Sustained growth in specialty medications continues to create ongoing hope for patients and the potential for strong return on investment (ROI) for drug developers. But launching these highly specialized therapies—which are used to help patients manage chronic, sometimes debilitating or life-threatening diseases and genetic conditions—is no easy task; it requires doing all that is necessary to remove barriers to access and points of friction that threaten drug access, affordability and adherence.

Today, specialty medications are used to treat chronic conditions, such as rheumatoid arthritis, multiple sclerosis, Crohn’s disease, many forms of cancer and more, and they share a number of defining characteristics. These premium-priced therapies—whose costs can run into the thousands or even millions of dollars per patient over a lifetime—typically have complex self-administration or titration-based dosing requirements, significant potential safety issues, and exacting logistics requirements to safeguard temperature-sensitive therapies that must be maintained at refrigerated or cryogenic temperatures from the point of manufacturing right to the point when the patient takes possession of their medications (see related story 

To give these lifesaving specialty medications a fighting chance in the marketplace, biopharmaceutical manufacturers routinely enlist one or more supply chain partners to develop and administer a tailored mix of wraparound services, which are collectively referred to as the product’s hub-services program. The explicit objective of any hub program is to reduce or eliminate barriers and provide easy access to all of the product and disease-specific services that will help the patient to get on—and stay on—therapy.

A well-designed hub program “provides a natural extension for pharmaceutical/life sciences manufacturers and their supply chain partners to demonstrate their value, and the most successful hub programs remain engaged throughout the patient journey and continue to evolve over time using data-driven insights,” says Tommy Bramley, PhD, president of Lash Group, a patient-support services company that is a part of AmerisourceBergen.

Failure to design an effective hub program to centralize and integrate all of the product-specific supports and interventions that can help patients and their physicians to overcome these barriers can thwart the therapy’s commercial success (at launch and over time) and undermine both clinical outcomes and brand reputation.

“Hub providers must build a quantified evidence base that can demonstrate that those services have a meaningful impact on outcomes for specific disease states and demonstrate to manufacturers that patients who engage with those services fare better consistently,” says Lili Ferguson-LaChance, an Accenture life sciences strategy executive. “Demonstration of relatively modest impact could translate to a point or two of rebate recapture for a manufacturer—a significant profitability gain, especially for common disease states with large populations on therapy.”

“Excellent hub programs can cast a halo on the entire brand and amplify a provider’s willingness to prescribe the therapy,” adds Tom Dmochowski, vice president and general manager, pharma and life sciences, Conduent, a business process services company based in New Jersey.

Bulldozing barriers for patients and physicians

Underpinning the entire hub concept is the fact that today’s specialty medications have put more and more responsibility directly into the hands of the patients—no matter where they may be on the health-literacy spectrum. Such patients must now:

Master complex, self-administration routines (i.e., the self-administration of injectible or infused biologic therapies, or precise titration-based dosing regimens that are required for today’s growing number of oral oncology agents).

Monitor and manage side-effects from home.

Take ownership of potential safety or toxicity issues that could become life-threatening or undermine adherence.

Advocate for themselves to navigate complex coverage and affordability issues that could hinder access in the first place, and undermine adherence over the long run.

As a general rule of thumb, a hub-services program should strive to put the needs and preferences of the patient and physician first. “Drug manufacturers must integrate the right balance of technology-based and talent-enabled support services that improve patients’ treatment outcomes,” says Jan Nielsen, division president, AssistRx Patient Solutions. For example, she notes that a program may need to involve more high-touch human support at launch, but then transition to increased use of high-tech, self-service program components as the product gets onto more payers’ formularies and the program matures (see Figure 2).

To speed time to therapy and deliver a quality brand experience, “a well-designed hub must not only support the overall patient experience but connect and support prescribers, payers, pharmacies (retail and specialty) and manufacturers in a way that provides real-time visibility into insurance benefits, patient-support programs, timing of delivery/pick-up and associated costs to patients,” adds Maria Kirsch, SVP and head, patient services, Eversana.

Importantly, hub vendors must provide both nurturing soft skills and a solid technology backbone. “The best hubs are those that can provide near flawless program design and execution while thoughtfully embedding the solutions deeply and seamlessly within the workflow of the physicians and within the health-journey flow of the patient,” says Dmochowski.

Similarly, the best hub partners are those that are able to provide guidance in terms of regulatory, competitive and technology over the lifecycle of the brand. Toward that end, “a good hub provider should be monitoring federal and state sample-in-name requirements and advising on alternative models or forecasting funding in the copay assistance program escrow account to ensure adequate funding throughout the year,” notes Nielsen.

When it comes to structuring hub programs that will make sure patients can get started on therapy and stay on therapy—and eliminate barriers along the way—the various program elements are typically organized along four pillars (each is discussed ahead):

As specialty medications are among the most expensive prescribed therapies, health plans have understandably created mechanisms to ensure that only the most appropriate patients can access them. However, delays often result when physicians are not able to successfully navigate prior authorization (PA), step therapy and other administrative requirements imposed by the patient’s health plan.

Hubs play an essential role by providing a range of tailored programs to support reimbursement, including electronic tools for rapid benefits verification and streamlined processing of PA requirements.

“Generally, hubs are acting as the agent for the pharma brand team, so we inform and educate doctors on payer-specific PA processes, and then provide easy-to-use tools that are visible through the hub and present the necessary questions to the clinical, in electronic form, right in the physician’s workflow,” says William Dupere, practice lead and VP, market access solutions, for TrialCard.

A key access challenge in this area is keeping any temperature-sensitive specialty therapy within its required temperature range (refrigerated, frozen or deep-frozen).

