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Pharmaceutical Commerce - April 2024 Issue (PDF)

, which continues the trend of touching on a core aspect of supply chain and logistics, patient services, and trade and channel. In this case, our cover focus is on the pharma cold chain and temperature-controlled monitoring space.

There continue to be endless developments within the cold chain sector, and in April’s 

, Editor Emeritus Nick Basta dives headfirst into the latest technology surrounding temperature-sensitive transport of medicines, including the daily challenges in end-to-end visibility and sustainability that are dealt with. Alex Guite, SVP and GM at World Courier, a division of Cencora, explains to Basta that the preservation of the carbon footprint has now become a necessity in cold chain transport and storage, adding that “a couple years ago, sustainability measures were a ‘nice to have’ part of client conversations; now they are table stakes.”

Cold chain containers only represent one link—or step—in the pharmaceutical supply chain; patients, after all, are ultimately the ones who receive the medications that have endured such calamities as blizzards or hurricanes, or the various other disruptive forces at play throughout the course of a year. In a sit-down 

 with Editor Nicholas Saraceno, Kim Plesnarski, Syneos Health’s VP of market access and patient services solutions, tackles the many diverse issues impacted, including—further down the chain—patient adherence and the tools necessary today to help boost compliance to drug treatments and regimens. Notably, she advises that a “one-size-fits-all” approach to patient education and support should be avoided.

Turning to perspectives on the healthcare policy and access front, Michael Grosberg, VP of product management at Model N, presents an 

 of how current and future legislation might impact the role of pharmacy benefit managers, also known as PBMs. This includes a look at the present-day, 2024 PBM model—one, says Grosberg, designed to encourage payers to cover more expensive drugs because it's more economical for them.

, Bill Roth of IntegriChain pens the third installment of his “Who Moved My Prescription?” series. The newest entry offers an analysis of the issues pertaining to retail pharmacy and how to address them.

These highlighted articles only begin to scratch the surface of our coverage this month; we hope you enjoy perusing all of our content offerings at your leisure. Thanks for reading.

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

An exploration of the new demands in cold-chain visibility and sustainability—and the resulting tech-driven efforts to address them—leads off our coverage in this month's issue.

Cold Chain, PBMs, and More

It was very tempting this month to title my "From the Editor" column something along the lines of “Bonjour, France!” but in an effort to avoid being cliché, we wisely decided against it. As you can tell, I am ecstatic to be heading to France later this month for LogiPharma Europe, where, just like last year, 

This will be the second consecutive year that LogiPharma Europe is being held at Centre des Congrès de Lyon, named after the city in France where it is located, Lyon. It’s been hailed a “mini-Paris” from various rideshare drivers I’ve encountered, while being the capital city in France’s Auvergne-Rhône-Alpes region, and the nation’s third-largest city to only Paris and Marseille.

It’s safe to say that history is deeply ingrained in this city, just as the pharmaceutical supply chain is rooted into most of the attendees’ professional lives.

Speaking of which, although difficult to pick just one, I am very much looking forward to attending the opening day's keynote panel discussion on how to mitigate exposure to supply chain risk and improve disruption readiness while driving efficiency and sustainability goals. Lisa Callinan, PwC’s supply chain strategy partner, is going to be moderating the chat, and will be joined by Erica Olson, Gilead Sciences’ SVP of global supply chain; Igor Shtainberg, Teva’s VP of supply chain international markets; and Niklas Adamsson, Envirotainer’s chief operating officer, who I had the chance to interview as part of our conference coverage of last year’s show.

I would also like to tip my hat to Will Robinson, the commercial director of LogiPharma, who has now officially put together the conference agenda a whopping seven times. In fact, when it comes to structuring said agenda, in an article appearing exclusively in our publication in February, he described the process involved.

“The first thing I’m looking for are the topics with universal reach. When everybody from manager level up to C-suite is mentioning a certain subject, you can pretty much guarantee that those themes will draw the big crowds to the plenary sessions in the main hall. At the same time, though, I’m also looking for those topics which might be mentioned less, but make up for quantity with the importance attached to them. It is from these topics that I will draw up the tracks.”

Without further ado, I wish you all a wonderful conference, which will officially take place April 16-18, and please say hello if you see me roaming the halls.

Nicholas Saraceno is Pharmaceutical Commerce's Editor. He can be reached at nsaraceno@mjhlifesciences.com.

We'll be back in Lyon, France, this month to capture the latest insights and advances in pharma logistics—as leaders seek to build the supply chains of the future.   

Looking Ahead to LogiPharma Europe

These past few months have been action-packed in terms of travel for the 

team, but I wouldn’t change a second of it. Riding the momentum off of Trade & Channel Strategies late last year, we since returned recently to Philadelphia, this time for Access USA, a conference serving as a resource so valuable that it’s actually comprised of three components: Patient Assistance & Access Programs (PAP); Hubs and Specialty Models East (Hubs East); and the Rare Disease Summit.

’s coverage aligns most closely with PAP and Hubs East, we decided to dedicate our efforts to those two areas. Across the pair, a plethora of subject matters were covered, including but not limited to:

A state of the biopharmaceutical industry, in terms of healthcare coverage and access.

A current look at patient access and affordability.

The use of artificial intelligence to boost medication adherence.

Leveraging digital hubs to improve retail and specialty-lite access.

Collaborating for patient assistance excellence.

A first-hand account of the value in patient assistance.

These sessions—along with the others that our team covered—certainly left a lasting impression, but the seminar that set the tone for the rest of the show was “State of the Industry—The Changing Landscape of Healthcare Coverage and Access,” featuring Corey Ford, Cencora’s VP of reimbursement and policy insights.

