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Things to know about the increasingly popular--and competitive--orphan drug space

Common misconceptions about the orphan drug designation

Heading into the New Year, many insurance companies are adjusting their coverage, either by ending an existing plan altogether or updating the plans that are being offered, by making changes to costs and benefits and costs. Statistics show that approximately 1.5 million American seniors could lose their Medicare Advantage plans, while another 3.5 million will lose their Part D drug plans by 2025.

US News & World Report, a media company specializing in healthcare rankings and consumer advice, unveiled its top Medicare Advantage and Medicare Part D companies, based on their national performance among various consumer-value award categories.

"With rapid, significant changes to Medicare Advantage and Part D plans this year, Americans can't rely on simply rolling over their current coverage," said Sumita Singh, senior vice president and general manager of Health at US News. "US News is committed to helping beneficiaries navigate this complex Medicare landscape and find the best plan for their individual health needs."

When it came down to the 2025 national Medicare Advantage and Part D company winners, US News computed insurers' ratings for three Medicare Advantage award categories: Screening & Prevention, Care Continuity and Highest Satisfaction, and one specific Medicare Part D award category: Highest Satisfaction.

The winners of the aforementioned categories included:

Best for Screening & Prevention: Devoted Health, Inc.

Best for Care Continuity: Devoted Health, Inc.

Highest Satisfaction (MA): Aetna Medicare, Elevance Health, Inc., Humana, Inc. and UnitedHealth Group, Inc.

Highest Satisfaction (Part D): Aetna Medicare, Centene Corporation, The Cigna Group, Elevance Health, Inc., Humana, Inc. and UnitedHealth Group, Inc.

Many might be wondering what the methodology was for selecting these companies.

 the ratings are gathered from the Centers for Medicare & Medicaid Services (CMS), which the federal agency that administers the Medicare program.

“Every year, CMS evaluates each Medicare Advantage contract on dozens of quality measures. A Medicare Advantage contract is a Medicare Advantage plan or a group of related Medicare Advantage plans offered by a single insurance company,” explained Ben Harder and C.J. Trent-Gurbuz in an article for U.S. News.” For each contract, CMS also issues an overall rating, ranging from 1 star to 5 stars, with 5 being the best.

“In profiling individual Medicare Advantage plans in its directory this year, U.S. News included the CMS star rating for the contract to which that plan belongs; all plans belonging to a given contract received identical ratings because CMS does not make plan-level quality data available.”

1. US News Recognizes Medicare Advantage, Medicare Part D Companies for Top Beneficiary Benefits. 

. November 20, 2024. Accessed November 20, 2024. 

https://www.prnewswire.com/news-releases/us-news-recognizes-medicare-advantage-medicare-part-d-companies-for-top-beneficiary-benefits-302310817.html

2. Trent-Gurbuz CJ. Best Medicare Advantage and Part D Companies Award Winners. 

. November 12, 2024. Accessed November 20, 2024. 

https://health.usnews.com/medicare/articles/best-medicare-advantage-and-part-d-companies-award-winners?ABSwitch_varName=MedicareSponsor&ABSwitch_varValue=variation1

3. Harder H, Trent-Gurbuz CG. How U.S. News Picked the 2025 Best Insurance Companies for Medicare. 

https://health.usnews.com/medicare/articles/how-us-news-picked-the-best-insurance-companies-for-medicare

The media company utilized CMS data and worked with Medicare experts to pinpoint qualities that were highly valued to consumers.

US News Ranks Its Top Medicare Advantage and Part D Companies

Enhancing Empowerment in Patient-Focused Research

How the inclusion of measures centered on net treatment benefit can drive an effective multifaceted approach.

Researchers are currently enrolling participants to test the effectiveness of a rectal douche containing the antiretroviral drug tenofovir in a study that is expected to finish in January 2026.

Trump Wants RFK Jr. to ‘Go Wild’ on Healthcare. Investors Need Not Panic.


