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Click the title above for a link to open the Pharmaceutical Commerce December 2023 issue in an interactive PDF format.

 Pharmaceutical Commerce - December 2023 Issue (PDF)

’s December issue is a special one for myriad reasons, beginning with the fact that it marks our final issue of the year. This edition also highlights the return appearance of our patient support/hub services dedicated coverage. For example, in their 

, Rohit Gupta and David Laros of Beghou Consulting opine that with opportunities to successfully use patient hub data, pharma companies have the capability to make these hubs more experiential and personalized. The potential end result: businesses becoming more patient centric across their commercial operations.

Speaking of patient support, Matt Wolf, Cencora’s president of biopharma services, sat down with Editor Nicholas Saraceno to discuss how data innovation can drive 

. Wolf sums it up best in stating that “we believe an effective adherence strategy must also account for two critical variables that can affect a patient’s ability to start and stay on therapy: access and affordability. We work with our pharma and biotech partners to understand their specific needs and then deliver services tailored to the patient population to reduce access barriers, improve speed-to-therapy, and keep patients engaged and supported throughout the treatment journey.”

As it pertains to affordability, this issue's “

” column touches on the many moving parts presently at play and their future implications. PAN Foundation’s Kevin L. Hagan and Amy Niles note that about 800,000 beneficiaries in 2024 and more than 200,000 beneficiaries in 2025 are predicted to spend more than 10% of their income on prescription medications each year.

" column, Bill Roth of IntegriChain explains that 2024 is going to be the year of “Who Moved My Prescription?,” driven by a shift in product mix; the decline of reimbursement; the rise of the digital patient treatment journey; and a desire by the old guard to maintain their own status quo.

Highlighting some of our other coverage this month is a guest feature by Maria Cipicchio of OptimizeRx on the 

. Cipicchio points out that although these products have slowly, yet steadily, gained market traction and focus, the argument could be made that they haven’t necessarily made the splash thus far that many had anticipated.

And last but not least, as Saraceno alludes to in his editor's letter on the facing page, we hope you enjoy our updated design—and look forward to receiving your feedback.

— Mike Hennessy Jr., President and CEO, MJH Life Sciences

December's installment reinforces the publication's commitment to covering the latest updates on patient support.

Patients are the Priority

The past few months have been pedal to the metal when it comes to 

’s presence at conferences. As I detail in this month’s “

 LogiPharma USA continues to be a successful show for the industry, thanks to the skillful work of the Worldwide Business Research team in searching out and assembling the topics and SMEs that will resonate most with attendees.

After covering LogiPharma USA in early October, I was fortunate enough last month to report from the Access Insights Conference in Orlando, Fla., an event dedicated to data-driven trends and strategies in drug access commercialization, co-hosted by IntegriChain and Blue Fin Group. As the preferred media partner, 

, topics on the docket included but were not limited to:

As part of our video coverage, I also had the chance to pick the brains of Bill Roth, Blue Fin Group’s SVP and managing partner, and a regular contributing expert to 

, as well as Andrew Bronwnlee, a director with Berkeley Research Group.

In separate news, as you've no doubt noticed, I would like to announce that the redesign of the 

print publication is now officially live! We hope that you are as excited about it as we are. This process has been in the making for quite some time—the goal has been to provide a more modern feel to the publication, while keeping its core intact. You’ll notice that each feature and section of the magazine has its own unique layout, and images have taken on an entirely new level of importance to us. This new flare will also be translated over to our website, which is expected to roll out its own redesign in the coming months.

As we close out the year, I greatly appreciate the unwavering support from you, our readers, and can't wait to hear your thoughts and feedback on all of our changes—and ways we can perhaps make your experience with us even better.

Nicholas Saraceno is Pharmaceutical Commerce's Editor. He can be reached at

Introducing a new style and feel to Pharma Commerce.

Brand Evolution and Engagement

From Oct. 4-6, the Pharma Commerce team returned to Boston for LogiPharma USA, this time as the show’s media recording partner. The argument could be made that this event is the largest conference of the year that we cover, alongside its European counterpart.

Organized by Worldwide Business Research, the goal of the conference is to unite supply chain professionals in the life sciences industry under one roof. It successfully achieved that—in fact, LogiPharma invests over eight months of research into choosing the right topics that will truly hit home for attendees.

Speaking of topics, we attended and covered a variety of sessions, including:

“Navigating the E2E Global Pharma Supply Chain Using Digital Transformation”

“DSCSA—Final Checks to Have Before Deadlines”

“Identifying Ways to Make International Cold Chain Shipping Efficient and Sustainable”

Roundtable discussions surrounding data-driven decision-making and cold chain logistics

Without restating too much of what I shared in October’s “Conference Connect” regarding LogiPharma Europe, in Boston, I leaned significantly into both the Drug Supply Chain Security Act (DSCSA) and women leaders items. In regard to the former, although DSCSA full enforcement is delayed until Nov. 27, 2024, that did not change the fact that this year’s Nov. 27 deadline was still active. The panel spoke on best practices for manufacturers to create and maintain serialized transactions information; issues around transaction statements; and strategies in securely exchanging DSCSA traceability data with wholesale distributors, health systems, and retail dispensers (such as via EPCIS).

In another panel, experts aimed to provide an honest conversation surrounding the challenges faced by women in the life sciences space. The discussion started off with a provoking statistic per Gartner: in 2022, 39% of the total supply chain workforce consisted of women. However, this represented a 2% decrease from 2021, suggested that raising these numbers will require a continuous effort from the supply chain community.