The main purpose of the Access USA general session was to provide insight on the changing landscape (keeping regulations and insurance coverage in mind), while further examining potential policies that can disrupt the patient access and affordability space. This includes the Inflation Reduction Act (IRA) and its included Medicare Part D reforms, inflationary caps, Medicare negotiation, biosimilars, and Affordable Care Act (ACA) subsidies.

Such insights were captured in the wide array of video interviews that we conducted on-site. We had the privilege of speaking with Amy Niles of the PAN Foundation; Michael Galarraga of OutCare Health; Adrianna Nava, PhD, of the National Association of Hispanic Nurses (NAHN); Monique French of Rx4good; Tiara Green of Accessia Health; and John Hoffman of Advocate for Success, LLC.

To view and read all the coverage, please visit 

pharmaceuticalcommerce.com/latest-conference

Pharma Commerce makes a return trip to Philly for insights on the latest approaches in patient assistance and adherence.

An 'Access' Double-Take: Fresh Views on PAPs and Patient Hubs

Addressing the needs of the life sciences industry for reliable, cost-effective cold chain solutions remains fertile ground for developing new technologies. Even after a decade or so of advances in insulation, refrigeration techniques, and packaging innovation, new challenges are arising: chief among these are better visibility (via data generation and transmission) of real-time actions in the transportation process; the need for comprehensive capability of ultra-low temperatures for cell and gene therapies (CGTs) and vaccines; and an emphasis on sustainable environmental practices in transportation and materials management.

Market data quantifies the growing emphasis on pharma cold chain practices. The 2024 IQVIA Global Use of Medicines report projects a 2.3% compound annual growth rate (CAGR) for 2024-28. By contrast, biopharma market growth is estimated at 15.2% CAGR by Emergen Research; multiple other market surveys are in the double-digit range. (Nearly all biopharma products are cold chain ones.) A Visiongain report from January measured the global pharma logistics market (all pharma, not just cold chain) at $93.3 billion in 2024 and forecasts a 7.5% growth rate through 2034. A ResearchandMarkets.com report from 2023 projects a 5.26% CAGR for global pharma cold-chain logistics specifically and predicts a $27.7-billion market by 2028. Looking at the CGT market exclusively, a December report from InsightAce Analytics says the current “supply chain/logistics” CGT market (which would include patient identification through to biobanking and hospital administration) was worth $1.23 billion in 2022, rising to $3.12 billion by 2031—an 11.2% CAGR.

The year 2024 is proving to be a pivotal one for pharma’s evolution. Last year saw the end of US exclusivity for Humira, AbbVie’s blockbuster biologic that ended 2022 with a record-breaking $21 billion in annual sales (2023 sales had slumped to $14.4 billion)—more or less signaling the emergence of biosimilars in the world market. There are now 45 biosimilars approved in the US, competing against 14 originator products (most of which are monoclonal antibodies). An additional 20 originator products “have biosimilars approved or in clinical development in the US,” according to a 2023 report from IQVIA. That source also notes that “the introduction of biosimilars frequently leads to higher utilization of the molecule, as lower costs offer increased access to patients.”

Biosimilar distribution is expected to slide smoothly into existing cold chain practices, notes Alex Guite, SVP and GM at World Courier, the Cencora division that handles clinical trial logistics and related services. “We’ve been working all along the way to approval of biosimilars, in Europe and the US; for us, commercialization will be ‘business as usual.’”

A somewhat mixed message arises from the CGT segment. The CGT sector experienced some cutbacks, with companies laying off employees and new ventures finding it harder to get financing (a booming stock market in early 2024 is already changing that picture). Still, the Alliance for Regenerative Medicine (which covers tissue engineering as well as CGT) counted 1,894 clinical trials going on globally (down from 2,022 trials in 2022) and the list of CGTs going from research projects to commercialization continues to grow. The vast majority of CGT work involves not only the cold chain, but the lowest, cryogenic temperatures that necessitate liquid nitrogen storage and some shipping.

“We weren’t happy with flat revenue in 2023, but you have to recognize that this is still a nascent industry, and it will not have straight-line growth from year to year,” says Jerrell Shelton, CEO of Cryoport, which provides comprehensive services to the sector. “We’re in the early stages of how the practice of medicine is changing,” he adds, noting the recent approvals of therapies for Duchenne muscular dystrophy and sickle-cell disease.

Meanwhile, events are hardly standing still in the rest of pharma. The takeup of the relatively new GLP-1 drugs (which require 2-8°C handling) reached a crescendo during 2023 as their utility as a weight-loss drug became known. At the beginning of this year, Eli Lilly announced the “Lilly Direct” program to self-distribute Zepbound, its weight-loss GLP-1 version. Earlier GLP-1 versions, including that of Novo Nordisk, were intended for diabetes patients, which itself is a huge market. Research is going on to expand GLP-1 drugs for cardiovascular and even anti-addiction therapies. Just about any form of this drug requires cold-chain delivery; Lilly packages its drug in an injectable pen that needs to be kept refrigerated. There are other direct-to-patient drug-delivery practices (usually by specialty pharmacies using mail-order), but the sky-is-the-limit aspect of these drugs will expand the cold chain market.

