub industry, and BioSolutia, an award-winning Hub company in Lake Mary, FL. Today it has five offices and operates as a national patient access company offering turn-key solutions, proprietary e-services and collaborative patient support programs. Most recently, it launched a new business unit, OutcomeRx, designed to provide holistic solutions for new personalized medicines, such as cellular and genetic therapies, that require innovative value-based contracting between manufacturers and payers.

 sat down with Hansan; here’s what he had to say about the evolving hub services/patient support arena.

1. What is the CareMetx origin story? How did you come to concentrate on this part of the healthcare ecosystem?

I was very fortunate to start my career at the Cystic Fibrosis Foundation, just after Bob Dresing became the president and CEO. Bob had a son with CF and he focused the organization on raising money to cure the disease. Over the next 10 years we achieved some remarkable accomplishments including establishing a research framework leading to the discovery of the CF gene in 1989, funding early stage biotech companies for drug development and gene therapy and creating the first disease-specific specialty pharmacy in 1988.

While operating the pharmacy, we saw first-hand the challenges patients and their families faced in accessing the drugs they needed. This was a time of pre-existing conditions, lifetime caps and HMOs and as a result the uninsured rate for CF patients exceeded 15%. This led Bob to push the Pharmaceutical Manufacturers Association (then PMA; now PhRMA) to encourage all member companies to offer patient assistance programs. PMA even dedicated their first PAP guide to Bob for his leadership.

While we worked aggressively to ensure every patient had insurance whether private or government and got the uninsured rate to below 2%, we also witnessed the affordability challenges that all rare disease patients faced. I was inspired and motivated to do something about this issue. When you know the patients and their families, you have a clear view of what they go through just to stay healthy. Why create even more stress in their lives by placing obstacles that create access challenges?

Our response at that time led us to found TheraCom, one of the original Hub providers, in 1996. That company was acquired in the early 2000s, and we subsequently founded CareMetx (after trying to buy TheraCom back) in 2011.

CareMetx is based on two core beliefs — first, the traditional Hub business lacked the technology necessary to improve automation that could reduce the manual processes, and second, there would be an increasing need for payers and manufacturers to move towards more value-based contracts. The initial tagline — “From Intake to Outcomes”—reflects our commitment to our beliefs about the Hub industry.

2. What is CareMetx’ stance in the market in terms of services and capabilities? What are the company’s competitive advantages?

In my opinion, this industry is experiencing a shift from the analog or traditional Hub to a digital-hybrid Hub model. The stakeholders involved in our industry – and healthcare generally – are becoming more digital and reliant on data to make decisions. Partnerships are expanding providing the industry with access to better data capture methodologies and analytics. Tools like APIs are more pervasive and make it easier than ever to access the latest digital transactions. Even patients themselves are cutting the cord and going only mobile. These trends are transforming the Hub business model away from the legacy processes to a more nimble, customized, digital experience for patients, providers and even payers.

To answer the second part of your question about CareMetx, we are comfortable with our market position as a collaborative disruptor. We have all the traditional solutions of a modern Hub, but we have unbundled our proprietary capabilities and provide them to other Hubs, including internal manufacturer Hubs and even our Hub competitors. We have been in the business long enough to know the decision to move a Hub, especially some of the larger ones, is fraught with difficulties and even risk.

We want to minimize these potential issues by allowing others to connect to our tools. Don’t get me wrong, we would love to take over the entire Hub, but in some instances, the best way we can provide immediate value is to leverage our plug-in technologies and e-service transactions.

For the Hub programs we operate, we are proud to support some of the most innovative therapies on the market. We are comfortable with everything from the Hub-lite models to ultra-rare, high-touch Hub programs. Our roots as patient advocates have never left us.

3. What do you mean by “digital-hybrid Hub”? Can you explain more about that?

Sure. There are three aspects of a digital-hybrid Hub: a front-end digital experience; a pathway for manual intervention; and the high-touch services themselves. All of these assets, correctly assembled, create a value proposition in which providers enjoy a more seamless and responsive process, patients start therapy with fewer obstacles, and the manufacturer-sponsor can bring more services to their stakeholders at a lower fee structure than legacy Hub services alone.

A prime example is a pilot program where we are collaborating with a major specialty brand to place our e-service transactions directly into the providers’ EMR system, allowing them to complete an electronic benefit investigation while performing their daily tasks in their EMR. The digital assets support the front-end of the patient onboarding process where tasks such as consent/enrollment, benefit verifications, prior authorizations, and copay support can be performed wholly or partially by our e-service transactions. This not only improves the rate at which these tasks are completed and speeds the patient towards therapy, but it also creates a digital data stream that can improve all aspects of the operation.