The vaccine skeptic may find it hard to enact sweeping changes to American healthcare.



National Ataxia Foundation Hosts Congressional Briefing with Bill Nye, The Science Guy


The National Ataxia Foundation (NAF) partnered with members of Congress to host an informational meeting for legislators, their staff and other interested parties to provide education regarding Spinocerebellar Ataxia (SCA), a group of rare and debilitating hereditary neurodegenerative diseases that frequently impact multiple family members at the same time, with no cure or FDA-approved treatment.





Learn from UBC on how artificial intelligence (AI) is benefitting patients, prescribers and biopharmaceutical companies to increase adherence and compliance driving up outcomes, improving efficiency & overall cost of care.

It is well documented that the vast majority of expense to bring treatments & therapies to market is spent on drug development and new product launches, yet the key to brand success is getting patients on therapy and staying on therapy over time.

Listen to Amanda Scholz, UBC's Senior Clinical Program Manager, as she speaks with Pharmaceutical Commerce Magazine to discusses the important role that clinical adherence and patient support programs play in empowering patients and bolstering medication persistence.

To learn more, reach out to schedule a call.

#patientaccess #patientadherence #UBC Eric Reichwein, MBA Constance Taylor, MBA



Have news you want us to share in Pharma Pulse? Reach out to Social Media Editor 

The latest news for pharma industry insiders.

Pharma Pulse 11/20/24: NIH Tests New PrEP Delivery Method, Empowerment in Patient-Focused Research & more

In today’s fast-evolving pharmaceutical landscape, innovation is no longer a luxury—it’s a necessity for patient support programs to thrive. As the industry faces increasing pressure to adapt and deliver results, manufacturers must embrace innovative trends to stay ahead. While some start by streamlining internal processes, others partner strategically to develop groundbreaking solutions. No matter the path, early alignment of key stakeholders and clear goal setting are essential to driving sustainable success. Most importantly, innovation must be seamlessly integrated into the organization’s broader mission, ensuring it enhances patient outcomes and operational efficiency in a meaningful way.

Pharmaceutical manufacturers must prioritize innovation in their patient support programs to elevate the patient experience, optimize outcomes, and secure their competitive advantage. Aligning these initiatives with overarching organizational goals is vital for sustainable, long-term success. In this article, we explore the top reasons why investing in innovation in patient support programs is essential, along with key strategies and best practices that manufacturers can employ to maintain a competitive edge.

Top Five Benefits of Investing in Innovation

Today’s patients expect more from their healthcare experience, and pharmaceutical manufacturers must rise to the occasion by prioritizing patient-centric innovation. Enhancing the patient journey is no longer just about offering services and medication; it’s about delivering a seamless, supportive experience at every touchpoint. Manufacturers can truly put patients first by streamlining patient support, communication, and access to care.

: Innovation enables manufacturers to eliminate friction points throughout the patient journey, such as complicated enrollment processes, delays in therapy initiation, and challenges in patient engagement. By implementing digital tools, streamlined communication, and automated processes, manufacturers can create a more seamless experience that truly puts the patient first. This patient-centric approach enhances satisfaction and strengthens the overall customer experience by prioritizing ease, accessibility, and support at every stage.

: Meeting patients where they are is essential in today’s healthcare environment. Whether through mobile apps, text messaging, telehealth, or other preferred channels, innovative solutions enable patients to engage with their healthcare on their own terms. By providing flexible, easily accessible tools and resources, manufacturers empower patients to stay informed, connected, and actively involved in their treatment journey. This patient-centric approach improves patient engagement and demonstrates a commitment to prioritizing patients’ needs and preferences.

: Understanding insurance coverage, prior authorization, and treatment logistics can overwhelm patients. Innovative solutions, like digital tools and Artificial Intelligence (AI) powered support systems, simplify this process by providing clear, accurate information in real-time. These tools guide patients through each step, ensuring they have the support to make informed decisions quickly and with less stress. By addressing these challenges directly, manufacturers ease the patients’ journey and reinforce their commitment to a patient-first approach.

