Articles

2022 Patient Support Vendor Directory

Click the title above for a link to open the Pharmaceutical Commerce April 2022 issue in an interactive PDF format.

Pharmaceutical Commerce - April 2022 Issue (PDF)

, the first for me as the publication’s editor. As former Editorial Director Michael Christel indicated in his introduction to the last issue (February), his recent promotion to a new role at 

’s parent company, MJH Life Sciences, now takes him away from the day-to-day oversight of the magazine; however, as group managing editor, Mike will still be playing a major part in informing and shaping 

s content. I look forward to working with him to maintain the quality and consistency he and Associate Editor Nicholas Saraceno have brought to the publication since it became part of the MJH stable in June 2020.

Over the last couple of years particularly, many trade and B2B magazine editors have had to juggle, assess, and prioritize the assorted contributions for any particular issue without leaving their desks, but I know from experience that I’ll need to get into the weeds a bit more in the coming months, interviewing experts and getting out to conferences to really understand the 

world and the latest thinking around it. Fortunately, the climate for industry events is improving again and in-person conferences are making more of a return in 2022. On that note, I’ll be attending LogiPharma in Nice, France (April 5–7), which looks to offer a thorough and expansive introduction to the current challenges and opportunities prevalent in the global pharma supply chain space. I look forward to harnessing some of the ideas and expertise from that show to inform our upcoming issues; I also hope that this and other events give me the chance to catch up with some of 

’s readers, contributors, and would-be contributors to keep those ideas coming!

e, I’m no stranger to the term “patient centricity.” But in familiarizing myself with some of the thinking and practices around this month’s focus on patient support and hub services, I realized that I’d perhaps fallen into some of the lazy thinking around the idea of “the patient” that has arguably prevented pharma companies from radically advancing their patient-centricity strategies since the term was first mooted well over a decade ago.

 was to speak to the editors/co-authors of a new book from global professional services firm ZS called 

. I found this conversation with Hensley Evans and Sharon Suchotliff somewhat revelatory, not least in their suggestion that the word “patient” itself might have run its course, with growing calls from the advocacy community for a term that carries less stigma and promotes a more human view of those who are suffering from a particular condition or diseases. More immediately impactful, though, is Evans and Suchotliff’s benchmarking of a number of pharma firms that reveals no company has yet implemented any real “transformational change” in the patient-centricity space, and their argument that some of the patient-support advances brought about by COVID-19 were not only very implementable well before the pandemic, but were also well known to be implementable.

All of this, of course, leaves room for patient support/hub services providers to expand their efforts to further “humanize” patients in the eyes of the pharma industry and to encourage improved offerings that 

 take the patient’s needs into account. As Evans and Suchotliff conclude, their aim is not to disparage pharma but to expand the scope of the conversations around patient centricity and to truly “make it a reality.”

Julian Update is Pharmaceutical Commerce's Editorial Director. He can be reached at

PC's new editor-in-chief details his thought process on familiarizing himself with a different side of the industry

Diving in Headfirst

While the prospect of a cancer diagnosis understandably brings a range of emotions for everyone involved, there is considerable excitement throughout the oncology sector. Such optimism is being driven by breakthroughs in advanced therapy options and improved overall clinical outcomes in terms of progression-free survival across many different types of cancer. Ongoing efforts to both optimize trial enrollment and improve prescribing through the strategic use of genomic profiling, growth in the use of oral versus traditional infused oncology agents, and initiatives to address persistent diversity gaps and information gaps in the traditional randomized controlled trial (RCT) process also herald a bright future in this space.

At the same time, there is growing appetite among drug developers and regulators for gathering real-world data (RWD) that is collected outside of a clinical trial and analyzing or modeling it to create actionable real-world evidence (RWE). Regulators are increasingly receptive to using such findings in regulatory decision-making.

According to a December 2021 report from IQVIA,

 oncology is the therapeutic category that is forecast to grow the fastest, by a 9% to 12% compound annual growth rate (CAGR) through 2026. This increase is being propelled by significant development of therapeutics and expanded treatment indications, despite offsetting the growing use of biosimilars and other exclusivity losses.

Oncology therapies represented 37% of the overall drug-development pipeline in 2021, with 2,226 products currently in clinical development, according to IQVIA. The majority of therapies in the cancer pipeline (75%) involve some type of targeted therapy (that is, based on a predictive biomarker), and 42% (930 products) are aimed at treating rare cancers, says Murray Aitken, senior vice president and executive director, IQVIA Institute for Human Data.

Meanwhile, clinical trial activity—a good bellwether of the health of the oncology sector—also remains robust, despite ongoing disruptions caused by the COVID-19 pandemic. According to IQVIA, oncology trials accounted for 13% of the industry’s clinical trial subjects in 2021 (a 15% increase over 2020). New cancer trials that began in 2021 required 300,000 study participants, up from 150,000 a decade ago, and the number of oncology trial starts reached historically high levels in 2020 (1,600 starts)—up by 70% from 2015.

Despite this collective activity to pursue novel oncology treatments, drug developers still face stiff headwinds. “We calculate a composite success rate of just about 5% for all cancer drugs,” says Aitken. “While that may sound discouraging, it really underscores the complexity and explosive growth in scientific innovation in oncology. The relatively low success rate is truly a reflection of the appetite for greater scientific risk companies are willing to take on.”

 IQVIA says that the next-generation therapies (cell-and-gene, mRNA, immunotherapies and others) “are increasingly being pursued and are creating opportunities for enormous growth,” notes Aitken. “Collectively, these therapy classes are still relatively small, but a huge amount of investment is happening now, so it’s a really exciting time.”

While the overall approval rate is low, over the past five years, 62 novel oncology therapies have launched in the US—approved for 130 different indications across 24 different tumor types (bringing the total to 169 over the past decade). Rare cancers represent the majority of recently approved treatment options, with 16 of the launches in 2020 receiving an orphan designation. “When we look at the pipeline to predict what will emerge over next five years, the future will be even more exciting—and also more crowded and competitive,” says Aitken.

Meanwhile, global spending on oncology drugs reached $164 billion in 2020 (increasing at a CAGR of 14.3%). IQVIA projects that global spending on cancer therapies will reach $269 billion by 2025, even as growth rates are expected to slow to about 10% a year.

Biomarker-directed therapies and genomic testing

From a clinical standpoint, biomarker-directed therapies are heralded for their ability to improve prescribing efficacy, help to predict a patient’s response to therapy, drive improved clinical outcomes, help patients to avoid treatments that are unlikely to have a positive clinical impact, and help payers to avoid paying for such suboptimal treatment options. Predictive biomarker testing is now required or recommended for 79 approved oncology drugs in the US—double the number in 2014, according to IQVIA.

While the list of identified biomarkers grows every year, “the industry still needs to fine-tune its understanding of which biomarkers are actually oncogenetic drivers and correlate those to clinical outcomes, and this remains challenging,” explains Jennifer Harris, vice president, clinical development and head of the oncology scientific strategy and innovation team for Syneos Health. “We work with a lot of smaller companies that are entering the oncology arena, and it’s the rare trial that doesn’t have a robust, exploratory biomarker aspect to the trial program, often as early as Phase I. That’s grown a lot over the past five to 10 years.”