When something in the digital process hits an obstacle, whether with an electronic benefit investigations or electronic prior authorization, the partial data from that transaction is captured and automatically sent to an integrated “off-ramp” where a team completes the transaction manually. Once completed, the full result is delivered in a digital format back to the requestor (for example, a provider). The end result enables a closed-loop digital experience for the provider. There is real value in the provider never having to leave their native workflow to reach out to a Hub for service. It’s efficient, cost-effective, and reduces the providers’ workload while moving the patient forward toward therapy.

4. In recent years, CareMetx has made a significant commitment to its IT platform. These days, many hub service providers are touting their platform, which leads to two questions: a) are the various platforms essential to the success of a patient services program? b) are there meaningful differences among the platforms?

This is another area we are disrupting because we think of ourselves as a platform company with technology for the entire process needed to support a patient from the beginning of treatment through achieving the desired outcomes. All parties are seeking a more nimble, digital, self-service model. Stakeholders interface with the platform through different user interfaces (UIs). These could be the EMR, apps, portals, partner software, laptops or maybe a mobile phone. The UI layer—wherever it resides—is now the front door for Hub interactions. Underneath the UI layer, you must have the right technology, tool or platform for whatever the stakeholder is trying to achieve. As an example, you don’t need a big CRM platform to return an electronic benefit verification.

As to meaningful differences among Hub platforms, I would say at this point, there are a lot of strong options available. I believe the CRM system is important for the success of a Hub program, but more so from a flexibility, database, compliance and privacy perspective. We have a proprietary CRM platform called CareMetx Connect supporting all of our traditional Hub programs. But many of our e-service apps are deployed on our clients’ and even some of our competitors’ Salesforce platforms. For CareMetx, we have partnerships for clients that are building their own Salesforce environment. Again, we look at our technology platform through a wide aperture to ensure the right combination of technology and services to produce an optimal result for providers and patients.

5. You have mentioned insource, outsource, hybrid, hub-lite and traditional Hubs. What’s your position on how best a pharma company should structure its programs?

This question has been asked for the last two decades and the answer remains the same—it depends. What I mean is the manufacturer needs to first decide whether they want to take on the responsibility for an internal Hub. There is no doubt we are seeing many major manufacturers invest in an internal Hub with the goal of owning their data and system infrastructure. In doing so, they are able to better define workflows, specify which technologies add value for their brands and improve access to program data and performance metrics.

However, internal Hubs also face a range of competing priorities within a manufacturer and as a result, compliance may be challenging. In fact, executives from one manufacturer were just convicted in part because their internal Hub fell out of compliance.

Structuring a Hub program begins with the product driving the program strategy and understanding the dynamics of the disease including the patient and their providers. We believe the digital-hybrid model with its combination of e-services and complementary manual support systems holds the most promise and value in today’s marketplace.

There is no longer a one-size-fits-all solution. Manu-facturers want significant input and more control over how their brands are accessed and consumed. That’s why our technologies have been designed to support a variety of use cases. For example, we have developed a family of “bolt on” apps around our most common e-services transactions that enable the trans-action to be quickly activated with-in a manufacturers own CRM Sales-force environment. These apps deliver a turn-key product in that the workflows, user interface, and connectivity are already enabled in the solution.

6. What’s your take on the current level of per-formance of pharma com-panies in running their patient-support programs? What could the industry be doing better?

Many manufacturers do an outstanding job running their patient-support programs. I think this is due in part to executives realizing the importance of understanding the challenges the patient is facing. Also, manufacturers know access and affordability can be a brand advantage or disadvantage but patients are sophisticated and know whether there is a genuine commitment by the manufacturer. I believe this is why we are even starting to see C-suite level roles focused on the patient.

In terms of what they can be doing better, well, I think we all can do more to eliminate the access and affordability barriers which still exist. Hubs remain viable because considerable process friction remains in healthcare related to access and delivery of specialty medicines. Isn’t it time to solve some of the foundational problems? For example, CareMetx has been working for the past few years to advance a collaborative agenda that brings together manufacturers and payers to find common ground to ensure no patient waits for a life-saving treatment due to ineffective business practices or lack of information.

Specifically, we believe the increasing number of cell and gene therapies will accelerate the need for these new approaches. Is it realistic for a patient to have a copay when a one-time cell or gene therapy can cost millions of dollars? The industry is challenged to create a new model that is focused on meeting stakeholder needs. We are embracing this challenge. In 2019, we launched OutcomeRx, which is an entirely new business infrastructure that contemplates 360-degree solutions for manufacturers and payers. We’ve been pleased with the response from manufacturers and payers. The key to these efforts is a focus on payer collaboration in the form of innovative financial contracts that change how drugs are paid for by tying payments to predetermined clinical outcomes and long-term patient results.

7. So as you look ahead to the next decade, how do you see Hub services evolving?

Well, over 20 years ago we used to be called “hotline providers.” I doubt in 10 years, we will be using the term “Hub” to describe what we do. The name emerged due to the access challenges and the need to navigate issues and solve problems among stakeholders.

