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Click the title above for a link to open the Pharmaceutical Commerce June 2024 issue in an interactive PDF format.

Pharmaceutical Commerce - June 2024 Issue (PDF)

 officially puts us halfway through the year, and I could not be any prouder of the important topics and business-essential subjects the publication has explored thus far. Transitioning from earlier coverage dives into such areas as third-party logistics providers to the state of affairs for pharmacy benefit managers, this current issue is headlined by a look at the influence of artificial intelligence and real-world evidence/real-world data on patient behavior and ultimately, the many factors and complexities of medicine adherence. In the 

, contributing editor Suzanne Shelley describes how the challenges that patients face when it comes to starting and staying on therapy can prove detrimental to the point of disease progression, along with a rise in morbidity and mortality. Notable as well is the wider impact on other pharma and healthcare stakeholders. For example, as Shelley reports: “Insurance companies end up paying for expensive medical interventions that could have been avoided by more stringent adherence to therapy; even pharmaceutical brands fail to recoup the sunk costs associated with drug development and miss the opportunity to achieve competitive success for the brand when their often life-saving medicines—which were proven to be safe and effective in clinical trials—fail to deliver on their promise due to adherence lapses.”

Sustainable practices in pharma—which consist of implementing environmentally-friendly practices into clinical, manufacturing, and commercial operations—continues to be a paramount topic as well. In our June issue, Craig Wilson, senior director of strategic planning at Marken, specifically 

 the value of environmental, social, and governance practices, including his company’s role in practicing decarbonization strategies, which are vital when working to conserve resources.

Examining the drug pricing landscape, Blake Powers, CEO of Medigi and a member of 

 that new digital solutions and dynamic pricing advantages can have application beyond the generics drug world, trickling into branded and specialty lite products, while trending direct; in turn, pharma manufacturers are providing unique price points to certain sites of care.

 this month, Amy Niles of the PAN Foundation suggests that there should be urgency in making the telehealth flexibilities that were given to Medicare enrollees during the COVID-19 pandemic a permanent fixture. These flexibilities are set to expire Dec. 31, and if Congress doesn't step in, it could result in additional health inequities, Niles contends.

I hope you enjoy this month’s issue. As always, thanks for reading.

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

The June issue of Pharmaceutical Commerce is headlined by a look at the influence of artificial intelligence and real-world evidence/real-world data on patient behavior and ultimately, the many complex factors that go into medicine adherence.

AI and Patient Behavior 

 was focused largely on setting the stage for 

’s coverage and experience at LogiPharma Europe in mid-April—and I am happy to report that the show was officially a success. In my opinion, our 

, do a stellar job at capturing the essence of the conference’s offerings, alongside the editorial content gathered by our publication.

When I spoke to Will Robinson, LogiPharma’s commercial director, about future plans for the show—including if it will continue to be held in Lyon, France, and if there were any talks of switching venues—he noted that “We're definitely here next year; we'll be here for the 25th anniversary."

Robinson continued: "We don't see any reason to change it. [Centre de Congrès de Lyon] is on a high-speed rail line, which is certainly where we're trying to drive as many of our attendees to be using. The venue's great. ...For the vast majority of those who attend, it is actually quite easy to get to. It’s a bit of a break from the office—it takes you away. It puts you in a different headspace. It makes you engaged in the event for two or three or four days, or however long you're here. I think we're going to stick here for at least the next couple of years.”

I can only imagine the hype that is expected to surround next year’s milestone show, especially with 70% of exhibition booths already being booked.

Perhaps the limited availability should come as no surprise, given the invaluable benefit that events like these offer. I thoroughly enjoy the “organized chaos” that they present, and from an editorial perspective, they always serve as a great reminder that content continues to be king. Particularly actionable content. Whether in the form of articles, Q&As, podcasts, videos, you name it, shows such as LogiPharma Europe spotlight the valuable opportunity to leverage and expand one's Rolodex of KOLs in the industry to further educate our most valuable asset—our readers—and to help them make sound and informed decisions in their daily practice.

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

Beneath all the “organized chaos,” industry shows such as LogiPharma Europe spotlight the valuable opportunity offered by these events to further educate our most valuable asset: our readers.

Content is Indeed King 

Echoing the sentiment expressed in our recently published 

 that explored the trends and highlights that came out ofLogiPharma Europe, this year's April show provided a unique forum for discussion and dialogue across the distribution and healthcare logistics landscape.

The event was again hosted at the Centre de Congrès de Lyon in Lyon, France, and as Jake Brown, LogiPharma’s sponsorship director, stated in its 

, it “continues to be the only event globally where you can meet all the key stakeholders within the life sciences supply chain.”

About 2,000 people attended the show's 24th installment, which featured numerous sessions revolving around the following themes:

“Not another dashboard! How to infuse pulse into your supply chain operation.”

“How can you transform digital capabilities in your temperature-controlled supply chain to improve visibility, quality, and reactivity?”

“Why must our industry collaborate to reach its most ambitious sustainability goals by 2030 and what is required to meet them?

“How can you implement scalable networks to overcome the challenges of complex supply chains for personalized therapies?”

“Properly applying diversity, equity, and inclusion initiatives within the life sciences supply chain.”

One of the above sessions—“How can you transform digital capabilities in your temperature-controlled supply chain to improve visibility, quality, and reactivity?”—particularly piqued my interest for covering the relationship between two of 

’s largest topics: product visibility in the supply chain and the cold chain specifically.