Mostly as a result of the new vaccines that addressed the COVID-19 pandemic, but also because of the growth of the CGT sector, there are a growing number of options for “frozen” (0 to -20°C), “deep frozen” (-20 to -80°C ) and cryogenic (below -80°C ) containers for transporting biological substances. In 2023, Tower Cold Chain announced the Evolution 1600 Universal Shipper Pallet, for air or ground movement (see below). The “universal” moniker refers to its range of cooling options, from ambient to deep frozen, based on the choices of phase-change materials (PCMs) or dry ice. 

Similarly, CSafe, a longtime supplier of active (powered) and passive shipping containers, announced new -20°C capability for its active RKN pallet shipper. The company also offers parcel-size passive containers for the same temperature range.

Meanwhile, Cryoport, which specializes in deep-frozen and cryogenic processes, is about to announce its Cryosphere, a cryogenic shipping device that gets around the age-old problem of conventional dewars that can tip over, affecting their cooling performance. The company says this shipper’s design allows for any orientation without affecting performance.

Another new packaging solution that was recently launched is Cryoport’s Elite -80°C Ultra Cold Shipper. It is targeted to support those gene therapies that are not able to be stored and shipped in a cryogenic environment. The Elite -80°C is available in two sizes, far exceeds standard industry hold times, and meets ISO standard 21973 for advanced therapies.

Having appropriate containers is one part of a successful shipment; the other is to have a network of services and providers that keep the shipment in compliance. World Courier announced recently three more “transport stations” (facilities to coordinate shipments) in Denver, Indianapolis, and San Diego, bringing the total to 17 in the US alone. Some of these stations are equipped with liquid nitrogen tanks and charging capabilities. “As more complex and sensitive pharmaceutical products enter clinical development, the demand for highly specialized logistics continues to increase,” comments Matt Virgilio, a regional VP for World Courier.

The World Courier transport-station announcement aligns closely with another unveiling the company made at the same time: a real-time location management (RTLM) solution, powered by technology from Controlant, a software developer. This will be paired with World Courier’s existing transport and inventory management systems spanning the company’s global network. “Visibility” is a catchword often mentioned in supply chain circles—there are lots of claims, but the reality is that supply chains often involve handoffs to multiple providers, and getting comprehensive data coverage is difficult. “The difference with RTLM is that we are offering it throughout our network as a standard service,” says World Courier's Guite.

World Courier is by no means alone in this effort. Not only are the major international logistics companies—DHL, Kuehne+Nagel, UPS, and others—in the game, but also many of the packaging companies and the electronic condition-monitoring providers as well. There are also collaborations, like World Courier/Controlant, coming together: Elpro, a leading provider of condition monitoring in labs as well as in transit, has partnered with Tower Cold Chain for real-time tracking and condition-monitoring communication. Envirotainer, a leading provider of air-freight cold-chain containers, has integrated what it calls “live monitoring” into its Releye pallet containers, and can further link that to a control-tower service that provides ongoing review of operating conditions.

The latest entry into this visibility scramble is AeroSafe Global, which provides reusable parcels and larger containers to pharma. The company has just announced the Cold Chain Intel Service (CCIS), which builds on its existing control tower services with enhanced, artificial intelligence (AI)-based predictive control. According to Jay McHarg, CEO, “With CCIS, a customer can easily access shipment location at any time, along with the probability of a delivery interruption and thermal battery status of shipment.” He adds that this kind of detailed, real-time information is critical for the safe and effective delivery of therapeutics, particularly as weather conditions become more extreme across the globe.

Although AeroSafe Global calls this service a “core differentiator” in the market, many other organizations are pairing supply chain software with AI/machine learning (ML) techniques, and claiming better predictive capabilities as a result. Last November, for example, Cryoport acquired Tec4Med GmbH, a German software developer that “provides next-generation pharmaceutical supply chain visibility by integrating condition monitoring, cloud, and AI solutions.” Cryoport’s Shelton says that the acquisition will complement AI/ML techniques the company is already using for its CGT clients.

Meanwhile, global logistics giant DHL is pushing forward with a variety of advanced software projects, including for digital twinning (see below), the process of building software representations of the physical actions of its vehicles, warehouses, and delivery processes. With a digital twin, it’s possible to simulate upcoming shipments and analyze risk.

“End-to-end visibility of cold chain shipments has never been more attainable than it is right now,” says Adam Tetz, a former marketing director at Peli BioThermal, a packaging provider, and now an industry consultant at Bright Sun Marketing. “The physical design for shipping containers now often includes accommodation for a range of form factors for internet of things (IoT) devices to track the shipment as shippers travel around the world via GPS, GMS, Bluetooth, RFID, dynamic QR code, etc. Since the underlying technologies are mature and the combined solutions of hardware and software are customized for cold chain pharma logistics, the use of these solutions will accelerate quickly this year.”

“A couple years ago, sustainability measures were a ‘nice-to-have’ part of client conversations; now they are table stakes,” says World Courier’s Guite. Historically, in a pharma cold-chain context, sustainability usually translated into offering reusable packaging, thus avoiding landfill costs, and doing what one could for reducing transportation emissions (such as shifting from air to ocean freight for international deliveries). For the most part, air freight, pallet-size containers are inherently reusable, and are typically leased rather than sold—but even there, an emphasis has been placed on lighter container weights and better volume utilization. Over time, packaging providers have made a compelling case that higher-performance (and more expensive) reusable containers could, with the right reverse logistics processes, result in lower overall costs.

“The global service networks for reusable and rental products have some major gaps in ability to service these thermal shippers worldwide,” notes Bright Sun Marketing’s Tetz. “From company to company, there are strong regional disparities; even country by country and airport by airport.” He expects these gaps to be filled with “universally robust” networks to meet pharma demands.

