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:
Read the full article on PRMA Consulting’s website