Harris also points out that biomarker-directed therapies tend to command premium prices because the biomarker requirements mean there will be fewer potential patients and thus a smaller overall market. Nonetheless, “the higher likelihood of clinical benefit associated with biomarker-directed oncology agents also increases the probability of clinical trial success, which, in turn, increases adoption rates of payers and prescribers,” adds Bruce Feinberg, DO, chief medical officer for Cardinal Health Specialty Solutions. As the saying goes—there’s nothing more expensive than a drug that doesn’t work.

“Payers are rapidly embracing genomic profiling as a cost-effective strategy. I think the more pressing barriers today are logistical and educational,” continues Feinberg. For instance, one of the important questions in the oncology sector today is what is the best strategy for carrying out genomic testing—should such testing be carried out on an ad hoc basis, only after an initial diagnosis has been made? Or should we, as a society, begin to move toward routine, large-scale, panel screening to identify many genetic mutations in all patients?

“Broad molecular testing will—and should—become more widespread,” says Marcus Neubauer, MD, chief medical officer, The US Oncology Network, which is supported by McKesson. “Cancer is a devastating disease and treatment is very expensive, so knowing the cancer molecular profile can improve outcomes and direct therapy, which reduces costs by avoiding ineffective therapy.” But he adds that “the explosion of new information around biomarkers is difficult for oncologists to keep up with, and inconsistent reimbursement for testing remains an issue.”

All stakeholders are struggling with how to best execute on this objective. “If we begin carrying out widespread, panel-type testing for many biomarkers, what is the patient supposed to do with the information—live their whole life in fear?” says 

Harris. “We have to better understand which biomarkers are really oncogenetic drivers, and I don’t think we’re there yet. Payers are understandably more reluctant to pay for testing if the information yields no actionable options.”

Tissue-agnostic therapies—the holy grail in oncology

One particularly promising opportunity in oncology is the ongoing evolution of so-called tissue-agnostic therapies—whereby a single therapy is able to gain regulatory approval across multiple oncology indications, “because the drug targets the presence of a particular specific biomarker—irrespective of which organ system carries the malignancy,” says Neubauer.

Perhaps the best example of a tissue-agnostic oncology therapy is Keytruda (pembrolizumab), an immune checkpoint inhibitor from Merck. Essentially, Keytruda’s success has been based in part on the fact that testing for the protein PD-L1 can identify patients regardless of where the cancer originated, Neubauer explains.

Since its initial approval by FDA in 2014, Keytruda is now approved for use in 18 different oncology indications in cancers that express PD-L1, making it a blockbuster drug—something that doesn’t happen often in oncology. In fact, according to Merck, 2021 sales data for Keytruda topped $17.2 billion, up 20% from the year before.

A second tissue-agnostic oncology therapy—Vitrakvi (laretrectinib) from Bayer and Loxo Oncology—hasn’t enjoyed the same commercial success. First approved by FDA in November 2018 to treat patients whose tumors are caused by chromosomal mismatch neurotrophic receptor tyrosine kinase (NTRK) gene fusions, Vitrakvi is now approved for use in a growing number of cancers, including lung, thyroid, gastrointestinal cancers, and others. However, despite its clinical success, Bayer has said it continues to struggle to identify patients who have the rare genetic mutation that would make them eligible for it.

 And Bayer doesn’t report Vitrakvi sales separately.

Aitken of IQVIA says: “We are tracking about 100 drugs that have the potential to be tissue agnostic in clinical development right now. If they succeed, this will provide further impetus for appropriate testing—and science-based cancer care—taking more of the guesswork out of cancer care.”

In recent years, ongoing advances in the field of oral oncology—whereby therapy options are now approved in pill form—have continued to drastically alter the landscape. The convenience of at-home administration of oral oncology medications cannot be overstated, as an alternative to regular trips to a clinical setting for intravenous infusions of traditional oncology drugs. Oral oncology agents are now available in breast cancer, leukemia, colorectal and renal cancers, multiple myeloma, lymphoma, prostate cancer, and more. More than 60% of the new active substances in cancer are available as oral formulations, according to IQVIA.

However, oral oncology regimens create specific challenges for patients and providers. “These range from affordability issues, to challenges for providers (to navigate the complexity of competing oral therapy options), to adherence (once patients must manage their drug regimens at home versus in a traditional acute care in a clinical setting), to challenging dosing regimens and safety issues that may not be recognized quickly enough by patients at home,” explains Mark Alwardt, vice president of medically integrated dispensing for McKesson.

A variety of focused support programs and wraparound services have begun to emerge to help patients manage the challenges of oral oncology therapies and improve the odds of success. At a basic level, this includes basic telemedicine options and apps that can potentially help patients to manage complex dosing regimens, remain on therapy, and manage safety issues and adverse events.

“We are using artificial intelligence (AI) and machine learning (ML) technologies to more accurately help predict or enhance the opportunities for medication-support programs to promote adherence for administration of oral oncology medications at home,” says Janmejay Singh, associate director, decision science, Axtria. “For instance, we have designed drug-adherence estimation analyses based on algorithms that can tell us what drivers will and will not keep cancer patients on their medications at home, and score these drivers based on drug adherence or non-adherence.” Such insights can inform nursing and specialty pharmacy initiatives, helping them to target the right patients at the right time to help them remain on therapy.

Meanwhile, to support patients and oncology practices, several pharmacy benefit managers (PBMs) have recently launched initiatives that are focused on addressing the challenges in oral oncology, notes Alwardt. For instance:

IntegratedRx, a progressive oncology network co-developed by Prime Therapeutics in collaboration with McKesson, is providing holistic patient care to reduce time to therapy, improve adherence, and streamline any therapy adjustments.

Optum recently launched Specialty Fusion, a real-time medical and pharmacy tool that gives providers therapy guidelines and recommendations, benefit coverage information (medical and pharmacy), cost information, and manufacturer-assistance programs.

Highmark recently launched Free Market Health (FMH), a new specialty pharmacy model to streamline drug authorizations and referrals for providers; it offers a process for pharmacies to submit bids to fill prescriptions versus having exclusive contracts, and for participating pharmacies to earn additional value-based reimbursement.

Alwardt notes that “Oncology providers are also making investments to build integrated dispensaries and pharmacies that support the broader use of oral oncology drugs, based on a concept called medically integrated dispensing (MID), that focuses on quality systems and accreditation, patient-reminder notifications, and integrated patient education and medical care management.”

Clinical trial design: Addressing key shortcomings

There are currently 400,000 active trials underway across the globe, with nearly 2,400 of them addressing various cancers. However, a persistent lack of diversity in clinical trials is a big problem throughout the pharma/life sciences sphere, and it is a particularly big issue in oncology. “It’s becoming readily apparent that RCTs are inefficient, costly, and not representative, as 90% of the population of patients with cancer do not participate,” says Cardinal Health’s Feinberg.