As access challenges are managed more effectively with technology, I believe the next focal point will be to ensure the patient achieves the results expected from the treatment. Frankly, outcomes matter more than ever. Manufacturers and payers will be working together to ensure the patient gets the appropriate treatment which achieves the desired results. And our industry will be right in the middle, helping all parties work in the patients’ best interests to get them healthy again. On second thought, maybe Hub is the right name, but in the next decade, we will play an expanded role and the name will have a different meaning.

A Conversation with Mark Hansan, CareMetx

Patient support services—supported directly or indirectly by pharma companies—have gone from a ‘nice to have’ feature to a ‘must have’ one in recent years. The reasons are not hard to find: the growth of specialty pharmaceuticals (now representing nearly half of the drug-spending dollar in the US); the complexity of treatment, requiring administration by infusion (for example), and genetic and diagnostic testing; and the high cost of those specialty products, making successful treatment a high-stakes commitment by patients and payers.

 has been tracking the evolution of this field for nearly a decade. In this year’s review, several trends have become apparent: more extensive digitization of the services, including mobile interaction; a stronger push toward in-field services (at patients’ homes, or at doctors’ offices); and a stronger drive toward providing so-called “end to end” services, ranging from patient acquisition, through drug dispensing, and on to followup care. That drive is compelling a wave of acquisitions, as various organizations build out a more complete suite of services. However, at the same time, new organizations are springing up, swelling the slate of service providers and service options.

All that being said, it remains remarkable how disparate the field is, with software developers, data aggregators, nursing and clinical education providers, and call-center case managers all playing a role. Pharmaceutical Commerce prefers the term “hub provider” for those organizations that bring all these and more services together; even so, numerous organizations shy away from the term. Meanwhile, specialty pharmacies continue to raise their profile with pharma manufacturers as a viable alternative to patient support.

One reason for the lack of clarity is how pharma itself looks on the topic. According to a broad survey by Helio Health, a consulting firm for commercial compliance, pharma companies differ in where patient support is located in the organization, including whether or not it is carried out internally. As Fig. 1 shows, “patient engagement” ranges from a dedicated corporate function to a subsidiary of brand/commercial teams, managed markets, or medical affairs.

That same Helio Health survey also provides revealing data on trends in patient support. Fig. 2 shows that outsourced hub providers are most heavily utilized for managing prior authorization (PA), benefit verification (BV) and reimbursement support/patient assistance programs and copay assistance—all areas with significant regulatory risks when not properly handled. the Helio Health data show an increasing involvement of specialty pharmacies (SPs) in these areas, as well as adherence programs.

As numerous sources interviewed for this report state, PA and BV support are “table stakes” for the patient support field. Automation in this area, as will be shown later, is a big driver.

A recurring theme among service providers is the goal of “end to end” solutions. The meaning changes slightly from one vendor to another; in some cases, it includes patient support in clinical trials; in other cases it includes providing field sales support. This comprehensive approach has driven significant M&A activity in the past year:

TrialCard, long known has a leading provider of copay support programs, acquired a closed-door pharmacy, PC Scripts in late 2018; it is now licensed inall 50 states to support free-drug programs and PAPs. In 2019, it acquired Rx Solutions, which offered both copay programs and support for clinical trial patients; Mango Health, a mobile-app developer in support programs, and Policy Reporter, a database developer of insurance and hospital formulary-practice data, used by pharma for market access research.

Eversana, already a conglomeration of distribution, channel management and patient services, added Cornerstone Research Group, a Canadian specialist in health economics and outcomes research (HEOR) in October, Alamo Pharma Services and BexR Logistix Telesales, for field sales, in May, and Seeker Health, an analytics firm for identifying potential patients for trials, in late 2018. It also opened a new consulting practice early this year, Eversana Consulting, and a marketing services agency, Eversana Engage.

Diligent Health Solutions, roughly a year old now, acquired WRB Communications, a patient-support call center, from Diplomat Pharmacy late last year; the acquisition returns a business that one of the principals of Diligent had sold to Diplomat in 2017. Diplomat itself, once the leading unaffiliated specialty pharmacy, was absorbed into Optum, one of the leading pharmacy benefit managers, earlier this year. (It’s also worth noting here that Optum also acquired another leading specialty pharmacy, Avella, in 2018.)

“End-to-end solutions provide benefits to the pharma sponsor as well as to the patient,” says Joe Abdalla, chief commercial officer at TrialCard. “It’s one point of contact for the pharma company, and the patient has a better experience from enrollment, financial support, dispensing and longterm engagement. The better experience from this can result in better outcomes.”

Bhaskar Sambasivan, President of Patient Services and Chief Strategy Officer at Eversana, notes that an integrated solution is a powerful benefit for small to mid-size companies, who might not have the investments needed to get products out of the lab. Eversana’s ability to provide complete commercialization support – innovative programs that combine patient access, distribution, 3PL, agency services, field solutions – end-to-end – is a game-changer, he believes.