AeroSafe’s McHarg is bullish on his company’s capabilities for reusable containers—something the company has been touting for several years as a “cold-chain-as-a service” approach. “Once the total cost of owners is evaluated, it is easy to see the value and cost savings with a well-managed reuse program,” he says. "The key to the success of the AeroSafe Global Reuse Program (see below) is our ability to achieve a return rate of over 98%, the highest in the industry. As emphasis on environmental sustainability continues to increase, with many companies setting ambitious sustainability goals, reusable solutions will not only be environmentally responsible but also a strategic choice to enhance patient experiences and improve outcomes.”

Some insight into industry’s current outlook on sustainability initiatives comes from a survey conducted in the fall by Worldwide Business Research, sponsors of the annual LogiPharma meetings. About 150 industry executives (mostly in Europe) were polled by the company; 85% of them said that their current supply chain practices are “somewhat sustainable.” A slight majority (55%) said that their organizations have “partially concrete goals including few defined measurable metrics.” And—watchword to service providers—51% of respondents "expect our [supply chain] partner to set auditable targets and measure progress against them” in the future.

Finally, when asked “When do you expect thermal packaging decisions to be impacted by sustainability targets?” 65% said the next 3-4 years, while 33% said the next 1-2 years. While this survey was mostly focused on packaging materials and design technology (a corporate sponsor of the survey was SkyCell AG, a provider of reusable freight containers), the overall direction seems to be clear: sustainability is a rising priority.

A mostly-US survey, just published by the Healthcare Distribution Alliance, finds similar conclusions. Of four measured criteria (on a 1-to-10 scale) of “current challenges,” dealing with sustainability was the lowest-ranked:

The study, “The Future of US Pharmaceutical Cold Chain Distribution,” noting the increased pace of cold-chain pharma introductions, recommends that the industry makes infrastructure investment in storage, packaging technology, and enhanced analytics to prepare for the coming surge.

— Nicholas Basta is Editor Emeritus and Founder of Pharmaceutical Commerce.

Although time has welcomed novel advances in the space, new challenges pertaining to data and the physical technology, along with visibility and sustainability, are emerging.

The Pharma Cold Chain: More Visible, More Sustainable—and Colder

Healthcare journeys vary widely from patient to patient, impacted by unique factors such as age, gender, severity of symptoms, access to specialists, insurance coverage, and more. Amid these complexities, adherence to prescribed therapies emerges as a linchpin for achieving positive health outcomes. However, the healthcare industry continually grapples with persistently low adherence rates, posing a significant challenge to patients’ well-being.

Addressing low adherence rates demands a holistic approach that integrates patient-centric strategies and innovative technologies across the entire patient journey. In order to be successful, manufacturers must embrace proactive measures to eliminate barriers and empower patients to navigate their own healthcare journeys.

By providing accessible, personalized, and technology-driven solutions such as telehealth services, electronic benefit verification (eBV) tools, and mobile applications that deliver real-time reminders, manufacturers have the opportunity to foster greater adherence and promote patient autonomy.

Furthermore, advancements such as predictive analytics and machine learning offer invaluable insights into patient behavior, enabling tailored interventions to support adherence. By analyzing historical data and identifying patterns, manufacturers can anticipate patients’ needs and deliver targeted support, ensuring timely access to care.

Expanding access to healthcare services through telehealth and channel management strategies also can increase adherence rates by enabling patients to access care remotely, securing seamless medication distribution and minimizing supply chain disruptions.

Transparency in pricing and cost verification is also paramount when addressing affordability barriers. Price transparency and a timely, streamlined benefits verification processes can allow patients to make informed decisions about their healthcare, alleviate some of the burden of financial stress, and result in accelerated access to medications.

Finding the right solutions to drive better access for patients, improve affordability, and drive adherence is challenging. In a sea of vendors, here’s what should manufacturers look for:

 There are a lot of great companies with amazing platforms, but a common challenge we see with vendors is, while their tech is strong, their intricate knowledge of the life sciences or pharmaceutical industry, specifically around commercialization, may be limited. Find partners who have the technological backbone but also have helped—through their technologies—bring therapies to market to help patients.

2. Knowledgeable in direct-to-care models:

 A growing facet of the life sciences industry are models that offer connectivity directly to patients. Can your partner combine advertising, telehealth, pharmacy billing, benefit verification, reimbursement, and dispensing in one model that can empower patients to obtain faster access to providers and their prescribed therapies, while also benefiting from the latest affordability automation that provides price transparency? If so, it’s a model worth looking at that can reap tremendous rewards.

 A buzzword for years in the industry has been omnichannel—delivering connections across multiple channels (email, social media, website) to multiple audiences (patients, physicians) in an orchestrated manner. Most companies have built platforms to connect with clinicians, but will that be enough to produce a successful connection? Make sure you consider all options.

4. Embracing AI and innovation at every step:

 Technology is important, as it’s the backbone of what we do. But you also need a partner that embraces new ways of thinking and innovative solutions that are quickly evolving. Artificial intelligence, machine learning, and similar technologies are changing how we can stay connected and interact with patients. They are driving more efficiencies than ever before. Yet they also must be utilized carefully in the highly regulated pharmaceutical industry.

Manufacturers that embrace the future of technological innovation, lean on trusted partners with a proven record of delivering, and remain relentlessly focused on the needs of patients are the ones that will rise to the top. And that’s how we as an industry can continue to make an impact.

Maria Kirsch is President of Patient Services at EVERSANA.

Why manufacturers should leverage technology to address low adherence rates.