“As a result, the findings emanating from such trials are limited and often lack critical data related to health outcomes and social determinants of health (SDOH) of diverse patient subpopulations, says Jenny Sherak, SVP and president, specialty physician services, AmerisourceBergen. “These trials provide access to innovative therapies that aren’t available yet for widespread use and offer hope for patients who have exhausted all available treatment options. However, clinical trial enrollees are often not reflective of the diverse patient populations that are in most need of the therapeutics being studied, and the benefits of clinical research tend to disproportionately favor white, male patients.”

To address the inequities, “you really need to get to the root cause of why so many clinical trials aren’t truly diverse today,” notes John Doyle, DrPH, group vice president and principal scientist for Exponent, Inc., and adjunct assistant professor at Columbia University’s Mailman School of Public Health. “It’s not as simple as setting targets to enroll specific population sub-groups in specific proportions. That’s a good start, but you also have to understand and overcome the intrinsic barriers.”

Contributing factors, such as a lack of local trial availability, restrictive eligibility criteria, transportation issues, medical mistrust, and stigma associated with clinical research, can deter or inhibit trial participation. Particularly challenging is the lingering misunderstanding as to the intent and structure of clinical research among some potential participants, notes Robert L. Coleman, MD, chief scientific officer for US Oncology Research (McKesson).

To address this common misconception, Harris of Syneos Health says: “It’s important for stakeholders to develop improved messaging to convey that when patients are enrolled in an oncology clinical trial, they get the standard of care plus the investigational agent, so they are not losing any time.”

Similarly, efforts to partner with the entire community—not just to reach out to individual patients—can help to build trust and increase the likelihood that potential participants will become aware of the trial opportunities and be more willing to enroll, adds Feinberg.

Coleman believes that when more opportunities are accessible for frequently disenfranchised populations, “you see an immediate positive effect. And importantly, increased diversity enables better extrapolation of the trial findings as to how the agent or intervention will perform after receiving approval,” he says.

Currently, around 85% of patients with cancer are treated in a community setting, rather than in a large academic hospital-based setting, yet only 3% of those patients are enrolled in clinical trials, according to Sherak of AmerisourceBergen. “Through our ION Solutions network, which works with roughly 60% of community oncology practices across the US, we are helping community practices to identify qualified patients and connect them with clinical opportunities they might not otherwise have access to,” she adds.

Another way to expand trial diversity would be to expand the eligibility criteria, which, by design, often excludes participants with comorbidities. “This is a major concern given racially marginalized groups often have a greater likelihood of experiencing one or more underlying conditions due to historical health and economic challenges, says Sherak. “If an investigational therapy, once approved, will be used among a broader patient population, it’s advantageous to expand eligibility criteria to include those with coexisting health conditions during the trial process.”

Decentralized clinical trials on the rise

As an alternative to the traditional RCT model, decentralized clinical trials (DCTs) are carried out by in multiple, localized sites, often aided by telemedicine and a network of local participating physicians. Patients in rural areas, in particular, can benefit from DCTs, as they do not require close proximity or frequent travel to large academic research institutions, notes Sherak.

“The purpose of decentralized clinical trials is to develop a more representative data set that reflects patients in the real world by reducing barriers and broadening the pool of eligible candidates,” adds Feinberg.

While the DCT may increase the initial management burden for drug companies because there are more nodes in their research network to activate, it also creates a faster, more nimble network that can generate more valuable, real-world data, explains Doyle of Exponent. “When there are dozens of sites in a decentralized clinical research program, trial sponsors can continually learn and gather real-time insights and share that with the other nodes, and they can use advanced AI and ML techniques to recognize signals earlier to improve efficiency and effectiveness of the clinical trial program,” he says.

Real-world data and real-world evidence in oncology

Doyle also points out that RWE provides an important option for closing the information gap between what’s been studied in the trial environment and what is happening in real-world prescribing situations, particularly with regard to the health-economic impact of competing treatment options. “Oncology is leading the charge with regard to RWD/RWE studies because of the overarching budget impact in terms of both the size of the population and the high cost of therapy,” he says.

“Retrospective studies have been carried out for a long time, but there are numerous opportunities to collect and study valuable RWD from multiple sources and create actionable, data-driven RWE from it,” adds Nicholas Robert, MD, chief medical officer for Ontada, McKesson’s oncology RWD and evidence business. “But it is challenging because inconsistent data quality remains a big concern that can undermine the evidentiary value of the findings.”

When extracting data from an EHR system, there needs to be a serious, detailed process to verify that the collected data is correct if it is to have any value. Even more challenging are the requirements to collect and use unstructured data from progress notes, pathology data, medical imaging, and more. “Consistent guidelines and common templates must be used to extract relevant data from unstructured sources in order to ensure uniformity and reproducibility of the results,” says Robert.

“In recent years, regulators have come to appreciate the ability of RWE to complement—not replace—clinical trial data,” adds Doyle. “But we still need to do more work collectively to close that gap and to improve generalizability of the available data by better representing diverse populations in their communities by incorporating SDOH.”

Harris believes that within the oncology setting, it’s not fair to randomize patients to receive the standard of care plus placebo, or the standard of care plus the investigational drug to prove that the drug being evaluated works. “As an alternative, we can create RWE studies to develop synthetic control arms to study existing data on patients who have already been on the standard of care alone (as a virtual alternative to an actual trial arm that would study the standard of care plus placebo), to 

augment the clinical trials that focus on giving trial participants the standard of care plus the investigational therapy,” she explains, noting that the FDA has been increasingly receptive to this approach.

Such external control arms provide another mechanism for addressing the diversity shortcomings of today’s clinical trials by allowing outcomes to be assessed in specific patient sub-populations that were not enrolled in the original trial, adds Feinberg of Cardinal Health.

Robert notes that RWE studies have yielded first-line approvals from FDA, approvals for additional indications for an existing therapy, approved label changes related to dosing regimen, and independent confirmation of clinical trials. In fact, over the past decade, RWE has been used in the new approval or expanded use of existing drugs 31 times, including 11 drugs in 2021, according to IQVIA,

 signaling growing receptivity at FDA. Synthetic control arms have also been used to approve six drugs over the past six years (not all in oncology), based on data from registries, EHR systems, or literature reviews.

There are also exciting inroads being made in the way AI and ML can be used to derive RWE insights from RWD in oncology, particularly to address patient adherence challenges, notes Singh of Axtria. In a recent example, Axtria conducted a deep analysis using these technologies to help determine the probability of whether chronic lymphocytic leukemia (CLL) patients would continue or stop taking their specific targeted therapy over a longer-term based on the impact of the comorbidities they had. “We used a number of advanced data-analytics and machine-learning techniques that helped us identify the most important factors that could be attributed to a patient’s discontinuation of their therapy,” explains Singh. “These types of analyses could help enhance communications from drugmakers to physicians, to help them take effective steps to manage a patient’s disease burden.”

Another use of AI and ML-based analytics has been to design studies that can identify patient pools that are most eligible for a promising new cancer therapy when the product is launched on the market. “Such an application of advanced data-analytics techniques involves identifying ‘look-alike’ patients based on key patient behaviors and patient-history, medical-journey patterns that then assigns an ‘importance’ score to these factors,” says Singh. “Such insights can help to pinpoint the best opportunities for drugmakers to educate and communicate with healthcare providers, and create precise field force-detailing plans about the therapy, based on the probability of patient adoption.”

