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1rem

 interview, Vibhu Tewary, project director, IQVIA Institute for Human Data Science, discusses:

Highlights of the company’s report surrounding the “Long-term Market Sustainability for Infused Biosimilars in the US: Foundational Analytics on Emerging Risks to Sustainability”

The process that constructing and piecing together a report of this magnitude entails, along with where the idea itself came from

The ongoing challenges surrounding ASP-based reimbursement

A closed-door, multi-stakeholder virtual roundtable (based on his original report) that was previously held

Vibhu Tewary offers insight on this market segment, including a behind-the-scenes of what goes into designing a report. 

The Path Forward for Infused Biosimilars in the US

 interview, Mark Bouck, chairman and CEO of PharmAlliance, a pharmaceutical and life sciences services platform, dives into:

How PharmAlliance’s acquisition of Complete Health Economics Outcomes Research Solutions (CHEORS) helps expand global reach

The platform’s biggest goal to when it comes to CHEORS and market access services

How CHEORS helps navigate cost-effectiveness and market access hurdles

Acquisitions in the space that are currently in the works

Mark Bouck discusses PharmAlliance’s latest acquisitions, while reiterating its goals surrounding health economics and outcomes research.

Navigating Market Access Hurdles

 interview, Brandon Newman, Xevant’s CEO and founder, explores:

The implications of the Inflation Reduction Act’s price negotiation provisions, and how these could result in ripple effects across the healthcare system

The role that pharmacy benefit managers (PBMs) and other intermediaries' play when it comes to determining drug costs, and how spread pricing is involved

How Xevant helps improve drug cost transparency efforts

Strategies for affordability Newman would offer the pharma industry that can be implemented immediately

Brandon Newman joins The Pharmaceutical Commerce Podcast to discuss the evolving role of PBMs, including the importance of drug price transparency. 

A Further Examination of Pharmacy Benefit Managers

A panel examines the gross-to-net bubble across various product mixes, how pricing impacts market access, and more.  

Trade & Channel Strategies 2024: A GTN Bubble Balancing Act

Breakout session explores how direct-to-patient models shorten the time to diagnosis and therapy to improve patient outcomes.

Trade & Channel Strategies 2024: Patient-Centric 3.0 — How Direct-to-Patient is the New Commercialization Model

Access Insights Conference delves into the latest obstacles,   while mapping out potential solutions to address them. 

Conference Connect: Tackling the Issues that Matter in the Access Space

A cohort study of cancer drugs analyzes where the priorities of pricing policies should lie.

Examining Launch, Post-Launch Price Developments in the United States and Europe

Is the potential of a more formal policy integration for health issues and disease prevention a scary suggestion or a good Idea?

Policy and Population Health

PC: What roles do patient services teams play in driving adherence within the direct-to-patient model, and what tools have been most effective?

A patient service team can help from the initial script coming in through ongoing adherence and persistency initiatives. We’re going to help them understand where they from a reimbursement perspective are and keep them aware of the status. There’s a prior authorization required to help them with copay, enrollment, and affordability. They can also get help from us and other partners in the ecosystem from clinical education, ongoing medical information and support, and refill reminders.

PC: Can you share examples of how Direct-to-Patient initiatives have accelerated time to market for new therapies?

It’s not only time to market, but also faster time to therapy for a patient. It used to be, you write a prescription, maybe it goes off, maybe the pharmacy has it in stock, maybe they don’t. They might have a different product in stock, maybe they support the prior authorization. DTP can really help when that script comes in. This way, resources are in place to help a physician go through the reimbursement process and can get the product back to a patient as quick as a day. Maybe from a launch perspective, DTP can be driving awareness and help patients with self-assessment tools so they can understand what's happening. What are some of the options? It might be a physician finder or a telehealth provider, helping them get that initial access to therapy.

The "Patient-Centered 3.0: How Direct to Patient is the New Commercialization Model" panel explored the evolving landscape of direct-to-patient (DTP) models in pharmaceutical commercialization. This approach emphasizes empowering patients to understand their disease states, raising awareness, facilitating access to therapy, and ensuring adherence. The panel discussed the complexity of navigating today’s healthcare ecosystem and how DTP models address these challenges.

