CapSys Group’s latest global research, reveals that the pre-external trends that the global pharmaceutical and life sciences industries are facing continue to intensify. Although bringing products to patients and gaining access should be the responsibility of the whole organization, Market Access teams carry the most considerable burden in addressing payer expectations, evidence requirements, pricing pressures, and cost of assets and market competition. In doing so, organizations and their Market Access teams are having to re-evaluate their working strategies to address these growing demands. Based on the input of Market Access leaders, experts at CapSys identify six success requirements to enable market access to strategically withstand market pressures and achieve Market Access Excellence.
‘Re-thinking Market Access’ is CapSys’ global study of Market Access which aims to understand the current challenges and trends that the Market Access function face today. The research derived implications and levers of success for the organization on a strategic and practical level. Subsequently, CapSys provides a systematic approach along the success levers to assess performance and develop solutions to overcome the challenges.
Through interviews with global and regional Market Access experts and key opinion leaders (KOLs) from pharmaceutical and life sciences organizations, CapSys identified the three primary and most challenging external trends for the Market Access function. Although they are well known, these market trends are becoming increasingly demanding, requiring stringent assessment and development of a targeted and concerted response by organizations and their market access specialists.
Major External Challenges Facing Market Access are Well-Known but Increasingly Demanding
Figure 1: Pre-Existing challenges that impact Market Access Excellence. CapSys Group
Regulatory approval ensures that a safe and efficacious product is available to the market, while payer approval is crucial for market access, commercial viability, and success in the market. Evidence requirements to achieve regulatory approval can differ substantially from those required to address payer or HTA needs and, in some cases, may be difficult to reconcile. must demonstrate added value beyond the clinical evidence required for regulatory approval. Added value can include additional medical, societal, economic, or quality of life benefits and cost-effectiveness compared to the current standard of care to receive coverage from payers. Further, evidence requirements differ from payer to payer across reimbursement systems, with even more pronounced differences across geographies. These differences can result from varying constraints on budgets or resources and variations in standards and policies. Variations in evidence requirements are also apparent across therapy areas due to differences in the disease landscape, such as patient populations, unmet needs, and available treatments.
With new, innovative, and higher-cost products constantly entering markets, payer expectations are becoming more demanding and evidence requirements even more rigorous. For instance, with increasing complexity of therapies in some disease areas, such as onco-hematology and rare diseases, payer or HTA appraisal processes may also become more challenging or require longer timelines. Organizations and their Market Access functions face significant market access hurdles in ensuring adequate demonstration and communication of value for their products. The rising scrutiny from payers across various landscapes adds pressure to generate the right quality and quantity of evidence while addressing market-specific requirements.
Early planning and preparation are essential for optimal payer acceptance and coverage and optimizing access conditions. Organizations need to gain insights to understand how payers will evaluate their data. Further, they need to identify potential evidence gaps and define an evidence generation plan early in the product lifecycle to address them. Organizations can then gain better visibility on their HTAs and understand the outcomes.
The rising cost of healthcare due to population growth, an aging population, increased prevalence of chronic diseases, and the recent COVID-19 pandemic has led to increased healthcare utilization. Subsequently, innovations and an emphasis on personalized care and specialty medicines, for instance, are resulting in inflation in healthcare service costs and rising drug prices. These lead to burgeoning healthcare expenditures, forcing governments, payers, and healthcare systems to attempt to reduce the impact by becoming increasingly cost-conscious and applying cost-containment measures. Consequently, pharmaceutical and life sciences organizations face increasing pressure to reassess their market access strategies or evaluate their internal effectiveness.
Market access strategies must consider the target market and may aim to reduce the prices of medicines or demonstrate cost-effectiveness (as in the UK) and added therapeutic benefit (as in Germany). Variations in payer or healthcare systems and their requirements occur at the country and regional levels. The disparities in their available budgets and resources add weight on medicines manufacturers to provide more substantial evidence, such as added benefit, to justify higher prices. Organizations increasingly face tougher negotiations with payers demanding more attractive or flexible pricing and payment models, such as value-based and outcomes-based payments.