Tony Fonk, president and CEO of SpotSee, moderated the panel, and was joined by Amy Shortman, a logistics representative with DeSpir Logistics; Cesar Gil Martinez, director of procurement logistics, EMEA, Bayer; Tomas Fant, temperature-controlled logistics project lead, Pfizer; Marie Berranger, cold chain logistics project and launch manager, Galderma; and Linus Wollentz, senior manager, Envirotainer.

When asked what "digital maturity" meant to her, especially in terms of digital capabilities and temperature-controlled operations, Shortman mentioned that “digital maturity is really about understanding the value of the data that we’re feeding through those digital services provides. So it’s making sure that we understand how we’re using visibility and using that to really drive down risk and add value to the customer. What we’re seeing in the market in a general sense is that not all players within the supply chain ecosystem and logistics ecosystem are at the same level of digital maturity.”

These were words that truly resonated with me, being that they served as a reminder to all pharma stakeholders: never lose sight of 

To read and view all our coverage from LogiPharma Europe—plus other past shows—including special video interviews, please visit 

pharmaceuticalcommerce.com/latest-conference

LogiPharma Europe captured many timely topics, including the importance of next-level approaches in aligning temperature-controlled transit and visibility. 


'Maturity' Matters: Fortifying Two Key Cogs of Pharma Supply Chain 

We’ve all witnessed the retail, transportation, and travel industries undergo a transformation based on new digital models. Outcomes include lower cost, improved safety, more consumer choice, and ecosystems that serve as a haven for a variety of market players to coexist and compete on price, quality, demand, and reputation. These dynamic pricing models leverage data analytics to make pricing decisions that benefit both businesses and customers through timely, market-aligned adjustments. Yet, with all the innovation applied to pharmaceuticals, e-commerce has yet to gain traction in the space. Pharmaceuticals stand to benefit with the same outcomes as other industries embracing digital approaches to their pricing models.

The recent US Department of Health and Human Services (HHS) white paper, “Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States,” published in April, suggests it’s time to reevaluate, noting that “Incentives throughout the supply chain must be reimagined to ensure the resilience and supplier redundancy required to prevent drug shortages from occurring.”

We habitually use dynamic pricing models in our daily lives, whether it’s travel reservations, ride hailing apps, or online marketplaces to stock our pantries or to find the perfect gift. Still, the pharmaceutical industry, by and large, has yet to adapt. It still depends on older models that rely on long-term price negotiations that lock in prices.

Online marketplaces and aggregators have a historic track record for debuting new business models, amplifying transparency, fixating on source suppliers’ unmet needs, and obsessing about the perfect user experience for the buyers engaged with their applications. Something that would have required either the services of a travel agent or hours of comparative research now only takes 10 minutes.

Up-and-coming creators and artists don’t need to invest in the overhead of a gallery or peddle their wares on the street anymore; they simply list their pieces online for greater customer reach. So many aspects of our lives have changed in the last 20 years, yet what’s fascinating is how within the ecosystem of healthcare providers (HCPs) sourcing drugs, it hasn’t really changed at all.

Take, for example, the 90% volume that generic drugs represent in the US pharmaceutical market. For HCPs, 80% to 90% of their medication purchases are negotiated on their behalf by their group purchasing organization (GPO) as “contracted products.” The philosophy is that when you combine a GPO membership’s total purchasing power (representing one-third of the hospital beds in the country), each hospital member will have the most competitive price. It’s one less detail for HCPs to worry about, and with multiyear awards from drug manufacturers committing to a price for five to seven years, the argument is that it helps pharmaceutical companies better plan for market demands while ultimately, creating more stable supply.

From the reliability perspective, outcomes of the status quo static-pricing model are concerning, with drug shortages reaching a reported two-decade high.

It assumes that the sole (or dual) manufacturer(s) awarded will have uninterrupted supply of the product for five to seven years. Are the lowest bidders always the most reliable?

The model doesn’t encourage other players to be ready to serve the market in situations where a hurricane shuts down the island of Puerto Rico, or FDA suspends the operations of a production plant due to a failed inspection.

With the trend of M&A, it leaves the number of major national hospital GPOs to three. This means, as a drug company, if you don’t win the award of a particular GPO, you are boxed out of the market until the time rolls around where the other two major GPOs have a bid cycle.

It discriminates against emerging/midsized pharmaceutical companies because the sheer volume of the bid requires enormous production capacity.

Long-term prescription demand is tough to forecast and often the expected volume of the awarded product does not match up with the actual pull-through (creating excess supply, risk of waste for manufacturers, or shortages).

Artificially setting fixed price points insulates the pharmaceutical supply chain from the basic economic law of supply and demand. If the price is set too low, only the largest players (or those with the thinnest margin tolerance) can compete with the economies of scale necessary to make the math work, and such concentration only leaves the supply chain more vulnerable to shortages.It doesn’t entice other manufacturers to stay or enter into the space.

If the contracted price is set too high, you’ll have too many manufacturers producing the same product in the market, creating overstocks, and ironically, pharmacy acquisition cost (at a fixed contracted price) would be greater than what it would be in a free-market environment. With static pricing set by long-term GPO bid cycles, it removes the ability for price points to float into its real-time equilibrium price guided by current supply and demand conditions.

How dynamic pricing is starting to unfold for pharma

New digital solutions and dynamic pricing advantages extend beyond the generic drug world. With more branded and specialty-lite products trending direct, drugmakers often offer unique price points to certain sites of care. For instance, pharmacy-specific prices can be adjusted by the supplier based on the pre-committed or historic pull-through volumes of the pharmacy customer.