Today’s hub programs routinely embed highly engineered processes and tracking systems to ensure reliable temperature-controlled delivery and precise chain-of-custody of the drug—from the manufacturing site right to the patient’s door, with high-visibility tracking along the way.

Meanwhile, adding another potential access challenge, many of today’s specialty medications are part of the personalized-medicine revolution, and thus require that the patient undergoes genetic testing to verify the presence or absence of one or more targeted biomarkers or genetic mutations (as required by the original label indication) prior to prescribing. “Today, a growing number of specialty medication hubs are including program elements that help physicians and patients to manage genetic-testing requirements associated with the targeted therapy and speed time to therapy,” says Heather Morel, SVP/GM, access and adherence, RxCrossroads by McKesson.

 For many patients, affordability gaps are literally where the rubber meets the road in terms of getting on and staying on therapy. As such, a core function of any hub program is “to help insured patients to understand what is required to gain access to costly specialty therapies via their insurance plan, and to help uninsured or underinsured patients gain access to the therapy in other ways, to reduce out-of-pocket expenses by accessing other sources of funding via manufacture-sponsored copay-assistance programs, or free medications via patient assistance program (PAP) or charitable foundations,” explains Morel.

Self-service capabilities provided through the hub help patients to screen for and enroll in a manufacturer-sponsored copay-assistance programs in real time. This also gives prescribers confidence that their patients will be able to access the therapy they are prescribing.

“Improved price transparency at the point of prescribing—and providing immediate screening and enrollment into available patient-support programs—can not only speed time to therapy but help to differentiate brands in a crowded market,” says Nielsen.

Working to familiarize physicians with any product hub is critical to removing access and affordability barriers for patients.

“Today we have an engaged an active network of over 700,000 healthcare workers working with our CoverMyMeds offering—through efficient processes that are right in their workflow,” says Morel. “This is important because most patients won’t even have an opportunity to be part of a financial-support program unless they hear about it from their doctor.”

The impact of financial and health disparities has been a long-running challenge for all stakeholders across the US and elsewhere, and it has come into sharper focus once the Covid-19 pandemic descended.

“Last year, we saw people with chronic conditions like diabetes and obesity—especially within communities of color—hit hard by the Covid-19 pandemic,” says Doug Langa, executive vice president, North America operations, and president of Novo Nordisk Inc. “It’s vital that we continually identify and reduce the barriers that may contribute to people not getting the care they need.”

“In early 2020—after the pandemic hit—we implemented a PAP that was specifically designed to help people who had lost their health insurance or had their insurance changed because of Covid-19. The program has helped these individuals to get free insulin for 90 days,” he continues.

Novo Nordisk’s product hub sends out not only reminder texts, but motivational messaging and educational materials for patients and healthcare providers to support diabetes management and drug adherence. It also offers complimentary access to live Certified Diabetes Educators, either via phone or virtual chat for anyone taking a Novo Nordisk diabetes medicine.

Meanwhile, under the affordability umbrella, the subject of copay-assistance and copay-maximizer programs (described ahead) has been causing considerable storm clouds to gather. Over the past few years, such programs have been increasingly put in place by commercial health plans and pharmacy benefit managers (see Figure 3), and the trend is creating concern among all stakeholders, as such programs produce a critical affordability barrier for a growing number of patients.

By design, such cost-shifting programs prohibit the counting of any financial subsidies a patient receives from a manufacturer-sponsored, copay-assistance program from being counted toward the patient’s annual out-of-pocket (OOP) health plan deductible. This creates direct impact for both patients and drugmakers:

Patients are more likely to end up shouldering their entire plan deductible with OOP expenses, rather than satisfying their deductible earlier in the year and having the plan pay for their medications after that.

Drug manufacturers may end up having to provide the copay-assistance subsidy to a given patient for an entire year—whereas, in the absence of a copay-accumulator or copay-maximizer program, the copay assistance would typically be paid for just a portion of the year, until the patient’s deductible has been met, and then the cost burden would shift back to the insurance plan.

“A year ago, the existence of copay-accumulator and copay-maximizer programs was just a patchwork; a year later, this is definitely a trend that’s picking up steam,” says TrialCard’s Dupere. “These programs effectively rob qualified and eligible patients of benefits, creating affordability gaps that greatly undermine the patient’s access to therapy and their ability to remain adherent over time.”

“This ongoing tug-of-war around cost-shifting is creating big implications in healthcare,” adds Jason Zemcik, senior director of product management for TrialCard, who notes that “in 2020, among the drug franchises we support, nearly 12% of patients were already impacted by copay-accumulator or copay-maximizer programs (up from 8% in 2019).”

Such cost-shifting is also greatly undermining the future of copay-assistance programs, as any given specialty medication brand ultimately, in most cases, has a finite budget for patient assistance. “Because accumulator-impacted patients will continue to require assistance throughout the entire year—as opposed to simply receiving copay assistance to satisfy their deductible early in the year—many pharmaceutical manufacturers’ costs to operate these programs have increased significantly,” adds Zemcik. “This is causing many to evaluate the long-term viability of such programs, which puts patients who rely on them to afford costly therapies at risk.”

In a recent study conducted by Xcenda, a strategic global consultancy and part of AmerisourceBergen, of the commercial payers in its managed care network, the company found that the percentage of plans that were already using copay accumulator or copay maximizer plans (or both) had grown from 39% in 2018 to 60% in 2020 are currently restricting the use of manufacturer copay-offset plans, according to Corey Ford, director, reimbursement and policy insights for Xcenda.