Eversana scored something of a coup with a pharma client, Evoke Pharma, at the beginning of this year. Under a comprehensive, multi-year agreement, Eversana is taking on a full range of commercialization services for Evoke’s Gimoti, a nasal spray formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis. Evoke expects FDA approval in June.

Not only is Eversana handling patient support services after the drug is approved; it is also managing launch, distribution and sales. (As distinct from many companies involved in patient support services, Eversana has substantial—and recently expanded—third-part logistics facilities.) The company will receive reimbursement of certain costs and a percentage of product profits in the mid to high teens when Gimoti net sales reach a preset milestone. Eversana is also providing a $5-million revolving credit to Evoke, subject to FDA approval.

“Eversana has been built up over time to provide exactly this sort of integrated service to a pharma manufacturer,” says Greg Skalicky, chief revenue officer at Eversana. “Most small pharma companies, if they’re not planning to commercialize themselves, look either to out-licensing, or being acquired. We’re providing an alternative option.”

Connecting early with an emerging pharma company is also an objective of PharmaCord, a relatively young (two-year-old) hub provider based in Louisville, KY. “We’re willing to make bets [on an emerging company’s eventual success],” says Nitin Sahney, CEO, who says that the company’s current mix of clients is half existing brands, and half companies involved in product launches. “We’ve been getting engaged 12-14 months before launch.” That willingness to take on risk might be part of the company’s success: Sahney says the firm is on track to nearly double its staff (to 400) by the end of this year; it is also planning to double again by 2023—and is building its own operations center in Jeffersonville, IN, to accommodate that future growth.

Each of the Big 3 wholesalers has a comprehensive patient services function; AmerisourceBergen’s is arguably the oldest, centered on Lash Group, complemented by third-party logistics, specialty product distribution to physician offices, and specialty drug pharmacy. Cardinal Specialty Solutions is centered on its Sonexus hub service (acquired in 2014), along with specialty distribution services. McKesson Life Sciences was restructured in 2018, bringing together the acquisitions Biologics (a specialty pharmacy), RxCrossroads (a hub service provider) and existing businesses in patient support.

“My first job in McKesson in 2003—my first general manager job—was running our specialty pharmaceutical business … and candidly, we probably weren’t too relevant,” Brian Tyler, McKesson CEO, told attendees of the JPMorgan Healthcare Conference in January. “But over the course of the last years, we’ve very systematically built great franchises in these markets.” Tyler used the occasion to tout a new McKesson product, Access for More Patients (AMP), which combines patient support with the data and service offerings of CoverMyMeds (a $1.3-billion, 2017 acquisition). (More about AMP later.) Tyler noted that specialty is among the “key channels that we’re in and our key manufacturer service business that leverages off those channels.”

There’s no question that an end-to-end solution provides simplicity in project management; nevertheless, there can be significant reasons to pick and choose among service offerings from multiple vendors. For one, a manufacturer might choose to retain some part of the patient-service offering internally, while outsourcing other parts—the so-called hybrid solution. For another, pharma management might prefer a best-of-breed solution in several distinct areas of patient service.

And while most patient support vendors offer a broad range of services, some of them put an emphasis on one or another of their capabilities. “We do everything except field services,” notes Anthony Bianchini, VP and GM, pharmaceuticals and life sciences, at Conduent. As befits its historical roots as part of Xerox business services, the company has resources and expertise to process “millions” of documents or transactions across a range of industries, he says. That capability works well for handling patient enrollment, benefits verification and prior authorization paperwork—all key components of getting patients on therapy quickly. Conduent also has the advantage of being a global organization, thus able to conduct patient outreach in multiple geographies. And while it does have staffing in nurse educators for patient interaction, Bianchini touts the company’s IT system, branded as IntelliHealth, to digitize many interactions (for example, email or text), and then direct case managers more toward exception management.

Another benefit of Conduent’s broad reach, says Bianchini, is its substantial business with healthcare providers. The company is developing a network that would quickly link patients who need diagnostic services (a common element in dispensing specialty pharmaceuticals) with the laboratories that provide such testing. “Driving service costs down, while providing a better patient experience,” he sums up.

The flip side of that capability, perhaps, is seen at Covance, which has long experience in patient support in both research and clinical settings. “We have field teams for clinical education, reimbursement support at doctors’ offices, and even field training of other field personnel,” says Adrienne Stofko, senior director in the Patient Services Group. “Some of our field personnel transition to the client pharma company” while performing this role.

