OR WAIT null SECS
© 2023 MJH Life Sciences™ and Pharmaceutical Commerce. All rights reserved.
Drawing on best practices distilled from recent engagements across a range of pharma organizations, Richard Ogborne and Chris Reynolds discuss how cross-functional pharma commercialization teams might adapt from traditional models to hone their role within clinical management pathways, communicate value to all stakeholders, achieve excellence in evidence generation, and maximize the opportunities of digital technologies.
Most pharma organizations know and accept that commercialization planning should start much earlier in the product development lifecycle. The pressure to be more forward looking is increasing, given the growing sophistication of therapies and the rising financial challenges facing healthcare systems. So, how can companies deliver the shift that’s needed, going beyond traditional sales and marketing planning to create a commercialization capability that will achieve greater success?
From our recent discussions with clients about the growing impetus for change, and the new ways with which brands must differentiate themselves in the market now, some strong themes have emerged.
The need for revised commercialization models is being driven by:
The companies that are successfully aligning their commercialization strategies with accelerating healthcare transformation, through sufficiently early planning, are finding that they can differentiate their organizations and individual product brands in new and important ways. They are able to create and communicate richer value propositions that resonate across the different stakeholder groups, for instance. And they can continue to build and enhance the economic case for their products with insightful data captured post-launch, through strategic real-world evidence capture. Harnessing digital diagnostic and monitoring tools and co-creating digital patient support platforms are potential examples .
Adequate resourcing and the right capabilities across the cross-functional team are key to providing the platform. Having people with specific expertise in the right areas from across adjacent disciplines (medical affairs, clinical, market access), for instance, with capabilities and expertise—e.g., around digital health tools and intelligent data analytics—is becoming increasingly important.
Transformed commercialization strategies, then, start with pooling resources, talent and knowhow from across the key internal teams, and looking to plug any gaps in knowledge and capability through strategic hiring and targeted external partnerships.
From a point of acceptance that change is inevitable, a cross-functional team, incorporating Medical and Clinical representatives initially, can start to look more closely at existing patient pathways and treatment guidance, to map and understand where there may be new opportunities for the pharma company to add new value and gain more visibility and influence.
Equipped with a fuller appreciation of existing patient pathways and official guidance, the cross-functional team can start to explore how they can look to improve the uptake of their drug or therapy within that pathway. By mapping out care pathways in hospitals—the specifics of how the patient flows through the system, and where they're likely to receive the given therapy—they can start to understand gaps in care and build quality metrics and improvement plans to address them.
Unless there is a physical hurdle , barriers may be addressable through improved, targeted value communication—not just about the efficacy of the therapy, for instance, but also about its known impact on patient quality of life, on the length of hospital stay, on reduced cost of care.
While the relative emphasis of the value proposition is likely to vary by stakeholder group (physician vs. payer/insurer vs. patient), the richer the data package that’s built as a drug is developed, put through trials and finessed for launch, the stronger the impact as commercialization teams start to talk about the product in the market.
This points back to the criticality of early commercialization planning—and the design of clinical trials, planning for target indications, and the need to ensure that the right data is being captured from the outset to support initial and future market messaging, ongoing reimbursement cases, and pricing negotiations into the long term.
Communicating and potentially extending its value proposition is hugely important in the age of more personalized treatments that are very costly to develop yet have only a finite market (e.g., in the case of very rare diseases, and subsectors of oncology where patient populations are small).
Opportunities here include designing Phase III registrational studies with economic endpoints in mind, as well as pragmatic post-launch/phase IV studies for real-world evidence generation, which support a compelling value proposition for all stakeholders (physicians, payers, patients, providers).
Real-world evidence is a powerful means of justifying the investment long after a new treatment has entered the market, not just as part of required pharmacovigilance/safety monitoring, but as a means of demonstrating and quantifying the value experienced by healthcare providers, payers and of course patients.
This is one area where digital health applications can play a strategically important role, simultaneously adding value for patients and healthcare providers by extending monitoring and support beyond a hospital setting and provide a vehicle for tracking how patients fare, feel and draw on healthcare resources over time. The digital health intervention may itself be part of the solution (reducing dependency on in-person interventions), but even if it is purely a support platform it can play an important role in gaining feedback about how a patient is responding to a drug, and how it is transforming their day-to-day life and mental wellbeing while reducing their dependency on health services.
The opportunities to harness digital platforms and apps, touched on above, are a subject in their own right and this scope will only grow and deepen over time. For now, the important thing is to recognize and plan for these opportunities, sufficiently early in the development cycle for a new or repositioned product brand.
Strategic opportunities for digital interventions need to be incorporated into pre-launch and brand planning processes based on what by now should be a richer and more nuanced understanding of the patient pathway and where any current gaps might be (which pharma companies could help to fill). Options range from digital pathology tools to identify patients; use of wearables to detect disease-related events; and the collection of real-world evidence data, as already referenced.
The good news is that leading pharma companies are already pushing the envelope and looking to smarter trial design, evidence positioning and value proposition building as new levers for differentiation, recognizing that a shift in commercialization strategy is paramount now, and that embracing it will unlock new opportunities.
The challenges that remain have to do with time, resourcing and cultivating the right balance of skills and experience to do more of this early groundwork, well before the product launch. Ideally, strategic commercialization activity should begin at the point of Phase III, or even Phase IIb investment decisions, when a cross-functional team spanning market access, medical affairs, real-world evidence and commercial roles can help de-risk these decisions, by building the bigger market story around the overall value proposition of the product.
Beyond scoping and looking at ways to capitalize on the wider opportunities, companies need to think about building optimal market access plans and pursuing fair pricing and reimbursement—again with the fullest view of the opportunity, and by capturing and harnessing the right combinations of data at each juncture. Where available resources really are a sticking point, the case for starting sooner is all the stronger.
Richard Ogborne (email@example.com) is a Partner at Vintura, which provides strategy consultancy to pharma and healthcare providers that are embracing transformation. Chris Reynolds is a Director at Vintura and has extensive expertise in providing advice to biopharma leaders from global to local country affiliate.