IQVIA forecasts that more than $300 billion will be spent on cancer medicines in 2026. “When we look back periodically and reflect on what was in the pipeline, what’s come out of the pipeline, and the uptake of the new drugs and improvements, we can see what a remarkable journey we’re on, and the scientific advances will keep that progress moving forward for at least the next decade,” says Aitken.

1. The Global Use of Medicines 2022—Outlook to 2026, Published December 2021, IQVIA Institute for Human Data Science; 

https://www.iqvia.com/insights/the-iqvia-institute/reports/the-global-use-of-medicines-2022

2. Global Trends in R&D 2022—Overview Through 2021, Published in February 2022, IQVIA Institute for Human Health Data; 

https://www.iqvia.com/insights/the-iqvia-institute/reports/global-trends-in-r-and-d-2022

https://www.reuters.com/article/us-bayer-results-vitrakvi/bayer-says-struggling-to-find-patients-for-precision-cancer-drug-vitrakvi-idUSKCN2501RU

https://www.fiercepharma.com/marketing/unconventional-move-bayer-pits-genetically-driven-cancer-drug-vitrakvi-against-roche-s

6. Global Oncology Trends 2021—Outlook to 2025, IQVIA Institute for Human Data Science, Published in June 2021; 

https://www.iqvia.com/insights/the-iqvia-institute/reports/global-oncology-trends-2021

Ongoing challenges—ranging from the growing complexity of today’s advanced
therapy options, to inherent shortcomings in the clinical trial process, to ongoing adherence challenges and more—must be reconciled to ensure both clinical and commercial success throughout cancer care

Oncology Innovation: Optimism & Obstacles

Industry-sponsored patient support programs have become an essential “lubricant” for coordinating care of patients with complex medical needs. By bringing together the drug developer with the healthcare providers (HCPs) and the payer network, therapies can get to patients sooner, with better overall results for all. Especially with complex specialty pharmaceuticals. And most especially for the fast-growing field of rare or orphan diseases.

That being said, patient support programs, or hubs, remain an underutilized part of healthcare. A 2020 survey from Accenture found that only 18% of patients are aware of the programs being offered—a number essentially unchanged from 2015, when an earlier survey was performed. This is despite indications that industry is funneling more funding into the programs.

There are two basic problems that account for this lack of uptake, according to Anthony Romito, life sciences lead at Accenture. One is organizational issues inside pharma companies that limit how well the organizations promote their services; another is the lack of communication to HCPs of the value of patient support.

On the organizational side, “Most organizations’ hubs are either outsourced and operated by a third party, or they sit in med affairs or market access” departments, he says. “For brand teams, these organizations are not necessarily knitted into the DNA of their go-to-market strategies; there are big gaps despite increased investment.”

Equally problematic, “Pharma companies have generally done a poor job of measuring the clinical effectiveness of patient-support programs, and so HCPs have been reticent to recommend them to their patients.” However, Romito sees some progress here: demonstrating values like reducing time to first dose, or improvement in patients staying on therapy, enable the pharma companies to demonstrate value to the HCPs.

Romito cites the variety of support programs sponsored by AbbVie for its blockbusting Humira treatment (currently the most valuable drug in the world, with sales of $20.7 billion) as an industry pacesetter. “AbbVie has been diligent in demonstrating longer-term patient retention and better outcomes through its support programs,” he says. The equation is simple: provide the service, measure the outcome, and communicate to HCPs.

Even so, industry appears to be moving in the opposite direction when it comes to close coordination of patient-support services and product management. Helio Health Group, a consulting firm, has surveyed the field for five years running; its 2021 survey, published in December, showed that, when a patient-support program exists inside a pharma company, it was placed within the brand/commercial team at 37% of pharma companies in 2017—but only 8% were so situated in 2021. (Conversely, there was growth in placement in managed markets teams, and dedicated patient-service teams.) A major reason for this decline is the difficulty in maintaining a compliant program, avoiding such federal restrictions on patient-data access, or providing improper financial inducements to patients.

The ”classic” (circa five to 10 years ago) hub program was focused on moving patients through the obstacle course of paperwork for getting a prescription and getting it reimbursed. The process often starts with a benefit verification (BV) process to determine insurers’ policy on a drug or therapy. Payers’ use of prior authorization (PA) procedures require physicians to complete sometimes complex diagnostic evaluations, and symptom descriptions. Payers can also require so-called step edits that call for trying a variety of other treatments (usually, the less expensive ones) before the physicians’ preferred choice is permitted.

All these complexities are magnified for many rare diseases which, as Jan Nielsen, division president for patient support solutions at AssistRx, says, can take upwards of six to nine years to correctly diagnose. Testing that might originate with a patient’s primary care physician can itself require a fight with an insurance program’s benefit structure.

For the most part, patient-support providers have built information technology (IT) tools and databases to handle the paperwork, so now there are eBV and ePA resources to be used either by physicians or by the hub providers to assist physicians’ offices. Similar programs are in place for copay analysis and availability, and in some cases, patient assistance programs sponsored by manufacturers. (These have their own requirements for financial disclosures, and might have only limited durations during the patient journey.)

So-called “hub-light” programs pretty much start and stop with these digital services (perhaps with some in-person call- center activity included). But for complex pharmaceuticals, and especially for the newly establishing field of cell and gene therapies (CGTs), many more services are wrapped around the prescription. “There are between 5,700 to 6,000 preclinical and clinical assets that are being developed globally in terms of CAR-T and inclusive of gene therapies,” says Maria Kirsch, GM and head of patient services at Eversana. “This will be a massive wave of the most powerful therapeutic modality in the history of our industry that will address some of the most severe unmet needs for cancer patients, rare disease patients, and other patients who are, unfortunately, on their last hope of treatment, as they have failed other treatments.

“Taking that a step further,” she adds, “We estimate approximately 900 assets are in clinical-stage development. There is a higher likelihood of clinical trial success, for example, with Phase III, CAR-T programs, so hundreds of new CAR-Ts or cell therapies coming into the market will help patients’ lives, but make no mistake, there will be major implications and a significant amount of overhaul to our healthcare systems globally, to be able to absorb the clinical impact, operational impact, and financial impact of these therapies.”

Eversana supports seven exclusive rare disease products, according to Kirsch, “all with patient-service offerings being a critical component.” For companies like Eversana and others, patient support in rare diseases often involves coordination with family caregivers, in addition to the interactions with providers and payers. An estimated 60% of patients with rare diseases are under the age of 18, and a high proportion of such diseases involve chronic care. “We are often working with parents or caregivers to coordinate therapy, schedule adherence plans, and coordinate life coaching for major life events like starting school, going to college, or starting a family,” says Kirsch. “Through education and close connections with patients, we are able to anticipate challenges they may have, such as dietary restrictions, and provide them with the skills to overcome them.”

