Women in STEM: Building Sustainable Cost and Access Models for Advanced Therapies (Part 1)

*Full transcript available below

As cell and gene therapies (CGTs) move from scientific breakthrough to commercial reality, manufacturers face mounting pressure to design sustainable, patient-centered models. In a discussion with BioPharm International® as part of its Women in STEM coverage, Anna Catalanotto, director of Advanced Therapy Commercial Strategy at Cardinal Health, outlines how integrated commercialization planning can support both near-term launch readiness and long-term access.

Catalanotto emphasizes the importance of “starting with the end model in mind,” mapping out distribution, evidence needs (clinical, safety, and economic), and the treatment site network long before a CGT product launch. Equally critical is understanding the full patient journey, including when patients are diagnosed, how they move through the system, and what support they and their caregivers require. Treatment centers also need clear plans for staffing, education, and patient support to ensure they are ready for patients on day one.

How can early commercialization planning support long-term access?

Catalanotto stresses the need to integrate the payer perspective early, ensuring payers understand the therapeutic area, unmet need, and clinically meaningful endpoints. That foundation helps manufacturers generate the right data and education to support durable coverage decisions.

Cost and reimbursement structures are another linchpin for sustainability. As Catalanotto notes, “The cost structure and reimbursement of these complex, highly personalized treatments is really critical for commercialization and for access.”

Transparent, predictable models are essential for providers that often pay upfront, as well as for payers evaluating long-term value. Looking ahead, she sees growing interest in outcomes-based contracts, milestone or durability-based models, and alternative financing approaches, all solutions that will require cross-industry collaboration to sustain these high-cost, life-changing therapies.

About the speaker

Anna Catalanotto, Director, Advanced Therapy Commercial Strategy, Cardinal Health

Catalanotto drives commercialization strategy and market access initiatives for CGTs at Cardinal Health. She works with biopharmaceutical manufacturers, payers, and health systems to build integrated solutions that accelerate patient access to advanced treatments. Before joining Cardinal Health, Catalanotto worked in life sciences consulting, specializing in CGT and rare disease. She advised leading biopharma companies on go-to-market strategy and market access planning, across patient, provider, and payer engagement strategies. Catalanotto holds a Bachelor of Science in Biology from Davidson College and is passionate about supporting patient access to innovative therapies that have the potential to redefine treatment possibilities.

Transcript

Editor's note: This transcript is a direct, unedited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

Speaker 1

Anna catalanotto, I'm a director on the Cardinal Health Advanced Therapy Solutions team and at the ATS team at Cardinal Health, we really work across our different business units, from regulatory sciences, distribution and three PL, Patient Support Services, market access, consulting and more, to really bring tailored solutions to Advanced Therapy manufacturers

for the long term sustainability of cell and Gene and other advanced therapies. I think it's really important to start the commercialization plans really early and starting with kind of that end model in mind. So thinking about the distribution the evidence needs, whether that's clinical safety, economic information, thinking about the treatment site, network that's going to offer and administer these therapies, thinking about the patients and the patient journey and where these patients are. So thinking about that kind of endpoint in mind, and building the commercial commercialization plans early around that model, and then building to strengthen that model and that ecosystem around the patient and product journey. So again, thinking about what the treatment centers that are going to be administering these products need the level of potential resourcing or education that might be needed, the level of patient support that's going to be needed, and making sure that those things are all built and configured and ready to support the patient and product journey on day one, and then thinking about, you know, how that product is going to evolve in the market, and thinking about the scalability of that product and potential access of that product to patients down the line. And then the other piece that I would also mention is the importance of integrating the payer perspective early and, you know, ensuring that there's a strong understanding of Payers awareness of the therapeutic area of the patient need, the unmet need, so often, for these indications and for these patients, and getting that perspective on potential clinical endpoints, making sure that there's, you know, payer awareness around the clinical meaningfulness of those things, and then also making sure that, you know, as the manufacturer, they really understand what sort of additional education resources data is going to be needed to best communicate the clinical and economic value of that product, so that the payers have what they need For Long Term coverage and patient access.

The cost structure and reimbursement of these complex, highly personalized treatments is really critical for commercialization and for access. So the cost structures, you know, they really need to be transparent and predictable for both treatment sites, payers and patients and so from a cost structure perspective, you know that transparency and predictability for the payer to be able to evaluate the long term value is really important, especially for these, again, very complex, often one time therapies that have a front loaded cost. Oftentimes, you know, that high upfront, one time cost, potentially so from that, I think we see kind of growing interest in more innovative pricing and reimbursement models. We see that through outcomes based agreements and contracts different models that might be milestone or durability based, you know, potentially rebate, rebate models based on the outcomes, or other, you know, alternative financing models. So I think that you know that that cost structure piece, it's something that payers are, of course, paying a lot of attention to, to understand how the how the covering these therapies is going to impact their plans, but also understanding from the provider side as well, making sure that the reimbursement plan is very clear for them, so that they are able to have that predictable reimbursement when they're oftentimes the ones ordering and kind of paying upfront for these therapies. So I think both from the payer and provider side, it's really important to have that kind of transparent and and clear pricing model. But as we look toward the future, you know, will be really interesting to kind of see how we can collaborate across the industry to create those more innovative models to help the sustainability of these extremely life changing but also high cost therapies.