Helping to drive this trend at the policy level, in 2020, the Centers for Medicare & Medicaid Services (CMS) finalized a new rule in 2020 that allows commercial plans to employ copay accumulators within the commercial market—even for brands that do not have a medically appropriate generic alternative. “Several states have tried to fight back, by enacting legislation that outright prohibits copay-accumulator programs or limits their use in commercial plans, but many large employer-based health plans are exempt from such state plans,” explains Ford. “With a growing number of large health plans pursuing accumulator models targeting medical benefit products, manufacturers offering copay assistance will need to work closely with their hub designer to incorporate accumulator-mitigation strategies into their program design.”

In light of this trend, many stakeholders worry that drug manufacturers may ultimately move away from offering direct copay assistance to patients. Without such financial scaffolding from manufacturer copay-offset subsidies, impacted patients would then be more likely to abandon their prescribed drug regimens.

Throughout the entire healthcare arena, poor adherence is one of the biggest factors to blame for reduced clinical outcomes and diminished brand success. “Through every hub, we try to match up different touch points in way patients will best respond to them” says Myra Reinhardt, vice president of production innovation and analytics, Lash Group “You want to automate as many of the program offerings as you can, but you also need the right type of in-person support (from pharmacists, nurses, coaches and more), using empathy and problem-solving skill sets that can never be addressed with automation.”

Today, the digital capabilities are available to push training videos and tutorials related to self-injection and side effects right into the patient’s digital device, making it easier than ever for them to access the information, notes Bramley.

The more steps a patient has to take to get what they need from the drug manufacturer or their insurance plan, the less likely they will be to be adherent. “A common mistake among brand teams is to take on the time and cost to craft patient-facing applications that are not easily integrated into the patient’s day-to-day lifestyle,” says Assist Rx’s Nielsen.

Meanwhile, the national conversation continues to grow around the impact that the broader social determinants of health (SDOH) have on medication adherence and clinical outcomes. As a result, hub designers continue to work with their biopharma clients to design HIPAA-compliant interventions that can help patients to address SDOH factors—such as transportation and housing issues, health literacy, food insecurity and more.

“Our nurse navigators conduct onboarding assessments and welcome calls so they can get to know patients on a personal level and can identify what challenges they may be facing at the onset of the program,” says Jason Monteiro, director, access and patient support, Cardinal Health Sonexus Access and Patient Support. The use of natural language processing (NLP) technology also plays a key role in identifying barriers throughout the patient journey and can help nurse navigators to make sure they’re understanding a patient’s situation holistically, he adds.

Having complete data and robust analytics capabilities can also help the hub to develop more-tailored patient-support programs and interventions to address certain SDOH. “For example, if you understand that cancer patients in a rural area have longer commutes to get care and have limited access to transportation, help finding a transportation service and getting it paid for could really help this population get access to care and improve adherence to treatment and overall health outcomes,” says Jennifer Spada, an Accenture Life Sciences strategy partner.

While many biopharmaceutical brand teams may want to address all specific SDOH, “there are real limits on services that can be provided based on health laws,” cautions Morel of RxCrossroads by McKesson. However, she notes that the landscape continues to evolve. For instance, the US Office of Inspector General (OIG) recently wrote an 

 that stated that one specific company’s program can furnish travel and hotel/meal expenses to patients, and in the specifics of that program and clinical context, it is compliant and lawful. “Generally, assisting patients with these complex logistics in an effort to help improve adherence would have been out of the question,” she notes.

Typical metrics that are tracked through a product hub include (but are not limited to) the number of calls handled, average speed to therapy, time to refill, duration on therapy, turnaround time for benefits verification and PA reconciliation, prescription-abandonment rates, patient health-literacy scores, use of manufacturer copay-assistance programs, number of preventable hospitalizations and emergency room visits and more. Gathering data on the most relevant key performance indicators (KPIs) can also help stakeholders to identify bottlenecks, inform continuous improvement and drive process efficiency.

“We have implemented platforms to enable electronic benefits verification (eBV) and electronic prior authorization (ePA), and these allow us to streamline and automate what traditionally have been time-consuming manual processes,” says Monteiro. “As a result, tracking the average time to get a patient on therapy has become an important metric for measuring the success of the overall hub program.”

Such efforts have helped Cardinal Health “to reduce approval wait times from several days down to just a few hours,” Monteiro adds, noting that this also helps to reduce the staffing costs for the company’s biopharma clients to manage this part of the process.

Meanwhile, advanced data-analytics capabilities—based on the use of NLP, artificial intelligence (AI) and machine learning (ML) techniques—are enabling patient hubs to uncover hidden trends from massive amounts of structured and unstructured data.

“The use of predictive analytics and machine learning is also helping biopharmaceutical manufacturers and their hub partners rapidly identify patient behaviors and patterns that lead to treatment drop-off, and respond with targeted corrective actions,” says Eversana’s Kirsch.

Cardinal Health currently records all of its patient calls and then analyzes them using NLP technology. “At the onset of the Covid-19 pandemic, we updated our program to account for words associated with the coronavirus and have continued to adjust as it noticed related trends in conversations around the pandemic,” explains Monteiro. “This has enabled us to identify new barriers patients were facing, such as challenges with affording their medications, so we can work with our biopharma clients to intervene with the timely resources to support the changing needs of patients.”

Similarly, by segmenting data-analytics efforts across the payer, provider and business operations, Conduent’s Dmochowski says that “we are able to understand the general coverage landscape and identify outliers, considering such things as time, geography and outcomes.” For instance, with regard to providers, “we are able to compare and contrast outcomes with timing and normalize this along geography and payer,” he adds. This is helping Conduent to identify payers and practices that are comparatively low performers and identify root cause that inform the “next best action.”

Conduent is also actively deploying AI technology to gain greater insight into call-quality metrics—by analyzing emotional quotient and sentiment analysis—and deploys AI when monitoring calls, chat and communications to detect adverse events more effectively. The company then uses the derived insights to trigger outreach, engage third-parties or loop in agents.