By contrast, the appeal of many of the CGTs—commercial or in clinical-stage—involve what amounts to a “one-and-done” procedure (at least, this is the promise of many of them). Once a patient’s cells have been collected, manipulated at a cellular or genetic level, and reinfused, the potential for a near-complete cure of a cancer or birth defect is high. Getting the patient to that point, however, can require travel accommodations (since many of these therapies are available only at selected medical centers), multiple trips, and—most significantly—long-term follow-up to ensure that the therapy is permanent.

“Give credit to Novartis for getting an OIG (Office of Inspector General of HHS) ruling that allowed low-income Kymriah patients to have their travel and related services legally reimbursed,” says AssistRx’s Nielsen. This occurred in early 2021; Kymriah, one of the first commercial CGTs, nominally costs $475,000 per patient. For support programs like these, AssistRx enables patients to be quickly reimbursed via e-banking services like Zelle or PayPal.

Mention of the HHS OIG highlights the line patient support providers must constantly adhere to, because poorly monitored practices can lead to serious HHS violations. Helio Health, which runs the aforementioned survey, notes that manufacturers have been increasing their oversight of nurse educator practices and awareness of patient privacy requirements, while reducing their support of some patient assistance programs (which provide direct financial support). Caution is the watchword.

It’s hard to say whether the pharma industry’s emphasis on CGTs is influencing patient-support providers to get into clinical trial engagement, or whether those providers’ growing expertise is being better appreciated by clinical trial managers, but the upshot is that there is substantial value in providing patient support during trials, and business is growing for those providers. This trend has also been boosted by the pandemic, which drove many clinical trials into a decentralized, remote-services version.

“Over the past 18 months, we’ve become engaged in about a half-dozen programs,” says Nielsen. The main driver is trial patient retention. “Especially for some rare diseases with limited trial populations, the need to keep patients in the trial is critical,” she adds. “Service providers like us provide adherence nurse educators, helping remote patients with complex diagnostics and drug-delivery devices, or complicated drug regimens. We’ve become the 24/7 hotline for trial patients.”

In a February announcement, Eversana debuted a data-driven service for clinical researchers by partnering with Thread, a provider of decentralized clinical trial management and clinical outcome assessments (eCOA). The company will combine its commercial capabilities in linking real-world data and electronic health record (EHR) data with Thread’s, thus enabling “continuous active, passive, retrospective, and prospective data collection with patient consent and identity security as central tenets,” according to Eversana. Another Eversana partner, Datavant, provides patient privacy and security.

“In the evolving world of real-world data, registries, and clinical trials, it has become increasingly likely that a patient could end up participating in all three through the course of their care journey,” says Eversana’s Kirsch.

The clinical-to-commercial spectrum could have important benefits for winning over HCPs by the time a drug is approved. Accenture’s Romito says that the ideal entry point for getting patient-support programs engaged is in Phase II of a drug trial. “Today we have long lag between measuring the clinical value of the drug and the impact of the patient support service,” she notes. “There are untapped opportunities to have collaboration between the clinical development team and the commercial development team. We’re seeing more of this in the CGT space, with less walls between two organizations.”

There are unplumbed opportunities in bringing advanced digital technologies, some of them cloud-based and utilizing artificial intelligence, to better serve patients and the clinical research organizations driving for drug approvals or for payer acceptance. Accenture has rolled prior work in digitizing patient services into a broader, cloud-based platform it calls Intient. Eversana has a “next-generation” patient-services platform called Actis Patient Relationship Management, which promises to use predictive analytics and behavioral science to improve the patient experience.

Another approach is from AiCure, which offers expertise in what it calls “digital biomarkers” of patient condition. It started out being able to confirm a patient taking a clinical trial drug dose by having the patient do a video recording of the act with the patient’s smartphone. More recently, it has developed methods to observe patient condition for diseases such as Parkinson’s to assess whether in-person intervention is needed. While the technology has been used mostly during clinical trials, “We are in discussions with patient support-groups to engage with them,” says Rich Christie, MD, PhD, chief medical officer of AiCure. Most recently, it has partnered with Science 37, a clinical trial IT provider, to monitor patient condition for those suffering from depression.

Yet another approach is being championed by BrightInsight, which offers a compliant, cloud-based platform with which to combine apps, devices, companion diagnostics, and other resources for remote patient support. A showcase example is a partnership with CSL Behring for the latter’s Hizentra (immune globulin subcutaneous) drug, used for the rare diseases primary immune deficiency or chronic inflammatory demyelinating polyneuropathy. These serious conditions require patients to self-administer Hizentra multiple times daily. The BrightInsight platform enables CSL Behring to provide a smartphone app to manage infusions, get reminders, and record and share their infusion journal with their doctor.

Biopharma sponsorship of patient-support programs and treatments for rare diseases is growing, but gaps remain 

The Pulse of Rare Disease Support

Whlie the pharma world has been talking about patient centricity for over a decade, a new book points out that executives and companies have only made piece-meal progress on this issue and have yet to deliver on their promise to hold the patients’ needs at the center of all decisions. 

, edited and co-written by Hensley Evans, leader of ZS’ patient and consumer health practice, and Sharon Suchotliff, who heads ZS’ patient centricity work, explores how pharma can move beyond just implementing what they call a “patient-centered corporate culture.” The editors and their contributors use real-world case studies, proprietary data from a range of studies, and insights from their own experience to offer tangible ways for pharma companies to make an impact on patient lives, from initial R&D stages, through to effective clinical trials and enhanced patient engagement during treatment.

Before joining ZS, Evans led consumer and patient marketing strategy at Saatchi & Saatchi Health and Wellness; she also spent eight years leading imc2’s health and wellness practice and four years as president of Harte-Hanks Direct and Interactive.

Prior to her role at ZS, Suchotliff led the engagement strategy practice at Saatchi & Saatchi Wellness, where she was responsible for developing and leading strategic marketing across the agency’s pharmaceutical, healthcare, and wellness clients.

 sat down with Evans and Suchotliff to chart the book’s development and tap into their vision for a future where patient centricity is not just a buzzword or a hackneyed term but a tenet embedded at the heart of the industry.

. “Reinventing” is quite a strong word, quite provocative. Does patient centricity need to be reinvented, and what would that reinvention actually mean?

 The reason we use the word “reinvention” is that we did want to be a bit provocative. We’ve been talking about patient centricity in the industry for a really long time. I think it was 2010 when UCB put on the cover of their annual report that they were going to be the leader in patient-centric pharma. But our benchmarking studies of where pharma is in terms of implementing patient-centric initiatives has shown that no one is transformational. Companies are instead making very incremental changes, moving their business models toward one that’s more focused on delivering to patient needs and being patient-value oriented. So, we wanted to issue a bit of a challenge to the industry to take more meaningful steps to transform their organizations toward a patient-focused way of doing business.

We looked at patient centricity, how companies are actualizing it, based on four dimensions (see chart on next page). We’ve benchmarked more than two dozen companies over the last few years. As Hensley says, no one is transformational. By and large, the industry is really foundational. We have seen changes over the last few years, but not enough. If we truly believe in patient centricity, we’ve got to change the way things are done. And we’re asking, “How might we do that? How do we walk away from the buzzwords? How do we make this meaningful and real?”