We shouldn't forget mentioning our video coverage as well, featuring the likes of Tracy Nasarenko, senior director of community engagement for pharmaceuticals for GS1 US, and Jenifer Smith, senior logistics specialist with Direct Relief. Among the various focus points, Nasarenko dove into the steps that the pharma supply chain should take in order to adapt to the new DSCSA laws, while Smith elaborated on what women and men can do to help foster growth and development. Both women were part of the panels mentioned above.

As always, you can catch all of our recent and past “Conference Connect” coverage at 

pharmaceuticalcommerce.com/latest-conference

Back in Boston, Pharma Commerce tackles all things logistics at LogiPharma USA.

A Supply Chain Overhaul

Effective Jan. 1, 2024, individuals with Medicare Part D coverage may start to see their out-of-pocket (OOP) costs for prescription medications decline. This is a result of a Medicare reform, enacted through the Inflation Reduction Act, that eliminates 5% cost-sharing in the catastrophic phase of one’s benefit. With this reform, OOP costs should be limited to about $3,250 for the calendar year. Further patient-centric reforms take place Jan. 1, 2025, when a $2,000 Part D cap on OOP costs for prescription medications will go into effect, coupled with the opportunity to enroll in the “Medicare Prescription Payment Plan” that will enable these costs to be distributed across the calendar year.

In late 2022, the PAN Foundation commissioned research by Avalere, a healthcare consulting firm, to examine the projected beneficiary utilization and spending by Medicare Part D beneficiaries under the new reforms. The analysis found:

More than 2.6 million non-low-income subsidy Medicare Part D beneficiaries will have OOP spending high enough to reach the new $2,000 annual OOP cap on prescription drugs in 2025.

Additionally, about 800,000 beneficiaries in 2024 and more than 200,000 in 2025 will spend more than 10% of their income on Rx each year.

A higher share of beneficiaries who qualify for Medicare based on disability, as well as greater shares of Hispanic and Black beneficiaries, will have high spending levels early in the calendar year. Building upon this research, a new study from Avalere explores the potential impact these reforms could have on non-low-income subsidy patients taking drugs within eight therapeutic areas (TAs). These include autoimmune diseases, HIV, and multiple sclerosis (MS). Avalere assumed conservative or low-level estimates of beneficiary utilization and plan formulary management responses. Select findings are presented here:

More patients will be able to start and stay on prescription drugs.

Following implementation of the Medicare reforms, Avalere projects that the number of 30-day prescriptions for drugs within the TAs studied to increase between 1% and 10%.

Patients in TAs studied will reach the annual cap of $2,000 in a conservative scenario.

While the Medicare reforms are expected to lower OOP costs for Rx for non-low-income subsidiary beneficiaries across the TAs, most patients taking medications for an autoimmune condition, HIV, and MS will have spending of more than $1,750 in 2025. In a situation where beneficiary use and plan formulary management responses are increased, OOP costs may increase for beneficiaries.

About 135,000 patients across the eight TAs analyzed will spend more than 10% of their income on OOP costs, leaving them underinsured. 

These individuals will be at increased risk of delaying or forgoing treatment. In a medium-response scenario, this number could increase to 365,000 beneficiaries. These affordability challenges are estimated to disproportionately affect patients with incomes between 150% and 300% of the federal poverty level.

The analysis illustrates that in particular, individuals living with autoimmune conditions, HIV, and MS are projected to spend more than 10% of their income on drugs. For those on autoimmune therapy, the analysis points to the outsized affordability challenges that historically marginalized and underserved patient populations will continue to face.

Affordability challenges will continue to be faced by those with high OOP costs late in the calendar year.

These individuals will not fully benefit from the Medicare Prescription Payment Plan, as they will be unable to spread their costs across a large number of months.

Plan formulary response will impact patient behaviors.

It is not clear how plans will respond and adjust their formularies over time. Should plans implement higher response scenarios through formulary management, patients will be impacted more when it comes to access, affordability, and medication uptake and adherence.

Kevin L. Hagan is president and CEO and Amy Niles is chief advocacy and engagement officer, both at PAN Foundation.

Will result from Medicare reforms, despite increased drug uptake.

Continued Affordability Challenges in the Offing

After exploring the “Fight for the Dollar” in 2023, as I look forward to 2024, this is going to be the year of “Who Moved My Prescription?”

The world of pharmacy used to be a lot more simplistic: we had retail pharmacies and hospital pharmacies. By my rough count, I see 25 main forms of pharmacy today, and new forms keep emerging every day. As George Van Antwerpt from Deloitte likes to muse, “there are pharmacies of the future on the way.” I agree with him, and they can’t get here soon enough.

We’ve all seen the recent headlines. Brick-and-mortar retail is struggling. Reimbursement is declining. Cost of goods is increasing. Cash-pay pharmacies are eroding the commercial pharmacies’ insurance business, especially for generics. Discount card companies such as GoodRx, new cash pharmacies such as Mark Cuban’s Cost Plus Drugs, and Amazon Pharmacy are shining lights on new ways for consumers and plan sponsors to think about the economics of prescription medicines. Meanwhile, brick-and-mortar pharmacies are dealing with store closings, walk-out protests, theft, and opioid lawsuits, and are turning away branded prescriptions.