Modern technology now provides procurement professionals with real-time optics into what’s available at the manufacturer level and allows for more convenient, open trade.

Would a free-market system create price erosion?

By its very nature, dynamic pricing does not discriminate. In moments of abundance, prices tend to decrease, and in situations of scarcity, prices most always bounce up. The price equilibrium in a dynamic pricing model is discovered immediately. With prenegotiated long-term pricing models, it delays where the market price should really be at.

Considering the number of backorders and the influx of volatility in medication supply, drug manufacturers who can deliver reliable supply at fair market prices should be the ones positioned for success. The aforementioned HHS white paper states, “hospitals can spend at least $600 million per year managing shortages and diverting essential personnel who are needed for direct patient care to find alternative treatments for patients.” Contrary to the common assumption that pharmacy buyers always go for the cheapest available product, procurement teams do indeed make restrictions/soft blocks on certain national drug codes/manufacturers because of physician preference; ease of patient administration; reimbursement implications; shipment turnaround; lack of historic reliability; and even the coloring of the label/vial cap. Price is certainly a major dimension of the purchasing decision, but it’s not the only factor. A platform that provides the freedom of direct dynamic pricing offers a new approach to a supply chain that is experiencing no shortages of new challenges.

The gross-to-net economics of what the product sells for versus what is retained by the manufacturer at the end of the day is beginning to have a negative impact. It starts with the drug company trying to sustain a product line where 40% to 65% of gross sales are being consumed by pharmacy benefit manager rebates, higher distribution fees, chargebacks, 340B penny pricing, and GPO administration fees. After all the upfront expense of R&D and manufacturing capabilities, the costs of the active pharmaceutical ingredient and labor, and obtaining FDA approval, it’s becoming a greater challenge to forecast the viability of a product once pharma companies analyze the bottom line of what it takes to also launch and distribute the product.

Arguably, the costs should be lower for manufacturers to digitally price and distribute their drugs to HCPs and their patients. Having the ability to manage price based on real-time market data puts companies in control, preventing unstainable erosion, and allowing for a more rapid response to any unmet needs.

Is it time to contemplate medications as we do other commodities, embrace digital formats, and allow for more dynamic pricing to occur? Perhaps this shift in thinking is just the remedy the drug supply chain needs.

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

With pharmacies under pressure to lower drug-acquisition costs, a look at how digital formats can help manufacturers better manage price based on real-time data.

Dynamic Pricing: What Pharma Needs?

It’s widely understood that poor adherence to prescribed medication regimens has far-reaching clinical and cost implications for all healthcare stakeholders.

For example, patients who never start or don’t stay on prescribed treatments fail to control their symptoms and often experience disease progression and increased morbidity and mortality. Insurance companies end up paying for expensive medical interventions that could have been avoided by more stringent adherence to therapy. Meanwhile, even pharmaceutical brands fail to recoup the sunk costs associated with drug development and miss the opportunity to achieve competitive success for the brand when their often life-saving medicines—which were proven to be safe and effective in clinical trials—fail to deliver on their promise due to adherence lapses.

“Additional tangible and intangible societal costs arise in terms of job loss and reduced work productivity for both patients and caregivers,” says Pierantonio Russo, MD, chief medical officer for EVERSANA.

Considering how many clinical and financial factors, unmet social needs, mental health challenges, and comorbidities are at work, it’s no surprise that patients have a hard time remaining adherent to one or more complex therapy regimens as they struggle to manage one or more chronic conditions. While the reasons are varied, there is one thing everyone can agree on: No single “one-size-fits-all” intervention will suffice when it comes to helping diverse patients to overcome the diverse adherence challenges they face.

Fortunately, two factors are working in tandem to break the logjam on adherence:

The collection of real-world data (RWD) from both established and novel sources continues to grow throughout the healthcare arena.

The number of artificial intelligence (AI) methodologies—including those based on machine learning (ML), natural language processing (NLP), generative AI, and more—continue to mature, enabling stakeholders to convert RWD into real-world evidence (RWE) that provides actionable insights.

When it comes down to interpreting patient data, specificity is likely to garner better outcomes.

“The goal is to use today’s advanced modeling technology to better understand the complex relationships between patient-level characteristics, adherence-related behaviors, and health outcomes, and then use the data-driven insights to deliver individual level outreach, making them patient-specific (not generalized) to improve outcomes,” says William Grambley, CEO, AllazoHealth.

In fact, being able to connect the source of information to one individual creates a more streamlined process.

“The ability to access many sources and link them to the same patient is really extraordinary in terms of increasing efficiency and helping us to make connections and predictions we could not have made before,” adds Amanda Bruno, PhD, MPH, senior vice president in real-world and late phase at Syneos Health. “It will be exciting to see how this increased sophistication in data will impact the pace and integrity of future evidence generation."

Ensuring quality, accuracy, and reliability of insights and predictions generated by today’s AI models is paramount. Stakeholders must prioritize the development of algorithms using credible real-world healthcare data, while also leveraging expertise from scientific and medical professionals. Validating models of predicted results against real patient outcomes is essential to ensure confidence and trust in AI-driven healthcare advancements, notes Christina Mack, chief scientific officer, real-world solutions, for IQVIA, adding: “Today’s predictive models continue to get better in terms of identifying which patients are at high risk for non-adherence, and that helps stakeholders to create personalized adherence interventions that are informed by the patient’s actual personal choices and barriers.”