It does indeed feel like we’ve been talking about patient centricity for a long time. I’m surprised it’s only 10 or 12 years. So, we can ask, is that a long time, really? Haven’t we had to wait for technological advancements to really allow for patient centricity?

 I think technology has a lot to do with it. We now live in the “I want what I want when I want it” world. That’s been facilitated by personalization, and, of course, data and technology have helped to drive that. But there are other reasons. There’s the external environment, there are also business reasons, in terms of the decline in the return on investment of clinical development. And there is the fact that specialty and rare diseases, oncology, personalized medicine, gene therapy—all of these require a more focused and a better understanding of patients. We’re also seeing a shift in the regulatory environment. Both the European Medicines Agency (EMA) and FDA are asking for patient input. In the next couple of years, we can expect the regulators will want to see more of this input. And on the payer side, we’re at a place where payers are looking for value beyond clinical outcomes. Are patients better able to engage in their life? Do we see a reduction in overall healthcare costs? So, I think there’s a lot of different reasons that have led to this change.

 Technology is a great enabler, so I was a little disappointed when we did the benchmarking last year to see that we hadn’t come further as a result of the incredible leap that we’ve made in terms of data and technology. And COVID pushed the pedal down further in terms of accelerating technology adoption. I don’t think that the lack of technology was what was holding pharma back. We talked to executives on our advisory board and they listed things like silos, concerns about regulatory issues, compliance. And yet I think the single-biggest reason is that pharma has been phenomenally profitable and successful for decades, if not more than a century, without having to make a radical change in this way. It’s kind of the “If it ain’t broke, don’t fix it” approach. There’s no burning platform to make companies adopt a radically different approach to their business. But a lot of the things that Sharon mentioned are driving senior executives to think, “Yeah, maybe I’d better start moving off this platform before it’s really on fire,” so I’m hopeful that we’ll see some more dramatic change.

We hope that by writing the book, we’re going to help push some of the folks who are behind the leaders to move more quickly. It’s doubtful that anyone who’s not already thinking about patient centricity would bother to pick up the book in the first place, but we are trying to preach beyond the choir, to reach a broader audience and move beyond the apple-pie notion that “Of course, patient centricity is a good thing.”

 You can have the best strategy, the best intentions, but without a focus on shifting the mindset, you’re dead in the water. I think a big cultural shift has to happen, and a lot of it has to be around what we believe and how we define value. Can we get to a place where value to the patient equals value to the company? I think that’s the biggest change, and it’s one that pharma’s coming around to very slowly.

 A company can say, “I want to improve the experience that a patient has starting my therapy.” Primarily, that is a business objective—to get patients on a therapy faster. A delay of two to three months has a significant business impact. If a company delivers a much smoother and more pleasant experience to its patients, those delays and barriers can be eliminated; the patient appreciates it. It’s kind of a win-win. But if it’s only done for a business reason, then a company is only solving things in little silos, e.g., decreasing the patient burden in your clinical trials because, otherwise, patients are going to drop out or fail to enroll.

There has to be a cultural or mindset shift, or you are only ever going to get incremental change.

What did your collaborators bring to the book?

 Everyone that we approached early on about collaborating on the book was hugely enthusiastic. One of the reasons we decided to write it in the first place was that we had so many different parts of the organization focusing on different aspects of patient centricity: the data and technology team; the digital connected health team; the rare-disease vertical focused on partnering with patient advocacy groups; the R&D excellence team looking at clinical development. ZS is a very entrepreneurial organization. We have lots of practices that are really able to innovate and independently develop solutions. We thought it would be a great way to bring together a group of people that are looking at different ways to help the pharma industry really evolve and change.

 One of the things that I really like about working at ZS is that on one hand, we have lots of innovation—big thinkers, folks who are really willing to challenge the status quo—and at the same time, there is this recognition that we’ve got to be a bit pragmatic. That was a big driver for us in terms of the book. In having conversations with many executives, sometimes the patient-centricity ambitions just seem unachievable, too lofty. We wanted to present the pragmatic ideas, the pragmatic solutions, so that folks can see they’re taking good steps. But we also invited a lot of external folks to contribute, so sometimes we heard things that were hard to hear, but that’s okay, right? I think it made our work better.

 An early piece of feedback we got, actually from one of our patient advocates, was, “Do you guys have a group of patients that you work with consistently to get feedback on the work that you’re doing?” Of course, we advise our clients all the time to get patient input and take the patient perspective, but we kind of sheepishly said, “Um, no.” Well, now we do. The time it takes to publish a book gave us time to stand up a patient advisory panel. So, we learned a lot along the way; challenges from some of our collaborators caused us to do a little bit of rethinking.

 One interesting question we wrestled with, honestly, was around the use of the word “patient.” The industry, of course, has used this word consistently for a very long time. But most of the patient advocates we spoke to don’t like to refer to themselves as patients. They’re people; they’re more than someone who suffers from any particular condition or disease. We debated quite a bit about whether we should try to change the language that’s used around patient centricity.

But ultimately, we decided we’d reach a larger audience if we used the language that most people are kind of comfortable with or use now.

The book was being written as the COVID-19 pandemic was raging. What impact did that have on how the

 It changed a lot. To some extent, it made it easier to collaborate because, all of a sudden, we’re working in this virtual world. Collaborating virtually became second nature. And of course, in terms of the information we were including in the book, COVID certainly changed things.

 Yes, we had one conversation with an organization during COVID who put in place a mechanism to provide home care for patients because, of course, patients were unwilling to go to the physician’s office. And I said, “That’s great; it that a new insight that came up?” But they said, “Well, we always knew that patients didn’t want to have to go to the doctor’s office. It was always inconvenient for them. But they used to do it anyway.” So, it was only when patients insisted on not doing it that the company started accommodating them. Now, I don’t know that I want to call that patient-centric, right? It’s self-centered. The company only did it because it was hurting them financially, even though they knew that the patients would have preferred that all along. That was quite revealing.

How do you see the book being used? Will it become part of ZS’ package for clients or something independent

 In many ways, the book synthesizes a lot of thought leadership we had already been working on. Our company vision is “transforming global healthcare, driving toward a connected ecosystem, leveraging the power of data, science, and technology to make more intelligent healthcare decisions, and delivering innovative solutions to improve health outcomes for all.” The focus really is about patient outcomes and having an impact. At our partner meeting last August, which was exciting because it was the first time we’d come together in two years, our CEO held up the book during his keynote speech and said, “This really represents the thinking across the firm.” Everybody feels that the patient and patient outcomes are a critical orientation of our company as a whole.

 is also a book in its own right. And I hope it helps us to create some new conversations, particularly with more senior executives. One of the things we see is that there are some incredible evangelists for patient engagement and patient centricity at the senior director and VP level. But if a pharma company doesn’t have vocal SVP and c-suite leaders really pushing patient centricity, they’re only going to get so far.

We’d like to expand the scope of the conversations we’re having with the c-suite about patient centricity and how to make it a reality.

