Changing the Pharmaceutical Commercialization Landscape

By Leslie Orne, President and Chief Executive Officer of Trinity Life Sciences

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The pharmaceutical commercialization landscape is becoming increasingly complex. Tried and true paradigms for capturing market share and securing reimbursement must evolve in the face of demand for novel pricing models, challenges in capturing and retaining physicians’ attention in an increasingly crowded marketplace and meeting the needs of patients who are empowered to play a greater role in their health decisions. Over the two decades during which I’ve helped diverse companies across the pharmaceutical industry plan, execute, assess and refine their commercialization strategies, I have learned the only constant is the importance of recognizing the need for and ability to adapt to change. 

Within the ever-changing landscape of commercialization, three emerging trends have the power to reshape multiple aspects of the commercialization process. These include: 1) the value of taking a phased approach to product launches, 2) the rapidly expanding potential of artificial intelligence (AI) based technologies to optimize multiple aspects of the commercialization process, and 3) the unprecedented degree to which the pricing of pharmaceutical products is under a microscope.

A Phased Approach to Product Launch

The common belief that the overall success of a new drug launch is determined in the first six months following approval has shaped stakeholders’ expectations. According to a Trinity analysis of actual sales compared with Wall Street expectations, a growing number of pharmaceutical launches—62% of the products launched between September 2019 and December 2021, including 24 out of 28 non-rare, non-oncology products—underperformed expectations. But are these failures, or should launch strategies and expectations evolve in the face of rapidly changing consumer and prescriber behaviors?

Rather than the “go-big-or-go-home” approach that is needed to reach peak sales in a short period, a phased launch approach may be more sustainable and enable maximum market penetration and commercial success, with less upfront commercial investment. At Trinity, we designed a phased approach that starts with the basics and expands based on real-world data for patient and physician engagement:

1. Achieving Access: Building evidence and access to ensure product gets to patients seamlessly
2. Fit-for-Purpose Field Development: Developing a customer engagement model that optimizes demand
3. Expand as You Go: Adjusting and expanding as launch progresses

In addition to changing launch strategy, pharmaceutical companies also need to manage stakeholder expectations about the pace of uptake and help them move from the entrenched focus on short-term gains to understanding the benefits of a slower climb toward potentially greater peak sales.

The Rapidly Expanding Potential of AI-Based Technologies

For pharmaceutical commercialization, effective use of AI holds great promise in optimizing a variety of launch and marketing strategies and spend. Artificial Intelligence and Machine Learning (AIML) is here to stay and understanding the basics and harnessing the potential of advanced analytics and AI is imperative for its effective deployment across commercial operations activities. 

Patient finding is one of the most exciting applications of AIML in the commercialization arena. At Trinity, we believe there are four key pieces to patient finding:

1. Identifying, collating and integrating the right data
2. Defining the appropriate test population
3. Building the right features in the model
4. Planning and executing actions once you’ve found the patients

Pricing of Pharmaceutical Products is Under a Microscope

The pricing of pharmaceutical products has come under intense scrutiny in recent years, sparking widespread debate and concern. This includes the Centers for Medicare & Medicaid Services (CMS) coverage rules for innovative medicines, such as those for Alzheimer’s disease and provisions within the Inflation Reduction Act that authorize Medicare to negotiate directly with drug manufacturers to lower the price of some of the costliest single-source brand-name Medicare Part B and Part D drugs. Together, these efforts demonstrate payers and legislators are taking action to address drug prices and, whether the above-mentioned efforts succeed, these actions are likely to continue. Consequently, the ability to develop compelling value propositions and pricing models that distribute risk among payers, patients, and pharmaceutical companies is essential.

There are many factors to consider when pricing novel therapies that have the potential to transform disease outcomes, like gene therapies. Companies should carefully consider their pricing strategy as flexible pricing approaches can aid in payer negotiations and assist in unlocking access to large segments of the eligible population. Designing clinical trials to ensure they generate the data needed to demonstrate health economic benefits is also critical for obtaining pricing that reflects the value that a new therapy brings to patients and payers.

Trinity is a Constant in the Evolving Landscape of Pharmaceutical Commercialization

Change is inevitable, and Trinity understands there are human consequences to every decision, and every decision impacts a life. With Trinity’s deep industry expertise, powerful tools, and focus on evidence-based insights, our commitment and ability to help our clients succeed will never change.