The Power of Patient Adherence Tools to Improve the Patient Journey

Many would agree that our inclination toward picking a career is often inspired by some form of epiphany—a realization that a said role is “meant to be.” This is true perhaps even more so in the healthcare sector, where an experience has either directly impacted a person individually, or affected a friend or loved one.

Kim Plesnarski, vice president of market access and patient services solutions at Syneos Health, has worked with the biopharma clinical and commercial solutions organization for nearly nine years, but her career in the patient access and reimbursement sector dates back beyond that.

 to share her muse for pursuing her passion, the formula for an effective patient support plan, and even provides a detailed list of “do's and don’ts” when it comes to patient adherence.

This interview has been edited for length and clarity.

 Your career in the patient services space alone spans more than a decade. Could you describe a “lightbulb moment” that encouraged you to pursue a position in this field?

For me, it was a dealing with our healthcare system as a caregiver. To sum it up, it is complicated. In-network, out-of-network, covered, covered with restrictions—it is enough to make your head spin while you are already dealing with the prohibitive cost and stress of battling an illness. I think everyone has had this shared experience. This brought me into marketing where I learned more. Once there, I understood the healthcare landscape better, and then saw it happening to patients trying to get on a brand I supported. Unbelievably, that was our biggest challenge. Once I saw this, it made me want to continue to learn more, challenge the status quo, and do what I can to make it better. Having great medicine does not mean a thing if it does not get to the people that truly need it. That is what got me into patient support and what keeps me here.

From a macro level, what challenges are companies trying to tackle when it comes to patient support growth in retail? Having a lower price point no longer mean that products are easy to access.

There are two big shifts happening right now, and our primary care providers and staff are right in the middle of it. The first is that retail products now face payer challenges like prior authorization or step edits. This means the amount of complexity and paperwork has gone up even for low-cost products. The second is specialty products/biologics are now replacing a lot of small-molecule products. There will continue to be a shift here. The impact is our primary care providers are prescribing these and are not set up to deal with the level and complexity of prior authorization, patient education on how to administer, and helping patients navigate the prohibitive cost. Manufacturers will need to be able to provide much-needed support to these patients to fill a gap. To do it, they need to think about economies of scale, efficiency, and modern engagement tactics to reach all patient types.

 As you know, there has been a significant rise in the number of biologics/specialty products in primary care, which means that there is a demand for patient support for services in this niche space. What advice can you offer customers, especially with healthcare providers (HCPs) often having limited time to interact with patients?

You can no longer rely on a large sales force and free trials to drive demand and volume. I would say to my partners to re-think the right mix of resources and get to your root problems. In order to get things right, start with how you will create access and make it easier for patients versus focusing on driving volume at the start. The right commercial plan now must first consider market access coverage, patient support, and then a strategic sales plan that considers these market dynamics. Your patient support plan must be sustainable and scalable, and you must be thinking about how you use digital and AI tactics ethically while keeping the patient at the center. My last piece of advice is finding the right partners for technology. Being that technology is advancing and rapidly changing, it is best to partner so you can focus on strategy versus technology investment and development.

What tools are necessary in order for a patient to successfully adhere to his or her medication regimen?

You must address behaviors that may be preventing patients from starting or staying on the medication. This means a customized support journey that lets the patient take more ownership and shifting away from a “one-size fits-all” approach to education and support. It also means evolving your support over your brand lifecycle based on data and insights, as well as addressing the changing market and environment your patients are navigating.

 Looking ahead to the future, if you had to craft a patient adherence guide on “do’s and don’ts” that helps avoid past mistakes, what would you include on that list and why?

Throw out the old way of thinking about retail.

 Consider what barriers prevent patients from starting and staying on a therapy, as this will help you build the optimal strategy and mix of deployed resources. Demand means nothing if your patients cannot access the medication.

 Technology is rapidly changing, so finding the right partner can ensure you can quickly meet the needs of your patients and engage with them the way they want and need.

Field teams, like HCPs, are navigating more complexity. Make sure they know about your programs and how to explain them. Excellent product support does not work if there is low awareness and enrollment.

Create a “one-size fits-all” solution.

Make sure your programs are flexible, scalable, and modern. Programs should evolve over your product lifecycle and change with data-driven insights and adapt to the current market landscape.

 It may be tempting to say cost is an issue and change your copay program, but it could be that your patients simply do not know about your program due to HCPs not having time to educate or that the patients do not trust the healthcare system. Take time to understand and address access and adherence problems holistically. You may need to solve a problem at the HCP and staff level or address the patient mindset to better serve your patient population.

 It is important to strike the right balance of technology and human touch to have an effective program and one that your patients will want to engage with. Make sure you assign and cultivate the right talent for your programs—they are the “face” of your brand.

Syneos Health's Kim Plesnarski uncovers the key issues that customers are currently trying to address, including the retail shift from small-molecule products to biologics. 

Tackling Patient-Related Challenges Along the Pharma Supply Chain

Step therapy, also known as “fail first,” is a tool used by health plans to control spending on patients’ medications. And while it can be an important tool to contain the costs of prescription drugs, in some circumstances, it has negative impacts on the patients themselves. This includes delayed access to the most effective treatment, severe side effects, and irreversible disease progression.

Currently, when a physician prescribes a particular drug treatment for a patient, the patient’s insurance company may require them to try different medications and treatments, and “fail first” on those before they can access the drug originally prescribed by their physician. This protocol is known as step therapy and may ignore a patient’s unique circumstances and medical history. That means patients may have to use drugs that previously failed to address their medical issue, or—due to their unique conditions—could have dangerous side effects.

