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1rem

 interview, Steve Silvestro, president of OptimizeRx, a digital communications platform, details:

The benefits to integrating direct-to-consumer (DTC) and healthcare provider (HCP) marketing strategies with technology, especially for patients and providers

The application of artificial intelligence (AI) toward the pharma marketing stage of commercialization

Ways that pharma marketers can navigate the rapidly changing landscape of state-level consumer privacy legislation

Recommendations for pharma brands as they start to think about 2025 planning

Steve Silvestro explains the value of artificial intelligence in launch plans, benefits to integrating DTC and HCP marketing strategies, and more. 

Incorporating AI into Commercialization Plans

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

Operating Without a Commercial Blueprint: Empowering the Field for Niche Therapy Launches

A panel dives into the current and future outlook of healthcare policies. 

Access Insights 2024: Playing the Chess Endgame 

The session dives into the obstacles surrounding data usability, mandate compliance, initial adoption, and limitations in this arena. 

Access Insights 2024: Analyzing Drug Pricing and Reimbursement Data Amid a New Wave of CMS Price Requirements 

The conference’s opening keynote sets the scene for 2025 and the years to come. 

Access Insights 2024: Commercialization’s Financial Headwinds and Tailwinds

Why this trend is occurring and ways that drugmakers are pivoting in order to remedy the situation.

Who Moved My Prescription? Part VI: Abandonment of Branded Prescriptions

Reassessing Pricing and Commercialization Approaches

, 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

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.

Latest Conference Coverage

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

Financial Headwinds

PC: What were some of the main talking points of your “Financial Headwinds and Tailwinds to Commercialization” keynote speech?

 I wanted to conclude something I started last year, which was the move my prescription presentation. Around two and a half years ago, we started getting calls from general medicine manufacturers, and they were hearing that patients weren't able to get their products. We had always taken that part of the industry for granted. It just moved slowly, and it took us a while to unearth what the problems were with it. The generics just kept deflating after the patent clip that started in 2017 and they reached a point now where some of the nation's pharmacies are literally losing between $1 billion to $3 billion a year on brands, and we have verified it over the last two and a half years, where launching a brand in a retail space is incredibly difficult right now.

So, 92% of what flows out of a retail pharmacy is generics, and that's where they make all their money, plus a cover a portion of the loss of their brands. Of the remaining 8%, 6.4 is top 100, so they have to have those, or they lose foot traffic. But the rest of it, the 1.6% that's left, that's the space in which all new items have to launch. There are 4,400 brands in that space. The pharmacies don't have it on the shelf, and a lot of these newer products are coming with prior authorizations and step edits. We’re seeing rates of abandonment between 40% and 50%, and manufacturers are realizing this more and more, and they're calling back. The industry is trying to respond by offering new models, such as digital pharmacies tech enabled hubs, but there's really no silver bullet to it. Patients are struggling to get access, and new non-specialty brands are struggling with this new model.

The reason I felt that it was important to talk about is because I don’t believe many people are aware, because the data that we need to highlight it, it's not available in any third-party data set. The e-prescription that flows through to the pharmacy is not picked up. So, the first time we as manufacturers can see the problem is in claims data, and that's where we have the 40% front end abandonment before we even run a test claim. That’s just become very problematic.

The second piece is seeing the problem and knowing what to do with it. This where I’m personally frustrated right now with a lot of the industry, because the market research leads understand it. I think the channel people understand it. But because the gap in the gross tenet is so great, the upper management of the pharma companies are trying to go in and they’re realizing how much has changed. Without the data, they don’t know what to do. The industry is either grasping at straws or not doing anything.

For now, our mission is to go therapeutic area by therapeutic area, product archetype by archetype, and drug class by drug class, and figure out, how do we optimize? These days, manufacturers are launching it typically takes nine to 10 months to establish a formulary position. In the meantime, you want to get demand flowing for your product, so they're finding ways to basically compensate pharmacy for the dispense without the drug being covered. But they're establishing a $35 copay. It’s a money losing proposition out of the gate, they're not standing up cash offerings, which I think is really where this should be going, and not just running at a loss leader position, because even as they establish the formularies, they are having trouble weaning themselves off those affordability programs.