Lash Group has also been applying AI to its benefits-verification efforts, and in doing so, it has been able to reduce BV time “from hours to minutes or seconds,” says Bramley.

Meanwhile, by leveraging AI and ML techniques, Eversana is “helping manufacturers rapidly identify patient behaviors and patterns using our technology solution, which provides data to develop patient personas and predict the next best action to enable more personalized engagement,” says Kirsch. “With integrated commercial services support, the ultimate result—improved patient outcomes—drives value for payers, providers and patients alike. In this way, the hub offering can ensure that products find the quickest route to patients with minimal steps and faster, two-way communication.”

Efforts based on AI and ML techniques can also be used “to predict, for instance, which patients may be at risk for non-adherence and produce model assumptions on the optimal types of support needed based on zip codes and other regional factors,” says Nielsen of AssistRx. “Such insights can help to shape decisions related to channel, content and timing to deliver the most effective adherence engagement.”

“A comprehensive program must meet the patients’ needs in a way that seems effortless, despite a tremendous amount of complexity in the background; interactions are straightforward and effective,” adds Reinhardt.“It’s about doing everything we 

 be doing. When the hub is able to take what’s very complex and make it really understandable and hassle-free for the patient and the physician—that’s a winning strategy.”

Articles

A well-oiled, data-driven hub program is critical for stakeholders in supporting patients—and clearing a successful path for specialty therapies

Today's hub blueprint: Lock in on the journey

 on the latest from the hub service/patient support world is “Securing the Journey.” You can argue that the “journey” part of it, and in this case referring to “the patient journey,” is perhaps an overused phrase. Often used to add a touch of show, 

 book or movie title, or slipped nicely into a market research report, press release, or conference session title. But what does it really mean? After all, a “journey” can come in all shapes and sizes and durations; can even be infinite.

But when applied in the context of healthcare and medicine, and what the essence of being a patient today entails—all the relationships and support systems and treatment regimens and unknowns along the way—I think there is really no more apt description, as simple as it may be. 

Especially now, in the age of Covid, with the virus, of course, challenging that journey; but more so, the converging of other factors— some exciting, some a little perilous—that will influence those journeys beyond the pandemic. Things like the rise of specialty drugs and advanced therapies, which, in tow with an aging population, offer great opportunity, but also complex coordination around disease management and quality of life. There seemingly is more touchpoints than ever on a patient’s healthcare journey—that passage from symptoms/diagnosis and understanding to “okay, let’s maintain, stay engaged.”

Or maybe the touchpoints haven’t really grown, they’re just more complicated. But in good and promising ways, too. Take, for example, the various data- and tech-driven specialty pharmacy models that are emerging to help manufacturers and their vendor partners better support patients, providers and payers (see 

 throughout our March issue). And, not to be overlooked, the important role non- commercial pharmacies are playing in patient assistance and adherence in the realm of specialty care (see 

The goal of all these moving parts, and the players involved, if they can operate in unison, is where the “securing” part comes in. Because it’s about protecting the patients along their journey as well. 

We always preach about the importance of the outcome, the destination, if you will, of a healthcare intervention or program. But the rewards, however slight they may be for some patients, are not realized without the ride. We hope you enjoy your journey through our March issue.

Mike Christel is Editorial Director of Pharmaceutical Commerce. He can be reached at

Catchphrase or not, the patient journey is seemingly more complex than ever these days—upping the ante for new strategies in specialty-care support

All about the journey

Affording the high cost of specialty medications can feel insurmountable for many patients. For others, simply accessing their prescribed therapy can prove daunting. For example, take Kathy *, a patient featured in the 

. Kathy juggles treatment plans and test results to manage her multiple sclerosis (MS)—a process she described as stressful and detrimental to her health. Some days, she’s left with a momentary loss of mental clarity, or “cognitive fog.” “It’s too much to ask a patient to have to do, and it’s affected my health, no question,” Kathy said.

Specialty patients surveyed to inform the 2021 Medication Access Report shared similar access challenges. Eighty-two percent of those prescribed specialty therapies reported spending an hour on the phone coordinating care to begin their therapy. Over a third spent at least three hours.

 Medication access and adherence challenges can be so significant for specialty patients, up to 27% of prescriptions and therapies are abandoned—or never started at all.

Historically, support services have been available to help patients with these obstacles. But traditional hub programs and specialty patient workflows have faced significant hurdles over the years. Their impact tends to be dampened by low awareness, minimal connectivity and manual workflows.

And since traditional, manual workflows rely on outdated, less immediate forms of communication—including phone and fax—they often leave providers in the dark about the patient journey once they’ve prescribed therapy or enrolled their patient into the manufacturer-sponsored patient services. These inefficiencies can result in treatment delays of up to eight weeks.

 In the interim, patients have reported deteriorating health and worsening of symptoms.

But it’s not all bleak news. Progress is here. Social distancing measures sparked by the Covid-19 pandemic might have cleared long-standing access obstacles for specialty patients. Among them: eased restrictions which enable some patients to take their therapies at home and tech-enabled patient support services that electronically connect the healthcare network to clear access hurdles for specialty patients. These solutions were already primed for widespread use, but the Covid-19 pandemic is helping achieve widespread adoption.

How Covid-19 uncovered and helped solve unique access challenges

In the 2021 Medication Access Report, we investigated the unique access challenges specialty patients experienced due to Covid-19. For one, patients with preexisting conditions—such as chronic and rare diseases—faced a higher risk of contracting Covid-19. This risk made any in-person interactions to access their needed medications (such as a doctor’s visit) potentially life-threatening.