Experts believe any opportunity to build an algorithm that accurately reflects patient behaviors in the real world can feed further understanding of the many barriers patients are facing, and from there, "then develop more targeted outreach that helps to personalize each patient journey based on predictability,” says Angela Wlodar, MS, Syneos Health’s senior vice president, medical affairs in business development.

In the clinical trial setting, safety and efficacy is validated in a highly controlled environment where drug regimens are administered and monitored closely by healthcare professionals, so adherence lapses are not a factor that impacts the drug’s performance.

“By contrast, once the drug moves into the real world, healthcare systems, providers, and patients become responsible for many of the factors that impact adherence, so a large amount of control is lost,” says Mack.

She notes that the types of adherence challenges patients face can be organized broadly into the following three buckets:

 Challenges that relate to access to healthcare resources and communication methodologies and format that may not be in the patient’s primary language.

 Obstacles such as cost issues, complexity of the drug-administration requirements, and the impact of adverse effects.

Challenges that connect back to comorbidities, management of side effects, mental health issues, and other considerations related to social determinants of health (SDOH).

“Creating effective interventions requires us to consider all of the factors we can modify to make the patient journey more successful, not just focus on what the patient is or is not doing,” adds Mack. “We see a lot of promise in marrying AI and RWE to meet the challenge, and we are pushing the envelope and investing in targeting these capabilities in a robust and validated way.”

One particularly vexing challenge for brand teams relates to patients who are prescribed complex drug regimens to manage potentially life-threatening conditions that present no real symptoms or discomfort on a day-to-day basis, such as cardiovascular disease, hypertension, high cholesterol, and diabetes.

“Patients are much more likely to remain adherent to their drug regimens if they feel their medications are helping to alleviate symptoms, make them feel better, and improve the quality of life,” says John Doyle, DrPH, president of consulting for Fortrea, and adjunct assistant professor at Columbia University’s Mailman School of Public Health. “Brand teams can be more effective in how they engage with patients by deploying AI to personalize messaging and behavior nudges, helping them connect the dots and really understand how the medications work, how their disease will progress, and what risks arise if they don’t remain adherent to therapy.”

Yet every patient has different needs and preferences related to this knowledge gap.

“If we’re not finding ways to personalize outreach to help patients and their caregivers manage their expectations and clarify how the health journey will continue to evolve at every inflection point, we’re missing a key opportunity to help the patient remain on therapy over the long term,” says Wlodar.

As an industry, “we do a lot of great marketing to physicians to support prescribing practices,” adds Bruno. “But not enough of the outreach is directed at patients to help them truly understand what’s at stake so they can take control and become better healthcare advocates for themselves.”

There’s another often-overlooked aspect when crafting patient-focused outreach.

“The tech industry and other consumer brands do a very good job persuading consumers to believe their products can really improve their lives and help them to be their best selves,” says Doyle. “Drug companies can learn from them and should make such targeted messaging a bigger part of their overall health and adherence intervention campaigns.”

Affordability, or lack there of, is another major contributor to poor adherence. Healthcare programs that implement technology advances on a continuous basis can help. For example, they can aid in streamlining the benefits-verification process or automating the steps required to onboard patients into a health plan. This can "help to instill confidence in access and reduce the burden for patients and healthcare providers by removing one more barrier to therapy,” notes Jordan Armstrong, VP of business development for AssistRx. Meanwhile, complex drug-administration regimens—particularly those associated with self-injected and infused biologic therapies—can be daunting, so quickly identifying which patient needs what type of support can be a benefit.

“Whether the patient needs support to coordinate travel to a doctor’s office or infusion center, or must learn how to self-administer these high-cost, high-stakes therapies at home, both can be difficult—even for the most motivated patients,”adds Armstrong.

Predicting behaviors, tailoring the outreach

All of this becomes even more daunting for patients facing structural health equity issues. Such SDOHs include challenges related to healthcare literacy, education level, socioeconomic status, lack of transportation, childcare challenges, and the inability to take time off work to manage health conditions. “More than ever, addressing these multi-faceted challenges requires tailored interventions, education, and support to enhance adherence and improve outcomes,” says Russo.

One proven strategy uses modeling and predictive capabilities to stratify patients by adherence risk factors as they are being enrolled into patient-support programs, so that tailored outreach can be offered based on individualized risk factors and communication preferences. “Using data-driven insights into the barriers a given patient is facing, pharma companies may choose to provide even more-targeted interventions, such as transportation, childcare, or lodging coordination and services to help them remain on therapy,” says Armstrong. Similarly, he notes that providing remote nursing-support resources is particularly useful to help patients master self-injection routines without the hurdles they may face in traveling to a provider’s office.

Deciding what to send to patients at what time

Pharma brand teams have a lot of options when it comes to how and when to influence and engage the patient, in terms of phone calls, email, and SMS text campaigns that provide reminders, information about adverse effects, access to nurses for clinical information, and benefits counselors. All of these avenues reduce the administrative burden for coverage.

But knowing exactly what to offer at what point in the patient journey so that a given touchpoint will be most effective is still a mystery to most brand teams, contends Grambley, whose company uses AI to make predictions on specific patients in order to tailor their results.

“By optimizing communications for patients at the right time, on the right channels, at scale, we have proven that we can get them on therapy sooner, stay on therapy longer, and get more benefit from the medication,” he says. “For the most part, we do not change the branded program offerings and messaging that the pharma company has already developed. Rather, by studying and modeling more than 500 different variables related to their preferences and behaviors in the past, we can deliver decision intelligence that allows the brand team to proactively target the timing and fine-tune which program elements reach which patients at what time.”