Key obstacles identified include payer contracts, reimbursement hurdles, and prescribing difficulties faced by physicians. These factors collectively complicate patient access to therapies. DTP models aim to simplify the process by offering greater transparency around pricing and coverage, expediting access to medications, and supporting patients throughout their treatment journey. This support extends from initial prescription authorization to affordability assistance and refill reminders, ensuring patients remain adherent to prescribed therapies.

Patient service teams were highlighted as pivotal in improving adherence through education, ongoing support, and affordability programs. These teams help patients navigate insurance processes, manage prior authorizations, enroll in copay assistance, and access clinical resources. Effective tools include self-assessment platforms, telehealth services, and physician locators, which streamline access to care and reduce time to therapy.

DTP initiatives have also accelerated the speed of therapy delivery. By enabling real-time coordination between prescribers and payers, patients can receive medications in as little as one day. The panel noted that DTP approaches drive awareness during product launches, enhance patient engagement, and foster a more efficient healthcare ecosystem.

Looking ahead, the next evolution of patient-centric models will focus on simplifying the increasingly complex healthcare environment. Innovations could include payer reforms, improved pricing structures, and enhanced pathways to ensure faster, more affordable access to therapies while prioritizing patient outcomes. The ultimate goal remains a seamless, patient-focused experience that delivers optimal care at reduced complexity.

Kevin O’Meara discusses how patient service teams influence adherence from Direct-to-Patient models. 

Latest Conference Coverage

Trade & Channel Strategies 2024: The Role of Patient Service Teams in Driving Direct-to-Patient Adherence

PC: This morning, you were part of the ‘Patient-Centric 3.0 — How Direct-to-Patient is the New Commercialization Model’ panel. Can you provide a brief synopsis of the panel?

When we think about direct to patient, it's all about the concept of helping patients understand the disease state, drive awareness, and then help them get access to therapy. It's the whole ecosystem from helping them understand the situation that they may be in, talking to the patient community, and gaining access to physicians. Whether that’s real life, brick and mortar, and then ultimately helping them get on therapy because t's never been more complicated to get through this system than it is now.

PC: What key challenges do you see drug manufacturers facing when implementing direct-to-patient models, and how can these be addressed to improve accessibility?

When I come to this conference every year, I joke that it gets more complicated. You have challenges from payer contracts, reimbursement challenges for patients, difficulty for doctors to prescribe and support reimbursement, and so that's that all makes the whole process a lot more difficult for patients get out of therapy. It’s really about helping patients get easier and faster access to therapy and then through that process, helping them navigate the reimbursement piece, simplifying it, and driving for pricing and reimbursement transparency, then helping them get to the right place to fulfill the therapy.

Kevin O’Meara discusses Patient-Cetric 3.0 breakout session and the challenges of drug manufactures implementing Direct-to-Patient models.

Trade & Channel Strategies 2024: Key Challenges of Implementing Direct-to-Patient Models 

Shaping the Future of Commercialization

, Chase Feiger, MD, co-founder of Ostro emphasizes the value of AI technology in addressing challenges in digital commercialization within the life sciences industry. The main gap being addressed is the lack of personalized, intuitive, and engaging user experiences for healthcare professionals (HCPs) and patients, especially on digital platforms like brand websites. Feiger compares traditional digital experiences in life sciences to consumer-driven platforms like Netflix, where content is personalized based on past behavior and preferences. In the life sciences sector, however, regulatory constraints—such as the need for compliance with medical, legal, and promotional review processes—complicate this kind of personalization. Despite these challenges, AI and other consumer technology solutions can be adapted for this sector, prioritizing regulatory compliance while enhancing the user experience.

The solution, Ostro, was developed with this mindset: to create a digital experience for life sciences that balances personalization with strict regulatory standards. Feiger’s team includes experts from consumer tech, privacy law, and compliance fields to ensure that the platform is both effective and compliant. Ostro aims to transform the way HCPs and patients interact with medical content.

Feiger also shares the up-and-coming trends that he anticipates in relation AI and life sciences, and how the industry can position itself to capitalize on these trends.

A transcript of Feiger’s conversation with

What emerging trends do you foresee in the intersection of AI and life sciences, and how can we as an industry position ourselves to capitalize on these trends over the next 10-15 years?