Further complications arose when the condition required a specialty medication, which are often administered non-orally or require diagnostic testing prior to use. Importantly, a medicine’s method of administration can influence where patients receive therapy. Some may be able to stay home, while others may need to go to a provider’s office or outpatient facility with clinical staff on standby.

When Covid-19 prompted social-distancing measures, the use of key autoimmune, oncology and osteoporosis drugs fell by as much as 53% below 2019 levels.

 Data from the 2021 Medication Access Report point to reasons why we may have seen such a decline in utilization. Nearly half of providers said they changed how they approached specialty patient appointments due to Covid-19. Nearly one in five said they saw a decrease in patient therapy compliance.

Kathy was among those who stayed away from medical facilities used by providers to administer specialty therapies like infusion and injectable drugs.

 (“I’m scared to go any place,” she said.) When her neurologist ordered routine blood work, Kathy asked if they could use results from a previous visit.

For the same reason, Kathy said she’s grateful for the increase in telehealth appointments over the past year. Even after the initial Covid-19 spike in spring 2020, telehealth use stayed exponentially higher than ever—over 2,000% over baseline levels through the end of 2020—suggesting a more permanent option for provider access.

In other words, the therapies patients were prescribed before the Covid-19 pandemic became easier to access because of a shift toward remote-capable technology solutions. What’s more, patient support services driven by technology have contributed to a 34% reduction in time to therapy.

But even though the Covid-19 pandemic disrupted specialty medication prescribing, distribution and administration, the shifts to keep patients out of healthcare facilities may have paved the way for more accessible therapies.

When many payers eased restrictions on home infusions to allow specialty patients improved access to their medications,

 Data shows many patients who received provider-administered drugs in hospitals or healthcare facilities shifted to self-administered oral, patient-injectable or home infusion drugs.

 While in-person treatments are currently below baseline levels, remote treatments are up by nearly 600% over baseline levels, now accounting for over 20% of specialty treatments.

Many providers also saw improved quality of care and patient satisfaction in these moves.

 After all, home administration means patients don’t have to miss as much work, reduce time spent in waiting areas and even learn more about their own condition and medications as they become further integrated in their own care.

These trends show promise for the future.

Tech-enabled hubs were developed to help patients navigate the process of starting and maintaining complex therapies, but other stakeholders stand to benefit from this electronically connected healthcare network, too.

These models connect an established and engaged healthcare network—from providers to payers to pharmacists to life sciences—via a single platform. Through these innovative services, providers can electronically navigate affordability, pharmacy access and clinical support—and have real-time visibility into the status of each step.

Ideal tech-driven patient support programs allow providers to electronically enroll patients into support services designed to provide financial assistance, benefit coordination, pre-therapy support, necessary lab work and managing adherence programs in one, centralized place.

Such technology also allows for automatic prior authorization (PA) determinations based on preset payer-defined criteria. The opportunity for real-time responses can accelerate provider decision-making and limit unnecessary treatment delays for patients. Most importantly, these programs meet the provider within their current workflow and create immediate awareness of patient assistance support. This helps solve access challenges for providers and the patients they serve.

To keep this momentum going, lessons can be drawn from other healthcare advancements driven by innovative technology. Through our work automating the PA process, we found that disjointed processes can be streamlined through connectivity, but for these advancements to be meaningful to patients, provider adoption was critical. It’s heartening knowing what we’ve learned about how technology has advanced patient support services as well.

Finally, we must not forget about the person at the other end of the computer screen. Patients build trust and confidence in providers and their treatment plans through personal interactions with their clinical and care teams.

The ideal technological solutions don’t ignore these interactions but instead embrace them. By connecting all the stakeholders working for the patient—from the field team to case managers—tech-enabled patient support services that connect the healthcare network make sure everyone has a real-time view of the patient. This synchronicity also means all stakeholders can work together to support the patient without duplicating work.

For the patient, these experiences can build trust and confidence, which are particularly important factors in clinical and care coordination. And though more work remains, these moves are encouraging and show us a path forward—raising awareness of the positive impact of tech-enabled patient support services and continuing to push forward innovation within the specialty workflow.

The work is worth it. The impact potential is real.

Erica Conroy, PhD, VP of Specialty Business, CoverMyMeds

* The patient’s last name has been omitted to protect their privacy.

2. IQVIA Medicine Use and Spending in the US: A Review of 2016 and Outlook to 2021

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6234348/?report=classic

https://www1.magellanrx.com/documents/2019/03/medical-pharmacy-trend-report_2018.pdf/

6. Monitoring the Impact of COVID-19 on the Pharmaceutical Market, IQVIA, 2020

8. Specialty Pharmacy Keeps Disrupting Buy-and-Bill—and COVID-19 Will Accelerate It, Drug Channels, 2020

https://www.iqvia.com/library/white-papers/monitoring-the-impact-of-covid-19-on-the-pharmaceutical-market

11. “New Federal Rule Could Affect Infusion Site of Care Amid COVID-19 Pandemic,” Avalere, 2020

12. “Monitoring the Impact of COVID-19 on the Pharmaceutical Market,” IQVIA, 2020

13. “Monitoring the Impact of COVID-19 on the Pharmaceutical Market,” IQVIA, 2020

14. “Monitoring the Impact of COVID-19 on the Pharmaceutical Market,” IQVIA, 2020

15. “Home Infusions and Home-Based Chemo: The Innovation of Penn Cancer Care at Home,” Penn Medicine, 2020

2020 was a difficult year for many patients, but new data may signal a brighter future ahead

Specialty access barriers: How technology can help

The Covid-19 pandemic has been particularly tough on patient advocacy and support organizations—groups traditionally accustomed to zigzagging to industry events and medical congresses to share and collect the latest disease information on the communities they serve, and where expert advocates are often patients themselves. Immunocompromised as it is, Covid has bolted the doors shut on such activities, as these patients, and their caregivers, simply can’t afford to risk exposure. 