In one example working with a pharma brand that offers a therapy for a major depressive disorder (MDD), AllazoHealth’s AI platform was used to predict which patients were at risk of non-adherence to their MDD medication, determine the most impactful email content to address that risk, and personalize the communications for each patient. According to Grambley, doing so boosted first-fill rates by 8.4%, while average time a patient remained on therapy rose by 13%. Also, emails sent to MDD patients were 2.5 to 4.2 times more effective with AI optimization than those without.

Meanwhile, AllazoHealth is also piloting an advanced approach to personalize “dynamic modular content” with pharma clients. Consider a matrix that involves different versions of the approved subset line, headlines, email content message, and images that may resonate differently with different people, and specific calls to action that relate to different challenges patients may be facing.

“Using our data-driven intelligence, we are able to drive the optimal combination of elements from the matrix that will provide the most personalized and impactful outreach for any given patient," says Grambley. AllazoHealth plans to roll out this feature more broadly later this year.

Mack adds that having patients on the correct treatment pathway to begin with is a key component to adherence, and a place where leveraging AI and RWE can drive improvements. In a recent study in Germany, IQVIA leveraged local RWD to identify and profile unmet needs among asthma patients, based on demographics and other clinical drivers, leading to a 17% reduction in uncontrolled asthma in six months following new treatment initiation.

RWD sources that provide insights into patients’ lives

Traditionally, identifying non-adherent patients has relied on direct inquiries, surveys, and analysis of pharmacy data for missed refills, notes Ramaa Nathan, PhD, VP of data science and RWE insights, EVERSANA. However, both approaches are costly and time-consuming; frequently, they do not allow for the discovery of all non-adherence contributing factors.

By contrast, today’s AI methodologies are able to produce sophisticated pattern recognition and build models based not only on EHR data, lab tests, and phenotypes and genotypes associated with the disease, but can identify relevant patterns and make predictions related to patient demographic data and SDOH.

“We know these factors play a direct impact on drug adherence and clinical outcomes,” says Doyle.

“Today, we are able to build ML predictive models with inputs from extensive datasets, including clinical notes, administrative claims, behavioral health profiles, SDOH, patient-reported data, and social media listening for early identification of at-risk individuals,” adds Nathan. “This provides a superior approach over traditional regression methods, as it recognizes complex, non-linear patterns and its predictive accuracy improves over time with the input of new data.”

According to Nathan, classifying patients into different clusters and recognizing those patient sets that are most likely to encounter adherence issues can help when developing personalized outreach methods.

IQVIA is working to use NLP to simplify medical terminology for patients (removing a common adherence barrier),and has developed an AI-powered patient-relationship management tool, which, Mack says, is being used by several pharma brands.

“The chatbot can digest the patient’s input and route them to the most appropriate person or resource to triage the situation in a personalized and accurate way, allowing both patients and physicians to overcome barriers in access and affordability to promote adherence,” she adds.

Meanwhile, AssistRx’s patient-support programs currently use voice/tonal recognition technology to identify, address, and report on access and affordability challenges patients are facing that can reduce adherence. “As AI becomes more sophisticated, we’re excited for the opportunity to be able to flag patient behaviors and interactions—live during calls with our representatives—that are barriers to access and adherence, then proactively address those challenges,” says Jordan.

Success in this department, however, will ultimately come down to continuity.

“Once we as an industry put these life-saving therapies out into the world, sustained patient adherence is one of the most critical factors to ensure these products can deliver on their promise and potential,” says Mack.

The ability to implement AI, catered to specific patient needs, as detailed, will be a major catalyst in these efforts.

“Any given patient program will always help some people but not all of the people,” notes Grambley. “But when you can apply AI to really tailor the options and help patients to get exactly the type of support they need at the right time, it’s kind of magical.”

By marrying real-world evidence and AI, pharma stakeholders can identify new opportunities to tailor interventions in a way that is most impactful to patients—helping them overcome roadblocks in initiating and maintaining therapy. 

Combining RWE and AI to Bend the Adherence Curve 

Global price comparisons for prescription drugs continue to draw the attention of politicians, medical groups, and patient organizations. WHO and lower-income countries advocate for income-based pricing to address their low levels of affordability. However, higher-income countries systematically use lower prices around the world to lower their prices through international price referencing. Is the US subsidizing healthcare in other countries around the world? What is fair?

Given different income levels in countries around the world, the question is whether adoption of prices adjusted for gross domestic product (GDP) yields better commercial results for a drug manufacturer than a fixed price across countries (if that was even feasible given price controls). As variable production cost of most pharmaceuticals is relatively low, price adjustments to address local affordability tend to lead to a higher financial contribution to cover global infrastructure and fixed organization cost. However, the use of international price referencing by higher-income countries can pose serious challenges to this strategy.

Fair Prescription Drug Prices for Americans Act

Medicare price controls, introduced through the Inflation Reduction Act of 2022,

 did not satisfy the appetite for US government intervention in prescription drug pricing. The Fair Prescription Drug Prices for Americans Act

 was introduced on April 19, 2023. It includes regulations that the retail list price in the US for a drug or a biological product may not exceed the average retail list price for the drug or biological product among Canada, France, Germany, Italy, Japan, and the UK. This bill proposes to establish maximum US drug prices through the international price referencing principle, using prices in a basket of other countries with a lower income level without any consideration of differences in GDP between countries.

