Finding the 'HUB' in Specialty Pharma Services

Pharmaceutical CommercePharmaceutical Commerce - September/October 2013

For specialty pharmaceuticals, the connection between manufacturer, payer and patient is the rising crop of hub services

Fig. 1. Hub vendors place themselves as the interface between the manufacturer and the other components of prescription delivery to patients; but in many cases, the hub is internal to a specialty pharmacy—or even the manufacturer

A thought experiment: Picture, if you will, the discovery and development of a new continent. Where would the towns or settlements be located? One set of priorities would be military protection (well-defended forts); another would be rapid exploitation of, say, natural resources. Where would highways or train tracks or airports be established? And, fast forward a decade or a century, how does the resulting landscape appear, with thriving cities and towns, or with withering outposts or empty buildings?

That’s one way of looking at the rapidly evolving landscape of the biopharmaceuticals marketplace, especially as specialty pharmaceuticals become a more central part of the market terrain. Specialty pharmaceuticals are changing the dynamics of drug distribution as manufacturers, payers and providers jockey for controlling positions in the process of managing the healthcare of patients. When a new drug, representing a first-of-its-kind treatment for a disease, enters the market, the manufacturer has a controlling interest. But as competing products—and, make no mistake, the specialty arena is becoming more and more competitive—appear, the dynamics change to a complex interplay of mandated step therapies, preferred providers, patient outcomes and manufacturer countermeasures.

Enter hub services as one of the mechanisms by which manufacturers can keep a grip on the marketplace (Fig. 1). “Hubs” have been around for over a decade, starting out as “reimbursement hubs,” usually provided as a service by manufacturers to help patients and providers navigate the process of obtaining permission to use, and reimbursement for, expensive specialty therapies. Industry observers look to pioneering efforts by Genentech and Genzyme, when some of their earliest biotech products entered the marketplace. Along the way, there has been the growth of specialty pharmacies (as the preferred dispensing point for many specialties), the growth of medication-adherence and similar patient follow-up services, and the evolution of patient assistance programs (PAPs) to combine insurance payments (when available) with qualified financial assistance and copay programs, and care coordination (necessary for drugs that, for example, require an infusion center along with office care). The range of specific services is large—and growing (Fig. 2).

Fig. 2. The range of hub services. Source: Occam Health

The “hub services” term is not universally recognized, although that is changing rapidly. Sandy Robinson, VP of reimbursement and product commercialization at Avalere Health (Washington, DC), prefers the term “comprehensive patient support services”—which is in line with a common refrain throughout the specialty pharmaceutical distribution environment: “At the end of the day, all these complexities should boil down to one thing: how the marketplace can engage to provide better patient support,” she says. “Better patient support should result in better outcomes, lowering costs for healthcare and improving patient lives.”

Dan Steiber, a partner at D2 Pharma Consulting (St. Charles, MO) refines that message even more: “If you take care of the patient, the business will grow.”

All of this is about to take a quantum leap as the Affordable Care Act, which will bring millions more consumers into healthcare coverage, kicks in next year, putting an added emphasis on getting specialty distribution and hub services right. “I expect that we’ll see a repeat of when Medicare Part D went live,” says David MacLeod, a VP for program development at inVentiv Health (Burlington, MA), which is in the process of building out a hub services offering in its Patient Access Solutions group. During the first year of Medicare Part D, reimbursements to pharmacists were slowed; there were disconnects between where pharmaceutical inventories had been stockpiled, and where pharmacies needed deliveries, and generally, significant confusion on the part of patients who weren’t sure what was free (subsidized by the federal government) and what was in the “doughnut hole,” and needed substantial copays. All that confusion settled out fairly quickly, but the process took its toll on harried pharmacists, anxious patients and confused physicians.


Logistics can be a critical part of specialty distribution, and cold chain is a critical element to that type of logistics. The reasons are simple: many specialty products are biologics and/or injectables, and their relatively high value means that a mishandled drug is a cost to both the healthcare system and the manufacturer. Pharmaceutical Commerce publishes an annual Cold Chain Sourcebook that forecast, in 2013, that the overall cold chain market is growing at double the rate of conventional pharma products, and will reach $288 billion (out of a $1.3-trillion) global biopharma market in 2017.