New book attempts to cut through pharma’s patient-centric posturing and start a conversation about real, transformational change

Patient Centricity: Banishing Buzzwords

Specialty-lite drugs, recognized as products positioned between the specialty and retail spaces, often require specialty services such as access and reimbursement support, while also having a lower-than-specialty wholesale acquisition cost (WAC) that makes full-time equivalent (FTE) models less financially feasible. For life sciences organizations, striking the balance between enhanced services for patients/healthcare providers (HCPs) and cost-effective solutions is critical for ensuring the long-term success of a specialty-lite drug patient-support program (PSP).

During the last decade, FDA approved more treatments annually, on average, than it did in the prior two decades, resulting in increased competition. Specialty-lite drugs are set to dominate growth in the space, with many life sciences companies leveraging technology-based solutions to remain competitive.

 securing formulary positions costs more every year. One organization saw the average list price for its insulin product up 141% since 2012, but average net price down 53% over the same period.

Challenges don’t cease once formulary is secured, however. An American Medical Association (AMA)-conducted survey found that 83% of physicians report the number of prior authorizations (PAs) required for prescription medications and medical services has increased over the last five years.

 Drugs with lower WACs are now finding a slew of new PA requirements needed for their patients to access therapy.

A Drug Channels Institute analysis of company reports

 found that the unweighted average gross-to-net gap in drug prices was -6.0% for 2020. The analysis also found that prices for brand-name drugs dropped, and drugmakers sold their products for less than half of the list price. This gross-to-net squeeze causes cost shifts that can negatively impact the patient if not handled correctly.

These trends prove that specialty-lite drug programs need services that benefit the patient at a cost that is attainable for the manufacturer. To accomplish brand goals at this cost, companies launching specialty-lite drug programs need a solution that addresses both sides of the coin. Unfortunately, few players in the industry have the technology and expertise needed to meet the nuanced needs of this growing market segment.

Innovative technologies can deliver automated specialty services such as e-benefit verification (eBV) and ePA, minimizing FTE requirements, making the cost to companies more economically feasible. Combined with deep expertise on pharmaceutical access challenges, new market entrants are taking on the needs of specialty-lite programs. However, the specific modalities in which these entrants deliver vary based on the vendor and their capabilities. New offerings positioned to meet the needs of specialty-lite drugs include:

 Built similar to specialty pharmacies, this model focuses on leveraging technology to speed access to therapy. While these pharmacies deliver some electronic support services like eBV and ePA, leveraging a single pharmacy entity may create concern for steerage. In addition to a specialty pharmacy for dispensing, the associated e-services may have limited reach and technology-first functionality.

 This model tends to focus on retail and lifestyle drugs. Often, telehealth services are core to access to specific therapies. Driven by patients, digital pharmacies leverage an e-commerce model and lean on the patient to self-serve throughout their journey.

 Using technology and mostly delivering reimbursement support, hub-lite models provide some e-services like eBV and ePA, but may not be able to evolve with the specialty-lite drug’s lifecycle without costly system and process changes.

 CoAssist, for example, AssistRx’s digital patient service, differentiates from the above models, with the ability to kick-off advanced and automated real-time e-support services at Rx intake from the electronic health record (EHR). Support services also include real-time eBV, ePA, eConsent, and eEnrollment. The platform features a limited pharmacy network and its own consignment pharmacy to support the clinical decision and gain visibility to the patient journey, as well as identifies the best affordability option for the patient, and deploys the necessary technology and expertise to evolve the program alongside the product lifecycle.

Selecting an offering for a specialty-lite drug program requires an understanding of the product and the patient/healthcare provider (HCP) population, as well as thoughtful planning for drug lifecycle. The optimal offering for a product meets HCPs in their workflow and patients in their lifeflow to improve access to therapy while reducing or eliminating FTE costs. 

The optimal offering should be able to evolve throughout the specialty-lite drug’s lifecycle. Many programs require some white-glove services at launch but later can be supported completely via e-support services. It is key that the infrastructure of a product program can address this shift when needed.

Challenges a specialty-lite drug program will face include securing formulary position and navigating access challenges like PAs. Your solution should be flexible enough to implement additional initiatives that can roll on and off over time as needed. For example, payer nudge campaigns that demonstrate demand, volume, and clinical effectiveness of the therapy can be implemented within the first year to improve coverage of the drug and be removed as payers add the product to formulary.

Second, your offering of choice should support a configurable program and selective pharmacy network. These characteristics drive access to the best fulfillment option for the patient, whether that be a free goods, commercial, or cash dispense. This, in turn, drives access, affordability, and adherence for your patients.

Third, e-support services should be initiated at the point of prescription, likely through the EHR, to best meet HCPs in their established workflows. For specialty-lite drugs, this design can make the largest impact on improving uptake, visibility, and outcomes through automated therapy initiation and fulfillment, both accelerating and simplifying the process. As these programs typically won’t leverage FTEs, automated e-support services help fill in the gaps of moving a prescription forward to fulfillment utilizing transactional, manual services when needed.

As more solutions come to market to support the segment of specialty-lite drugs, life sciences organizations should consider which solution will deliver optimal, cost-effective services for their drugs that aren’t quite specialty but aren’t quite retail either. The optimal solution takes both sides into consideration to generate services that support brand goals while ensuring unique HCP, patient, and caregiver needs are met.

Michael Carr, RPh, is CoAssist Group Vice President, AssistRx.

1. “Pharma Giants Get Their Pennies Pinched on Drug Pricing,” Wall Street Journal, March 12, 2021.

2. American Medical Association, Measuring progress in improving prior authorization, 2020.

3. “Gross-to-Net Bubble Update: Net Prices Drop (Again) at Six Top Drugmakers,” Drug Channels, April 14, 2021.

Not quite specialty, not quite retail: Cost-effective access and support strategies for a growing, yet underserved, treatment market

Adding Might to ‘Specialty Lite’

The 30 million Americans who live with a range of rare or orphan diseases usually manifest complex medical needs that require a high level of therapy adherence and support. Expanded, specialized services help these individuals to better address not only the challenges associated with specialty drug management, but also everyday lifestyle issues related to missing work, retiring early and foregoing income, and relying on unpaid family caregivers.

A patient-first care model can enable every stakeholder involved in the rare disease care continuum—patients, payers, providers, and manufacturers—to more effectively overcome problematic issues related to access, compliance, and adherence to treatment. These care strategies are often included in uniquely designed targeted programs, which engage the services of specialty-focused pharmacists and professionals with the experience and capabilities to mitigate costs and improve outcomes. This specialized expertise transcends the scope of competencies provided by traditional, legacy-care organizations, which are often designed exclusively for scale.

A specialty pharmacy (SP) solutions provider with a patient-first approach to rare disease management is imperative for deploying optimal solutions that offer interventions at key points in therapy to drive compliance and persistency, along with clinical outcomes tracking. Select organizations provide a boutique, consultative patient support/hub model that includes a dedicated, branded team. This is important for overcoming the limitations of the standard SP and hub service providers that often rely too heavily upon technology solutions that fail to address human needs and variability, as well as the need for customizations to fill specific manufacturer needs.

Currently, specialty drugs account for up to 52% of an employer’s total pharmacy spend. In fact, specialty rare diseases have led to substantial direct and indirect economic burdens for the patient, unpaid family caregivers, and the US health system.