First and foremost, I think that every single brand experience 10-15 years from now is going to be vastly different in that there will be no one-size-fits-all brand.com or brand experience—it's going to be one that's really driven by personalized engagement, i.e., one that's going to understand where I am from a health literacy perspective, where I am from an HCP specialty perspective. It's one that's going to be entirely focused on things like personalization. If we look more holistically in the industry, we've seen the introduction of new technologies being able to support things like digital twins and virtual clinical trials, i.e., being able to create virtual control group solutions—with companies like Flatiron Health. I still think that there is a tremendous amount of innovation to occur, specifically on that side of the sector as well, when it comes to clinical trial research and how clinical trials are run.

I also think we're still in the very early stages for things like AI for market access and value communication, i.e., being able to leverage market access strategies to and conjoining that with a lot of what's happening in artificial intelligence. You'll be able to forecast things like payer trends, being able to optimize formulary positioning for new therapies. I think there that we're in the very nascent stages of that as well. But really where I'm going to go, and everything I'm going to hit on is all going to come back down to largely the commercial side, this idea for patient and HCP as AI to drive true personalization.

If you think about it, that is the thing that we keep hearing across the board. We've been hearing about personalized medicine for a very long time. We continue to hear about personalized medicine, but we're not actually practicing personalized medicine right now. We're practicing evidence-based medicine, which is good because we have the evidence, we have the real-world data to support the clinical decisions that we're making as providers. Imagine an era where we're doing genomic sequencing, we're looking at things like proteomics. Imagine what we're going to be able to do on the personalized level, and having all of that data from a personalization perspective to be able to support very important clinical decisions that we make. I think we are in the very early stages of that, and it'll be very interesting to see what comes in the future. A lot of that is going to tie to commercialization methodologies in some very exciting ways.

In the final part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Chase Feiger, MD, co-founder, Ostro, outlines the trends he expects to see over the next 10-15 years when it comes to the intersection of AI and life sciences.

Pharmacy Benefit Management Trends

, Albert Thigpen, co-founder, Talentwise Consulting, discussed how the panel on “Playing the Chess Endgame–Healthcare Policies Targeting Drug Commercialization” underscored the complexities of implementing the Inflation Reduction Act (IRA), predicting significant challenges for stakeholders like retail pharmacies, payers, and pharmacy benefit managers. They highlighted concerns about the unintended consequences of negotiated maximum fair prices (MFPs), particularly on the generics industry and oncology drug distribution, which could complicate decisions for companies and affect in-office dispensing practices. Overall, the panelists noted that the IRA's intricate framework might lead to unforeseen difficulties in the healthcare landscape.

Thigpen also emphasized the importance of taking a long-term and measured perspective for manufacturers when it comes to strategic approaches to pricing and commercialization in light of future US. healthcare policies. He noted that, similar to the evolving landscape of Medicare Part D over the past 20 years, the Inflation Reduction Act (IRA) will also undergo significant changes. Manufacturers should prepare for initial challenges and be ready to reassess their strategies annually, adapting to new rules and market dynamics as they emerge. This approach may involve delaying product launches or adjusting commercialization tactics based on negotiated MFPs and market conditions, akin to the strategies seen with AbbVie and Humira. Beyond that, Thigpen dove into key trends impacting the pharmacy benefit management and specialty pharmacy spaces, while providing a crash course on retail consumerism.

A transcript of Thigpen’s conversation with

Could you describe some of the key trends that are impacting the pharmacy benefit management space?

I think there are a couple of things. I think regarding the PBM benefit by itself, you have split it into two buckets. I view the PBM benefit of the vertically integrated companies very differently than the PBM benefit of a non-vertically integrated company. Just to be clear on what those are, the vertically integrated companies are those that are also tied to a rather large insurance carrier: UnitedHealthcare and OptumRx has integrated; Cigna and Express Scripts have integrated; Aetna and CVS are integrated; the true vertically integrated companies that do that, they view that very differently.

The pharmacy benefit continues to be our first line of defense for treating disease states across the board. I'm a pharmacist by training, and I love the pharmacy benefit, but it has become incredibly commoditized over the course of the years, but it's also a very valuable piece of the healthcare benefit architecture. Those vertically integrated companies, specifically in the government space, have figured out a way where they can lose money in the pharmacy benefit, but also be much more profitable in the medical space. A company like United, for example, can say, “hey Nico, I'm going to cover you as your medical carrier and also provide your prescription drug coverage through OptumRx. The premiums I'm charging you, in total, I could actually do quite well onm even though I may not be doing quite well on the pharmacy side.” Those vertically integrated companies have the ability to manage to spend very differently than a standalone PBM that is just out there, only surviving and trying to operate their business on prescription benefit drugs alone.