I see four main drivers for the problematic situation: a shift in product mix, the decline of reimbursement, the rise of the digital patient treatment journey, and the desire by the old guard to maintain their own status quo.

First up is that the ratio of branded Rx to generic Rx has changed dramatically. For brick-and-mortar retail, they have been on a mission to convert branded prescriptions to generics. Pharmacy benefit managers (PBMs) drove retail with economic incentives, both with script economics but also with generic utilization targets. Wholesale distributors did the same on the buy side of the pharmacy channel. With the end of the primary care patent cliff in 2017, the new item generic market is a shadow of its former self. Sure, there are still some big ones out there such as in the anti-coagulant and the diabetes markets, but these aren’t enough to reverse the tide.

Now let’s tackle the decline of reimbursement. With direct and indirect renumeration (DIR) fees set to be added to the front end of the adjudication, some industry pundits are expecting to see reimbursement decline to average wholesale price (AWP) less 21% or even greater. This new low threshold comes as pharmacies are seeing cost of goods increase as wholesalers no longer have their same mix to pass on aggressive cost  less pricing.

Next is the rise of digital. From e-commerce pharmacies to the world of the tech-enabled hubs, prescriptions are being routed to points of assurance that the script that was written is the one that gets filled.

Lastly, let’s explore the archaic thinking of the legacy pharmacy market and their lack of ability or willingness to evolve. As opposed to servicing branded Rx, they are converting them to generics if generics are available in the class. Primary research that Blue Fin Group conducted in late 2022 through 2023 yielded clear insight that pharmacies proudly switch prescriptions even when there isn’t a direct generic equivalent. They perceive themselves to be patient ambassadors, lowering the patient’s out-of-pocket exposure while also lining their pockets with the high-margin generics. They call back to the prescriber, explain the patient economics, and the script gets switched. This is a problem for emerging brands, unless you’re an instant blockbuster like the GLP-1s in weight loss and diabetes, and even then, retail pharmacies don’t want to process the prescriptions. Pharmacies lose money on these. Products like the GLP-1s are brands and go against the wholesalers’ generic utilization rate targets; the more successful the brands, the greater the risk the pharmacies will experience another cost of goods increase. This is a problem for branded manufacturers.

So what are pharmacies doing about it? The national chains are out in the manufacturer community seeking their own form of a bail out. They signed contracts with the PBMs that they now deem unprofitable. The pharmacies are asking for any help possible, but really don’t want to do anything incremental or different than what they have been doing. Manufacturers aren’t buying it. They don’t see the problem as real. The responses I hear from pharma include:

“The pharmacy signed the PBM contract—they have to honor the prescriptions.”

“They make exorbitant margins on generics—brands are loss leaders.”

“They have a fiduciary duty to fill prescriptions as part of their state pharmacy license obligations.”

“They’ll turn patients away and their entire book of prescriptions.”

“If they turn down the service levels, they’ll negatively impact theirstar ratings.” 

“If they move the brands to e-commerce and out of brick and mortar they’ll will be handing your business to Amazon Pharmacy ... and what happens to front-end profitability?”

There are additional issues with the situation. The two main solutions for the problem are pharmacy improving reimbursement or lowering cost of goods. The challenge with pharmacies going back and renegotiating with their PBMs is that these are longer-term contracts, and even vertically integrated pharmacies don’t seem optimistic of this approach. If retail can’t do the job, the PBM will likely be more than happy to dust off their mail order models and control another vertical channel. The challenges with lowering the cost of goods are that the two options are discounts or fees. The discounts are problematic for manufacturers because these would need to be applied to the retail pharmacy class of trade. With all the problems retail already has, manufacturers aren’t about to expose themselves to a Robinson Patman Act situation. The fee approach is likely to be problematic for two reasons. First, changing a core service to an enhanced service is tough to pass legal review, as it easily can be construed as an inducement and violation of the Anti-Kickback Statute. Second, once fees get bona fide, they will likely not close the financial gap the pharmacy needs simply to break even. So, we are in a Catch-22. Did branded pharmaceutical companies ever think they’d be in a position to worry about whether a pharmacy would service their prescriptions?

The solutions stepping forward are where we should focus our energy. Tech-enabled digital hubs have grown rapidly in the last few years. Prescribers can send eRxs to a non-dispensing pharmacy directed by the field represented, and a mix of tech and human services connect the patient and prescription with a pharmacy capable and willing to process the prescription. Yes, patient services have evolved beyond specialty and even specialty lite (averaging ~$8,000 to $20,000 year) down into general medicine/primary care.

For the legacy pharmacies, they will need to think through how they buy, sell, and operate. They will have to break through their "92% of prescriptions are generics and low cost wins the day" way of thinking. Branded prescriptions will find a way to their patients. Branded manufacturers have built skills for their own network design after 2.5 decades of specialty pharmacy experience. They are hungry for data around the prescription journey and want an experience around their brand that matches the quality of their science. Many models are standing by hoping for their chance. Ironically, this is reminiscent of specialty pharmacy when the legacy channel couldn’t get the job done and a new form of pharmacy stepped in. Given we have 25 to choose from and more on the way, let the games begin.

Bill Roth is the SVP of IntegriChain’s consulting business, which includes Blue Fin Group, a strategic consulting company he started in 2001, and the existing IntegriChain operational consulting business.