A recent national poll from the PAN Foundation finds that most adults (55%) who have been required to “fail first” say the policy delayed their access to the medication their healthcare provider (HCP) originally prescribed by up to 11 weeks. Other findings include:

1 in 6 (16%) adults say their HCP has required them to “fail first” before authorizing drugs prescribed by their HCP.

The majority (59%) of adults who have been required to “fail first” say they appealed their health insurance provider’s request.

1 in 5 adults who were required to “fail first” say they had to visit the emergency room (21%) or be admitted to the hospital (20%) because of the policy.

These polling results reinforce the fact that step therapy harms patients by delaying care. Because when patients are prescribed medication by their provider, they shouldn’t have to wait weeks or months to access that treatment.

Current policy landscape and call to action

While most states in the US have passed laws that address problems with step therapy, federal legislation is still needed. This will help create more transparency and ensure that more patients are protected, including those with employer-based health insurance plans regulated by the US Department of Labor.

That’s why it’s time for Congress to pass the Safe Step Act, a bill that would amend the Employee Retirement Income Security Act (ERISA) to require an exception process for any medication step therapy protocol within a group health plan. More specifically, the bill would require insurers to implement a clear and transparent exemption process for a patient or physician to request an exception to a step therapy protocol, while calling for a group health plan to respond to an exemption request within 72 hours in all circumstances, and 24 hours if the patient’s life is at risk.

The bill would also require a group health plan to grant an exemption if an application clearly demonstrates any of the following five exception situations:

The patient has already tried and failed on the required drug.

The required drug is reasonably expected to be ineffective, and a delay of effective treatment would lead to severe or irreversible consequences.

The required drug will cause harm to the patient, meaning the treatment is contraindicated or has caused/is likely to cause an adverse reaction.

The required drug will prevent a patient from working or fulfilling “activities of daily living.”

The patient is stable on their current medication, which has been covered by their previous or current insurance plan.

The Safe Step Act is supported by hundreds of patient advocacy organizations and healthcare provider associations and has strong bipartisan support. In my opinion, it is a common-sense, patient-centric legislation that will safeguard patients from potential adverse medication consequences and ensure access to the treatment that is best for them. Let’s urge Congress to get this bill across the finish line and make it easier for patients to access the healthcare they need and deserve.

Amy Niles is chief mission officer at PAN Foundation.

Patients should not have to wait to access the medication they need.

Fail-First Policies Are Harming Patients

Affordability of healthcare and prescription drugs is a serious issue, but there is not always a “bad guy” in societal challenges. Patient affordability of drugs is important to everybody; after all, medicines on a shelf don’t do anybody any good, certainly when patients go untreated.

 Rachel Cohrs called it “Sen. Bernie Sanders’ prescription drug pricing theater,” where Merck CEO Robert Davis, Johnson & Johnson CEO Joaquin Duato, and Bristol Myers Squibb CEO Chris Boerner were grilled with the same questions that were asked in a similar congressional hearing five years ago. Subsequently, the Inflation Reduction Act (IRA) of 2022 passed, under which Medicare was authorized to negotiate drug pricing with the pharmaceutical industry. Many might be wondering, why did Sanders need a sequel?

Complaints about company profits, CEO salaries, and price differences with other countries were the highlight of the event. With respect to company profits, an annual Deloitte analysis

 shows that the internal rate of return on R&D investments for the top 20 companies by R&D spend was only 1.2% in 2022. We may run the risk of killing one of the last remaining US industries. High CEO salaries may raise some questions. However, this would be a general societal discussion about income distribution, as high CEO salaries are not unique to pharmaceutical companies.

The overall healthcare cost has been rising rapidly in the US, reportedly tripling from 6% to 17% of gross domestic product over the last 45 years.

The cost share of prescription drugs has been very constant at 12% to 13% of healthcare cost since 2000. Drug costs carry the brunt of political attention, where they are only a small part of a broader healthcare affordability problem. Cost of healthcare cannot be simply blamed on a “bad guy.” Scientific advances create many opportunities, but also come with resource trade-offs.

US list prices for prescription drugs are often higher than in other countries. Net prices can be much lower. European countries, Canada, Australia, and Japan typically have government price controls for prescription drugs. They have a vested interest in using their monopsony power and price control legislation to minimize the government funded drug bill. That does not necessarily mean it is done fairly.

In England, the National Institute For Health and Care Excellence (NICE) is setting the maximum price at which a prescription drug can be reimbursed by the national health system. However, the calculation has not been corrected for inflation since its institution in 1999, 25 years ago. Correcting for cumulative inflation, the “acceptable” price levels are now less than half of what they were at NICE’s inception in 1999. On top of that, the UK government demanded rebates of 27.5% in 2023 to address budget overruns.

Through international price referencing, this directly affects pricing in other countries. As another example, Canada has artificially reduced pricing by instituting compulsory licensing, which was only reversed in 1987 with safeguards that prices could not substantially increase from the then-established generic price levels.

Since drugs rebates are confidential, it is hard to know the exact cost to the managed care organization (MCO) or pharmacy benefit manager (PBM). Unfortunately, MCOs and PBMs don’t typically pass on rebates to patients, so, in some cases, the patient copay can even be higher than the cost of the drug. As a typical example, seniors pay a $205 copay for a 110-mcg inhaler of fluticasone propionate (generic Flovent; the least expensive option in the drug class) with WellCare Value Script, but pay $118 without insurance through GoodRx. Obviously, the health insurance company is making profit on each of these prescriptions.