To be sure, Covance also has internal staffing, IT systems that collect data and other features of a hub provider. The driving force in its offering, she says, “is to move beyond the current paradigm” of responding to a query in a certain number of minutes, “to measuring outcomes, patient quality of life—a more holistic view of the patient experience.” To that end, the Patient Services Group also taps into a health economics and outcomes research (HEOR) group, which can provide guidance to pharma clients in program design and operation.

Yet another perspective is offered by Human Care Systems, where the emphasis is on the combination of a comprehensive IT system, branded as Resilix, and what it calls “treatment experience nurses” who work with patients (usually electronically) to improve adherence. The cloud-based Resilix platform, says Thom Doyle, CEO, is designed to provide a 360° view of the patient experience by interfacing with both electronic health record (EHR) systems at health systems, and the relationship-management systems at hub providers or at the pharma clients themselves.

Mention of relationship-management software highlights a powerful driver of hub service evolution: the development of IT platforms for collecting, recording and analyzing data from channel partners, health systems, pharmacies and even patients themselves. Within the hub service, the IT platform manages workflow for case managers and care coordinators themselves.

When it comes to these enterprise systems, there are those that are built on SalesForce software and the SalesForce Health Cloud; and then everyone else with home-grown systems. Deloitte’s ConvergeHealth software-development company, as well as Accenture, Cognizant and other systems integrators, take the SalesForce platform and configure it to the requirements of each client (which are the hub services, and the pharma manufacturers themselves). The process is said to be expensive and time-consuming—but the systems work.

Cardinal Health Specialty was an early adopter of the SalesForce.com platform for patient support; in its case, it hired Deloitte ConvergeHealth the build the system, and then customized it and branded it as ConnectSource. “We’ve been stable in our implementation now for a couple years,” says Steve Jansen, VP of technology at Cardinal, “but we continue to evolve it.” A key benefit, he says, is that a new client can be onboarded with a tailored ConnectSource system in a matter of a few weeks—a vital consideration given that the company has had some success, it says, in winning switchovers from one hub service to Cardinal’s.

 on one such switchover, noting that the disruption in moving patients from one set of case managers to another, along with all the data collection and interfacing can lead to a 5-10% loss in revenue for the manufacturer if not handled well.

Eversana is in the process of building out its SalesForce implementation; Conduent is up and running with its version. But other hub providers interviewed for this report—TrialCard, PharmaCord, CareMetx—pride themselves on their home-grown systems. Human Care Systems Resilix platform uses a “document-based” database program, MongoDB, said to streamline extracting data from other data sources. CareMetx says that it has built numerous application programming interfaces (APIs) in its CareMetx Connect platform, to work with Salesforce and other systems; it also licenses its software out to other parties. PharmaCord’s CorSend platform has its own API tools.

“We wanted to be agnostic in the IT platform we provide,” says Trialcard’s Scott Dulitz, chief strategy officer. “Building our own platform enables us to work with many EHR systems at healthcare providers, and pharmacy management systems at pharmacies. In fact, we’ve had multiple integrations with the SalesForce systems at pharma clients.”

McKesson has combined IT, data and services in the aforementioned Access for More Patients (AMP) service, which went live late last year. The offering is based on CoverMyMeds software and data, which automate the processing of prior authorizations paperwork, together with the patient care services of RxCrossroads. According to the company, patients have been shown to gain access to prescriptions (after the PA work) 27% faster than industry norms, among other benefits.

CoverMyMeds has the capability to interface with common EHR systems, both to provide PA documentation and a real-time benefit check at the point of prescribing.

“AMP is a new approach to patient intake by transitioning data electronically, then bringing in case managers as needed,” says Heather Morel, VP of Access & Adherence. “It can eliminate hours of non-value-added work” by case managers and healthcare providers. AMP is also helpful, she says, in cases where outsourced hub services are bypassed entirely by working with the specialty pharmacy that dispenses the drug.

Another significant feature of AMP touted by Morel is that it can interface directly with a specialty pharmacy, so that a physician using it can write a prescription and direct it to the specific pharmacy (SP) where the drug is dispensed. (Many specialty products have a limited or exclusive distribution with SPs, and the difficulty of locating the right SP is a common obstacle to getting drug to the patient.) “Today, some manufacturers want to engage SPs directly, and the ability to use the ePA environment of CoverMyMeds to speed access to therapy benefits both the provider and the patient.”

Mention of direct linkage to SPs raises a contested area of patient support services: whether the assistance is provided by a hub service that coordinates the various activities, or the SPs themselves, many of whom have built up staffing and resources to support patients themselves.

The SP business is one that has undergone tremendous growth, commensurate with the growth of specialty pharmaceuticals themselves. The big integrated health providers (Cigna/Express Scripts; CVS/Aetna, United Health/Optum) dominate the SP world (as they do traditional pharmaceuticals), but the ability to provide a higher level of personalized attention at independent SPs has helped their growth. Traditionally, a hub service helps to “triage” a prescription by directing it to the appropriate SP; but if SPs themselves are connected to prescribers, that loop becomes less necessary.

