Andre Moa
1 Oct 2024
5 minute read
Market Access 2025, a new report from TRiBECA Knowledge, offers a fresh perspective on how the market access landscape for medicines continues to raise the bar for launch success and consistently better patient outcomes.
The ultimate goal of drug development is not just regulatory approval and launch impact, but achieving optimal market access (MA). This involves entering multiple markets with an appealing and versatile product profile, refined through years of development and conveyed through a variety of integrated channels. It means launching at the right time and the right price, with the right reimbursement or insurance coverage to drive product uptake, improve corporate margins and seed future therapeutic advances.
In an MA environment shaped increasingly by payer preferences and health technology assessment (HTA), biopharmaceutical companies must develop compelling yet flexible propositions that address a broad range of customers, stakeholders, and needs. New medicines must offer innovation as well as meaningful and multifaceted value, distinct from the current standard of care and from any existing or emerging competition.
New frontiers in innovation, such as disease-modifying Alzheimer’s treatments or weight-management therapies, have undoubtedly injected fresh momentum into the pharmaceutical market post-COVID. However, these large population breakthroughs, countering the dominant trend of specialty drugs built incrementally on niche indications, are just one more challenge for drug budgets.
Premium-priced medicines cannot succeed without first persuading payers and health technology assessors that they are worth the investment, both now and in the long term. Payers are also under pressure to absorb the often staggering upfront costs and logistical challenges of cutting-edge treatments supported by tentative evidence of efficacy and safety, such as cell and gene therapies.
Divergence in MA criteria
MA programmes aimed at an expanding global marketplace are further complicated by persistent divergence and cost-driven shifts in MA criteria across different countries, regions, institutions and healthcare channels. For example, the European Union is, at some levels, a single market in name only.
The latest W.A.I.T. (Waiting to Access Innovative Therapies) Indicator Survey, conducted by IQVIA and the European Federation of Pharmaceutical Industries and Associations, found that market access across the EU has not improved, either generally or in terms of market-to-market discrepancies. In the EU27 countries, the average time between marketing authorisation and product availability (when a centrally approved medicine appears on a country’s public reimbursement list) in W.A.I.T. was 531 days as of 5 January 2024.
This is 14 days longer than in the previous W.A.I.T. survey published in 2022. Across all 36 European countries in the survey, median patient-access inequities between 2019 and 2022 ranged from 47 days to availability in Germany to 794 days in Lithuania.
Expanding value parameters
In this unpredictable climate, MA considerations need to be front of mind at every stage of pharmaceutical product development, launch planning and life cycle management. This includes clinical trial outcomes, regulatory changes, pricing and reimbursement, contracting, positioning, usability or potential impact on healthcare budgets and treatment pathways.
It is essential for MA teams to understand what truly matters to payers and health technology assessors; for example, their conception of product value may be to focus on immediate budget impact than the industry gold standard. Efforts to level the HTA playing field across national markets, and to embed a more holistic conception of value in the cost-benefit assessments governing MA, have made some headway. But they still have a long way to go.
A relevant example is the European Union’s regulation on HTA, which came into effect in 2022 and will apply EU-wide from January 2025. There are concerns in industry that the regulation and its mandatory yet non-binding joint clinical assessments could become a fragmented mix of national practices, further entrenching disparities in HTA mechanisms across member states.
Real-time alignment of MA activities
With so many different capabilities informing each evolving product proposition, only innovative technologies will ensure that MA strategies are fully integrated and that MA developments can be tracked in real time. Our Market Access 2025 guide explains how digital transformation and agile launch software can support companies in managing, monitoring and aligning their MA activities business-wide.
By choosing the right technology platform, full visibility of MA developments across brands, functional silos, organisational hierarchies and national borders can be achieved. At the same time, core stakeholders can automate and streamline data collection, planning and reporting on MA activities through a single integrated tool.
By saving your MA team valuable time and effort, you will free up key team members to concentrate on MA strategy and execution, rather than administrative distractions. With cutting-edge digital resources, an integrated yet adaptable MA programme, and the best possible use of your MA team's talents, you can redefine market access from a competitive restraint to a viable platform for enduring product value and differentiation.