While new forms of pharmacy continue to surface beyond brick-and-mortar retail, a look at what is driving this shift in perspective—and "pharmacies of the future"—is warranted.

Who Moved My Prescription?

As launch timelines accelerate and competition increases, pharmaceutical companies must find ways to leverage the insights at their disposal to improve their engagement with healthcare providers (HCPs) and patients, while strengthening their brands. The patient hub provides a golden opportunity for this enhanced engagement, as long as pharma companies take advantage of the data contained within these hubs.

The rise of complex biologic therapies in the early 2000s brought the earliest patient support services, which essentially served as call centers focused on offering financial assistance. Today, hubs offer a variety of services, including onboarding a patient on therapy, adherence, support programs, supply chain coordination, and more. These hubs facilitate myriad digital interactions between patients and the pharma company. When they work well, hubs help patients start and stay on the therapies they need and ease workloads for HCPs and pharmacies. When they fall short of their potential, hubs decrease the original intention of supporting the patient across the journey.

While the hub has many features at the heart of these programs, what we will focus this article on is data. Essentially, pharma companies must do more with their hub data to improve the patient journey. Hubs have or possess the potential to have rich patient data that can be mined for insights on preferences and future behavior. By taking full advantage of hub data, companies can make their hubs more personalized and experiential. However, today, most companies are only scratching the surface and are not fully utilizing hub data. Turning granular data from hubs  into insights that drive action will help companies become more patient-centric in their commercial operations.

From a call center to a digital experience

The 1990s witnessed launches of numerous blockbuster drugs. The first hubs served as financial support for patients on complex and expensive biologic therapies. By the early 2000s, many pharma companies began realizing their blockbuster new offering faced competitors treating the same patients. Payers were growing stronger. And, in many cases, patients became a more important part of the equation. These factors helped create a second generation of patient hubs that included patient support features. These new hubs offered services such as processing and submitting complex claims for rare disease products and sending patient reminders—such as refill reminders—to improve adherence to prescribed therapies.

However, hubs were not taking full advantage of their data to achieve customized analytical capabilities, predictive models that could anticipate therapy adherence, and powerful patient-level individualization. These shortfalls limited the effectiveness of the patient hub.

More recently (2010-2020), as pharma organizations placed a greater focus on therapies for rare diseases, patients required more hands-on support compared to mass-market therapies. Thus, companies added more sophisticated services to support patients receiving rare disease therapies, such as coordinating treatments with HCPs and securing transportation to the treatment site (for example, for patients traveling to receive cell and gene therapies).

Moreover, this period is when digital transactions mushroomed. The digital revolution led to an explosion of data, as medical data were doubling every 73 days. Digital capabilities allowed larger (but not always insightful) amounts of information to be collected and analyzed. Such data involved product sales, purchase frequency, patient demographics, and more. Hubs were beginning to show their larger potential.

Today, while more progress is essential to improve patient centricity, a far more proactive patient hub has blossomed. The long COVID-19 pandemic brought with it an explosion in the number of digital prescription transactions. Many hubs now have a bevy of patient-centric features and benefits to those calling, emailing, texting, scanning, or engaging in chat. 

Telemedicine continues to grow, with patient hubs playing a key coordination role between prescriber and patient. For example, companies such as Hims and Ro provide a one-stop-shop for patients to digitally connect with HCPs, receive a prescription, and have the therapy shipped right to their doors.

Hubs are also playing a more central role in interactions with distribution and payer networks, helping facilitate prior authorizations, reimbursements, the delivery of documentation for rare and expensive drugs, and the production of data for pharma companies to ease the tracking and recording of sales. Hubs connect patients and HCPs with available resources. For example, nudging applicable patients to leverage phone apps for disease or medication management.

Turning the hub into impactful technology

Today’s patients are more tech-savvy, inquisitive, discerning, and more inclined to change their preferences or seek alternative therapies. A survey conducted by Accenture found that nearly three-quarters of respondents have used digital technologies to manage their health.

Further, patients seek highly individualized attention. According to a survey by software company Dynata, 75% of US consumers wish their healthcare experiences were more personalized.

 In response, pharma companies must leverage their hub data to uncover valuable insights that allow them to offer more engaging, personalized experiences.

Here are four keys to implementing enhanced patient hubs:

Build the underlying data infrastructure.

Hubs should be built with underlying data acquisition tools that are unified, free of patchwork designs. The challenge is huge. Proactive planning, instead of a patchwork approach, allows companies to strategize around data ingestion, governance, and use. Further, it helps companies design a hub centered on improving the patient organization. 

By proactively mapping out a hub system, companies can think more holistically about the potential use cases of their offering. Then, they can prioritize each use case to take a step-by-step approach to building out their hub program. This approach ensures organizations have a comprehensive hub and all of the features work together to improve the patient experience.

In many cases, a company’s hub is outsourced to a third party. Oftentimes, this can mean the company is a step removed from a patient’s hub experience—and the data that come with it. Pharma companies must have a thoughtful service-level agreement (SLA) in place and ensure they can collect the appropriate metrics to gather data and insights from their hubs. Additionally, they must closely oversee the hub provider to ensure they follow the roadmap and develop tools for impactful patient experiences.

Incorporate many channels to serve tech-savvy patients. 