A look at some of the biggest independent SPs shows how they are positioning themselves to manufacturers. The “Soleo Health Difference” at Soleo Pharmacy includes a “dedicated account team from pre-launch through program implementation and ongoing support … Preferred relationships with nationally recognized prescribers, healthcare systems and accountable care organizations (ACOs) [and] Reimbursement specialists dedicated to timely insurance verification and authorizations to expedite patient start of care and assistance with manufacturer copay programs.” The company also offers a data service, branded as SoleMetrics, that provides details on “prescriber utilization and clinical outcomes management.”

“As a manufacturer-focused, patient-centric rare pharmacy, we consistently exceed our partners’ expectations,” says PantheRx, a fast-growing SP in Pittsburgh.

“Carepoint is a nationwide specialty pharmacy helping manufacturers bring new products into the marketplace by keeping in step with every stage of the process. From research and development to clinical trials and educational programs, our clinical staff will work alongside you with one goal in mind … to offer our patients the best treatment available,” is how CarePoint Pharmacy describes its capabilities.

This SP-manufacturer relationship was brought to prominence by Diplomat Specialty Pharmacy, whose annual revenue approached $5 billion until last year, when a series of missteps caused its stock to tank; it is now absorbed into Optum. Another high-flying SP, Avella, also belongs to Optum now.

“We’re not competing with SPs,” maintains Nitin Sahney, CEO of PharmaCord. “SPs can have a difficult time maintaining their margins while providing patient services, and from the manufacturer perspective, SPs are usually not brand-specific [i.e., offering only one of what might be several brands for a particular disease state]. We are.”

Meanwhile, among wholesalers, in line with being all things to all pharma manufacturers, McKesson and AmerisourceBergen provide both hub services and SPs of their own: Biologics at McKesson; United Bioservices at ABC. Cardinal Health does not have an SP business. “We’ve carried out some hub switches from an SP to us,” says Tara Herrington at Cardinal Health Specialty. “SPs need very solid firewalls between their dispensing and their contractual relationships with manufacturers,” she notes.

Despite the growth that many SPs are experiencing, all is not sweetness and light. A 

* (a subsidiary of Intalere GPO, which in turn is a unit of the Intermountain Healthcare system) found that half of SPs surveyed are constrained by insurance networks and PBM practices on the one hand, while 17% were constrained by an inability to enter limited distribution contracts on the other. At the same time, manufacturers responding to the survey said, by an 80% margin, that their patients had some sort of issue being serviced by their partner specialty pharmacies (Fig 5.)

The CSI survey also asked manufacturers about their hub-provider relationships, and here there were similar perceived shortcomings, with 83% of manufacturers reporting that “there was room for improvement in their current third-party vendor hub model,” and that “17% indicated they are not pleased and are pursuing other options.” (The implication here is that the percentage of manufacturers happy with their current hub provider across the board is zero.) Two-thirds of respondents “would like to see improvement with respect to communication between patients and providers, and half of manufacturers seek enhancements in process/workflow, technology solutions, and FTE/resource review.”

Despite this potential friction, SPs and hub providers have worked out complementary roles, and most hub providers emphasize how the “get along with” the SPs with which they interact.

(There can be some confusion for participants in specialty pharmaceutical dispensing, in that numerous hub providers have so-called “closed door” pharmacies, from which free-drug, patient assistance program, or quick-fill scrips can be fulfilled. In fact, it is a competitive advantage for the hub provider to be able to provide this service. These programs, however, do not pertain to routine prescribing.)

There is more to the IT question than what enterprise system is chosen, or who is managing the patient interaction. The entire patient-support field is colored by gathering data from diverse sources, and presenting it in useful form to patients, providers and payers—and ultimately manufacturers.

There is a growing trend toward use of mobile technology to interface with patients, both as a means of communicating messages to them, and to gather patient-reported outcomes (PROs) from them. Use of conventional SMS texting has been commonplace for years, especially for refill reminders; now, there are efforts to communicate the status of reimbursement applications, status queries and the like.

“We’ve known we wanted to develop a virtual copay card for quite a while,” says TrialCard’s Scott Dulitz, “then the opportunity to acquire a market-leading app developer, Mango Health, came up late last year. Now, we’re working with the Mango platform to provide transparency to patients—they will be able to track enrollment applications, reimbursement actions and the like. This will be rolled out later this year.”

There are hundreds if not thousands of apps available to smartphone that have health information; the distinction here is to have an app closely tied to a hub service provider like TrialCard. Human Care Systems, developers of the Resilix CRM platform for managing the patient journey, uses text, email and click-to-chat to connect with patients even in a pre-treatment phase. The company says that a “rules-driven automatic cadences” of messages and communications both inform the patient, as well as collect responses that in turn guide adherence programs or other actions.