Typically, cold chain drugs are required to be kept between 2—8°C, and when in transit, are packaged in insulated containers with gel packs that keep the drug within temperature for a set period of time. Some drugs have a predetermined “stability regime” that allow excursions outside the 2–8° range for a defined period of time (usually specified on the product label), but the industry is still working out how that period can be calculated across the entire distribution process.

National and international standards have been set for life sciences cold chain distribution by organizations like the Parenteral Drug Assn., US Pharmacopeia, the International Air Freight Assn. and others; arguably the most comprehensive regulations come from the EU’s “Good Distribution Practices” (GDP) guidelines. Manufacturers, distributors and logistics providers tend to operate under these requirements; the guidance for pharmacy operations is more diffuse, under the control of state boards of pharmacy.

Bottom line: specialty manufacturers will want their supply-chain management along when evaluating the service offers of SPs, hub providers and specialty distributors.

MacLeod, who has worked for years in patient reimbursement and support, at manufacturers as well as service providers like inVentiv, notes that the usual complexity of access and reimbursement for specialty pharmaceuticals will cause similar confusion.

History and opportunity

The semantics of hub services are important because different players, with different histories, are all aiming at the patient services space, and positioning themselves as the best intermediary between manufacturers and patients. A spate of new entities, what some are calling the “next wave” of hub services, are also coming forward. A run-down of the biggest types of organizations:

Pharmacy benefit managers

The biggest and oldest are offshoots of insurance companies or PBMs, such as Express Scripts’ combination of Accredo and CuraScript (both specialty pharmacies) and HealthBridge (physician and patient support). UnitedHealth, an insurance company, operates OptumRx, a PBM, which has a specialty unit within it. Cigna has Tel-Drug, a mail-order pharmacy and support system.

Specialty pharmacy providers (SPPs)

Walgreens now has a large specialty pharmacy operation, as do most of the other major retail chains. Independent SPPs include Diplomat, Amber, AcariaHealth and dozens of others. Over the past couple years, two trade associations dedicated specifically to specialty pharmacy have arisen: the Specialty Pharmacy Assn. of America (organized by, but independent of, Armada Healthcare) and the National Assn. of Specialty Pharmacy (NASP).

Reimbursement service providers

Managing reimbursement has become an increasingly complex part of dispensing drugs, especially when there are steps to locating both the responsible payer, and when patient assistance like copays, coinsurance and charitable foundations enter the picture. Lash Group was one of the pioneers in this area, especially with oncology; now, it as well as many other reimbursement service providers have expanded their patient support to include other therapy areas. Omnicare, whose original business was in providing pharmacy-related services for long term care, acquired RxCrossroads several years ago, and made that part of the foundation of its Omnicare Specialty Solutions business, with an SPP and distribution arm.

Covance and Parexel, two prominent contract research organizations (CROs) have been building up their market access services to include related patient support. inVentiv Health, which combines a CRO with marketing and advertising services for pharma, has established a Patient Access Solutions group.

Distributor/hub providers

Each of the Big Three wholesalers now has a Specialty Solutions division, with AmerisourceBergen Specialty Group arguably the largest. McKesson bought US Oncology two years ago to boost its specialty business; Cardinal Health acquired P4 Pathways (dedicated to oncology care) and added it to its specialty services. Most recently, H.D. Smith (Springfield, IL) created a specialty unit that includes Smith Medical Partners, a specialty distributor, and acquired Triplefin (Phoenix, AZ), a patient-support services company, to flesh out its hub offering.

Sonexus Health (Lewisville, TX) was created in 2012 to combine a patient-support network (the former Chronic Disease Foundation) with a distribution arm.

Dedicated hub providers

Some of these are the newest entrants in the hub field; they position themselves primarily as the go-to resource for pharma manufacturers, and then connect with other companies to provide distribution, pharmacy services and the like. Names include CareMetx, Occam Health and ProMetrics, among others.