NATO countries are bound to contribute 2% of their GDP to NATO, yet only 11 of the 30 NATO member states contribute the agreed upon income-adjusted share. Former President Trump’s undiplomatic style of raising the issue with European countries was not ideal, but it did raise broader awareness that despite European concerns over Vladimir's Putin’s expansion interests beyond Ukraine, they don’t pay their fair share, even after adjustment for GDP. For drugs, we don’t accept GDP adjustments for price, while for guns, we accept that countries pay less than their GDP adjusted share.

One might ask: Why should I pay more for my medications than my friends in London or Rome? Is it fair to not pay the same? What’s the point of working hard for more income if each product is priced based on income level? On the other hand, if patients cannot afford it, then the cost of covering drug company overhead will have to be funded by the ones who can, but at even higher prices. For this reason, it makes economic and social sense to accept “differential pricing” across countries, provided that individual governments pay their fair share and don’t abuse it through price referencing and authorized importation, as recently authorized by the FDA for Florida.

Government payers use their monopsony powers to demand lower prices. Individual companies usually have no choice other than either accepting the price or staying locked out of local sales. Companies are not allowed to coordinate with other companies to break through the government’s purchasing power, as this would be deemed collusion. Just like with guns, European governments don’t pay their fair share for drugs. Many countries demand price reductions for drugs when they exceed budgets that did not adequately fund aging populations and growing healthcare needs.

,” the National Institute for Health and Care Excellence (NICE) in England has not adjusted its cost-effectiveness standard for inflation in 25 years. Canada is disallowing price premiums of new innovations based on local price levels that are founded in decades of compulsory licensing, allowing generic manufacturers to ignore patents and produce the product for a low royalty of 4% of its generic price. Fair pricing?

Rather than attacking the drug industry on its pricing, shouldn’t the US government help the industry to fight unfair price control practices that systematically leech on US subsidies, similar to lack of funding of the joint NATO task?

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

1. H.R.5376 - Inflation Reduction Act of 2022. Congress.gov. 

https://www.congress.gov/bill/117th-congress/house-bill/5376/text

2. S.1218 - Fair Prescription Drug Prices for Americans Act. Congress.gov. 

https://www.congress.gov/bill/118th-congress/senate-bill/1218/text

3. FDA Authorizes Florida’s Drug Importation Program. FDA. January 5, 2024. 

https://www.fda.gov/news-events/press-announcements/fda-authorizes-floridas-drug-importation-program

The impact of income-based price controls in healthcare. 

Justifying Price Fairness

Rising cost pressures demand more efficient operations. Micro-launches are creating shorter go-to-market runways. The continued rise of specialty drugs with small patient populations puts increased pressure on companies’ promotional efforts. In this landscape, there are many ideas for how to improve commercial focus and effectiveness. However, maximizing the impact of commercial efforts starts with putting patients first. In addition to being the right choice ethically, it has also become strategically imperative (hence, the widespread discussion in the industry about patient centricity).

Now, believing is one thing, but living the belief is another. Companies need to think differently to truly place patients at the forefront of their commercial strategies. One of the keys to making this shift is for a company to broaden its perspective on promotional tactics. Even if its current tactics—such as robust social media campaigns or healthcare provider education initiatives—are highly effective individually, they often optimize local impact rather than overall effectiveness. Therefore, instead of focusing solely on tactics, a company should adopt a holistic “customer engagement model.” Since patient-centric decisions involve multiple stakeholders, companies need to engage them comprehensively and strategically. Here are three key elements for developing impactful customer engagement models, which will go a long way toward helping companies achieve patient centricity.


Too often, customer engagement models that are well-designed end up being unsuccessful because they run contrary to existing organizational structures. Competing priorities across teams, misaligned corporate objectives, and a lack of senior leadership vision are the main reasons these initiatives fail. Therefore, enablement is as important as the design of the customer engagement model. To successfully deploy these models, companies may have to break through the internal silos that were built for a different, brand-driven era. An ideal model must truly cut across teams, and a company must put in place the proper incentives to facilitate this unified approach. In the end, companies should ensure that all practitioners engaged in the effort work toward the common, patient-centered goal.

2. Prioritize patients, but consider all involved


Companies should prioritize patients as the North Star of their commercial efforts but also address all the players that surround them in the treatment ecosystem—from their physicians to pharmacists, to nurses to regulators, to payers. To succeed, commercial teams must ensure they understand the treatment and emotional/decision journeys of all stakeholders, the different needs they have, and the barriers they need to overcome in order to best serve the patient.


A company should ensure it does not fall into the slippery slope of having the right design and enablement model for customer engagement but then pivoting around short-term, brand-focused objectives. Too often, drugmakers end up in this situation because at the time of enablement of the model, they start characterizing it as a big initiative with a large price tag, are unwilling to garner rank-and-file support for it, or feel overwhelmed by the need to continue investing in the model’s evolution. Therefore, companies need to think in a bit more like a purist and ensure they see the model right through to the end.

Rohit Gupta is a partner at Beghou Consulting.

Companies need to alter their thinking to better prioritize patients. Here are three simple yet impactful engagement elements that could help.

How Serious Are You About Patient Centricity?

As the benchmark of a successful business, sustainability and being environmentally focused is more than a symbol of advancement and efficiency; it is an absolute necessity for a world facing growing ecological concerns. Modern organizations must remain cognizant of their inefficiencies and their peripheral effects on our planet. To bring sustainability to the forefront, environmental, social, and governance (ESG) initiatives are the measures for which modern organizations achieve functional success. Only years ago, many companies would consider sustainability extraneous to more immediate performance indicators, but after years of research and catastrophic climate events, ESG is now a major criterion for weighing a company’s longevity.