Today’s patients and their caregivers—whether they are parents of newborns, teenagers, GenX, middle aged, baby boomers, seniors, or super seniors—expect maximum user-friendliness and ease of access. Segments within each generation will have specific communications preferences and expect the hub to accommodate those preferences. Companies must double-down on their omnichannel experience to ensure they are reaching patients at the right time, on the right channel.

By proactively mapping out the hub and developing impactful features that personalize the experience for each patient, pharma companies will improve the patient experience, ultimately leading to happier patients and better adherence. Hubs can also improve the HCP experience; by providing easy access to documents, and features to improve authorizations and other tedious paperwork, hubs can reduce the workloads of HCPs and other functions in the patient journey. Taking steps which help ensure hubs become more experiential and highly personalized is the ideal route to better serve patients.

1. Safavi, K., et al. Digital adoption: Reaction or Revolution? 

https://www.accenture.com/us-en/insights/health/digital-adoption-healthcare-reaction-or-revolution

2. 75% of US Consumers Wish Their Healthcare Experiences Were More Personalized, Redpoint Global Survey Reveals. 

https://www.businesswire.com/news/home/20200218005006/en/75-of-U.S.-Consumers-Wish-Their-Healthcare-Experiences-Were-More-Personalized-Redpoint-Global-Survey-Reveals

Rohit Gupta is VP of Analytics Strategy and Transformation,

David Laros is VP of Digital Strategy, Analytics, and Insights, both at Beghou Consulting.

Methods that pharma companies can use to make the hub more personalized and experiential. 

Transforming the Patient Hub into a Hub of Patient Centricity

As many biologic drugs approach patent expiration, with 20+ biologic products experiencing loss-of-exclusivity between 2022-24, the market is seeing an increased focus on biosimilars. However, while these follow-on products have shown promise as cost-effective alternatives to their originator biologics, some could argue that they have not yet had the transformative effect that many expected. Keeping this in mind, there are a multitude of challenges that have contributed to their struggle in the market.

For one, there is market competition. The best-selling drug, Humira, now faces competition in the US after a 20-year monopoly, with as many as 10 Humira biosimilars

 that were expected to launch in 2023. These drugs are designed to be highly similar to the originator biologics in terms of safety, efficacy, and quality. As a result, there is limited differentiation among biosimilars themselves, which makes it challenging for manufacturers to establish a unique value proposition and gain a competitive edge. This can lead to a crowded and highly competitive market with little product differentiation.

Established trust and familiarity with originator biologics can also make physicians and patients hesitate to switch to biosimilars. According to research from Cardinal Health, physician attitudes and openness to biosimilars varies by specialty.

 Even where physicians are comfortable with biosimilar prescribing, the data reveal a gap between physicians’ general comfort and their willingness to switch their patients, as well as notable concerns about efficacy. When physicians have concerns about safety, efficacy, and interchangeability, this may lead to resistance or slow adoption of biosimilars, despite their proven similarity.

We cannot forget about pricing and reimbursement policies—these heavily influence the adoption and uptake of biosimilars. For example, when rheumatologists, gastroenterologists, and dermatologists who have patients eligible to use Humira biosimilars were asked which patients they are most likely to prescribe a biosimilar to, the most common response among the Humira-prescribing specialists was “existing patients for whom payers have mandated a biosimilar,” suggesting that pricing and payer reimbursement policies will drive uptake.

However, in some regions, policies may still prioritize originator biologics or offer limited incentives for healthcare providers (HCPs) to switch to biosimilars, hindering their market penetration.

The result of these market challenges means that biosimilar brands face an extra educational lift compared to novel drugs or traditional generics; they not only need to raise general brand awareness, but they also need to build trust in their efficacy and safety data with physicians that are hesitant to prescribe a less familiar type of product.

However, currently, there is no singular/dominant source where physicians are learning about biosimilar availability, none are embedded in the care journey, and most rely on circumstance or resource-intensive channels.

 determined that physicians learn about new biosimilars via:

Choosing the right digital engagement strategies that align with the needs of physicians and patients at different stages of the care journey can significantly increase reach and awareness for biosimilar brands. One of the most powerful channels for targeted brand messaging is the electronic health record (EHR), which allows biosimilar brands to provide value at every stage of the patient journey, while maintaining competitive brand placement.

By understanding the EHR workflow and engaging HCPs where and when they’re making care decisions, biosimilar brands can tailor their messaging for each step in the care journey:

Focus on reinforcing clinical efficacy and safety, while building awareness of ideal patient profiles and specialty prescribing guidelines.

 Alert HCPs where your biosimilar has preferred access while also placing the resources providers need to educate and communicate with patients at their fingertips, such as access to branded vouchers and saving offers.

 Provide clarity on coverage, affordability, prior authorization processes, and specialty distribution information.

Emphasize clinical evidence, supportive resources, and cost savings of your biosimilar.

Digital engagement for biosimilar marketers

Content matters, especially given potential hesitations around biosimilar prescribing. Today’s digital, point-of-care solutions allow biosimilar brands to take a cost-effective, data-driven approach to identifying and engaging providers at these key moments.

By drawing on the data available in the EHR and other sources to turn patient profile triggers (ICD-10, NDC, etc.) into prioritized national provider identifier (NPI) target lists, applying artificial intelligence (AI) to predict future patient eligibility, and factoring in real-time data on physician channel preferences, these digital solutions align specific information to specific care situations, and deliver that content where HCPs are mostly like to value it.