Filling the void hasn’t been easy, but many are doing their part, including pharma. One such example is the Covid Advocacy Exchange (CAE), a partnership between Bristol Myers Squibb and GRYT Health that, via a virtual platform, brings together advocacy groups, patients and industry leaders to synchronize efforts, facilitate resource sharing and boost collaboration. First launched in May 2020, the CAE, according to Cathy Trzaskawka (Traz), executive director and head, global advocacy, BMS, has attracted 25,000 visitors form 90 countries to participate in live sessions, workshops, working group discussions and other programs.

“Just a place to go to say, okay, we’re all in the same boat, let’s talk about what’s happening,” says Traz, whose team of 20 acts as a “resource hub” for BMS’s wider advocacy needs. In making the CAE work (“we certainly wouldn’t keep doing it, if it wasn’t helpful”), Traz credits the combined efforts of the advocates, GRYT Health and BMS, the latter attributing especially to the direction of colleague Jodi Hutchison-Sanford.

caught up with Traz to discuss the importance of keeping patient advocacy members engaged and informed during the pandemic and how a passion for health policy and volunteer work vaulted her to a career in advocacy.

1. How has the CAE been able to navigate around the Covid-driven

limitations and still be effective in sharing and exchanging information?

We always met pretty regularly with our organizations, and we’ve had to just change them over to virtual. We continue to try and be really communicative with them, sending out any updates from our teams, any information that we have that are patient- and resource-helpful, or other [outside] meetings that we might know about that might be helpful for them.

2. Obviously a big challenge and task for pharmas such as BMS has been responding to the needs of the global advocacy community during Covid. At this stage, how has

The industry as a whole, with the vaccines, I think that’s been an amazing, amazing feat. And so many different people working together across not just industry but other sectors and really pulling together for this unbelievable need.

For BMS, in particular, we introduced many different initiatives to try and help—between donations of supplies or allowing for people that lost their jobs to still get our medications for free. But for the advocates, in particular, I have to say, they were really struggling, because as soon as [the pandemic] hit and travel stopped, they weren’t able to get to these meetings, and people weren’t able to connect and work together in our typical fashion. 

Leadership came to us and said, “what could we do to help during this time besides the other resources that we had sent out?” We said what would be great is if we had a networking opportunity that was kind of an online forum, 24/7, across diseases—so that everyone can talk together. 

We partnered with GRYT Health the year before for the Global Virtual Cancer Conference (hosted by BMS). I said, hey, these guys have a platform. I wonder if they would be interested in partnering to pull something like this together, and then working with the advocates to build it out?

As soon as I called Dave Fuehrer, CEO of GRYT Health, he said yes, without hesitation. And then we laughed because we thought, oh my gosh, now we actually have to pull this off and do it! I think, though, when you have the passion and when you know there’s a need, you just continue to drive to figure it out. Because they had the platform, we knew we had the resources to support it, but we wanted it to be built and co-created with the advocates. 

From our advocacy database, we reached out asking different organizations if they wanted to join us and build this network together. I think right away, we received 50 different responses, 50 advocacy organizations who wanted to create a booth in the virtual hall, wanted to get involved in the live sessions or just be a part of this 24/7 platform for the networking. The content is all co-created with the advocates. 

We’re trying to keep it pretty innovative, and not just talk about the problems, which we did a lot in the beginning, because you had to. But now we’re looking to really problem-solve, especially with the current challenges that the groups are having.

Starting in February, we launched four different work streams with the advocates around issues with Covid and then the long-lasting issues that we’re going to have around Covid. Issues like lack of screening, lack of care and mental health; there’s so many different issues that we’re going to be looking at. 

We really want to make it so that it’s a helpful networking platform where they can collaborate with other advocates—across disease areas. It doesn’t even have to be a disease area that BMS focuses on. That’s really not the point. It’s more about coming together for each other across the globe and across disease areas. Because they’re all facing a lot of the same things.

3. So the program is not really directly focused on Covid or interventions for Covid; it’s content that can help these patient communities navigate the pandemic, correct?

Yes. We’ve talked about practical solutions. We talked about mental health. We talked about telemedicine and how it’s helping access to care. Are there opportunities in diversity and in health equities? We talked about building stronger relationships with the advocates and their patients. We talked about resiliency and how we’re all having to change a lot and will continue to do so because of not being able to travel and see one another. We talked about returning to work, returning to care settings.

It’s more about how we’re having to think differently during and after Covid, and how we can collaborate and look at positive solutions going forward.

We’’ll talk about the patient organizations themselves. Patient advocacy groups have lost a lot of funding and have had to lose staff members. Some of them, sadly, might not survive. So we’re going to have to talk about how they’re coping amidst these challenges for their own organizations.

Of course, it started because of the pandemic and the issues that people were seeing with Covid. But now the conversation with the rest of us is evolving. I think that as hopefully people are vaccinated and when Covid isn’t the main topic of discussion, we will continue this exchange and just have Covid as one of the advocacy issues.

4. Are there any particular advocacy groups that you would like to highlight—that may have taken a lead in the CAE or have been a notable presence so far?

We’ve had some really big groups involved, and then some really small groups. And then even just some patient experts who are involved in social media.

We had Dr. Carrie Adams, who’s the CEO of the UICC, the Union for International Cancer Control, who was one of our panelists. We had Pat Garcia-Gonzalez, the CEO of The Max Foundation (focused on cancer-treatment access) as a panelist as well. Also Seth Ginsberg, who is the president of the Global Healthy Living Foundation and CreakyJoints, an arthritis support and advocacy organization. We’ve had people from cardiovascular and heart disease organizations. We’ve had representatives of a lot of different disease area organizations come on as panelists.