Therapy-based service providers

Today, a big chunk of hub services is simply dedicated oncology care; this is a core part of the Big Three wholesalers. But orphan and ultra-orphan diseases (which have seen rapid entry of new therapies) is a key part of the business. Centric Health Resources (Chesterfield, MO), a property of Dohmen, was one of the early entrants in this space. There are also a number of alliances between orphan disease advocacy groups and various combinations of SPPs and patient-assistance programs.

Specialty network GPO

Calling itself “a group purchasing organization with a twist,” (in the words of Mike Baldzicki, newly appointed EVP of industry relations), Armada Health (Florham Park, NJ) has pioneered the concept of a network of specialty pharmacies and service providers—a sort of “meta-hub” over the past several years. The company centralizes purchasing contracts, has a prior-authorization service, ApproveRx, among others, and then coordinates pharmaceutical distribution and dispensing through several hundred pharmacies and providers in its Aspen network.

PAP influence

To this list could be added select companies from the patient assistance program (PAP) world, as well as specialized firms focused on adverse event reporting, medication adherence programs and others. Their services have existed independently of distribution or pharmacy, but as the hub business swells, and as distributors and others angle for a piece of the pie, they become valued partners or additions to the latter companies. So, for example, H.D. Smith, the largest privately held wholesaler, has acquired Triplefin, a patient services company, to build out its Specialty Solutions platform. Dohmen has added an adverse-event reporting business, and a medical communications company, to its portfolio logistics service (DDN) and specialty pharmacy (Centric Health). More recently, Telerx, a dedicated call center company that is a subsidiary of Merck, acquired Sentrx, an adverse-event reporting company.

There is another dimension to the hub services concept: running the hub internally within the branded company’s own operations; outsourcing it completely; or a hybrid of the two. According to observers, the pattern for internal hubs was set with the early biotech products; but as with so many other functions of modern biopharma companies, the trend is to outsource it—which of course, is fueling the growth of the new hub-services ventures.

Internal hubs potentially provide a valuable asset to pharma: access to patients. But that access has to be carefully controlled to meet both HIPAA patient-privacy rules, as well as the marketing restrictions that companies operate under. “Internal hubs need to be set up with a complete separation from sales/marketing,” notes Steiber, “and I’m talking about secured offices with keypad access and the like. Some pharma companies don’t want to go this route just because of the risks it creates.”

Hub providers have some of the same privacy and security requirements, but provide that degree of separation from the manufacturer. “You start with attestations from the patient allowing privileged information to be obtained,” says MacLeod, “and then you de-identify the data in your record systems to put them in a form that can be shared with the pharma client and others.” Many of the common elements of a full-fledged hub program, such as copay cards and registries for FDA’s Risk Evaluation and Mitigation Strategies (REMS) programs require some degree of direct connection between the patient and the therapy.

Fig. 3. ‘Speed to therapy’ is affected by obstacles like these. Source: Occam Health

Channel management

HIPAA privacy issues are manageable either way, but what seems to be driving a lot of the action in hub programs is deciding what channels a specialty pharmaceutical will use to enter the market. Alongside (or even before) the hub structure is decided, commercial operations and product managers are making decisions about exclusive, limited or open distribution of the product. The decisions depend on how the pharma marketers want to balance access to the market with cost of distribution, and then how well they can control the competitive pressures that come with multiple drugs in one therapy class.

“The brand manager might say, get this drug stocked everywhere, but the commercial operations people will say, that can cost millions of dollars for a very specialized treatment, and the product is going to be sitting on shelves most of the time,” says Tom Doyle, EVP, commercial solutions, at H.D. Smith Specialty Solutions. Especially for orphan drugs (and multiple sclerosis, one of the hotter specialty areas in new drug introductions today, is actually an orphan drug), a limited network can lower distribution costs and provide more control for the marketer.

A pharma company can do a deal with a network of specialty pharmacies (or one of the big companies that operate pharmacies in many locations), but then runs into the dilemma of whether that network is open to a range of payer plans, and the price that’s available from each of the plans, in the case of commercial insurance.

Many of the networks—and a growing number of the independent specialty pharmacies—have built out their own suite of hub services, and position themselves as offering the equivalent service for the pharma marketer as would a hub provider.