: By leveraging cutting-edge technologies such as virtual support and AI-driven tools, manufacturers can tailor interactions to meet each patient’s unique needs. These innovations enhance patient engagement, offering customized information, reminders, and assistance that make the experience more supportive and efficient. Manufacturers demonstrate a commitment to patient-centered care by prioritizing personalization, ensuring patients feel understood and valued throughout their treatment journey.

Improving patient outcomes is the core objective of every patient support program. By leveraging data and innovative technologies, manufacturers can better understand patient needs, tailor support services, and ultimately drive improved health outcomes.

: Manufacturers should leverage data analytics and innovation tools to understand patient behaviors and needs comprehensively. This data-driven approach enables more informed decision-making and ensures that essential services are provided precisely when and where the patient requires them.

: Personalization is critical to maximizing patient outcomes. Using data insights, manufacturers can offer targeted services and messaging that resonate with individual patients, fostering better engagement and adherence to treatment plans.

: One of the most significant challenges in patient care is ensuring adherence to prescribed therapies. Through innovation in patient support services, such as automated reminders, virtual check-ins, and personalized follow-ups, manufacturers can encourage patients to stay on track with their treatments, ultimately leading to better health outcomes.

As the pharmaceutical landscape becomes increasingly competitive, driven by a growing range of treatment options and evolving patient experience expectations, manufacturers must differentiate themselves by offering comprehensive, value-driven patient support services.

: Innovation is essential for staying ahead or, at a minimum, on par with industry peers. Companies that fail to innovate risk falling behind as the marketplace evolves and new, improved offerings are introduced. A commitment to innovation helps manufacturers remain relevant and meet the changing needs of patients and providers.

: By innovating patient services, manufacturers can offer robust, integrated support that adds unique value to patients and healthcare providers. This differentiation not only enhances the patient experience but also strengthens brand loyalty in the marketplace.

: Some companies disrupt the market with bold innovations, while others take a more gradual, measured approach. Regardless of the pace, continuous innovation is vital to maintaining a competitive. Manufacturers must prioritize ongoing advancements to ensure they meet the evolving demands of patients and the healthcare industry.

4. Adapt to Rapid and Digital Advancements

In an era of rapid digital transformation, pharmaceutical manufacturers must adopt a forward-thinking approach to remain relevant and efficient in delivering patient support services.

: As technological advancements continually reshape the market, manufacturers must stay agile and flexible in their approach to patient services. By embracing an adaptive mindset, they can quickly respond to market changes and assess which emerging technologist offers the most value for their programs.

: Digital innovation allows for creating scalable solutions that grow alongside the patient support program. By investing in adaptable digital tools and platforms, manufacturers can enhance patient experiences, streamline processes, and manage increased demand without sacrificing quality or efficiency.

: To truly innovate, manufacturers must look to leaders in other industries for inspiration. Companies outside of healthcare are often at the forefront of digital transformation, offering valuable insights that can be applied to patient services. By adopting best practices from sectors like retail’s customer-centric approach or finance’s use of real-time data, manufacturers can enhance their patient support programs and set new standards within the industry.

5. Boost Operational Efficiency and Streamline Processes

Innovation is not limited to patient-facing services; it is equally crucial for enhancing internal operations. By leveraging technology manufacturers can create more efficient workflows, freeing up valuable resources and improving overall program effectiveness.

: Automation and AI reduce administrative burdens by managing repetitive, time-consuming tasks. This shift allows teams to focus on strategic, high-impact activities that drive greater patient outcomes and program success.

: Efficient internal processes directly impact how quickly patients receive their therapies. By streamlining operations, manufacturers can accelerate therapy initiation, enhance patient satisfaction, and improve overall health outcomes.