 In the US alone, the estimated total economic burden of 379 rare diseases with a prevalence of 15.5 million people in 2019 was $966 billion, including a direct medical cost of $418 billion and an additional $548 billion in indirect and non-medical cost. Because most individuals living with rare disease are between the ages of 18 and 65, commercial payers bear the largest share of medical cost, while employers pay for significant productivity losses associated with absenteeism and presenteeism.

Patient-first, specialty-focused care teams typically include care coordinators, pharmacists, nurses, and other specialists, all focused on the disease state, patient community and therapy. They deliver customized care coordination and telehealth solutions as an added layer that fosters discussion between the patient, pharmacist, and other clinicians.

By incorporating assessments and interventions at key points in therapy, the care team is able to stay ahead of side effects and capture real-world evidence around the therapy, condition, and patient’s well-being. All of this critical data is then compiled for outcomes reporting.

A patient engagement strategy also takes a multi-layered approach that includes various channels, such as text, phone, and email. The strategy should be based on customer’s preferences and what generates the best response for each patient.

In a world of shrinking options and sophisticated technology, this approach offers something that has gone missing in the US healthcare system: the “human touch.” In fact, too often patients experience the retail pharmacy approach in which they are treated more as a daily quota, and not as someone facing an enormous life challenge. This is where specialty pharmacists can play a significant role for patients and caregivers. Specialized training and experience with high-cost, high-touch therapies for patients with chronic, complex, and/or rare diseases make them uniquely qualified to address the challenges associated with rare conditions. By providing an elevated level of customized care, they help caregivers to manage side effects and ensure that the patient “feels heard.”

Specialty-focused pharmacists are also a resource for information about custom financial solutions to address financial concerns and refer patients to copay assistance as applicable. When these professionals take a patient-first approach, they are able to cultivate a deeper relationship with patients and family caregivers, offering personalized information, care insights, and greater support that leads to improved outcomes and enhanced quality of life. In many cases, specialty-focused pharmacists serve as a knowledgeable, supportive resource, helping patients make the best possible decisions about their health care. When patients begin new medications, for example, the pharmacist can address any concerns they may have about side effects in a way that optimizes the therapeutic opportunity and helps the patient feel more comfortable remaining compliant, whether that means altering the prescription dose or getting a second opinion.

Pharmaceutical manufacturers should look for partnerships with companies that offer a fully comprehensive suite of SP services, as well as a consultative approach that allows for true customization and flexibility. These options should not only include custom patient support and hub services, but also pre-commercialization, outsourced market access, wholesale, third-party logistics (3PL), and limited distribution drug (LDD) fulfillment, available as an end-to-end solution set or a la carte.

As standalone options or collectively, these services can act as an extension of the pharmaceutical company’s trade or market access team. Specialized outsourced market access solutions provide strategic payer expertise, utilization management, pull-through programs, and real-time data access. What’s more, these capabilities should span the entire product lifecycle and prescription process, streamlining communications between prescriber, patient, and pharmacy to eliminate barriers, decrease time-to-fill, enhance the patient journey, and optimize outcomes.

It’s important to align with a patient-first, pharmacy-first hub provider that serves as an industry partner—one that is backed by a team that has a thorough understanding of the payer mix and value. Ideally, the partner should offer:

Deep bench experience and expertise in payer reimbursement and strategy development.

In-depth understanding of the competitive environment.

Programs designed to drive branded volume and provide data-driven cost savings analyses that result in optimal patient access to products in major specialty and rare disease categories.

Customized clinical support and high-touch patient engagement to drive compliance and enhance outcomes.

Ultimately, a patient-first approach leads to a better understanding of the patient’s needs, focuses upon the impact of a particular drug or a combination of drugs, and monitors the patient’s overall health, resulting in an optimal patient journey and more favorable clinical outcomes.

Dea Belazi is President and CEO of AscellaHealth.

1. The National Economic Burden of Rare Disease Study, February 2021 (

The patient-first, pharmacy-first hub model optimizes outcomes and improves care journey for patients with rare disease

Success with SP Solutions

After a newly diagnosed illness or chronic condition, a patient may find that navigating the healthcare system can be bewildering. And making sense of how to begin a complex drug therapy without help can present them with a steep learning curve at an emotional time. Hub services can alleviate a host of anxieties related to starting, and adhering to, a complex drug regimen. From prior authorizations and copay assistance, to logistics and communication with the patient and their care team, the most effective hubs seamlessly remove barriers to a patient’s access to life-saving drug therapy. But all too often, the patient can feel lost in the process.

For specialty drug manufacturers, high regulatory pressures make it natural to view the hub program from the inside, out through the lens of compliance, performance, analytics, and reporting. The ability to control costs with an efficient operational model drives business performance but does less to illuminate where along the patient journey an individual struggled to navigate a confusing or complex process. It is time to look at the effectiveness of your hub program from the outside in, through the lens of the patient’s journey where a five-star hub experience translates to patient satisfaction, treatment adherence, and better health outcomes.

Specialty drugs account for 2% of total medications prescribed, yet over 50% of the total prescription costs in the US, according to Evernorth’s 2020 Drug Trend Report.

 The report predicts that specialty spending could increase 10% to 15% over the next few years. Given the expense and the known risks of incorrectly using prescription medications, a patient’s lack of adherence and persistency due to movable barriers within your hub program is a non-starter.

To create a more individual-centric experience—and reveal the not-so-obvious sources of frustration—every interaction that involves the patient should consider their journey, experiences, and their emotions.

These four considerations provide the framework to rethink a hub program from a patient’s perspective:

Understand the consumer’s choice: Self-service or high touch

Consumers have grown accustomed to the convenience of technology—whether they’re ordering produce or purchasing a new car. And in a world with same-day delivery, suggested purchases, and personalized ads, consumers expect more information and choices than ever when making buying decisions. Smart retailers are studying all these preferences to cater to the individual’s preferences in how they learn about a product and the information (what and how much) they want before making a purchase.

It should not come as a surprise that the consumers have the same expectations of their interactions with the healthcare ecosystem. The hub program is no exception. Even though they are engaging in an experience that may not be of their choosing, the consumer-become-patient wants ready information to understand their disease state and tools to view progress at every step of the hub experience. Pharma manufacturers can look to retailers for effective practices to quickly become the trusted, go-to source for accurate information that patients can rely on to help them manage their condition, learn more about therapy, and discover ways to stay adherent.

Disruption is the order of the day to create a more individual-centric hub experience from the patient’s point of view

Pharmaceutical Commerce - April 2022

2022 Patient Support Vendor Directory

Pharmaceutical Commerce - April 2022 Issue (PDF)

Diving in Headfirst

Oncology Innovation: Optimism & Obstacles

The Pulse of Rare Disease Support

Patient Centricity: Banishing Buzzwords

Adding Might to ‘Specialty Lite’

Success with SP Solutions

Hub Programs from Patient Perspective

Patient Support in Europe

Beyond Payment Methods

Empowering Patients in Oncology Trials

Going with the Phlow

Shedding the Secondary Label

2022 Patient Support/Hub Provider Directory

Harnessing Digital at the Point of Care