As a distribution network grows, the logic for having a dedicated hub provider also rises, says Dave Hileman, SVP of operations at Omnicare. “SPs get paid, primarily, for filling scripts, and with specialty pharmaceuticals costing thousands of dollars per patient per month, that can be substantial.” With multiple pharmacies handling multiple patients who have a variety of insurance plans, the “noise in the channel” increases from the manufacturers’ perspective—and the risks of falling behind in a competitive market correspondingly increase, he says.

For one recent client, says Hileman, Omnicare’s suite of hub services was able to help move a product that was seventh in market share in its category to second. “Consistent data, fewer handoffs to multiple parties and better patient support made a difference,” he says. (It should be noted in this context that Omnicare, through its Advanced Care Scripts SP, does substantial pharmacy business itself.)

Fig. 4. Specialty drugs have complex reimbursement patterns. Credit: EMD Serono Specialty Digest

The counterargument for dealing directly with SPs is that in much of the healthcare system, the pharmacist is both the most trusted provider, and the one that sees the patient most consistently, if only for refills. “I’m biased for pharmacists,” says D2 Consulting’s Steiber. “Is it a better experience for patients to see their pharmacists face to face, or to be talking on the telephone with someone in a remote location?”

That’s part of the logic that is driving Walgreens Specialty Pharmacy business, which includes infusion services. The country’s largest chain pharmacy, with over 8,000 stores, includes several hundred treatment centers for infusion patients. Last October, it took what it called a “significant” ownership stake in Cystic Fibrosis Services, a Bethesda, MD, SP operated by the Cystic Fibrosis Foundation. Walgreens’ public statement at the time said that its retail network would offer “enhanced services” to CF patients, while continuing to operate the Bethesda SP. And earlier in 2012, it acquired 30 community pharmacies of BioScrip, an SP based in Elmsford, NY, that handles a variety of specialty therapies.

Armada Health, the SP “channel management” company, touts its national network of several hundred members in its Aspen network (which includes pharmacies, infusion centers, home health and other outpatient services) to address this same geographic need. “We are not limited by geography, and equally importantly, we can be aligned with multiple insurers on a regional basis,” says Mike Baldicki, EVP.

Quite a few independent SPs have only a limited number of physical locations, so the ability to have face-to-face interactions can be a tossup. This fact highlights the importance of third-party logistics (3PL) services, usually making use of express-mail carriers like UPS or FedEx to deliver drugs, in a time-sensitive manner, to pharmacies, hospitals or even the patient’s home. Third-party logistics services are woven throughout conventional as well as specialty pharmaceutical distribution; each of the Big Three wholesalers (as well as others) have a 3PL unit, and there are multiple independent 3PLs that handle pharmaceutical shipments.

The 3PL element is part of what brought Sonexus Health, which opened for business this year, into being. The company took an existing business, CDF Services and combined it with a distribution center and a “noncommercial” pharmacy, says Mike Mullen, CEO. The pharmacy component (for which licenses for all 50 states are being obtained) will enable the company to send products to patients and physicians; at the same time, care coordinators who work directly with patients have worked through prior authorization issues and reimbursement support, and can then be involved in ongoing care. “Besides the value we believe we offer for ongoing patient support, our business is very focused on the ‘first fill’—getting a drug to a patient within the first 24 hours of diagnosis,” says Mullen. “For manufacturers, speed to therapy can be critical.”

Logistics also plays a more prominent role in specialty pharma because so many of the products are “cold chain” (see box). The specialized packaging, storage and handling of product that has to be kept within a set temperature range requires knowledgeable logistics service providers.

Fig. 5. Prior authorization growth adds to patient burdens. Credit: EMD Serono Specialty Digest

Tech edge

The core of traditional hub services has been a team of patient care coordinators—often nurses, but including pharmacists or pharmacy technicians, reimbursement specialists and various kinds of patient advocates—who, by working the phones, performed the benefit investigations, the details of prior authorizations, and requirements for administering complex drug regimens. Once a patient is on therapy, the coordinators follow up with refill reminders, investigations of side effects (or adverse events), REMS requirements and other features of specialty care. When care coordinators are paired over an extended period of time with individual patients, they become “the face of the brand” to that patient, as numerous sources put it.