: With automation taking care of routine tasks, staff can redirect their efforts toward activities that deliver the most value to patients and the organization. This focus not only enhances the quality of patient support services but also strengthens the program’s capacity to adapt and scale.

To achieve long-term success, manufacturers must align their patient service programs with innovation efforts and overarching organizational goals, ensuring stakeholders' engagement from the outset. Archbow Consulting is committed to helping pharmaceutical manufacturers of all sizes develop comprehensive innovation strategies. Our approach emphasizes thought leadership, cross-functional assessments, and creating a multiyear innovation roadmap to guide companies toward their ultimate objectives. Organizations can thrive in today’s competitive digital landscape by balancing immediate wins with future-focused planning. Effective strategic planning is the cornerstone of commercial success in the pharmaceutical industry, and with decades of experience, the right advisors can significantly impact your organization’s growth.

 to learn how our expertise can support your team.

Revolutionizing Patient Care: The Top Five Benefits of Investing in Innovation

I remember the gut punch 15 years ago when we opened the letter from Florida’s top payer. The words were stark: a 50% reduction in reimbursement rates were announced for the following year. Our small, independent home infusion pharmacy had a heavy patient census of these covered lives, and this news not only threatened our financial stability, but our very existence. As the initial shock wore off, reality set in. The cold, hard truth in business is rather simple: Revenue - Expenses = Net Income. For a buy-and-bill pharmacy, slashed reimbursements meant our revenue (and ultimately, bottom line) was about to take a devastating hit.

The first instinct was to appeal the payer cuts, but that went nowhere. Next, we considered increasing our patient base to offset the loss in revenue, but we quickly realized that such strategies merely added to the cost of business without the guarantee of revenue pull-through. Infusion pharmacies can’t simply scale up without a significant influx of physician referrals, just as hospitals can’t magically add beds without major buildouts or M&A. With limited options to guarantee revenue growth, the only viable path left was to focus on controlling expenses.

Fast forward to today, and the landscape for pharmacies remains as challenging as ever. Next year’s reimbursement forecasts predict more turbulence with drivers like: Direct and indirect remuneration (DIR) fees changing, price controls imposed by the Centers for Medicare & Medicaid Services (CMS), and new policies around site neutrality—all lowering pharmacy reimbursement forecasts. Whether you’re running an independent pharmacy or managing one within a health system, these changes threaten to diminish the progress made through recent improvements in revenue cycle management.

Meanwhile, attention on cost containment has strayed over the last three years. According to a focus group of pharmacists, primarily from integrated delivery networks (IDNs), the concerted efforts to take on the new identity as a revenue center has absorbed so much energy it’s almost as if pharmacy has lost sight of its cost center hat. With reimbursements expecting to slide, many pharmacies lament that little can be done to achieve the financial wins that their revenue cycle management programs have provided over the past few years.

In the sense that complaining is going to turn the hearts of payer decisions, yes, it’s probably a futile effort to express further dissent.

Yet, there are other moves to make. Savvy procurement professionals are looking to financially counterbalance this expected impact to the pharmacy’s profit and loss by seizing on drug manufacturers’ inclination to shift more of their volumes to direct channels, where the freedom to negotiate is opening doors for newfound cost savings. Most progressive pharmacy teams have rev cycle already tuned up as tight as possible, and they’re facing the reality that there isn’t anything further to be done with the front portion of the equation. Now they’re shifting focus to realize drug acquisition cost savings to offset the downgrade in revenue forecasts. With labor costs a distant second, drug spend is commonly pharmacy’s largest expense.

It’s remarkable how we now divide so much of life into pre- and post-COVID eras. The pandemic humbled us in ways we couldn’t have predicted. Before, the idea of buying directly from pharmaceutical manufacturers felt overwhelming, with manual price negotiations, tedious contracting stretching into months, and multiple vendor registrations bogging down operations.

Then, the pandemic hit. Drug shortages forced pharmacies to rethink everything, driving them to lean on direct manufacturer relationships out of necessity. In the process, many discovered that purchasing directly from drug companies not only helped procurement teams navigate shortages but also unearthed significant cost savings.

