Market access update
Preparing for market access success in a crowded landscape: learnings from a plaque psoriasis case study
Written by Roslyn Weaver
‘For successful market access in a crowded treatment landscape, early planning is the key,’ says Roslyn Weaver, Associate Director. Sharing learnings from a plaque psoriasis case study, Roslyn explores key challenges for manufacturers and presents a four-tiered approach to gathering strategic information that supports planning and decision-making.
The heightened challenges for market access in a crowded treatment landscape
In the years leading up to launching a product, much work needs to be done to prepare for successful market access. Understanding the disease burden, which patients will most benefit from a new therapy, the position in the treatment pathway, potential areas of differentiation, and payer evidence requirements in target launch markets all must be planned and executed well in advance for the best chance of getting the product to the patients who need it.
These challenges are exacerbated when the treatment landscape is already crowded. What can be done when the product is entering a disease area with multiple current and emerging competitors? When there are already other products in the same therapeutic class, what are the risks of being seen by payers and clinicians as a ‘me, too’, rather than meeting a genuine unmet need and delivering another valuable option to patients? How can we differentiate across or within classes when an additional benefit may appear marginal? Add in challenges of changing goalposts for trial endpoint thresholds and pricing implications for emerging biosimilars in the field and the path through these obstacles becomes harder to navigate.
Market access challenges for moderate-to-severe plaque psoriasis
This case study is from a dermatological disease that exhibits all the hallmarks of these challenges: moderate-to-severe plaque psoriasis. More than a simple ‘skin’ problem, moderate-to-severe plaque psoriasis is a chronic inflammatory condition affecting around 1–3% of the population, with psoriatic arthritis a common comorbidity. The condition can exert a substantial clinical and psychological burden on patients, adversely affecting employment, relationships, study, and activities of daily living, even leading to disutility scores in line with some cancers.
Moderate-to-severe plaque psoriasis is also a crowded space – the last two decades have been busy. The biologic era began with the introduction of TNF-inhibitors in the 2000s (etanercept, infliximab, and adalimumab), which were the reigning modality for years, followed by the IL-12/23 inhibitor ustekinumab in 2009. From 2015, an ever-increasing array of biologic options with different targets began emerging: IL-17 inhibitors (secukinumab, ixekizumab, brodalumab) and IL-23 inhibitors (risankizumab, guselkumab, tildrakizumab), another TNF inhibitor (certolizumab), and biosimilars of the original TNF inhibitors. Outside biologics, a small molecule agent PDE4-inhibitor, apremilast, also became available.
With new products and classes come new challenges:
- Changing goalposts for trial endpoints, with efficacy thresholds increasing (e.g., PASI moving from 50 and 75 to 90 and 100) and a shift to proprietary PRO endpoints, informed by extensive patient insight to capture elements not adequately addressed in existing measures, particularly itch and pain. These bring challenges for payers to compare therapies.
- A shift towards head-to-head trial designs, rather than earlier trials which were more likely to use a placebo-controlled design, reflecting a then-smaller market. This is further complicated both by choice of trial comparator, with superiority often harder to demonstrate against adalimumab or newer agents (e.g., IL-17 inhibitors) than earlier agents, and by increasing difficulty evidencing anything more than marginal incremental benefit on higher PASI thresholds.
Learnings for market access success in a crowded landscape
It’s clear, then, that companies in this area face a number of challenges in a crowded landscape. The first step is identifying changes over time, followed by planning evidence packages that will satisfy payer requirements in markets of interest. Work must also be done to understand the optimal patient – where in the treatment pathway does the drug best fit? Are there particular patient populations that are underserved by existing therapy and might benefit most from this new drug?
We worked with our client over a four-year period to develop a robust review of key evidence in the area, considering the shifting therapeutic landscape, efficacy thresholds, trial design, and the burden on patients.
A review of this kind is best seen as pieces of a puzzle that must be carefully assembled to give a bigger picture – too much data and it is easy to become overwhelmed by the wealth of information; too little and it is easy to miss the nuances of unmet need and burden that can help understand the value of a particular therapy.
A four-tiered approach to gathering strategic information that supports market access planning and decision-making
We chose a four-tiered approach to putting together a robust, bigger picture to help our client’s decision-making and planning.
- Targeted literature searches identified key publications in epidemiology, disease background, burden, and therapeutic landscape.
- HTA reviews provided a clear understanding of emerging patterns for payer expectations.
- Pricing analyses gave a valuable level of context.
- Primary research teased out the nuances of clinician and payer decision-making to layer over the other research.
The result was not simply a one-off review, but a document of key strategic information that helps challenge our client’s thinking about where they can differentiate and the extent to which their data will support value messages, helping inform strategic decision-making and further evidence generation to address priority gaps. The work can also be used to inform the development of a global value dossier to support payer submissions. This kind of planning ahead is the best way to anticipate and meet challenges in any therapeutic area, align the client’s team in strategic thinking, and prepare the evidence which payers will require for market access success.
What do you want from a strategic market access consultancy?
PRMA Consulting is a member of Fishawack Health; together, our agile, integrated, and tailored solutions ensure you’re one step ahead – from laboratory asset to launch and beyond. We are always happy to have a confidential chat about your complex and evolving value, evidence, and access needs; please get in touch.
Vaccine reimbursement: helping you prepare for success