Hub service providers compete on the quality of work of their coordinators and, ultimately, the outcomes that patients experience, but some of the new entrants have put an emphasis on the automated data gathering and processing that they can deliver.

“Traditionally, as a hub service grew in numbers of patients it was managing, the number of employees also grew, as would the costs of serving that population,” says Rujul Desai, president of Occam Health Services. “By employing the latest cloud-based technology, patients, providers and physicians can be connected, in real time. Occam provides its platform, branded as Cloud Script, both as a completely outsourced solution for manufacturers, and as a hosted solution that can exist in a hybrid hub. Among features that Occam (and others) tout with this technology is “dynamic prior authorization”—enabling PAs to be resolved in seconds, and rapid communication of patient status and condition to the physician. Considerable efficiency is obtained in generating reports on market activity and patient outcomes; rather than stopping everything periodically to file a report to the client manufacturer, the data come out of the system with a few keyboard clicks.

CareMetx, founded by some of the principals of a company called TheraComm (absorbed into AmerisourceBergen Specialty Group several years ago), emphasizes many similar features (including internal hosted solutions). Mark Hansan, SVP, notes that there is both a “patient journey” and a “product journey” as a specialty drug is prescribed; the patient might enter different aspects of healthcare (surgery, outpatient, home health) over time, even as a product goes from launch and first fill to related activities such as coupon programs or variations in drug administration. “Real world evidence of treatment is going to become more important going forward,” she says, “especially when care involves more than opening a case file, dispensing a prescription and then closing the case file.”

Several vendors of the new IT focus in hub services tout the benefits of using mobile technology to remain in contact with patients, an activity that opens up a tempting prospect of maintaining much or all of care coordination through automated systems. But while there might be some patients (with some therapies) who would be content to file refill or medical-status information on a screen and then receive further instructions via that same screen, most experts say that mobile technology only gets care coordination part of the way forward. “We’ve added patient portals and services like that,” says Lash Group’s VP of operations, Derek Cothran, “but we’re also very measured in how far we go with that. It can supplement but not replace the high-touch services that hubs offer. Obtaining a complex, high-value therapeutic is not like buying a song on iTunes.”

Fig. 6. Health plans see room for improvement in SPP performance. Credit: EMD Serono Specialty Digest

Scrip triage

Perhaps the most controversial part of hub services is the combination of prior authorization (which defines, in part, the cost of the medicine to the patient) and where the scrip is filled. Many of the participants in hub services say that two elements—cost of the drug, and geographic proximity (so that the patient can interact with the pharmacist) define how the scrip should be filled. Manufacturers negotiate a price with payers or distributors; and when a manufacturer chooses a limited or exclusive distribution, arrangements must be made to deliver the drug.

The best scenario, of course, is when the least expensive plan is included in the pharmacy that is close to the patient, but that is almost an accidental coincidence. Thus, the prescription gets “triaged”—balancing where the drug should go based on all these factors. One tactic in this mix is “white bagging”—sending the drug to a hospital, infusion center or clinic, then instructing the patient to go to that facility for the treatment. Some hospital systems are beginning to object to the practice, because it can run counter to the hospital’s own GPO arrangements, and puts an administrative burden on the hospital pharmacy. A common older practice is “brown bagging,” which is sending the prescription directly to the patient, and then leaving it up to the patient to arrange the treatment. Both these practices are somewhat in conflict with the oldest practice of all—the physician’s buy-and-bill model, where the physician practice buys drugs directly from the manufacturer, and can benefit (potentially) both from the drug-dispensing fee and some level of margin between the purchase prices and the reimbursement price.

Triage can become even more complicated between a dedicated hub provider that looks out on many pharmacies and hospitals, and fully integrated PBMs/SPs/hub providers, such as Express Scripts, the leading PBM, which also has a major SP network (Accredo and Curascript) and a hub services provider (UBC, an acquisition, and HealthBridge). “Manufacturers like our ability to reach nearly 100 million insured lives, and that we can handle the entire process within our own operations,” says Kevin Cast, VP of business development at Express Scripts.

What manufacturers don’t like, however, is cases where step therapies are imposed (requiring one drug to be used before another—perhaps the one the physician would prefer for a patient—is dispensed); a practice not universally applied by Express Scripts, and Express Scripts is certainly not the only PBM or payer to do so.