For large institutions with a drug spend in the hundreds of millions, direct purchasing opportunities may seem insignificant. Take a hospital pharmacy with a $500 million drug budget—saving $50,000 by switching one national drug code (NDC) represents only 0.01% in annual savings when looking top-down. But when that same hospital faces year-over-year reimbursement cuts, every dollar saved becomes a counterweight to lost revenue. A more ground-up approach to savings is gaining traction, as pharmacies realize that cutting drug acquisition costs can soften the blow of reduced reimbursements.

Let’s say your payer mix suggests a $5 million reduction in reimbursement for 2025. By creating an initiative to save $5 million for the institution through direct purchasing—just 1% of the overall drug budget—you could theoretically neutralize the impact on net income without jeopardizing rebate structures or cost-minus agreements. Surplus savings could cover annual salaries of pharmacy staff, fund new initiatives like central fill models, or even justify budget requests for continuing education (CE) travel.

Pre-COVID, manufacturer-direct commerce was riddled with friction, but today, advances in decision-support software and marketplace aggregators have made it easier by simplifying vendor setups, improving visibility into stock, streamlining price negotiations, and generating purchase orders in seconds. New technology also provides better optics into comprehensive savings analytics. More manufacturers are opening their portfolios directly to pharmacies to better manage channel fees, prevent product leakage into the grey market, identify prescription trends in real-time, and provide pharmacies with point-of-sale savings to enable cash pricing models whenever insurance coverage is either lacking or the out of pocket is too costly for patients.

Unlike pharmacy school, where 100% earns you an A+, procurement is a different game. While there are concerns about contracted volume obligations and maintaining rebates for better pricing, here’s the reality: if you’re 100% compliant to pre-committed vendor volumes, you exclude yourself from opportunities available on the open market that can make a difference to your budget. It’s not an overhaul of your entire purchasing strategy, but rather a closer focus on how to optimize the delta between committed and non-committed thresholds. Optimizing the 5-20% within your direct purchasing allowance can deliver enough juice in acquisition cost savings to compensate what’ll be missing from your reimbursement cup next year.

It’s easy to have a victim mentality, as I did 15 years ago, when external forces jeopardize your pharmacy’s ability to operate and serve patients. However, it’s the pharmacies who start thinking and surviving like a business who will be in the best position to adapt and thrive in this changing landscape.

Blake Powers is the CEO of Medigi, and a member of Pharmaceutical Commerce’s Editorial Advisory Board.

Tips for pharmacies with the reimbursement blues.

Dusting Off One’s Cost Center Hat

Pharmacies, most agree, are no longer simply just a place to pick up a filled prescription. Even before the COVID-19 pandemic, pharmacy services had begun to expand. The public health crisis, however, would thrust community pharmacies in the US into the spotlight, and they responded. Their offerings—and the reliance on them—exploded. 

Seemingly overnight, retail and community/independent pharmacies introduced virus testing clinics for COVID, then vaccination distributions at a large scale. Community pharmacies in particular have always been in the background, though, supporting doctors, patients, and communities. From prescription fulfillment, to test-and-treat services, to counseling, these entities play a vital role in the patient care ecosystem.

“The pharmacy itself has greatly changed—we're not just the destination you come to after you go to the doctor's office,” says Kathy Collier, DPh, regional vice president of operations, Express Rx Pharmacy. "We've had to shift in the pharmacy to be more of a destination healthcare place. We have had to pivot and become a place where we are part of that healthcare system.”

Pharmacists, of course, play a crucial role in public health. In addition to the COVID immunizations, community pharmacies administer vaccines for ongoing flu seasons, for global travelers, new parents, elderly citizens, and those immunocompromised—dealing with such afflictions as chicken pox to hepatitis A and B virus to yellow fever and respiratory syncytial virus.