We’re seeing to nets in the 70% to 80% that are that are persisting, even post-formulary coverage. As these manufacturers grow, they don't know how to pull it back, where to pull it back. So, our CEO talked about this. Really, we have to connect the commercial silos of the departments and make sure that the chief commercial officers understand how all these pieces are moving. Unfortunately, I'm being more unsuccessful than successful at the moment, and I'm not going to give up on it, because it's a big problem for our entire industry. We're facing the IRA, we're facing MF, we're facing MFPs, and we're still thinking through the ripple effects of what all that means to our industry.

The pharmaceutical industry is currently facing significant challenges, particularly in terms of product access and commercialization. Factors such as pharmacy economics, prior authorizations, and step edits are making it increasingly difficult for manufacturers to launch new brands in retail settings. Additionally, the growing prevalence of generic medications is contributing to these challenges.

To address these issues, manufacturers are exploring various strategies. These include greater collaboration with stakeholders, increased use of data and technology, and innovative approaches to product launch and commercialization. However, the industry still faces significant hurdles, and finding effective solutions will require continued effort and innovation.

By leveraging data and technology, manufacturers can gain a better understanding of the challenges they face and develop more targeted and effective strategies. Additionally, increased collaboration between stakeholders, including manufacturers, pharmacies, and payers, is essential for addressing the complex issues facing the industry.

Bill Roth, General Manager, Managing Partner, Blue Fin Group, discusses the key takeaways of this year's keynote speech. 

Access Insights 2024: Financial Headwinds and Tailwinds to Commercialization

Cencora ThinkLive CGT

: Cencora’s ThinkLive Cell and Gene Therapy Summit was an inaugural biopharma event dedicated to exploring the future of cell and gene therapies (CGTs). Could you expound on the goal of this event, and what excites you the most about it?

At Cencora, we really believe in cell and gene therapy. There’s so much promise for patients around the world, and we’re just thrilled by what has been achieved in the last five years. There are approvals in the US and Europe, there's a lot more in the pipeline that are coming. From what we can see, we're not entering a new era, where you have new modalities, or they're reaching the markets, and you have other pipeline assets that are targeting larger patient populations. If you think about the green pipeline and the potential, there is so much that's out there. At the same time, the path to commercialization is quite complex. There’s a lot of barriers and challenges that can really impact the success of the products and ultimately, patient access. So, at Cencora we partner with cell and gene therapy companies to provide what we call end to end solutions to help them bring their therapy all the way from discovery through commercialization.

The goal of the summit was to bring our leaders together from across the industry. We had representatives from biopharma companies, patient advocates, advocacy groups, trade associations, and the FDA to really foster that collaboration. I think best practices that will really support a lot of companies that are out there developing and trying to figure out how to really focus on their commercialization. I am most excited by the level of engagement, and the knowledge sharing that has occurred. I think all of this will ultimately support the growth of the sector and ensure more patients can benefit from these groundbreaking therapies.

: What specific trends in the space have been instrumental in driving the commercial success of CGTs?

The short answer is early planning. So, I’m a music fan. If you think about the commercialization process, that is cell and gene is like conducting a Mahler symphony, you have a lot of players. The music score is complex, there's so many moving parts. If you put that framework within the context of drug development, commercialization, similarly, you need to work with a lot of different stakeholders in that planning and execution process. I would say there's a couple of critical areas including patient access and support, regulatory strategy, supply chain design, market access, and then the overall stakeholder engagement. When we were putting together our meeting, we're very intentional in building out an agenda that really reflected all these crucial areas, and that we incorporated a different perspective. I know we talked about from pharma companies that participated, we made sure that we have leaders who've kind of been there. They’ve navigated through that so that they can share their perspectives.

We continue to really focus on best practices. We talked to a lot of companies. If you think about one example, and that is payer engagement, it is something that really needs to occur way early in that development cycle, understanding the payers’ expectations so that your evidence package can ultimately showcase the therapies benefit, and to justify the cost and to address the payer concerns and priorities.

The last piece I'll say as part of the early planning and going back to my analogy, being able to work cross functionally, being able to have that perspective as you develop your strategy is critical. That means you need to have crucial conversations around the different parts of the organization and an understanding the interdependencies between research development and commercialization.

In an interview with Pharma Commerce Editor Nicholas Saraceno, Lung-I Cheng, PhD, VP, Head of Cell & Gene Therapy Service Line, Cencora offers his thoughts on Cencora's inaugural ThinkLive Cell and Gene Therapy Summit.  

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