Coming from a different sector of the specialty pharmaceutical spectrum—orphan and ultra-orphan drugs—Centric Health, a unit of Dohmen, argues for exclusivity in hub services as the best way to meet the needs of the patient, while serving directly at the behest of the manufacturer. “Our model isn’t driven by volume; it’s driven by a very personalized, value-based approach to healthcare,” says Cynthia LaConte, president of Dohmen. “Being able to reach [our clients’] patients on a direct basis without the disruption of multiple channel partners has allowed our clients to connect and create lasting patient relationships.” With its focus on orphan drugs (which have the problem of small patient populations, widely dispersed geographically), Dohmen also offers relationships with patient advocacy groups, the better to bring an orphan drug population together for clinical trials, registries and the like. The company operates a warehouse and mail pharmacy, combined with teams of patient advisors, pharmacists and reimbursement support specialists.

Meanwhile, other market participants offer variations of these hubs. Omnicare, which does not have a formulary or its own step therapy plan, puts an emphasis on patient assistance plans and speed to therapy (through its internal network of SPs); Sonexus aspires to delivering “first fills” (the first prescription for a patient) within 24 hours—including a setup where the first fill is delivered even before the prior authorization is completed. At Armada Health, Mike Baldicki says that “We play nice with many SPs” inside and outside its network. Lash Group, which works with sibling business units of AmerisourceBergen Specialty Group, puts an emphasis on ongoing patient support, adherence programs and medical outcomes.

Pharmaceutical Commerce tried to get some detail of the financial structure of the various plans; in theory, an exclusive distribution arrangement with a limited network of hubs should be more expensive, on a per-patient basis, than a bigger, more open network with multiple SPs (and SPs providing their own hub services could be even less expensive to the manufacturer). But the only substantial information is that, as competition heats up, prices are coming down, going from average wholesale price (AWP) to AWP minus a double-digit percentage. Another financial factor is that distribution plans should be set up to avoid duplication of effort—specifically, the cost of the prior authorization process, which could be done (and billed for) by the hub provider and then again by the SP.

Lash’s Cothran also stresses that while it’s tempting to drive the cost of hub services down to a minimal level, the risk is sacrificing market share and patient outcomes. “You can look at cost per patient, cost per fill and other criteria, but you have to ask, ‘What is the client manufacturer actually paying for?’” he says. “If a better level of hub service can be shown to extend the duration of care from four months to eight months, and can show a better patient outcome that saves payers’ money, is that proportionate or disproportionate value? Answering that question should be easy math.”

“The more SPs there are, the more business models will evolve,” says Avalere Health’s Robinson. “The ultimate outcome is still to be determined.”


Acaria Health

Orlando, FL


Bethesda, MD

inVentiv Health Inc.

Burlington, MA

Accredo Health Group/Express Scripts

Memphis, TN

Centric Health Resources/Dohmen

Chesterfield, MO

Lash Group/ABSG

Charlotte, NC

Advanced Care Scripts

Orlando, FL

Cigna Tel-Drug

Horsham, PA

H.D. Smith Specialty Solutions

Springfield, IL

Amber Pharmacy

Omaha, NE

Commcare Pharmacy

Fort Lauderdale, FL

McKesson Specialty Health/ US Oncology Network

The Woodlands, TX

AmerisourceBergen Specialty Group

Plano, TX

CoramRx Specialty Pharmacy Services

Malvern, PA

Omnicare Specialty Care Group

Cincinnati, OH

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Armada Health Care

Florham Park, NJ


Princeton, NJ

Occam Health Services

Sterling, VA

Axium Healthcare

Lake Mary, FL

CuraScript/Express Scripts

Orlando, FL


San Diego, CA


Cary, NC

Diplomat Specialty Pharmacy

Flint, MI

ProMetrics, Inc.

King of Prussia, PA

BDI Pharma

Columbia, SC

FFF Enterprises

Temecula, CA

Sonexus Health

Lewisville, TX

Cardinal Health Specialty Solutions

Dublin, OH


Weston, FL


Cincinnati, OH

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