Today’s pharmacist focuses on enhancing overall community health through an increasing educational role—offering directives on medication use, preventive care, healthy lifestyle advice, and aiding in chronic disease management for conditions such as diabetes and hypertension by offering personalized care and monitoring.

“In pharmacies at large, not everybody who walks in is sick. A lot of people are there because they're caregivers, so they need counsel just as much,” says Ian Stone, senior vice president of Mesmerize. “They need those five minutes with the pharmacist on how to administer the pill, the liquid, or whatever the drug is. Independent pharmacists do a really good job coaching.”

While many are experiencing unprecedented market and business challenges, such as the emergence of online pharmacies, industry director-to-consumer drug delivery models, and other alternative point-of care entrants, community pharmacies believe they still offer a unique and significant position in the mix. They don’t just serve local communities, they’re often part of them, too. Whether that’s, for example, sponsoring local sports team, building relationships, or being a go-to or trusted source for advice and support. While the dynamic may not be the same as in decades past, their presence and value still resonates in the community and with longtime customers.

“…We've got some pharmacies that have customers that come in every day, literally because they have nothing else to do,” says Laura Edmundson, PharmD, MBA, vice president of pharmacy at Brookshire Brothers, Inc., a Texas-based employee-owned grocery store. “They'll just come and they'll sit down and check their blood pressure on our blood pressure kiosk and say hello. That's part of their routine, visiting the pharmacies.”

Pharmacy deserts has become a popular term in 2024. These are geographic areas—a neighborhood, town, or county—where some or even all of the pharmacies have closed. So what happens when a community pharmacy has to close? In rural towns, the local pharmacy is often the closest healthcare provider for miles. At these locations, people can check their blood pressure, access healthy foods, get advice on over-the-counter (OTC) aids, or better understand their prescription drug interactions and side effects. For patients with unreliable access to transport, local pharmacy delivery and walkability matter most.

“We have a lot of rural locations at Express Rx (based in Little Rock, AR), so it is very important for us to be able to offer some of these services that maybe people in our communities can't get because they don't have a local doctor's office,” says Collier. “It's huge now that we can offer immunizations and some testing that they would have had to drive to another town to get or just not get it at all.”

Adequate access to healthcare is an ever-present challenge. Telehealth boomed during the pandemic —telemedicine use among physicians grew from 15.4% in 2019 to 86.5% in 2021, according to the National Center for Health Statistics.

 But not every patient has reliable internet or the computer literacy necessary for telehealth visits, however. It’s important that pharmacies are there when patients have questions.

“We're the most accessible healthcare provider,” says Edmundson. “You don't need an appointment to ask your pharmacist a question or to get counseling from them.”

As mentioned, nationwide, pharmacies are closing. Across the US, more than 7,000 pharmacies have shuttered since 2019, according to data from Lucas Berenbrok, PharmD, associate professor of pharmacy and therapeutics at the University of Pittsburgh School of Pharmacy. He considers that estimate conservative. Of those pharmacies, 54% were independent drugstores, an AP analysis of Berenbrok’s data found.

 It’s not just the “little guys,” however. In June, CNN reported that Walgreens planned to close a “significant number” of its 8,000+ stores. CVS, reportedly, already closed 244 stores between 2018-2020, and had plans to close about 900 more starting in 2021.

“The biggest thing lagging behind now is that we don't have provider status. We can't bill, in many cases, for clinical services. We can put pills in a bottle, but we can't bill for every sort of point-of-care test,” says Michael Halliwell, director of pharmacy and whole health, Balls Food Stores, a longtime retail grocery chain serving Kansas City, KS

 “The hard part is that pharmacies have been crying about reimbursement for a long time, and it's gotten worse and worse. Over the last five years, there has been a dramatic reduction in what we get reimbursed.”

Halliwell adds that a big issue has been the increasing levels of direct and indirect remuneration (DIR) fees. “We're paying 2020-freeze clawbacks,” he notes. “We’ve been getting hit with DIR fees since January 1—twice the DIR fees, in fact, which literally levels so many independent pharmacies who don't have cash. It’s bad out there.”