I think that on the surface, those two business models had very different mechanics in their trends by themselves. I think overall, cost continues to decline in general. There are still a ton of generics that continue to be very important to the pharmacy benefit. Specialty continues to be a large driver of the spend. More drugs are in the FDA pipeline that are specialty and/or rare orphan, ultra-orphan drugs that are incredibly expensive across the board. How we figure out the best coverage mechanisms for specialty, biosimilars, rare orphan, ultra orphan—these are key issues and trends that everyone is focused on. Then I would say, just as another benefit design trend, is that the cash markets continue to thrive here. Bill Roth alluded to it in his opening comments that companies like GoodRx or Mark Cuban’s Cost Plus Drugs and the like, are there for a reason. The cost or the cash pay marketplace is important because you can get drugs pretty affordable through a cash benefit, much cheaper than sometimes your drug benefit that is covered, which is something that is going to continue to rise. It plays into the knowledge and the power of the consumer, and ultimately what’s best for them.

Albert Thigpen, co-founder, Talentwise Consulting, discusses the valuable buckets pertaining to the PBM space. 

Access Insights 2024: Pharmacy Benefit Management Trends

Reassessing Pricing and Commercialization Approaches

How can one strategically reassess pricing and commercialization approaches in order to anticipate the future US healthcare policy environment?

I think it's a couple things. If I were in a manufacturer’s shoes, you have to take the long game here. You’ve got to remember that in 2026, we would have 20 years of experience of the Medicare Part D benefit underneath our belts of expertise, and how it was originally intended to roll out is not how it looks in 2026 today, and that is because every year, the federal government allows for rule changes, business model changes, and open comment periods, and that is a fluid dynamic that evolves the program over time. I say that as context, because the IRA [Inflation Reduction Act] today is going to look like a one-year snapshot in time—it's not going to be the greatest implementation out of the gate, and it will continue to evolve.

With that in mind, the manufacturers have got to take a very long view and maybe a conservative view out of the gate. They should say, “I know this isn't going to be perfect, and I know I may lose on some and win on some others, but I've got to maybe take a measured approach to the business and continually reassess it every year.” The payers are going to do the same, the PBMs are going to do the same, the retail markets and the distributors will all do the same. They can only play the cards that they're dealt in year one, then they reassess, they re-evaluate, and then wait for rule changes to occur. They kind of figured out that plan, and lo and behold, over time, we figured out somehow to make Medicare Part D successful in 20 years.

I suspect that will be some of the same cadence with the IRA and the drug manufacturers, but I do think it changes the dynamic of where the manufacturer needs to focus. For example, being fully ready to launch on day one of the PDUFA [Prescription Drug User Fee Act] date when they launch and being ready to commercialize. Then, I follow this product life cycle, and maybe, if there's an MFP [maximum fair price] tied to a drug that I'm subject to, maybe a generic doesn't launch it, maybe I need to continue to ride that out and extend that product life cycle for a period of time. It’s similar to what we've seen AbbVie and Humira exercise with biosimilars, so I think it's a measured approach. I think it is a one-year reassess every time, every year, but knowing that the rules are going to change [I would], tread lightly this year.

Albert Thigpen, co-founder, Talentwise Consulting, explains how to use these tactics in order to anticipate the future US healthcare policy environment.

Access Insights 2024: Reassessing Pricing and Commercialization Approaches

Key Nuggets Surrounding the Chess Endgame

What were the main nuggets that came out of your “Playing the Chess Endgame–Healthcare Policies Targeting Drug Commercialization” panel?

I think probably the biggest takeaway is that the IRA is complicated. The implementation of it is going to be super complex. I think the panel universally agrees that the implementation of the IRA that has implications on the retail pharmacies, the payers, the patients, the PBMs, in general, hasn't quite been architected in the way for success, and we're just planning on some train wrecks, as we had referred to it in the panel. I think that's the first thing.