The pharmaceutical industry is a global powerhouse, delivering healthcare and life-saving treatments to billions of people around the world. As such, this vital sector must contend with making a significant carbon footprint. According to one study, the pharma industry puts out 13% more pollution than the automotive industry—at a market size less than 30% pharma’s value.

In the same study, it was determined pharma manufacturing’s annual carbon dioxide emissions were 48.55 tons of CO2e (carbon dioxide equivalent) per million dollars of revenue—55% greater than auto manufacturing in that same year.

 The supply chains for life sciences and healthcare are estimated to contribute 70% of the overall emissions pharma companies expend, highlighting an imperative for change.

Recent scientific evidence suggests climate change is rapidly accelerating, placing ESG initiatives in the spotlight as an inherent component of business.

 In the race to curb further damage from pollution, pharma and its supply chains are positioning themselves to lead the way. Fortunately, awareness of environmental degradation has accelerated along with the adoption of new innovations, and this confluence could not arrive at a better time.

Accelerating sustainable solutions through technology

At every level in the pharma industry, innovative technologies are being integrated to improve and assist in developing complex, ground-breaking novel therapies. These same technologies are also capable of analyzing big data and developing processes for sustainability. While the supply chain is integrating these technologies to optimize processes and elevate the movement of ultrasensitive drugs, it simultaneously offers the opportunity to improve sustainability initiatives through advanced data analysis and improved efficiencies. Digitalization for this new age of healthcare, in the form of automation, artificial intelligence (AI), blockchain, and the internet of things or more specifically, the internet of supply chains (IoSC) (also referred to as a connected supply chain), is shaping new processes and daily operations, presenting opportunities to greatly influence directives for ESG.

IoSC offers a major uptick in control, efficacy, and optimization by fully integrating components of the supply chain with the internet. This allows operations a robust set of informed solutions combined with faster, possibly instantaneous, decision-making. When combined with data analysis from other developing technologies, it will lead to a smarter, more intuitive supply chain with endless applications for determining ESG initiatives. By elevating the supply chain’s connection to the internet, we take a major step toward the next industrial revolution—Pharma 4.0—optimized visibility, traceability, predictive maintenance, streamlined transport operations, and increased cross-organizational communication.

AI joins IoSC to open even more opportunities for sustainability. It assesses big data sets to define processes, like analyzing routes and carriers to determine best practices to limit emissions, simulated clinical trials, or other virtual simulations, thus eliminating product loss and unnecessary lengthy studies. Also, AI will cut out laborious manual processes impacting traditional systems that churn out paper waste. It promises to bring many other technologies together as the computational power of standard systems is elevated to new heights through machine learning.

Blockchain, in tandem with these other technologies, has the potential to create some of the most balanced and well-kept supply chains. Blockchain acts as a digital ledger made infallible by connectivity across multiple channels to provide a deeper, impeccable look at inventory, status, and integrity of medical products across the entire supply chain.

Blockchain logs every step, preventing deficiencies in stock products and where they are available for relocation in times of demand. These elevated records facilitate sustainability by preventing oversupply and stockouts, maximizing accuracy of quantities for transport, which translates to less trips and fewer carbon emissions.

Closed loop and reverse logistics solutions

The World Health Organization estimates that the pharma industry produces over 300 million tons of plastic waste annually—with single-use plastics estimated to represent half this number.

 To circumvent this enormous amount of waste, supply chains use strategies to maximize the lifecycle and reuse of packaging assets.

Through collaborative efforts with partners, an ESG initiative to return this packaging by taking steps to track, return, and recondition in a process of reverse logistics not only saves resources, but prevents these containers from remaining indefinitely at a partner’s facility and potentially the landfill. By bringing all stakeholders together through a closed loop process, we maximize savings on transport expenditures and CO2 emissions while keeping partners supplied with packaging and returning assets to their original destination.

To enhance this process, radio frequency identification tags (RFID) have been incorporated into packaging for tracking and data collection, assisting managers by providing a robust view on regional quantities that perpetually drive this cyclical process. The smoothness of a well-maintained, closed-loop system is an orchestration of operations teams and sensors collecting copious data on assets that, when enhanced with other technology, such as AI and blockchain, organize, manage, and alert when an asset is nearing the end of its lifecycle.

Human insight fueling processes and accountability

The data for climate change has reached a pinnacle in recent years, after elevated media coverage and the release of extensive research from the Intergovernmental Panel on Climate Change in 2021 and the World Meteorological Organization’s State of the Global Climate Report from 2022 showing overwhelming evidence that global temperatures have reached an extreme level and our current processes are inadequate. Acknowledging the severity of the issue is the first step to bringing about change, and while our advancing technology will play a significant role in our future, human insight defines the direction, purpose, and adaptability needed to create a truly sustainable industry.

The best ESG practices are designed by experts familiar with the frontlines—scientists, logisticians, and project managers using detailed understanding for designing strategies to address inefficiencies. For our part in the supply chain, decarbonization strategies are important to conserving resources, and we take every chance to consolidate shipments and reduce fuel consumption whenever possible. Internal initiatives play a large part in implementing ESG into daily activities, such as eliminating waste, recycling programs, choosing reusable materials, and ensuring we get the most out of a product.