5. The concept of the “patient voice” has emerged even more amid the pandemic. Can you explain the fundamental idea of pharma listening (social listening), and its importance right now?

I love this topic because we launched another initiative in 2020 called PEER, which is our patient expert engagement resource. That basically is a process that we have built into our governance and standard operating procedures, where anybody in the company, from early development all the way through commercialization, can call the advocacy team and talk about what their needs are. We can link them up with one of our expert advocates from the nonprofit organizations we’ve contracted with. It can involve whatever kind of feedback folks are looking for—a lot of times it’s protocol development or in the clinical space. But we can then tell them, okay, for this disease area or for this specialty area, here are expert advocates that have been trained in those areas. They can get live feedback, and then we actually contract with the organizations and pay them for the time of that expert feedback. If it’s one question, if it’s a 20-page protocol review, we will reimburse the organization for their time.

This is hugely important because, at the end of the day, the patients and the caregivers are the ones who are receiving our products. We should be understanding from very early on what are the unmet needs of that disease area, that disease group, those patients, as we’re building out any kind of treatment for them. They should be involved.

I think the regulatory bodies are the ones that are pushing the patient voice involvement. The FDA and the EMA have advocated for patient-focused drug development committees, where they’re saying, we do need industry to talk to the patients and understand and get this right.

And then the advocacy groups themselves and the patients, to be honest, have really stepped up. They realize we can’t just come with our stories anymore. We need to come with data. We need to come with the language that they’re looking for and help them understand.

I see a huge shift in that whole patient voice continuum right now.

6. The CAE held one session on building stronger healthcare relationships through empathy.

Empathy is a difficult thing to instill or apply, I would think. How can companies and groups incorporate those feelings into practice?

We’re all human, we all have loved ones that are patients or caregivers, or we ourselves are one. Industry people are people too, and building the relationships is really about listening and that two-way conversation and communication.

It’s coming at it from that human side of life versus just a partnership. Again, you really need to talk and listen. We’re all going through this together with Covid, it has put us all in the same boat. But I do think it’s helped us to just listen a little bit more to one another, whether patients, companies, policymakers, regulators, insurers, anybody that’s involved in the health space. We should be sitting at the table together trying to solve these problems.

It’s been enlightening because what we’ve seen with the Covid Advocacy Exchange is a little bit more emotion than you might have seen at a [past] medical congress or an advocacy meeting. There’s definitely more empathy with one another in there.

It’s about harnessing our united strength. For our session held on February 11, we had asked the advocates at the end of the year about their four main priorities. They said they were health equities, access to care, patient-focused drug development and the future of advocacy. We’re going to establish these unique working groups; we’re looking at, how can we make meaningful impact?

7. Can you share any thoughts you may have on

the process of co-creation in this whole mix? How does that work?

I think in the past, industry was probably known for creating content and then just putting it out there—‘we’ve created this, you have it, look at it, read it.’ No matter if that was patient education or something else.

But now because of our partnerships and our strong individual relationships with the advocacy organizations, it’s more about asking them and working with them around what they need and what they want. It’s not just about what we want to say or put out there anymore.

They’ve been telling us for a long time that we should listen to them, that they should help us understand their needs. There are some regulatory boundaries that we have to, of course, stay within, but for the most part, advocates can be really helpful and save you a lot of time.

It comes back to that whole idea of the patient voice. Co-creation is similar in the context of patient education materials or resources—what is going to be helpful to those patients? You can’t just assume you know everything.

With our PEER program, we even looked at a voice technology where advocates could provide feedback, just taped; they wouldn’t have to write or type anything. But we got really interesting feedback from some of the advocates who were like, ‘that’s a little too high tech for me. I don’t need to do that, I can still email or talk on the phone.’ It’s good to get that kind of feedback because it helps you then grow and learn.

8. Absorbing the events of the last year, where do see the patient advocacy space evolving beyond the pandemic?

I can certainly see that the virtual opportunity is key. It’s not everybody’s favorite because most of us advocates are people persons—we want to see each other, it’s that kind of a relationship job. Having this virtual opportunity where you can see video is really helpful and I think helps people feel not so alone. I can’t imagine if we didn’t have these types of tools during these times.

The pandemic will change the advocacy space by allowing people to do things more virtually, especially if they’re compromised or not feeling well. We’ve had people attending from their hospital bed.

Another change is bringing the different experts to the table, where maybe that didn’t always happen. That’s happening a little bit more [today], because instead of coming to a physical meeting, you can get them to their computer screen [more easily]. Again, having that cross-sectoral conversation is going to change things with virtual and post-Covid.

Is it too convenient to say that these practices will become part of, pardon the overused expression, a “new normal”?

I think there are a lot of cringes when you hear that, because nobody wants to be completely cutoff. But we will have to rely more on these new things. We were used to seeing each other physically all the time. In most of our meetings now, we say, ‘we can’t wait to give you a hug, we haven’t seen you in so long.’ And not just the advocates, but even team members. We miss that personal connection because, again, our roles are very much about people. It’s definitely been a different world.

10. You’ve been involved in public affairs and advocacy since early in your career. What drew your interest to those areas and your eventual move to pharma?

It’s such a great question because there is no kind of advocacy track in college. There’s not an advocacy degree; there should be, but there's not. I graduated in political science [from West Virginia University] with a focus on health policy, and worked in government. I worked at the New Jersey State House, where I’m from, for several years. I did press and communications and then worked for the governor’s office. Most of the time I was either working in the health and human services space or as a liaison for the health and human services department.