HelpAround, which styles itself as a “mobile concierge platform,” has had some success with improving adherence and streamlining patient communications via its app. Behind the messages and notifications sent by the system to patients, it has what it calls “hyperpersonalized” AI-based technology to tailor messages and their timing to the patient. As shown in Fig. 4, it has provided a boost for adherence for an unspecified pharmaceutical, according to the company.

Eversana’s Bhaskar Sambasivan touts the company’s recent partnership with Noom, as an example of digital patient engagement and part of Eversana’s next generation of “Patient Services 2.0” solutions that include technology and data. The goal to combining Noom’s digital therapeutic platform with Eversana’s integrated patient services model is to improve therapy adherence and patient engagement for complex therapies. Sambasivan notes that his company is working to include other behavioral data in its CRM, such as financial ratings, to help predict the level of financial assistance patients need.

There is widespread agreement that mobile communications, both from and to patients, is transforming not only patient support programs for specialty pharmacueticals, but all pharmaceutical patient interactions. In the patient-support context, though, there is thought to bringing in another element: the community of peer groups of patients taking the same drug, or suffering the same disease state. “Imagine if patients on a therapy could join a group of their peers, moderated by experts from a pharma company, to talk about their treatment,” says Valerie Sullivan, an industry consultant and former president, inVentiv Patient Access Solutions. “In general, the pharma industry is petrified of the potential liabilities of such interactions, but this kind of communication should be a more meaningful way to engage.”

Direct interaction with patients in open forums might be a bridge too far for most pharma companies; they are continually balancing their interactions with patients with the restrictions imposed by governments. In past years, there were instances of violations in sharing protected health information of patients directly with the sales and marketing teams; this is one of the reasons for hub providers to exist in the first place—to be a clear buffer between the manufacturer and the patient.

In the past year, FDA, CMS and the US Dept. of Justice have mostly been focused on the workarounds used by some companies to provide financial support to Medicare, Medicaid and related government-insured patients; those patients are not eligible, in most cases, for copay or other financial assistance. Settlements between DoJ and manufacturers include Aegerion, Alexion, Amgen, Insys, Jazz Pharma, Lundbeck and US WorldMeds, who collectively paid hundreds of millions in fines for alleged violations of the False Claims Act and its Anti-Kickback statute. In all these cases, the government alleges, the companies paid funds into patient assistance foundations, who then reimbursed federaly insured patients’ copays. (Privately insured patients are legally allowed to receive copay assistance a manufacturer, usually through the intercession of a hub provider or copay-assistance provider.) In some of the cases, the foundation support was structured such that only one drug (of that manufacturer) was eligible for the assistance.

At least one foundation, Patient Services Inc., was also penalized for alleged violations in these patient-support efforts.

“When pharmaceutical companies use foundations to create funds that are used improperly to subsidize the copays of only their own drugs, it violates the law and undercuts a key safeguard against rising drug costs,” said Assistant Attorney General Jody Hunt of the Department of Justice’s Civil Division. “These enforcement actions make clear that the government will hold accountable drug companies that directly or indirectly pay illegal kickbacks.”

But fraud or misuse of patient support funds can come from other directions. TrialCard, which has years’ experience in managing copay programs, has been able to return roughly $10 million back to pharma companies in 2019 when it found pharmacies fraudulently claiming copay reimbursement for drugs that were never dispensed, or patients that never existed. “In the course of performing analytics on how we manage manufacturers’ copay programs, we noticed irregularities in where some of the reimbursement claims were coming from,” says Jason Zemcik, a senior director at the firm. Those irregularities were then investigated by an internal team at the company, and TrialCard was able to block reimbursement to some of the pharmacies, eventually returning the funds to the pharma client. The service has now been formalized as a TrialCard offering, RxSpotlight, and Zemcik says that the company is deepening the analytical tools it uses for this purpose.

Dramatic growth tracks the flood of new specialty    pharmaceuticals entering the market

2020 Patient Support / Hub  Services Report

Real-world evidence—a subject of interest for years among clinical researchers—is getting closer to what might be called “real-world applications”—that is, in the decisions made routinely by physicians and by payers to prescribe drugs to patients. For the most part, RWE has been of concern to researchers performing clinical trials. The field got a boost in 2016 with the 21st Century Cures Act, which made observational data (a type of RWE) eligible for consideration in drug approvals. Since then, a flurry of RWE projects have been announced, and large collaborations bringing millions of patient records together for evaluation have been undertaken.

Now, this sort of clinical RWE is getting closer to assessing patients’ ongoing care, and the more commercial considerations like drug pricing. The Institute for Clinical Evaluation and Research (ICER), which styles itself as “the leading U.S. health technology assessment (HTA) body,” has announced a collaboration with Aetion, a provider of software, branded as the Aetion Evidence Platform, that operationalizes health outcomes research. Aetion, in turn, has relationships with sources of health data.