Recently, OptimizeRx worked with a biosimilar manufacturer to raise brand awareness among potential treating physicians with a goal of increasing patient acquisition with contextual, relevant communications delivered via the EHR. What the brand found the most interesting from the campaign is the impact the engagement had on what they classified as “biosimilar dabblers” and “biosimilar avoiders.” Other concepts learned along the way included:

Drive patient acquisition with an omnichannel approach.

 Biosimilar brands need to meet physicians where they are—it’s not enough to rely on just one or two mainstay channels to deliver critical information. Omnichannel HCP engagement enables brands to provide a seamless and cohesive experience across all touchpoints where an HCP interacts with a pharma brand, whether digital or in-person. By leveraging real-time data and the latest data-driven omnichannel tools, biosimilar brands can ensure that their engagement campaigns aren’t just timely, but highly relevant and targeted, resulting in more effective communication with HCPs and driving patient outcomes.

 When providers don’t have a clear understanding of the best time to prescribe your brand, they can’t effectively consider it as a potential next step for a patient. By using a precision engagement methodology driven by sophisticated AI and real-world data, brand teams can predict when patients need to advance in line of therapy, and when they are likely to become brand-eligible. By analyzing the same factors used to determine clinical need for changing lines of therapy, as well as factors driven by the patients themselves, you can identify those patients and engage physicians at the relevant care milestones with timely information about the therapeutic fit and benefits of your biosimilar brand.

Deploy biosimilar brand content at an actionable time.

 The EHR is the ideal place to understand the right time to deliver a targeted message because of the visibility into a physician’s activities. Those activities are indicators for what stage a patient is at in their care. When combined with predictive AI models, EHR-based information delivery increases the probability that your messages are exactly the information that the physician needs, at exactly the time when they are treating eligible patients. This makes information more actionable and resources more effective for HCPs. For example, if a patient just switched to an insurance where your biosimilar brand is preferred, and the HCP is aware of, and able to, have this cost savings conversation with the patient, you may be able to create treatment switching from the biologic reference product to your biosimilar brand. 

1. Jeremias, S. Part 1: Biosimilars to Bring a Bumper Crop of Adalimumab Options. Center for Biosimilars,

https://www.centerforbiosimilars.com/view/part-1-biosimilars-to-bring-a-bumper-crop-of-adalimumab-options



2. Cardinal Health. 2023 Biosimilars Report. 

https://www.cardinalhealth.com/content/dam/corp/web/documents/Report/cardinal-health-biosimilars-report-2023.pdf

3. OptimizeRx. HCP Engagement and Awareness in the Emerging Biosimilar Landscape. March 2023. 

https://www.optimizerx.com/hubfs/23Q22190/OptimizeRx-Infographic-Biosimilars-Engagement-Landscape-062323.pdf?utm_campaign=23Q22190-BiosimilarsPromo&utm_medium=email&_hsmi=264351938&_hsenc=p2ANqtz-8IxUzPOHtcEwDtVCXbsojks_TUYl

is SVP of Marketing and Communications at OptimizeRx.

How to provide effective brand engagement in this rocky yet emerging landscape.

Navigating the Biosimilars Marketplace

Many would agree that medication adherence—whether it be pertaining to treating a rare disease or another illness—is vital to successfully improving one’s health. In fact, studies have shown that the use of a patient support program can help improve medication-taking habits in the long-term.

Matt Wolf, Cencora’s president of biopharma services, is an executive with over a decade and a half of experience working for the drug wholesaler in some capacity, whether it be alongside biopharma partners or from the healthcare provider’s perspective.

, Wolf breaks down his thoughts on what it takes to form an effective adherence strategy, and how the industry can leverage analytics and data innovation to drive positive patient outcomes.

This interview has been edited for length and clarity.

You’ve been serving in your current role as Cencora’s president of biopharma services for over a year now. What have you learned in your new position thus far, and how has your previous experience with the company better prepared you for it?

 Since I stepped into this role, I’ve had the opportunity to work more closely with our biopharma partners and dig deeper into their goals and the challenges they face. Throughout our conversations, one theme continues to emerge: pharmaceutical companies seek a partner that can help them overcome complex challenges related to the provider experience and patient journey.

Having spent the last 20-plus years working on the healthcare provider side of the business—both as a pharmacist in hospital and retail settings and then in various roles at Cencora—I am very familiar with providers’ unique needs and the value of solutions that can help them continue to deliver high-quality care, while reducing administrative burden. That experience is not only beneficial in conversations with our biopharma partners around solving for their needs, but it’s also helpful as our team works to introduce innovative solutions aimed at simplifying provider-related processes required to access patient support services and reducing potential barriers along the patient journey.

An ongoing challenge surrounding patient support is medication adherence. Generally speaking, how can wholesalers work with drug manufacturers to help ensure that patients are following their drug regimen?

Prescription abandonment and non-adherence remains a critical issue. In 2022, IQVIA data revealed that patients starting a new therapy abandoned 94 million prescriptions at pharmacies due, in part, to out-of-pocket costs.

 But cost is not the sole driver of those abandoned prescriptions; 42 million were abandoned when costs were under $10, including zero cost prescriptions.

No two patient journeys are the same. Therapy plans can be derailed by a variety of factors, so there can’t be a one-size-fits-all approach.