With the increasing share of high deductible plans, the rapid growth of exclusion lists, and formulary design shifts to higher copay and co-insurance rates, MCOs and PBMs have shifted much of the increasing cost burden to patients. Who is the bad guy?

Ed Schoonveld is a value and access advisor for Schoonveld Advisory and author of The Price of Global Health.

1. Cohrs, R. In a Showy Hearing, Bernie Sanders Gets Few Answers About Lower Drug Prices. 

https://www.statnews.com/2024/02/08/bernie-sanders-drug-prices-pharma-ceos/

2. May, E.; Gupta, L.; Taylor, K.; Miranda, W. Seizing the Digital Momentum: Measuring the Return From Pharmaceutical Innovation 2022. Deloitte Center for Health Solutions. January 2023. 

https://www2.deloitte.com/content/dam/Deloitte/ch/Documents/life-sciences-health-care/deloitte-ch-en-lshc-seize-digital-momentum-rd-roi-2022.pdf

The Price of Global Health: Drug Pricing Strategies to Balance Patient Access and the Funding of Innovation

. Routledge Taylor & Francis Group. 2020. 

https://www.routledge.com/The-Price-of-Global-Health-Drug-Pricing-Strategies-to-Balance-Patient-Access/Schoonveld/p/book/9780367279400#:~:text=Description,aspects%20of%20the%20pharmaceutical%20industry

4. Cohrs, R. Pharma Group Blasts UK’s Drug Rebate Scheme Shortly After Lauding 'Landmark' Spending Deal. 

https://www.fiercepharma.com/pharma/pharma-group-blasts-uks-statutory-drug-rebate-scheme-days-after-lauding-landmark-deal#:~:text=The%20Association%20of%20the%20British,the%20U.K.%20demanded%20in%202023

Fighting for patient affordability doesn’t necessarily require a scapegoat.

In Search of the ‘Bad Guy’

The pharmaceutical industry is rapidly approaching a breaking point with its current pharmacy benefit manager (PBM) model. Drug list prices keep rising, and so do required and negotiated rebates. The result is a significant gross-to-net bubble, which reportedly reached $256 billion in 2022.

 Patients continue paying more for drugs, while pharma manufacturers receive low or negative net price increases.

Some might argue that this cost trajectory is unsustainable. While the ideal resolution is murky, one thing is clear: Something must change. Several factors may influence future industry pricing practices.

PBMs deliver value to the healthcare system through medication price and access management. They negotiate with pharmaceutical manufacturers to secure discounts and rebates in exchange for including a manufacturer's drugs on their formularies. These negotiations influence which drugs insurance plans cover, how much patients pay for medications, and the overall cost-effectiveness of prescription drug benefits.

However, the current model drives payers to cover more expensive drugs because it's more economical for them. For example, Humira still dominates the market despite less costly biosimilars being available.

 In 2023, the drug only lost 2% of its market share.

PBMs prefer drugs with bigger rebates (i.e., the higher-priced ones) because the discounts make them cheaper than the alternative lower-price drugs, providing the lowest net cost to the plan sponsor. For example, if the rebates and discounts on a $275 brand-name drug add up to $255, the total price for the payer is $20 compared to the unbranded drug's $25. As a result of this preference, manufacturers say they must keep offering the higher-priced versions to gain a favorable spot on the formulary. That's how we've ended up with the current gross-to-net bubble.

The PBM model also squeezes small pharmacies' revenue. While patient copays are tied to drug list prices, pharmacy profits are tied to drug acquisition costs. Rebates reduce the acquisition totals, meaning the retailers earn less. This formula is particularly burdensome for independent and hospital-run pharmacies operating on small economies of scale.

The Inflation Reduction Act (IRA) is already shaking up the industry and may create unintended consequences, but we won't know the full impact for a few years.

 drugmakers and the Centers for Medicare and Medicaid Services (CMS) are currently negotiating Medicare Part D prices for 10 selected drugs. These discussions will result in a maximum fair price for Medicare prescriptions. At this moment, it's unclear how CMS will determine this number.

Negotiations could influence commercial drugs as well. Many people are focused on big-picture consequences, such as the price’s impact on capital availability for new drug development, but there are other questions that need answers, too, such as:

How would manufacturers technically deliver the IRA-mandated discount directly from the company to the pharmacy counter?

When the Part D benefit is restructured to reduce the out-of-pocket maximum, what will the PBMs and plans do to maintain profitability? Might they demand higher rebates from the manufacturers?

How will commercial payers react to theMedicare reimbursement landscape?

There are also many IRA regulations that CMS has yet to release. This uncertainty creates many challenges for manufacturers, and we're already seeing them pivot strategies in anticipation of changes. Some are delaying launches due to the IRA cycle and adapting their commercial approaches. Experts are concerned the law will reduce investments in post-approval research for new indications,

 resulting in less patient outcome data and fewer treatment options. How will this affect PBMs? Only time will tell.

Congress has taken notice of PBMs' role in drug prices. Last year, the US Senate introduced the Better Mental Health Care, Lower-Cost Drugs, and Extenders Act,

 one of at least three bills designed to reform PBM practices. While Congress won’t pass any of these proposals this session, the industry is closely monitoring future developments.

Pharma is also awaiting the Supreme Court's ruling on a case challenging the Chevron doctrine.

 The Chevron decision stated that courts should defer to a government agency's reasonable interpretation of an ambiguous law. If the justices overturn the Chevron ruling, it will significantly reduce the government's ability to regulate, introducing more uncertainty into the business environment and making an already highly complex pharmaceutical pricing process open to technical litigation.