The second thing is that the MFPs that have been negotiated as a result of the IRA are going to have some unintended consequences across the board to other constituents—for example, the generics industry. How does a generic company decide to launch or not launch because the MFP has already been negotiated to a very low point already, and what are the unintended consequences of that? Negotiating an MFP on an oncology drug: going forward, how much does that impact, or have an unintended consequence of a physician that does in-office dispensing? I think for the vast, high level, I would say the IRA is complex. It's not fully thought out of all the consequences that will occur. We're starting to figure out some of those solutions, but very murky waters as we know it today.

Albert Thigpen, co-founder, Talentwise Consulting, offers highlights of the drug commercialization panel that he participated in.

Access Insights 2024: Key Nuggets Surrounding the Chess Endgame

Access Insights

PC: What other sessions at the conference have you found to be the most interesting?

Well, I've been very impressed, and it certainly has fed my inherent pessimism, with the discussion about retail pharmacy, particularly as a sort of uniquely challenged aspect of the supply chain. Bill Roth had an absolutely fantastic presentation to lead off that really scoped out the many challenges and just how significant those challenges are. His takeaway was that we are really reverting to an almost pre-World War II world in which services are based on cash increasingly, and where compounding is a bigger and bigger part of the delivery of drugs to patients. But those were some really important observations there. A little later, there was a panel that talked about the state of retail pharmacy from a number of different perspectives, including large chain pharmacies, and even those big players are under huge pressure to innovate great drugs and get them through the FDA process. You can theoretically even create coverage and reimbursement for them at the payer level. But if there's not actually a means to deliver those drugs to patients, you've got a huge problem and the degree of pressure that retail pharmacies are under, certainly the independence, but even really the chains are a disturbing component of what we're facing as an industry right now.

 The implementation of the Inflation Reduction Act is expected to be challenging, with both short-term losses and operational difficulties. While the Act aims to help patients through measures like a $2,000 out-of-pocket cap and a smoothing mechanism, it may also lead to higher premiums and deductibles. Additionally, the negotiated prices might not yield the expected savings, and there could be negative consequences for biosimilars, generic drugs, and pharmaceutical innovation.

Retail pharmacy is facing significant challenges, including a potential return to a cash-based system and increased compounding. Even large chains are under pressure, impacting patient access to treatments. Other factors affecting patient access include the potential for plans and PBMs to move away from negotiated price drugs, maximizers and accumulators, and alternative funding programs involving unapproved drugs. These issues collectively pose a significant threat to patient access to treatments.

William Sarraille, professor, University of Maryland Francis King Carey School of Law, discusses other standout sessions at this year’s Access Insights conference.

Access Insights 2024: Notable Breakout Sessions

Chess Endgame

PC: You were recently on a panel entitled “Playing the Chess Endgame: Healthcare Policies Targeting Drug Commercialization.” What are the main points that the audience should take away from that presentation?

I think unfortunately, the implementation of the Inflation Reduction Act is going to be a bumpy thing, are going to be a lot of losers, at least in the short term, including patients. I think the panel was influenced by my pessimism. There were some optimists on the panel, but I was definitely the lead pessimist.

We saw some pretty significant challenges. Obviously, the statute is trumpeted as having a number of components that should help patients with a $2,000 cap on their out-of-pocket expenses over the course of the year. It’s a smoothing mechanism that will allow them to pay for their out-of-pocket costs on a smooth basis across the year. hose sound great, but unfortunately, they come with some countervailing pressures, such as higher premiums and deductibles for those patients who are under $2,000 in co-payments and co-insurance.

We also talked about some of the operational challenges that will be involved here, and I think the panel thought there were a lot of significant operational challenges. Those include whether or not the idea of having negotiated prices really are going to yield the kind of savings that MS is expecting them to, or whether plans and PBMs may actually push patients away from those drugs to high list, high rebate alternatives, whether the dynamic that's being created here will have a pretty detrimental impact on biosimilars and generic drugs generally, whether we could be on the threshold of an environment in which pharmaceutical innovation is negatively impacted. As a rare disease patient, that’s a huge source of concern for me. There are things in the IRA that are designed to make sure that rare disease development programs are not as adversely affected as other drug programs, but I don't have much confidence in those provisions, and I'm afraid that we're already seeing some very significant and negative consequences for innovation.