We believe an effective adherence strategy must also account for two critical variables that can affect a patient’s ability to start and stay on therapy: access and affordability. We work with our pharma and biotech partners to understand their specific needs and then deliver services tailored to the patient population to reduce access barriers, improve speed-to-therapy, and keep patients engaged and supported throughout the treatment journey. Just to give one example: extended time spent verifying benefits can be a crucial barrier between patients and their prescribed therapy. We use machine learning and artificial intelligence (AI) to automate and streamline the benefit verification process, enabling near real-time response, which helps to accelerate time-to-therapy.

As part of our approach, we leverage predictive analytics to better understand and identify a patient’s health-related behaviors and risk for non-adherence. We then develop personalized plans to engage and support patients throughout the journey. For example, we designed a program that incorporated a digital companion for a leading biologic manufacturer. During the first 90 days, 95% of patients self-reported completing their medication doses.

From an affordability perspective, what copay assistance solutions and patient assistance programs does Cencora offer, and how specifically are they helping patients?

When thinking about the affordability landscape, it’s really important to consider market dynamics—particularly the payer and policy environment and any potential impact on programs and patient access. Recently, a federal judge struck down a rule

 that allowed health insurers to exclude drug manufacturer copay assistance toward a beneficiary’s out-of-pocket costs. By working closely with teams across Cencora, including our policy and reimbursement strategies, we're able to help our partners anticipate and prepare for changes—including the potential impact to their brand and the patients they serve—and then work with them to devise new strategies or make necessary adjustments to their programs.

As the specialty pharmaceutical market grows, we continue to elevate our copay solutions and patient assistance program services to meet our partners’ evolving needs and deliver support designed to reduce patients’ financial burdens. For example, by adding FirstView Financial’s payment processing services to our portfolio of solutions, we are able to deliver more integrated, turnkey affordability services—from our traditional strengths of enrollment and eligibility determination through to advanced claims administration capabilities, funds management and omnichannel payments—to help patients start prescribed therapy sooner and stay adherent longer.

We also partner with biopharma companies to design and execute effective and compliant patient assistance programs tailored to the product and patient needs. We leverage advanced technology to simplify and streamline the enrollment process for providers and patients, helping to accelerate patient access to therapies. Through our dedicated free goods pharmacy, we support more than one million shipments of pharmaceutical products annually, serving more than 260,000 patients each year.

How do you envision the future of data-powered patient adherence shaping out, especially in regard to leveraging analytics and data innovation to drive positive patient outcomes?

 We know the patient’s treatment journey can be incredibly complex. There is tremendous value in analytics or digital solutions that can provide more visibility into the journey, enable teams to predict a patient’s risk of non-adherence more accurately, and support the development of personalized engagement plans that drive behavioral change. We have already witnessed the potential benefit: we delivered an AI-driven adherence program to a biologic manufacturer who wanted to improve first-fill rates. Among patients with higher adherence risk, we saw an 8% increase in treatment initiation within 90 days. Meanwhile, nearly 25% of dormant patients started treatment after prioritized outreach.

Our team of data scientists continue to pilot new approaches to visualize the complexity of the patient journey and predict outcomes. We are also using additional datasets to enhance our insights into the patient experience, providing us with an opportunity to understand what is influencing behavior so we can adjust the program design to help those patients.

Through investments in technology solutions, automation, and analytics, we’re better positioned to deliver solutions tailored to our partners’ unique needs. Whether it’s leveraging technology to rapidly scale a program or using analytics and data to help our partners anticipate changes and plan effective program adjustments, our focus remains on delivering patient-centered support that helps drive positive outcomes for our partners and the patients they serve.

1. Fendrick, A.M.; Brixner, D.; Rubin, D.T.; Mease, P.; Liu, H.; Davis, M.; Mittal. M. Sustained Long-Term Benefits of Patient Support Program Participation in Immune-Mediated Diseases: Improved Medication-Taking Behavior and Lower Risk of a Hospital Visit. 

https://www.jmcp.org/doi/full/10.18553/jmcp.2021.20560

2. IQVIA. The Use of Medicines in the US 2023: Usage and Spending Trends and Outlook to 2027. April 2023. 

https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/the-use-of-medicines-in-the-us-2023/the-use-of-medicines-in-the-us-2023.pdf

HIV and Hepatitis Policy Institute v. United States Department of Health and Human Services et al

https://hivhep.org/wp-content/uploads/2023/09/HIV-Hepatitis-Policy-Institute-v.-HHS-DDC-opinion.pdf

Matt Wolf, president of biopharma services, Cencora, discusses the importance of partnership in helping to combat prescription drug abandonment and non-adherence.

An Outlook on Data-Powered Patient Support

Pharmaceutical companies operate in a complex ecosystem with intricate supply chains, strict regulations, and high expectations for quality, timeliness, and trust. A single mistake, bad actor, or contaminated shipment can jeopardize years of research, substantial investments, and the availability of critical treatments, so it may come as no surprise that the industry has traditionally been adept with managing risks.

Take the pandemic for example. While many products were out-of-stock for long periods of time, pharma businesses generally kept their supply chains running, leveraging medication reserves, new delivery methods, and even their own capital to deliver medicines to markets worldwide.

Fast forward to today. Companies in this sector continue to navigate supply-chain disruptions and drug shortages, but that’s not all they’re contending with. Their suppliers source raw materials from around the world, ship resources across an interconnected supply chain, and deliver ingredients within strict service-level agreements (SLAs) for quality and timeliness. When managing these suppliers (of which there could be up to tens of thousands), these businesses must regularly assess ongoing third-party risks, such as anti-bribery and anti-corruption (ABAC), data privacy, pharmacovigilance, and more. Emerging regulatory requirements also necessitate standardized reporting processes with audit trails for both pharmaceutical companies and their third-party networks.