There are numerous ongoing efforts to evaluate how patients are affected by drugs, outside of a clinical trial; and of course, payers and pharmacy benefit managers have been making their own assessments for years. Now, ICER hopes to generate “decision-grade RWE,” as it calls it, which in turn will become part of the deliberations on drug pricing or product choices that ICER is known for.

“ICER has long sought data generated outside of clinical trials to enhance our understanding of how medical treatments perform in the real world,” said Pamela Bradt, MD, MPH, ICER's chief scientific officer. “Through this partnership we aim to set new standards for how RWE can better inform the consequential decisions that biopharma manufacturers, insurers, and other stakeholders make every single day around drug pricing and patient access.”

Last month, ICER published a “2020 Value Assessment Framework,” a 

 on how it would conduct its assessments going forward; incorporating RWE into its deliberations was part of the announcement. At the time, Steven Pearson, president of ICER, declared that “First, as always, we want to bring value assessment out of the back rooms of insurers and manufacturers, and make it a public exercise, open to scrutiny and input from all.”

Also late last month, the Office of National Coordinator of Health Information Technology, which has been coordinating the implementation of healthcare IT since the early 2000s, issued its 

2020-2025 Federal Health IT Strategic Plan

. “The volume of health and health-related data being generated and available for improving care quality has never been greater,” says the report. “Collecting, organizing, analyzing, interpreting, and applying this “big data” to clinical decision making is both a challenge and a significant opportunity.” The report has something of a mixed message for pharma and healthcare providers: at one and the same time, it calls for more data to be used for outcomes-based decisions, while “reducing the regulatory burden” of federal policy, and helping create “robust mechanisms for ensuring the privacy of health information.”

ICER will expand use of RWE, as the Federal ONC calls for broader use of healthcare data

Real-world evidence gets closer to everyday treatment decisions

Clarivate Analytics, the London and Philadelphia-based market-research and consulting firm, has launched a “Drugs to Watch” listing that offers to predict both what drugs currently in in Phase II or III will be approved this year, and also their potential $1-billion blockbuster status in 2024.

The list (see figure) is dominated by biologics and includes one genetic therapy, Biomarin Pharmaceutical’s Valrox (valoctocogene roxaparvovec), that is expected to come to market with a price tag north of $2.5 million. The “one and done” therapy is a potential cure for hemophilia A.

Clarivate’s in-house Cortellis team uses a combination of financial and medical data to perform its analysis. Sources of intelligence include annual filings, drug pipelines, clinical trials, patents, chemistry, deals, conferences and company announcements. A second step in the review is clinical trial results, regulatory status, the market for each drug (including analysis of competitor drugs) and regulatory designations.

Clarivate Analytics predicts both approvals and commercial potential

‘Drugs to Watch’ list tags 11 about-to-be-approved therapies with blockbuster potential

After a search, the board of directors at the Healthcare Distribution Alliance has chosen Chester “Chip” Davis to be president and CEO. John Gray, HDA CEO since 2004, announced his retirement 

Davis comes to HDA from president and CEO of the Assn. for Accessible Medicines (the former Generic Pharmaceuticals Assn.), which appointed him in 2015. 

, he was EVP for advocacy at the Pharmaceutical Research and Manufacturers of America.

“Chip’s leadership experience and strong advocacy background in healthcare make him the perfect candidate to lead HDA," said Greg Drew, president of Value Drug and chairman of the HDA board. “Chip understands the complex relationships and challenges of our industry and member companies and has a deep appreciation for ensuring that all patients receive the right medicines, at the right time, safely and efficiently.”

Davis’ statement, from the HDA press release: "I have long held great respect and appreciation for pharmaceutical distributors and the critical role they play to ensure the safety, reliability and value of medicine and medical products as they move through the ecosystem, from manufacturer to provider to patient, to achieve the ultimate objective of ensuring patients have access to the treatments they need. I am excited to join them as President and CEO to be able to convey their value, and the vital role they play."

Alok Sonig, chairman of AAM and an executive leader at Lupin Ltd., stated: “Chip's commitment, leadership and focus on patients took AAM to a higher level of effectiveness advocating for the US generic and biosimilar industry. We greatly appreciate his service and wish him success with his future plans.” AAM has appointed Jeffrey Francer, SVP and General Counsel, as interim CEO.

A former executive at PhRMA, Davis will now lead the wholesaler-distributor association

Pharmaceutical Commerce - March 2020

Hub providers can be the source of the best real-world evidence

2020 Patient Support Vendor Directory

A Conversation with Mark Hansan, CareMetx

2020 Patient Support / Hub Services Report

Real-world evidence gets closer to everyday treatment decisions

‘Drugs to Watch’ list tags 11 about-to-be-approved therapies with blockbuster potential

HDA board passes leadership to AAM’s Chip Davis