: The implementation of the Inflation Reduction Act is expected to be challenging, with both short-term losses and operational difficulties. While the Act aims to help patients through measures like a $2,000 out-of-pocket cap and a smoothing mechanism, it may also lead to higher premiums and deductibles. Additionally, the negotiated prices might not yield the expected savings, and there could be negative consequences for biosimilars, generic drugs, and pharmaceutical innovation.

William Sarraille, professor, University of Maryland Francis King Carey School of Law, discusses breakout session and the impact of healthcare policies on manufacturing and commercialization. 

Access Insights 2024: Playing the Chess Endgame: Healthcare Policies Targeting Drug Commercialization

Interview with Blake Powers, Part II

: With pharmacies being under pressure to lower drug-acquisition costs, how can digital formats help manufacturers better manage price based on real-time data?

 I'll start from really the pharmacy side. So pharmacy departments, whether you're a retailer or at a big integrated delivery network, they're responsible for their own P&L—their profit and loss statement—and most are leveraging strategies with revenue cycle management and reimbursement strategies, but now they're looking to the other side of the equation in terms of, what can I do from a non-labor perspective that's going to help me with my cost? And that's drug acquisition cost management. So there's definitely the pressure from the site of care perspective and pharmacy perspective to see what are some go-get goals for 2024, or the next fiscal year.

Now, from the lens of somebody in a trade function role at a pharma manufacturer—and you're maybe selling injectables into a hospital or maybe a new biosimilar has just been released. Chances are, you're probably choking on the price tags of your distribution fees, and you're concerned whether or not you're going to be able to land at a competitive price for each and every hospital, or retail pharmacy, and that's where having NDC-specific price dexterity via these digital distribution kind of models and platforms, really puts manufacturers in a better position to be nimble, to adjust when necessary, and really stay competitive. And I think, all-in-all, the theme of the piece is: doesn't that really help with the supply chain resiliency, if we have an atmosphere and environment where more and more pharma companies feel like they can compete in the space, not not just with price, but also with levels of service, with reliability, and the quality of the product? I

 What is the likelihood of NDC-specific price dexterity via these digital distribution models and platforms taking effect?

 I'm already seeing some success with my platform, Medigi, so it's having success with certain product archetypes, particularly ones that are going direct. You have generics, you have biosimilars, and specialty light product archetypes that are already trending direct, and especially when manufacturers think of it from an NDC specific mindset; it may not be applicable to their full portfolio, but there's probably certain products where they're wanting additional pull through, they're wanting increased market penetration, and they're trying to consider different avenues and direct product pathways for providers to have an optimal user experience when it comes to sourcing their treatments. We're already seeing signs of evidence that it is working, so it'll be interesting to see to what extent it's adopted in the space.

In this Pharmaceutical Commerce video interview, Blake Powers, CEO of Medigi, explains how digital formats help manufacturers better manage price based on real-time data, along with the impact of NDC-specific price dexterity.

Helping Manufacturers Better Manage Price

Interview with Blake Powers, Part 1

: You recently penned your first byline, which has appeared in the June issue of 

 What I'm doing here in the first write up is really contemplating digital platforms and dynamic pricing models, and what they've accomplished in other sectors. And really having an objective look about what it might appear if these technologies are applied to the pharma supply chain—taking a bit of a contrarian approach to some of the status quo models, and kind of looking at it from another angle and seeing what have other sectors accomplished from this kind of innovation and this dexterity with pricing, and how might it be applied to the pharma supply chain?

 Why do you believe the pharma sector is stuck in its ways, in terms of depending on older models that rely on long-term price negotiations that lock in prices?

 I think a major reason is that fragmentation in this sector is naturally creating an uphill battle for any change agent that's entering the space. In terms of looking at what other commodities and services have accomplished with dynamic pricing in these digital platforms, I think it is important to take a closer look at medications and how they're distributed. There's a certain degree of scrutiny that certainly needs to be applied, because these are life-sustaining and life-saving medications. However, in the piece, I take the stance that the status quo models have their shortcomings, and I try to highlight the benefits, and take that position of, what would digital models taking a free-market type of approach, what kind of benefits would they have for pharmacies, sites of care, and drug manufacturers?

In this Pharmaceutical Commerce video interview, Blake Powers, CEO of Medigi,  discusses his first byline with the publication, along with why the industry may be stuck in its ways in certain aspects.

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