As headway in ESG is made through these areas and record keeping is formalized, global organizations are in place to create standards, judge progress, and assess a business’s ESG actions to determine success.

Founded in 2011, EcoVadis is an innovative solution that empowers businesses with assessments and scores to award sustainability status. It offers a novel approach by collaborating to adopt new standards, implementing plans for controlling waste, cutting emissions, and keeping track of all sustainability initiatives. Savvy organizations are assessed by their plan of action and the resulting data collected from their ESG efforts.

At Marken, we view ESG as a long game and are in the late stages of a five-year campaign assessed by EcoVadis. We began with a robust communication program the first year to alert and educate employees and external service providers of our initiatives and their roles in them. This was followed by increased involvement the following year with targeted areas and metric goals. In the final stages, we implemented solutions for areas that did not achieve objectives. By following this strategy, Marken met the specifications for its EcoVadis reporting and adopted additional strategies to move from a bronze to silver status within a few years, a unique designation only the top 25% of reporting companies achieve.

A transparent approach with elevated communication to stakeholders is crucial for allowing outside processing to also become familiar with ESG initiatives and processes, building on the collaboration necessary to create change on a large scale. It is important to keep in mind as a global organization, different countries have various approaches to sustainability.

With so many touchpoints in the supply chain for different projects and regions, an individual company’s initiatives and ability to lower waste is often only as good as the next player in the process. This is why a well-informed and staged approach brings teams together with a common mission—eliminating unnecessary events and building reciprocal services to deliver the most out of resources.

To address the inefficiencies in the pursuit of optimizing sustainability, we must master our individual roles throughout pharma, revealing where there is room for improvement and taking action to implement changes to make a difference in concern of our environment.

By strategically combining human expertise, cutting-edge technology, and efficient processes, the pharma industry and its supply chains are reaching a new era of sustainable practices. Likewise, by focusing on ESG factors throughout the pharma supply chain, companies ensure the medications we rely on are produced responsibly. This translates to a healthier planet and a more sustainable industry with better access for patients. While challenges remain, the growing focus on ESG initiatives presents a significant opportunity for the pharma and its supply chains to become leaders in responsible manufacturing and distribution. 

Craig Wilson is Senior Director of Strategic Planning at Marken.

1. Lotfi, B. Big Pharma Emits More Greenhouse Gases than the Automotive Industry. May 27, 2019. 

https://theconversation.com/big-pharma-emits-more-greenhouse-gases-than-the-automotive-industry-115285

2. Heim, M.; Entrup, C.; Miranda, W. Making Biopharma’s Supply Chains More Environmentally Sustainable. Deloitte. September 20, 2023. 

https://www2.deloitte.com/us/en/insights/industry/health-care/scaling-pharmaceutical-supply-chain-sustainability-efforts.html

https://science.nasa.gov/climate-change/evidence/

4. Seethamariah, S. The Power of a Smart, Connected Supply Chain.

https://www.forbes.com/sites/forbesbusinesscouncil/2023/02/17/the-power-of-a-smart-connected-supply-chain/?sh=172929691b18

5. The Pharmaceutical Industry is Prescribing More Sustainable Practices. OWL ESG. November 22, 2022. 

https://owlesg.com/2022/11/22/the-pharmaceutical-industry-is-prescribing-more-sustainable-practices

New innovations that are contributing to industry environmental efforts. 


Medicine for the Planet: Building a Sustainable Legacy in Pharma Supply Chains

Millions of people enrolled in Medicare have benefited from the telehealth flexibilities that were granted during the COVID-19 pandemic, and, subsequently, extended in 2022. However, without Congressional action, these flexibilities will end on Dec. 31, 2024—impacting access and leading to further health inequities.

Telehealth flexibilities have played a critical role in expanding access to care and maintaining continuity of care, especially those living in rural communities and underserved areas. For individuals requiring access to advanced specialists, mental health providers, and those with mobility issues or lack of transportation, telehealth flexibilities have served as a much-needed lifeline to care.

According to a national poll conducted by the PAN Foundation’s Center for Patient Research,

 nearly one-third of adults who use telehealth services say they do so to refill their prescriptions (30%), to address less serious health issues (28%), and for mental health support (28%). Clinicians have used telehealth to expand access to care for patients and to support strong patient relationships, and they value the flexibility created by the option for remote care when clinically appropriate. Important safety-net providers such as community health centers and rural health clinics have depended on these flexibilities, as have clinicians such as physical, speech, and occupational therapists to extend access to patients.

Over the past couple of years, several bills to permanently extend telehealth flexibilities for people enrolled in Medicare have been introduced with bipartisan support. This includes the Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2023 (H.R. 4189), introduced by Rep. Mike Thompson (D-CA). While there are similarities between various telehealth bills, it is important that a final telehealth bill that is passed and permanently extends flexibilities includes the following:

Expands patient access to telehealth services by removing geographic and originating site limitations to enable patients to communicate remotely with their providers, regardless of location.

Removes distant site provider list restrictions to allow all Medicare providers who deliver telehealth-appropriate. services to provide those through telehealth. Providers would include physical and occupational therapists, speech-language pathologists, and social workers.

Ensures that federally qualified health centers, critical access hospitals, and rural health clinics can furnish telehealth in Medicare and be reimbursed fairly for those services.

Removes in-person requirements under Medicare for mental health services furnished through telehealth and telecommunications technology.

If Congress doesn't act soon, it could result in more health inequities.


Pharmaceutical Commerce - June 2024