Pharma historically handles these types of risk and disruption well. The key to its success? A mature and robust enterprise risk management program where visibility into third-party risks is unified so that multiple teams can identify and mitigate the exact areas of threat and liability. This includes regularly re-evaluating supplier risks across various domains (i.e., cybersecurity, attribute-based access control, data privacy, etc.), and placing increased focus on the sustainable operation of their entire supply chain.

Additionally, they rely on vital partnerships to validate their drug claims, conduct clinical trials, gain government approvals, and introduce new drugs to healthcare institutions. Third-party vetting, due diligence, and active monitoring are essential to ensure ethical and responsible conduct in these partnerships.

This industry has demonstrated impressive resilience in spite of constant market challenges, resulting in invaluable lessons learned along the way. For effective risk mitigation, all industries can take a page out of the pharma playbook:

 Take a comprehensive view of their third-party risk management strategy first and select a software platform that can support the majority of them with consistency.

 Implement one or two of the most critical programs, because third-party risks and regulations will change along with compliance requirements.

 Expand quickly through a series of implementations that incrementally add new risk domains as needed.

Despite today’s drug shortages and the onslaught of emerging third-party risks, pharma will continue to solve healthcare challenges that might arise. Pharmaceutical companies know that supply chain disruptions happen, but they are putting the right procedures in place for mitigation: a robust, scalable, and agile third-party risk management program that can support the necessary processes and protocols required to ensure supply chains go unbroken, allowing them to instead focus on delivering quality of life.

Dean Alms is Chief Product Officer, Aravo.

What stands between pharma and other industries when it comes to 
remaining vigilant?

Prescribing  Resilience: Third-Party Risks and Pharma

Real-world evidence (RWE) plays an essential—and increasingly viable and visible—role in enabling evidence-based medicine. Such data-driven insights, developed after a therapy has already entered the market, help to address critical clinical and safety questions that arise between the end of the randomized clinical trial (RCT) and longer-term use of the drug in day-to-day clinical practice. Evolving regulatory precedents and frameworks that signal increased receptivity among regulators are creating momentum for pharmaceutical companies to use RWE-based initiatives to drive both clinical and financial objectives and, where possible, demonstrate competitive advantage for their products.

Analyzing real-world data (RWD) from a variety of sources—including electronic health records (EHR), claims and pharmacy data, wearable monitoring devices, patient and product registries, patient-reported outcomes (PROs), and more—helps drug manufacturers to validate how a treatment (prescribed on- and off-label) performs in patients who are decidedly more heterogeneous than those who participated in the RCT.

Scientifically validated RWE findings are able to demonstrate the safety and efficacy of the drug in patient subgroups that did not participate in the underlying trial, especially those with comorbidities; provide evidence that supports different dosing strategies or methods of drug administration; validate that the drug provides superior comparative effectiveness against a competitor product or the standard of care; verify that the therapy improves quality-of-life for patients; and articulate the overall value or competitive advantages.

Outcomes such as drug adherence, hospitalizations, physician visits, and total costs of care are much more easily collected through administrative claims data sources rather than through randomized trials, yet they still represent important information for payer decision-making, notes Nicole Ferko, SVP and general manager, value and evidence for Eversana.

To date, the most commonly explored use cases for RWE-based efforts include oncology, precision medicine and niche indications, and orphan drugs for rare diseases. "Typically, the approval of these therapies within these indications is based on small clinical trial sample sizes (sometimes single arm and small patient numbers) and so it is difficult to make an accurate judgment of how representative the data is in relation to how the product will perform over time in a real-world patient population,” says Mike D’Ambrosio, VP, head of RWE solutions for Syneos Health, adding: “It is not uncommon for pricing/reimbursement discussions and future agreements in these situations to come with a commitment to demonstrate comparable effectiveness/value in a real-world patient population.” Today, health technology assessment (HTA) bodies are increasingly asking for RWE to help address uncertainty

 and develop more longitudinal data that verifies the durability of the clinical response over time. Today, health technology assessment (HTA) bodies are increasingly asking for RWE to help address uncertainty

 and develop more longitudinal data that verifies the durability of the clinical response over time.

This makes sense because it is not uncommon for drugs approved in these 

narrow indications to be used broadly off-label, where there may be no other therapeutic alternative. “Such high-cost specialty therapies have the most to gain when stakeholders can study RWD related to how the therapy is faring among diverse patients who were explicitly excluded from the underlying trial,” notes John Doyle, DrPH, formerly group vice president at Exponent, now president, consulting at Fortrea, and adjunct assistant professor at Columbia University’s Mailman School of Public Health.

Staggered approvals also provide opportunities for RWE insights to be developed. For instance, “in oncology in particular, on multiple occasions, drugs that have been approved initially in the US provide opportunities for other countries to learn from ongoing RWD collected in the US and generate evidence that can help to answer the health organization’s questions in those countries,” notes Javier Jimenez, chief medical officer, Flatiron Health.

How drugmakers can better harness real-world evidence to drive their clinical and commercial objectives, while also providing greater clarity for healthcare providers and improved access to therapy for the patients they serve.

Pharmaceutical Commerce - December 2023