Payers are adopting more restrictive practices in response to increasing market and price competition from the market entry of new, cheaper, or more innovative products. Notably, these challenges arise in increasingly crowded and saturated markets, such as those facing generic competition and those with smaller patient populations with high unmet needs, such as rare diseases. Identifying or addressing a clear unmet need, showing product differentiation, or demonstrating added benefits is more difficult in these scenarios. Cost-containment measures to tackle high drug prices have significantly impacted pharmaceuticals, such as biologics, which face generic or biosimilar competition upon patent expiry. With payer and healthcare systems incentivizing the development and uptake of these more affordable medicines, there is pressure on brand product manufacturers to prove the superiority of their therapies over the alternatives.
Underfunded, under-resourced, and overburdened payers or healthcare systems are faced with difficult decisions to redefine their priorities beyond clinical effectiveness and may be more open to commoditizing innovation over existing or me-too medicines. Payers are increasingly coFor instance, cell and gene therapies maximize the advances in medical technology for more personalized and targeted treatment. Despite often exhibiting higher costs, they demonstrate benefit by addressing previously unmet needs and smaller patient populations, often gaining accelerated market access.
However, it is important to note that HTA appraisal methods have not evolved at the same pace as innovation in certain disease areas, e.g., where therapies are showing early positive outcomes such as outstanding results in Phase II trials yet immature overall survival data. Engaging with payers to jointly evolve and shape appraisal methods is vital to ensure patients have timely access to these therapies. Further, early and continuous collaboration between Market Access and Clinical teams is fundamental to ensure clinical trials are designed to address different stakeholders’ requirements.
The Market Access function plays a pivotal role in a product’s commercial success and should be best positioned to seize market access opportunities and overcome market challenges. CapSys identified six technical and organizational success requirements to enable Market Access functions to strategically evaluate and respond to the external challenges and achieve Market Access Excellence in this rapidly evolving landscape (Figure 2):
Figure 2: Six Success Requirements for Achieving Market Access Excellence. CapSys Group
Four crucial technical success requirements should be considered and implemented to achieve excellence in Market Access:
Furthermore, two organizational success requirements form the fundamental bases for these technical success requirements to be assured:
Implementing these six success requirements will be paramount in enabling pharmaceutical and life sciences organizations and their Market Access teams to address the identified market pressures and achieve Market Access Excellence. The six success requirements will be described in more detail in the upcoming insights within the ‘Re-thinking Market Access’ series. Sign up here to receive upcoming articles in this series.
This article is the first in a series of eight insight articles based on CapSys’ global ‘Re-thinking Market Access’ study and focused on Market Access Excellence in Pharma and Life Sciences. The six following insight articles (Insights 2-7) provide key content and food for thought on the six success requirements for Market Access Excellence, including observed common shortcomings and improvement opportunities. The final insight article in the series (Insight 8) provides a framework and (self-)assessment tool, the ‘Market Access Excellence Canvas’, to assess your organization’s maturity level and potential gaps to close on the journey to achieve Market Access Excellence. Sign up here for upcoming articles in the ‘Re-thinking Market Access’ series.
Consultant at CapSys Group
CapSys provides top-tier management consulting support on strategy and execution topics. We are sector experts in Life Sciences and have a unique business model that provides flexibility and reduces risk for clients while maximizing impact.
At CapSys Group, we support our Life Science clients to overcome their most difficult growth challenges by:
- Strategic advisory to unlock growth
- Embedding capabilities to sustain value-adding growth
- Enabling execution & change to activate growth
CapSys Group’s ‘Re-thinking Market Access: An Overview of Key Challenges for the Pharmaceutical Industry and a Framework for Success’ is a global study of Market Access. The study aims to understand the current challenges and trends that the Market Access function is facing today, derive implications and levers of success for the organization, both on a strategic and practical level, and provide a systematic approach along the success levers to assess performance and develop solutions to overcome the challenges.
‘Re-thinking Market Access’ was conducted through interviews with global and regional industry experts and key opinion leaders in Market Access, from small to large pharmaceutical and life sciences organizations. Contributors had broad therapeutic area expertise, including oncology, orphan diseases, and dermatology.
There is a wealth of additional insights from the expert interviews. If you want an in-depth discussion on the gathered insights or a conversation on the implications for your company, please get in touch with our CapSys experts, Patrick Koller and Kenneth Weissmahr.