The margins, therefore, have gotten smaller and smaller, with more tasks falling on pharmacists’ plates and fewer resources to go around. Every time someone shops online or elsewhere for cheaper prescription or OTC products, the pharmacy loses ground. With rising prices for prescription drugs in recent years and new complexities emerging in payer coverage, pharmacies, much like patients, have felt the squeeze.

There is some help from new advances in technology and automation. Inbound call centers, as well, assist in managing the volume of pharmacy calls and utilize central-fill pharmacies to fulfill recurring prescriptions. This allows pharmacists more room to operate at the top of their license, offering in-person consultations and counseling, testing, and immunizations.

“Community pharmacies are stressed at the moment. We've got a lot on our shoulders,” says Edmundson. “All those patients have to go somewhere, which just puts more workload on the pharmacies that are still here. There have to be workflow adjustments to make offering these types of services viable.”

Without a significant shift, the current trend of pharmacy closures will likely continue. To turn back the tide, experts believe policies need to change, and community pharmacies need stronger support and advocacy to bridge the healthcare gaps that are steadily widening.

Marina Crouse is a copywriter with MJH Life Sciences®, parent company of Pharmaceutical Commerce. She works closely with such MJH media brands as Mesmerize, which specializes in patient education at the point of care.

Michael Christel is Group Managing Editor of Pharmaceutical Commerce, Pharmaceutical Executive, and Applied Clinical Trials.

1. Telemedicine Use Among Physicians by Physician Specialty: United States, 2021. National Center for Health Statistics. February 2024. 

https://www.cdc.gov/nchs/products/databriefs/db493.htm

2. As Pharmacies Shutter, Some Western States, Black and Latino Communities are Left Behind. AP. June 3, 2024. 

https://apnews.com/article/pharmacy-closure-drugstore-cvs-walgreens-rite-aid-91967f18c0c059415b98fcf67ad0f84e

3. Meyersohn, N. Why Walgreens, CVS, and Rite Aid are Closing Thousands of Drug Stores Across America. CNN. June 28, 2024. 

https://www.cnn.com/2024/06/28/business/walgreens-cvs-closing/index.html

With today's pharmacy landscape shaken by unprecedented and wider disruption to healthcare support and delivery, community and independent entities strive to remain an integral cog in the mix.

Community Pharmacies in Crisis: Navigating the Challenges and Closures

Emerging biotech companies launching niche therapies (e.g., CAR-T, radiotherapies) operate without a commercial blueprint. Each disease state is unique. Each account has its own mix of stakeholders. Companies can’t rely on syndicated data to help them uncover all essential account-level insights. As a result, these innovative companies are all pioneers at launch, creating their own custom commercial models. Further, these companies need to rely heavily on their field teams to gather granular intelligence about accounts that cannot be sourced from syndicated data.

It’s therefore imperative that these companies—which are often lean and budget-constrained—create fruitful partnerships between home office commercial teams and the field force. The most successful of these partnerships will be marked by seamless information exchange and robust insight collection. Success starts with appreciating the uniqueness of niche therapy commercialization.

The unique complexities of niche therapy commercialization

Unlike traditional pharmaceutical products that cater to a large patient base, niche therapies (in therapeutic areas such as oncology and hematology) target small patient populations and are therefore relevant to only a limited set of physicians. Further, the complexity of administering the therapies and the intensive training required limits the number of treatment facilities. In CAR-T, for example, treatment involves T-cell extraction, reinfusion, and close patient monitoring.

Companies must gather granular account-level information to accurately understand opportunity. For instance, the number of apheresis chairs a facility has or how many ICU beds it reserves are key metrics that help a company with a CAR-T therapy understand opportunity.