CVS Caremark launched its CostVantage and TrueCost programs last year with the goal of bringing more transparency and clarity to prescription drug pricing.

CostVantage is unlikely to lower consumer costs. Commercially insured patients would have to be savvy enough to ask pharmacies to provide different pricing options—something pharmacists are reluctant to do and consumers don't know to ask for. Uninsured patients may see cost changes, but it remains unclear if those prices will increase or decrease across different therapies. These changes won't impact government-insured patients (those on Medicare or Medicaid) for several years.

While the CVS TrueCost model offers some direct discounts on commonly used generic drugs at the pharmacy counter, it likely won't have a significant real-world impact. The core premise relies on employers adopting new "rebate-less" PBM plans. By forgoing rebates, these new plans will likely be more expensive. At this time, widespread adoption seems unlikely.

As manufacturers navigate the impending changes, they must optimize their revenue management processes. With today's rebate and pricing complexities, manual workflows are subject to mistakes and oversights, which can prove costly. According to Model N research, manufacturers can lose between $25 million and $75 million in overpayments due to improper rebate management.

Companies must invest in automated tools to enable revenue optimization. Real-time data and analytics support demand forecasting, pricing strategies, rebate calculations, and long-term business planning.

Michael Grosberg is the VP of Product Management at Model N.

1. Fein, A.J. Four Trends That Will Pop the $250 Billion Gross-to-Net Bubble—and Transform PBMs, Market Access, and Benefit Design. 

https://www.drugchannels.net/2023/04/four-trends-that-will-pop-250-billion.html

2. Manalac, T. AbbVie’s Humira Maintains Market Dominance Amid Biosimilar Launches: Report. BioSpace

https://www.biospace.com/article/abbvie-s-humira-maintains-market-dominance-amid-biosimilar-launches-report/#:~:text=AbbVie's%20blockbuster%20antibody%20Humira,Bioepis'%204th%20Biosimilar%20Market%20Report

3. Inflation Reduction Act and Medicare. Centers for Medicare & Medicaid Services. 

https://www.cms.gov/inflation-reduction-act-and-medicare

4. New Analysis Shows IRA May Lead to Delayed Launches, Fewer Subsequent Indications, and Less Evidence Generation. National Pharmaceutical Council

https://www.npcnow.org/resources/new-analysis-shows-ira-may-lead-delayed-launches-fewer-subsequent-indications-and-less

5. Tong, N. Senate Votes to Reform PBMs Again, Atop $16B in Hospital Cuts. 

https://www.fiercehealthcare.com/payers/senate-votes-reform-pbms-again-and-stop-16-billion-hospital-cuts

6. Howe, A. Supreme Court Likely to Discard Chevron. SCOTUS blog

https://www.scotusblog.com/2024/01/supreme-court-likely-to-discard-chevron/

7. Greenberg, C. Formulary Frustrations: Overpayments Plague Pharma Manufacturers. Model N

https://www.modeln.com/blog/formulary-frustrations-overpayments-plague-pharma-manufacturers/

Exploring how current and future legislation may impact the role of pharmacy benefit managers (PBMs).


What Will Change in the Pharma  Industry Look Like?

In this third installment of my “Who Moved My Prescription?” I provide the baseline framework to help manufacturers and pharmacies understand what is broken with retail pharmacy and what to do about it.

Just two months ago, we had several key indicators of the state-of-the-state of retail pharmacy and why it is struggling to support brands and keep their pharmacy doors open. On Feb. 21, Walgreens was removed from the Dow Jones Industrial average.

 Walgreens was added to the Dow in 2018, having been fueled by its “hedgehog strategy” that was called out in Jim Collin’s 2001 book 

. The strategy was simple: do one thing really well. For Walgreens, that was operating in the intersection of passion, talent, and the economic model. Clearly now, however, the economic model has been challenged.

Next, on Feb. 27, the National Community Pharmacists Association (NCPA), which supports almost 20,000 retail pharmacy stores, released a sobering report

 stating that a third of the nation’s community pharmacies are expected to either shutter their doors by mid-year 2024 or revert back to a cash-pay pharmacy model that resembles how retail pharmacies bought, operated, and dispensed drugs prior to the use of prescription benefit insurance that was materially introduced in the early to mid-1980s.

I keynoted the NCPA Multiple Locations meeting on March 2, sharing my thoughts on the situation and the views from the pharma manufacturer community on the problem and what is being done. At this meeting, it was apparent that retail pharmacy leaders do not understand how the reimbursement and cost of goods frameworks govern their businesses.

A breakdown of the issues surrounding retail pharmacy—and what can be done to address these difficulties in a timely manner.

Pharmaceutical Commerce - April 2024

Pharmaceutical Commerce - April 2024 Issue (PDF)

Cold Chain, PBMs, and More

Looking Ahead to LogiPharma Europe

An 'Access' Double-Take: Fresh Views on PAPs and Patient Hubs

The Pharma Cold Chain: More Visible, More Sustainable—and Colder

The Power of Patient Adherence Tools to Improve the Patient Journey

Tackling Patient-Related Challenges Along the Pharma Supply Chain

Fail-First Policies Are Harming Patients

In Search of the ‘Bad Guy’

What Will Change in the Pharma Industry Look Like?

Who Moved My Prescription? Part III

Revolutionizing Rare Disease Treatment: Embracing the Patient-Centric Transformation in Pharmaceutical Customer Engagement

Streamlining for Safety: Navigating Changes and Trends in the Pharmaceutical Supply Chain Post-DSCSA