While I was doing that, I also volunteered for the Leukemia & Lymphoma Society and for the American Diabetes Association. So I started to learn a lot about advocacy when I was doing the volunteer and policy work. I did a little bit of lobbying and some other work, but then actually went over and worked for the Leukemia & Lymphoma Society as their executive director. I learned so much about the nonprofit world and organizations and how they operate, but also from having to wear all of the different hats in that kind of a business.

It’s very rewarding as well, because you’re working with patients, or their caregivers and families, directly. That’s something that always sticks with you—how important that is and being there for people during those very tough times. I loved it.

While there, I was working with some pharmaceutical companies that needed help with patient education and making sure they’re providing the right information at the right level. I was helping one of the companies (GlaxoSmithKline), and when that project was done, they asked if I would come over and help them with advocacy. That’s how I got into pharmaceuticals (Traz joined GSK as director, advocacy and alliance development; she would later serve in a leadership role at Endo Pharmaceuticals before joining BMS).

I really thought I could be a voice for the advocates within pharma. And that’s what I’ve strived to do since I’ve been in the industry.

A conversation with Cathy Traz, global advocacy head at Bristol Myers Squibb

Keeping the message moving during Covid

There’s no question that when it comes to helping patients start and stay on their specialty medications, efficiency should rule from the moment the prescription is written. Every delay impedes the start of potentially life-saving therapy and decreases the likelihood of a patient receiving the first dose.

And while non-commercial pharmacies (NCPs) are well known as distribution channels for free products, reimagining how they function can greatly simplify the administrative process for providers and their staff, help patients get on their medications faster and provide value throughout the entire patient support journey.

Imagine a busy oncology office where a new patient requires multiple specialty medications to treat her condition, all of which are prescribed through different hubs, require prior authorizations and need to be filled quickly so she can begin her therapy as soon as possible.

An NCP can act as a streamlined, one-step enrollment channel, allowing the provider’s staff to remain in a single workflow and use the e-prescription module they already use. This eliminates the need to exit the patient’s electronic health record (EHR), log in to different enrollment portals, find and manually fill out paper forms and fax documents. The provider simply chooses the NCP to receive the Rx for the drug, just like they would any retail pharmacy at the point of prescribing.

Using the NCP to order the medication automatically enrolls the patient in the hub, enabling near instantaneous access to understand patient eligibility, drug coverage and even out-of-pocket cost. Providers don’t need to enter the data because it is already in the EHR, and the relevant information is automatically transferred to the prescription.

The extended period of waiting on payers to manually process prior authorizations (PAs) disappears, replaced by faster—often real-time—approvals and the ability to easily move patients along to the next step. In-workflow, EHR prescribing gives the provider visbility into PAs when they are writing the prescription—and gives patients access to their medication days or even weeks faster. The time that providers would normally have spent dealing with authorizations can now be used where it belongs: strengthening the relationship with the patient.

When a PA or letter of medical necessity is required, a concierge team can immediately activate that on behalf of the provider, also within the EHR workflow. This is a win-win scenario for all sides of the equation: the PA or letter can be expedited using the existing, streamlined system, and the patient is able to more easily and quickly get the necessary treatment.

The NCP makes the starting process easy, automated and seamless so the rest of the necessary patient support services can be put to work. Ultimately, making it faster and easier for patients to get started on their medications is just one of many successful strategies for improving adherence.

Additional services like mobile apps are also powerful tools for overcoming adherence barriers, especially during times when face-to-face interaction is limited. Enabling direct outreach to patients on their terms helps them get their medications faster and understand what to do at every step. For example, a text message can alert them that their specialty pharmacy will be contacting them and from what phone number. Tools like this that patients can use when and where they want empower them to become more actively involved in managing their own care, leading to improved adherence.

The days of archaic faxing and bouncing between multiple portals are quickly waning as automation takes hold. Leveraging an NCP within existing workflows turns what for years has been a laborious multi-step exercise into a streamlined and simple patient enrollment process, dramatically decreasing the burden on providers. Ultimately, rethinking NCPs helps patients get on their therapy more quickly, helps them stay on it and simplifies their entire medication journey.

Julia Laurin is Chief Product Officer at ConnectiveRx. She can be reached at 

Non-commercial pharmacies can be secret weapons for intake and adherence

Rethinking NCPs in support mix

Pharmaceutical executives are well aware of the disruptive potential of technology. Their organizations, once slow to innovate, are now rapidly adopting new use-cases for automation and artificial intelligence (AI) that expand empathetic touch points to better understand the issues and attitudes of their customers. Technology transformation, both in the context of delivery of reimbursement access solutions and customer engagement, is a core component to customer centricity. This realization is prompting leaders to give their hub/patient assistance program (PAP) customer relationship management (CRM) platforms—and their vendor partners—a closer look.

For many drug manufacturers, owning a hub/PAP CRM platform is part of a larger enterprise initiative, one that embodies all things patient centric, including R&D, wearables, mobile and real-world data collection. For others, it is more narrowly targeted to standard hub and PAP capabilities. Regardless of the scale or scope, motivations leading to full ownership generally fall under four categories:

Controlling delivery processes across vendors.

Swapping under-performing vendors more seamlessly.

Their promise is prompting pharma leaders to give their hub/PAP CRM platforms a closer look

Pharmaceutical Commerce - March 2021

Today's hub blueprint: Lock in on the journey

All about the journey

Specialty access barriers: How technology can help

Keeping the message moving during Covid

Rethinking NCPs in support mix

Hybrid hubs and today's patient-centric push

Health policies high on specialty radar in 2021

The legal landscape for patient support services

Raising the stakes for market access support