There’s a moral imperative here, as well. Patients suffering from rare diseases deserve access to efficacious treatment. Therefore, a company’s effort to optimize its commercial model and onboard more treatment centers is also an effort to improve patient access and outcomes. To succeed in this complex mission, a company must look across its commercial infrastructure, starting with technology.

Build a dynamic commercial technology infrastructure

The technology at the center of niche therapy commercialization is the customer relationship management platform. For niche therapy commercialization, companies need powerful, user-friendly and flexible commercial technology that enables them to build rich account profiles. These profiles should incorporate the various pieces of data and information (some quantitative, some qualitative) that capture key operational details and reveal true opportunity within accounts. It should also help the company map stakeholders accurately, which will help the sales team hone its efforts. Further, this technology should:

Empower the sales team in the field by equipping them with customized views summarizing target accounts and relevant insights.

Facilitate a smooth two-way information exchange between the home office commercial team and the field sales force. Commercial leaders should be able to deliver information that helps reps in the field. Reps should be able to easily do everything from entering a call to adding contextual information about an account.

Accommodate change as the company brings its therapy to market, expands its account targets, and adjusts to shifts in the dynamic niche therapy space.

Housing account plans in flexible, accessible, and user-friendly commercial technology can empower the sales force and add nimbleness to a company’s commercial operations.

Enable effective field intelligence gathering with sound process

A rare disease company can’t turn to syndicated data sources for certain insights into its target accounts. Uncovering opportunities within accounts requires specialized knowledge. A company gathers this knowledge to a significant extent through its sales force. Reps gather valuable insights about account capacity and capabilities, stakeholder mix, and more.

Commercial leaders must therefore equip reps with the robust and flexible technology tools we discussed in the last section, as well as clear instructions for how and when to share information via those tools. Asking for too much information from the sales force could limit information sharing, as reps struggle to comply with the commercial team’s time-consuming requests. On the flipside, sparse requests for information from the field limit valuable insight sharing. Commercial leaders should home in on the most essential pieces of information that will enable the company to develop rich account profiles and advance the commercial effort.

Prepare for a future of increased complexity

The niche therapy space is dynamic. For one, competition is increasing. As more therapies come to market, treatment sites will become increasingly crowded. Companies will battle over a smaller pool of opportunities, at least in the short term.

In the long term, companies are seeking to expand the number of treatment sites, equipping facilities beyond specialized tertiary care centers with the training and resources needed to administer niche therapies. The expansion of treatment will benefit patients. It will also further stretch biotech companies’ commercial teams as they expand their efforts to identify and engage with new stakeholders. In a hospital, for example, these stakeholders could span the entire organization—from the emergency room and intensive care unit to specific departments like neurology.

Companies that prioritize granular intelligence gathering in the field and enable it with flexible commercial technology (instead of trying to force new requirements into rigid tools), will be best equipped to navigate this complex and evolving space.

Develop two-way partnerships with the field

Commercial leaders at emerging biotech companies should view niche therapy commercialization as an account management exercise. Account management requires granular understanding of customers (in this context, treatment sites and the stakeholders within them). To gain that granular understanding, companies need to create a healthy two-way partnership between home office and the field sales force.

To enable this two-way partnership, companies must think bigger. View commercial technology as more than a place to log call activity. View sales force and home office engagement as something integral to daily operations (instead of something that happens during periodic status meetings). And understand the trajectory of the niche therapy space. It’s one marked by dynamic innovation, and, as a result, more competition and growth in the number of treatment sites. It's a space that promises to transform patient lives in the years to come. To ensure a company’s therapies breakthrough and reach patients in need, it must foster partnership with the field, putting robust and flexible commercial technology and sound process at the heart of the effort.

Jennifer Maurer is executive director of commercial and CAR-T operations at Legend Biotech, while Laura Riccio is an associate partner at Beghou Consulting.

How emerging biotech companies can create fruitful partnerships between home office commercial teams and the field force to enable this intelligence gathering, while driving commercial success.

Jeff Antos, Weinberg Group

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